Announcement • Jun 12
Cantargia AB (publ) Announces Start Of New Investigator-Initiated Lung Cancer Prevention Study Cantargia AB (publ) reported that the first patient has been dosed in a Phase 2 clinical trial investigating nadunolimab in up to 59 current or previous smokers with multifocal high-risk lung nodules, and therefore at risk of developing lung cancer. The study is an investigator-led initiative in collaboration with Drs. Robert Samstein, Thomas Marron and Miriam Merad at Mount Sinai Tisch Cancer Center, New York. Nadunolimab has been investigated by Cantargia in approximately 300 patients with solid tumor indications and has shown signals of clinical activity in pancreatic cancer and non-small cell lung carcinoma. Researchers at the Tisch Cancer Institute have performed preclinical work strongly implicating IL-1 signaling in tumor initiation and the development of early lung cancer. The new phase 2 investigator-initiated trial will be conducted at Mount Sinai Tisch Cancer Center, New York. The study, led by principal investigator Dr. Robert Samstein, is designed to investigate nadunolimab monotherapy in the high-risk population for 3 months. The study participants will then be screened repeatedly for 12 months, measuring the response of the lung nodules to treatment. In addition to investigating anticancer effects, the study will include comprehensive correlative studies to understand the effect IL1RAP targeting on inflammation contributing to cancer and other diseases. Announcement • May 30
Cantargia AB Reports Early Clinical Data And Expands Nadunolimab Development In MDS And AML Cantargia AB has reported promising early clinical data from an ongoing investigator-initiated Phase 1b/2a study at MD Anderson Cancer Center in MDS and AML, where IL1RAP is overexpressed. In the high-risk MDS cohort, all five evaluable patients achieved complete remission in Phase 1b, based on early but notable data. The study is now advancing into Phase 2a, expected to enroll approximately 40 patients. Preclinical data indicate that IL1RAP targeting with nadunolimab complements RAS inhibition and may enhance anti-tumor activity, supporting planned combination study. Continued development in combination with gemcitabine and nab-paclitaxel is supported by encouraging efficacy and manageable safety. These results expand nadunolimab’s clinical potential into hematology and, supported by the strengthened financial position, enable further development planning in MDS as a significant long-term opportunity for the Company. Announcement • May 29
Cantargia AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 124.305827 million. Cantargia AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 124.305827 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 32,266,667
Price\Range: SEK 2.25
Discount Per Security: SEK 0.18
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 22,980,368
Price\Range: SEK 2.25
Transaction Features: Rights Offering Announcement • Feb 20
Cantargia AB (publ) to Report Fiscal Year 2026 Results on Feb 24, 2027 Cantargia AB (publ) announced that they will report fiscal year 2026 results on Feb 24, 2027 Announcement • Jan 23
Cantargia AB (Publ) Reports First Patient Dosed in New US Investor-Initiated Colorectal Cancer Study Cantargia AB (Publ) reported that the first patient has been dosed in a Phase 1b/2 clinical trial investigating nadunolimab in combination with checkpoint inhibitor therapy in up to 24 patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer (CRC). The study is an investigator-led initiative in collaboration with Dr. Dan Fang at Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. Nadunolimab has been investigated by Cantargia in approximately 300 patients with solid tumor indications and has shown signals of clinical activity in pancreatic cancer and non-small cell lung carcinoma. Researchers at the Tisch Cancer Institute have a long-standing interest in developing new therapies for the treatment of CRC and have performed preclinical work strongly implicating IL-1 signaling in immune suppressive and treatment resistant pathways in this disease. The new phase 1b/2a investigator-initiated trial will be conducted at Tisch Cancer Institute,Iisch School of Medicine at Mount Sinai., New York. The study, led by principal NCT07281716 investigator Dr. Dan Feng, is designed to investigate nadunolIMab in combination with an anti-PD-1 inhibitor in up to 24 patients with MSS CRC. In addition to investigating anticancer effects, the study will include a comprehensive biomarker assessment package. Announcement • Nov 12
Cantargia AB (publ), Annual General Meeting, May 21, 2026 Cantargia AB (publ), Annual General Meeting, May 21, 2026. Location: at ideon gateway, scheelevagen 27, lund Sweden Announcement • Oct 03
Cantargia AB Announces Executive Changes Cantargia AB announced the appointment of Wolfram Dempke, MD, PhD, MBA as Chief Medical Officer, effective 02 October 2025. Dr. Wolfram Dempke is an internationally recognized expert in hematology and oncology with over 30 years of experience in academia, clinical research, and the pharmaceutical industry. Dr. Dempke holds an MD, PhD, and MBA from the Universities of Essen, London, Aachen and Halle/Saale. He is Professor of Haematology &Oncology at the University of Munich and the Cambridge (UK) University Medical School. Dr. Dempke has held leadership roles at several pharmaceutical companies such as Bristol-Myers Squibb, Merck Serono and AstraZeneca, and he oversaw numerous new drug applications (NDAs), including dasatinib, ipilimumab, gefitinib, mogamulizumab and others. His expertise ranges from early clinical development &translational medicine to managing late-stage clinical programs, regulatory strategy and execution. Dr. Morten Lind Jensen, who has served as CMO since March 2025, will leave Cantargia to pursue other opportunities. Announcement • Sep 03
Cantargia AB (publ) to Report Q1, 2026 Results on May 19, 2026 Cantargia AB (publ) announced that they will report Q1, 2026 results on May 19, 2026 Announcement • May 16
Cantargia AB (publ) Appoints Jenny Sundqvist as Board Member Cantargia AB (publ) announced that at the AGM held on May 15, 2025 approved election of Jenny Sundqvist as board member. Announcement • May 13
Cantargia Announces Successful Phase 1 Results: PK/PD Data of Subcutaneous Administered CAN10 Confirms Every 4-Week Dosing Choice in Phase 2 Pharmacokinetic Model Cantargia AB (publ) announced the results of the first CAN10 PK model with SC multiple dose PK data. The model indicates a high bioavailability of CAN10 and confirms every 4-week dosing choice for phase 2 studies. In addition, CAN10 shows potent and long-lasting inhibitory effects on several key inflammatory biomarkers, further strengthening the potential benefit of CAN10 in inflammatory diseases such as hidradenitis suppurativa (HS) and atopic dermatitis (AD). CAN10 is an antibody against IL1RAP designed to potently inhibit the activity of the pro- inflammatory and disease promoting cytokines of the IL-1-super family: IL-1, IL-33 and IL-36. CAN10 is currently being evaluated in a phase 1 clinical trial. The first multiple SC dose cohort in healthy volunteers has now been completed and determined safe, consequently the last multiple dose cohort in healthy volunteers has been started. The cohort of subjects with psoriasis continues recruitment and data will be analyzed and announced at the appropriate time. These data are not required to be able to start phase 2 studies. PK data from the completed single ascending dose (SAD) cohorts and the first multiple SC dose cohort has been used to generate the PK model to be able to determine dose and dosing regimen for future studies. The PK model confirms the predicted dose and dosing regimen for Ph2, including potential for SC dosing every 4-we weeks. The data also demonstrate high bioavailability and a dose proportional PK profile. In addition, new biomarker results show long-lasting effects of CAN10 with complete inhibition of IL-36 and IL-1 beta stimulation 14 days after SC dosing of CAN10. The effects of CAN10 are broad, with inhibition of several key inflammatory biomarkers known to play disease promoting roles in inflammatory diseases such as HS and AD. With the promising new results, Cantargia continues to plan for the start of two phase 2 studies towards the end of 2025; the first will be a randomized, placebo-controlled, dose and regimen ranging study in HS and the second will be a small pilot study in AD patients not responding to dupilumab treatment. Announcement • Apr 02
Cantargia AB (publ) Announces Chief Medical Officer Changes Cantargia AB (publ) announced the appointment of Morten Lind Jensen, MD, PhD, as Chief Medical Officer, effective immediately. Morten Lind Jensen has an MD and PhD from Copenhagen University and a Diploma in Pharmaceutical Medicine from the Royal College of Physicians in the UK. He joins Cantargia with extensive leadership in autoimmune and inflammatory diseases. He has led clinical development programs in psoriasis, atopic dermatitis, and hidradenitis suppurativa, which directly aligns with Cantargia's CAN10 program targeting inflammatory and autoimmune conditions. Dr. Lind Jensen's expertise ranges from early clinical development & translational medicine through to late-stage clinical programs and regulatory strategy and execution. Following a short transition, Dominique Tersago, who has served as CMO since 2022, will leave Cantargia to pursue other opportunities. Announcement • Mar 05
Cantargia AB (publ) to Report Fiscal Year 2025 Results on Feb 20, 2026 Cantargia AB (publ) announced that they will report fiscal year 2025 results on Feb 20, 2026 Announcement • Feb 07
Cantargia AB (publ) Announces CEO Changes Cantargia AB (publ) announced changes to its management. The Board of Directors, in discussion with CEO, Göran Forsberg, has decided to initiate a
search for a new CEO to lead Cantargia into the next phase of development and value creation. Göran Forsberg will be stepping down with immediate effect and will assist with the transition. During the recruitment process, Board Director, Damian Marron, a veteran four-time CEO, will assume the role of Interim CEO, supported by Chairman, Magnus Persson and the Board. Damian Marron is an accomplished Board Chair, Non-Executive Director and former serial CEO with a successful track record of leadership and value creation in public and private biotech companies, including two companies acquired and one IPO. Damian has a strong track record of public and VC financing (EUR 250 million raised), deal making, strategic and portfolio planning and company development. He possesses an extensive network of contacts globally from big pharma through to biotech companies and with investors, banks and analysts. Damian has a BSc Hons in Pharmacology and spent the first ten years of his career in big pharma clinical development. He is Chair of the Board of Circio Holdings ASA and Nicox SA and independent non-executive Board member of Onya Therapeutics Ltd. and Head of Biopharma for Treehill Partners. Announcement • Dec 19
Cantargia AB (publ) Publishes Preclinical Effects and Clinical Monotherapy Results on Nadunolimab in Pancreatic Cancer in Journal for Immunotherapy of Cancer Cantargia AB (publ) announced the publication of preclinical and clinical results using the IL1RAP targeted antibody nadunolimab (CAN04) in pancreatic cancer. Nadunolimab had pronounced effects on PDAC associated fibroblasts and inhibited recruitment of tumor promoting immune cells. These results were linked to monotherapy data in late- stage metastatic PDAC patients showing both clinically meaningful progression free survival and survival in patients with high IL1RAP levels. The studies were performed as a collaboration between Cantargia, Lund University and PanCAN. PDAC is one of the cancer forms with the highest medical need. The incidence is increasing, and the survival is poor. A major clinical challenge in PDAC is its distinct and protective tumor microenvironment, which shields the tumor from the immune system and facilitates tumor growth, metastasis, and resistance to therapy. The crosstalk between cancer cells and cancer- associated fibroblasts plays a pivotal role in shaping this TME. The IL-1 family, through IL1RAP, helps activate CAFs, which attract myeloid immune cells like monocytes and neutrophils into the tumor. This study reveals that nadunolimab blocks this process by inhibiting IL1RAP, reducing the number of immune cells recruited, which weakens the tumor's defenses. Through its other mechanism of action, nadunolimab enhances tumor destruction. The relevance of these preclinical results could be linked to clinical results using nadunolimab monotherapy in the CANFOUR study. In late stage metastatic PDAC patients, high tumor baseline levels of IL1RAP strongly correlate with increased progression free survival (IL1RAP high vs low: 3.5 vs 1.2 months; p=0.0023) and a trend for survival advantage (5.0 vs 2.2 months) with a follow up of 11.5 months. This is in line with previous published results examining nadunolimab with chemotherapies, gemcitabine and nab-paclitaxel, which showed promising efficacy in first line IL1RAP-high PDAC patients. These findings strongly signify the clinical relevance of targeting IL1RAP in PDAC using nadunolimab. This is particularly noteworthy since IL1RAP is considered as a prognostic marker where high IL1RAP expression is linked to shorter survival in PDAC patients. This study used data from the Pancreatic Cancer Action Network's Know Your Tumor precision medicine program as a validation dataset, accessed through the PanCAN SPARK health data platform. This dataset was used to study the impact of IL1RAP expression in PDAC and revealed IL1RAP as a prognostic marker. Announcement • Nov 29
Cantargia AB (publ) Expands CAN10 Phase 1 Clinical Program Building on Positive Results Cantargia AB (publ) reported initiation of an expanded part of CAN10's phase 1 clinical study to investigate higher dose levels of the antibody. The purpose of this expansion is to build on the good safety, potent effects on biomarkers and pharmacokinetic properties of CAN10. Current data indicate durable effects and potential for treatment every 4th week, which will be a competitive advantage. The first participant in this program has now been dosed. CAN10 is an antibody against IL1RAP, designed to potently inhibit the activity of the pro- inflammatory and disease promoting cytokines IL-1, IL-33 and IL-36. CAN10 is currently examined in a phase 1 clinical trial with the primary goal to investigate safety. So far, healthy participants have been treated in 9 single ascending dose (SAD) cohorts and the first multiple ascending dose (MAD) cohort in participants with mild to moderate plaque psoriasis is ongoing. No safety concerns have been reported and biomarker studies confirm binding to immune cells like neutrophils and monocytes as well as complete inhibition of IL-1 and IL-36 stimulation. The results obtained indicate that CAN10 has long-lasting effects that would allow dosing every 4th week, while several other antibodies use more frequent dosing. To further document this potential competitive advantage e.g. leading to improved patient convenience, the clinical protocol has been amended to allow up to two additional SAD cohorts as well as up to two additional MAD cohorts in healthy participants. The first participant in this new part of the trial has been dosed. The plan is to perform these activities during the upcoming months in line with the plan to start phase 2 during second half of 2025. New Risk • Nov 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 5.6% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (22% average weekly change). Earnings are forecast to decline by an average of 5.6% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr185m net loss in 2 years). Market cap is less than US$100m (€30.2m market cap, or US$31.7m). Announcement • Nov 14
Cantargia AB (publ), Annual General Meeting, May 15, 2025 Cantargia AB (publ), Annual General Meeting, May 15, 2025. Location: at ideon gateway, scheelevagen 27, lund Sweden Announcement • Nov 07
Cantargia AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 169.910183 million. Cantargia AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 169.910183 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 91,843,342
Price\Range: SEK 1.85
Transaction Features: Rights Offering Announcement • Nov 06
Cantargia Presents Promising Preclinical Results on Nadunolimab with Antibody-Drug Conjugates At Major Immuno-Oncology Conference Cantargia reported preclinical results on potential synergism between nadunolimab and antibody-drug conjugate (ADC) therapies. The new findings show that ADCs, just like chemotherapy, induce both tumor promoting as well as neuropathy inducing signals that can be counteracted by nadunolimab. Results will be presented in a poster session at the upcoming Society for Immunotherapy of Cancer (SITC), 2024 annual meeting. Traditional chemotherapy can induce the release of inflammatory factors (IL-1a and IL-1b), which act as " dangerous signals" and promote tumor growth, chemotherapy resistance, and immune suppression. In addition, these factors also stimulate inflammation-related damage to the nervous system, contributing to chemotherapy-induced peripheral neuropathy. ADCs, a form of guided missile delivering cytotoxic drugs ("payloads") precisely into the cancer cells via the antibody part of the molecule, is a approach in cancer therapy and the next generation of chemotherapy. ADCs have an edge over traditional chemotherapies as they are widely recognized for their improved tolerance levels and precise target recognition, sparing the healthy cells around the tumor. However, as for traditional chemotherapy, ADCs can also induce treatment resistance and side effects such as neuropathy. Cantargia's new preclinical data shows that ADCs (or payloads) increase the expression of IL-1a and IL- 1b when interacting with cancer cells, cancer-associated fibroblasts, or immune cells. In addition, the data also demonstrates potent inhibition of IL-1 signaling in these ADCs-treated cell culture systems when combined with a nadunolimab surrogate antibody. Furthermore, experiments reveal pronounced payload-driven neuropathic effects in a mouse model of neuropathy. Neuropathy is a common and serious side effect of several chemotherapies or ADCs. Neuropathy often leads to the drop out of patients from an otherwise effective cancer therapy. Announcement • Oct 29
Cantargia Reports New Results from Clinical Studies Investigating Nadunolimab in Several Forms of Cancer; Supporting Ongoing Strategies Cantargia announced new clinical results from two nadunolimab combination therapy trials in 54 patients. Positive signals of efficacy were documented in the key areas of nadunolimab development, non-small cell lung cancer and gastrointestinal cancers. In addition to the efficacy signals, nadunolimab appeared to counteract oxaliplatin induced peripheral neuropathy. No unexpected safety findings were observed. The clinical trials are CESTAFOUR and CAPAFOUR. CESTAFOUR investigated nadunolimab in combination with three different chemotherapies. The CAPAFOUR trial investigated nadunolimib combination therapy with FOLFIRINOX in first line pancreatic cancer, PDAC. Nadunolimab dose levels starting at 0.5 mg/kg, followed by escalation up to 2.5 mg/kg were planned in the two trials. The first arm in CESTAFOUR investigated combination with gemcitabine/cisplatin in 14 patients and generated the strongest signal of efficacy. In the five heavily pretreated (2-11 lines of previous therapy) patients with non-small cell lung cancer, NSCLC, the response rate was 40% according to RECIST 1.1 and PFS 10.2 months. The eight patients, predominantly second line, with biliary tract cancer also showed promising results with a response rate of 13% and PFS of 6.4 months. The second arm in CESTAFOUR investigate combination therapy with FOLFOX in 14 patients with 8 different cancer forms and varying treatment history. Interestingly, three patients had a confirmed partial response, one 4th line colorectal cancer, one first line gastric cancer and one receiving third line treatment of testicular cancer. The PFS in this heterogenous group of patients was 4.6 months. The third arm in CESTAFOUR investigation with docetaxel included eight second- or third-line patients with NSCLC. The protocol was designed to allow frequent dose reductions during the dose finding phase and the efficacy results are therefore not conclusive. The CAPAFOUR study included 18 PDAC patients receiving first line nadunolimab and FOLFIRINOX. The initial safety part at different dose levels is successfully concluded, allowing for start of a future phase 2 trial. The first part of the CAPAFOUR trial allowed frequent dose reductions which limits efficacy conclusions. Future studies in a larger number of patients will be designed to evaluate efficacy. Neuropathy is a major and serious side effect of several chemotherapies like taxanes and oxaliplatin. Adding nadunolimab to nab-paclitaxel in the previously reported CANFOUR trial correlated with a lower incidence and a slower onset of chemotherapy induced neuropathy. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab. addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis. Announcement • Oct 12
Cantargia Reports New Positive Results on Biomarkers and Safety in CAN10 Phase 1 Clinical Study Cantargia announced new results from the CAN10 phase 1 clinical study. All nine groups, including 68 participants receiving a single dose of CAN10 or placebo, show good safety and promising biomarker results. Importantly, even 1 week after the infusion, a single dose of CAN10 can completely block IL-1 signaling in the blood of the participants. Thereby, combined with the previous confirmation of complete blockade of IL-36 stimulation, key endpoints have been reached. Thus, the phase 1 single dose study strongly validates the potential and the unique mode of action of CAN10. The second part of the trial investigating multiple dosing is ongoing. CAN10 is one of two clinical projects in the Cantargia pipeline. The CAN10 antibody has been designed for treatment of several autoimmune/inflammatory diseases stimulated by IL-1, IL-33 and/or IL-36. The ongoing phase 1 clinical trial initially investigates increasing levels of CAN10 as single intravenous administration in healthy subjects followed by studies of subcutaneous multiple dosing in participants with psoriasis. The primary endpoint relates to safety. The first phase 2 clinical study is planned to start in H2 2025 to investigate CAN10 therapy in e.g. hidradenitis suppurativa or systemic sclerosis. All nine dose groups investigating a single infusion in healthy subjects have passed the protocol stipulated safety review after 2 weeks follow up. No safety concerns were reported and the next part of the trial, multiple dosing in participants with psoriasis, is ongoing. As previously communicated, biomarker samples taken during the study show a potent dose dependent blockade of IL1RAP function, which was measured as inhibition of IL-36 signaling in immune cells. The study also investigates blockade of IL-1 signaling in immune cells. Those analyses have now been finalized and as predicted, CAN10 completely blocks IL-1 signaling in immune cells even a week after a single dose of CAN10. The ability to block both IL-1 and IL-36 signaling is a unique feature of IL1RAP-blockade that is not recapitulated by drugs targeting the individual pathways. Announcement • Oct 10
Cantargia Announces the Publication of the Results Using Nadunolimab Combination Therapy in Advanced/Metastatic Pancreatic Cancer (PDAC) in the Scientific Journal Clinical Cancer Research Cantargia announced the publication of the results using nadunolimab (CAN04) combination therapy in advanced/metastatic pancreatic cancer (PDAC) in the scientific journal Clinical Cancer Research, a journal of the American Association for Cancer Research. Efficacy in the 73 patients treated was better than expected for chemotherapy only based on historical data. Strongest efficacy was observed in patients with high tumor levels of IL1RAP, the target of nadunolimab, with median overall survival (OS) of 14.2 months. The safety was acceptable and notably the level of neuropathy was much lower than expected from chemotherapy alone, suggesting a protective effect of nadunolIMab. Patients with metastatic PDAC have a poor prognosis, and survival probability is <5% at 5 years. The fibro-inflammatory microenvironment which characterizes pancreatic cancer has a stroma infiltrated by cancer-associated fibroblasts and immune cells, creating an environment which involves upregulation of IL1RAP and tumor promoting IL-1 signaling with associated downstream pro-tumor cytokines. Nadunolimab combines blockade of the IL-1 signaling pathway through IL1RAP inhibition with a pronounced ADCC activity. In the CANFOUR trial, 73 first line pancreatic cancer patients were treated with nadunolimab and gemcitabine/nab-paclitaxel (GN). The median OS of 13.2 months is longer than OS reported in Phase 3 trials for GN alone (8.5-9.2 months), FOLFIRINOX (11.1 months), or NALIRIFOX (11.1 months). Cantargia's oncology program, the antibody nadunolimab ("CAN04"), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab. The antibody nadunolimib binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1alpha and IL-1beta signaling. Nadunolimib can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. Nadunolim AB is investigated in multiple clinical trials; the phase I /IIa trial CANFOUR, evaluates nadunolimab in combination with standard NCT03267316. chemotherapies in patients with PDAC (gemcitabine/nab -paclitaxel) or NSCLC (platinum-based chemotherapies). Positive interim data show durable responses for the combination therapy in 73 PDAC patients, resulting in median iPFS of 7.2 months and median OS of 13.2 years. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels ofIL1RAP. Strong efficacy was also observed in 30 NSCLC patients with median PFS of 7.0 months and a response rate of 53%; even higher responses were observed in non-squamous NSCLC patients. Early efficacy data from the phase Ib/II trial TRIFOUR, also NCT05181462 shows signs of promising efficacy in TNBC with a 60% response rate for nadunolimab combined with carboplatin/gemcitabine. Nadunolim ab combined with carboplatin/gemcitabine. Announcement • Sep 09
Cantargia Announces New Data from Two Clinical Studies Strongly Support Nadunolimab Efficacy After Relapse on PD1-Inhibitors Cantargia reported data from two clinical trials including nadunolimab combination therapy in 55 cancer patients. Both trials show strong antitumor effects as well as very encouraging median survival times in patients previously treated with pembrolizumab. These clinical data combined with baseline biopsy analyses suggest a unique role of nadunolimab acting on immunosuppressive cells in the tumor microenvironment. The data will be presented September 14 at the ESMO Congress 2024 in Barcelona. The immunotherapy pembrolizumab is one of the most important cancer treatments with sales around USD 25 billion 2023. New data from two clinical trials in 55 patients highlight a unique opportunity using nadunolimab in patients after they have progressed on pembrolizumab treatment. The first trial, CANFOUR, investigated nadunolimab in combination with platinum doublet chemotherapy in 40 first- or second-line non-small cell lung cancer, NSCLC, patients. Stronger efficacy was seen in 2L pts (n=18 in total; n=17 post-pembrolizumab) compared to 1L pts (n=22) (ORR 72% vs 41%; PFS 7.6 mo vs 6.7 mo, p = 0.038; OS 15.7 mo vs 11.5 mo). Biopsy analyses showed that 2L pts had a higher number of IL1RAP-positive immune cells, CD163+ macrophages, CD56+ NK cells and CD8+ T cells in the tumor at baseline. Efficacy results were most pronounced in second line non-squamous pts (n=12; ORR 92%, OS 28.9 mo; PFS 13.0 mo) including two complete responders. The data suggest that nadunolimab may mediate its anti-tumor activity by blocking tumor promoting cells within the TME. The safety results of the combination have been presented previously and show an acceptable side effect profile. The second trial, CIRIFOUR, investigated nadunolimab combination therapy with pembrolizumab in 15 heavily pretreated patients who had previously progressed on pembrolizumab monotherapy or combination treatments. Nine patients had head and neck cancer, 5 NSCLC and 1 melanoma. In this trial, the median survival was 19.7 months and the disease control rate was 60%. Similar to the CANFOUR data, the strongest benefits were observed in the group of patients with a specific profile of immune and immunosuppressive cells in the tumor microenvironment. The combination therapy was well tolerated. The two posters will be presented at the ESMO Congress 2024 in Barcelona on Saturday, September 14th by Dr Luis Paz-Ares, Hospital Universitario 12 de Octubre, Madrid, Spain and Dr Roger Cohen, University of Pennsylvania, Philadelphia, PA, US, respectively. Announcement • Aug 27
Cantargia AB (publ) Reports Timelines for Nadunolimab Clinical Trials in Leukemia and Triple Negative Breast Cancer Cantargia reported currently expected timelines for nadunolimab clinical trials. The US FDA has granted MD Andersson Cancer Center the IND for nadunolimab related to the upcoming phase 1b/2a clinical trial of patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with an estimate for trial initiation during fourth quarter 2024. The first results on safety and short-term efficacy in the ongoing phase 2 clinical trial in triple negative breast cancer (TNBC), in collaboration with GEICAM, is expected during first half 2025. The new phase 1b/2a clinical trial is designed to investigate nadunolimab in up to 20 patients with AML and 20 with MDS. The trial is sponsored by a grant from the US Department of Defense, DOD, to The University of Texas MD Anderson Cancer Center which will be responsible for conducting the trial. More details on the trial, including estimated timelines will be disclosed once the trial has received full IRB approval, which is expected during third quarter 2024, followed by initiation during fourth quarter 2024. Based on the positive phase 1 clinical data previously presented for nadunolimab combination therapy in TNBC, the randomized, controlled phase 2 clinical trial in approximately 100 patients with TNBC is advancing even though recruitment temporarily slowed down during summer. The first results of the trial, including safety and short-term efficacy, are therefore expected during first half 2025. Announcement • Jul 22
Cantargia Announces Resignation of Liselotte Larsson as Chief Operating Officer Cantargia announced that its Chief Operating Officer (COO), Liselotte Larsson has resigned and will continue her career outside Cantargia. She will depart her role by mid-October, 2024. Liselotte Larsson joined Cantargia in 2014 and during her time at the company, she has played an important role in building the company. The process to recruit a replacement has begun. Announcement • Jun 15
Cantargia AB (Publ) Reports Further Progress in Ongoing Phase 1 Clinical Trial with CAN10 Cantargia AB (publ) reported progress in the ongoing phase 1 clinical trial of the CAN10 antibody. Seven dose groups have now been concluded without any safety concerns. Furthermore, additional receptor occupancy studies confirm that CAN10 saturates its target molecule, IL1RAP, on immune cells from the study participants. The study follows timelines with the next dose group starting immediately, followed by the first group investigating multiple dosing, planned to start during third quarter. CAN10 is one of two clinical projects in the Cantargia pipeline. The CAN10 antibody has been designed for treatment of autoimmune/inflammatory diseases and has "pipeline in a pill" potential with several possible target indications. The phase 1 clinical trial investigates increasing levels of CAN10 as single dose administration in healthy subjects followed by studies of multiple dosing in participants with mild to moderate psoriasis. The primary endpoint relates to safety. The first seven dose groups in healthy volunteers have now concluded the treatment period. No safety concerns have been observed and the eighth dose group is about to start in accordance with the protocol. In addition, the important receptor occupancy study continues to follow predictions from preclinical studies and complete target saturation has now been documented on both monocytes and neutrophils. Biomarker samples taken during the study are being analyzed to document a dose dependent inhibition of IL-1 and IL-36 stimulated release of biomarkers from immune cells. Additional biomarker results based on the first seven dose groups are expected mid-2024. Dosing in participants with psoriasis are expected to start Third Quarter 2024 ahead of phase 2 in 2025. Announcement • Jun 13
Cantargia AB (Publ) Announces Appointment of Ton Berkien as Chief Business Officer, Effective October 1, 2024 Cantargia AB (publ) announced appointment of Ton Berkien as Chief Business Officer. At Cantargia, he will be responsible for business development efforts and continue to maintain and foster relationships with leading pharmaceutical and biotechnology companies. Ton has a solid background through approximately 30 years in pharma, biotech, investment and consulting with significant experience in business development. He will commence his role October 1, 2024. Ton Berkien previously held senior business development positions at Amgen, Nuevolution, Takeda and Nycomed. Before that he held positions at Ferring, PWC, Rijnconsult, KPMG and Gilde Investment Management. He joins from the position as Chief Business Officer at Ultimovacs. Ton Berkien has a BA degree in economics from Saxion University of Applied Sciences in the Netherlands, as well as an LSid from PwC/Harvard Business School/IMD. Ton is a Dutch and Swedish citizen and lives in Sweden. Board Change • Jun 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 1 highly experienced director. Independent Director Damian Marron was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • May 24
Cantargia Presents New Positive Clinical Data on Nadunolimab Counteracting Chemotherapy Induced Neuropathy Cantargia disclosed new clinical data indicating that nadunolimab counteract the serious problem of chemotherapy induced neuropathy, in addition to previously reported promising antitumor effects. The new data in 73 pancreatic cancer patients receiving nadunolimab and chemotherapy show a statistically significant correlation between nadunolimab dose level and incidence of neuropathy as well as a low level of grade 3 neuropathy, supporting the protective effect of nadunolimab. This positive effect is further strengthened by preclinical in vivo studies on chemotherapy induced neuropathy. The new results will be presented at ASCO Annual Meeting May 31- June 4, 2024. Neuropathy is a serious medical condition and a side effect of several classes of chemotherapies. The main symptoms are weakness, pain and numbness in hands and feet. Neuropathy often leads to discontinuation of therapy in patients despite effective antitumor activity. The mechanisms behind chemotherapy induced neuropathy relate to damaged nerve cells and neuroinflammation, where the IL-1 pathway has been indicated as a key driver. With nadunolimab blocking IL-1 activity through its binding to IL1RAP, nadunolimab has the potential to counteract neuropathy during treatment with chemotherapies, such as paclitaxel. In the CANFOUR trial, 73 first line pancreatic cancer patients were treated with nadunolimab and gemcitabine/nab-paclitaxel. The median survival of 13.2 months and iPFS of 7.2 months are longer than expected from historical control data for the chemotherapy alone (1). The incidence of neuropathy was notably lower than expected from chemotherapy treatment. Only one grade 3 event was observed and a statistically significant (p=0.042) relationship between dose level and any grade neuropathy was observed. At 1 mg/kg nadunolimab, 60% of patients had any grade neuropathy with a median time to onset of 112 days. At 2.5 mg/kg or higher, only 36% had any grade neuropathy and median time to onset was not reached. Studies in mouse models show that several aspects of chemotherapy induced neuropathy, such as sensitivity to mechanical pressure, temperature and decreased grip strength, all were prevented by concomitant treatment with the nadunolimab surrogate antibody. Combination studies were performed with either paclitaxel or vincristine. Breakeven Date Change • May 22
Forecast to breakeven in 2026 The 2 analysts covering Cantargia expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 41% per year to 2025. The company is expected to make a profit of kr46.3m in 2026. Average annual earnings growth of 62% is required to achieve expected profit on schedule. New Risk • May 21
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.6% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr287m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 1.6% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr61m net loss in 2 years). Shareholders have been diluted in the past year (10.0% increase in shares outstanding). Market cap is less than US$100m (€57.3m market cap, or US$62.2m). Announcement • Apr 18
Cantargia Publishes New Data on the Can10 Antibody, Detailing Its Interaction with IL1RAP and Functional Inhibition Cantargia AB (publ) reported publication of new preclinical data in the highly reputable scientific journal Cell Reports on the clinical stage antibody CAN10, specifying the precise interactions between CAN10 and its target IL1RAP and highlighting its functional capabilities to block multiple signaling pathways. These analyses explain the unique properties that makes CAN10 a potent blocker of the disease-promoting inflammatory cytokines IL-1, IL-33 and IL-36. This mechanism could be of high value in the treatment of a large number of diseases. CAN10 is an IL1RAP-binding antibody in Phase I clinical development for treatment of autoimmune and inflammatory diseases. It has unique properties as it simultaneously blocks three inflammatory pathways important in several diseases. The data, now published in the journal Cell Reports, show in detail how CAN10, by binding to a specific part of IL1RAP, can efficiently block the IL-1 a/ß, IL-33, and IL-36 a/ß/? signaling pathways. The publication also details biophysical and structural properties of the interaction between CAN10 and IL1RAP and shows that IL1RAP blockade has functional impact in counteracting inflammation beyond blocking only the IL-1 signaling pathway. In addition, the now published data also details the binding and function of a second Cantargia anti-IL1RAP antibody, 3G5, which also efficiently blocks IL-1 a/b, IL-33, and IL-36 a/b/g signaling but does this via a molecular mechanism distinct from the one employed by CAN10. Thus, the new results combined with the knowledge in the Cantargia IL1RAP innovation platform add sophisticated understanding to the structure/function properties of targeting IL1RAP and thereby allows for continued strategic development of new therapeutic antibodies, tailored for specific medical needs. Announcement • Apr 11
Cantargia AB (publ) Publishes Preclinical Data on the Potential of CAN10 in Systemic Sclerosis in A Leading Scientific Journal Cantargia AB (publ) reported publication of preclinical results obtained with CAN10 in systemic sclerosis in one of the leading rheumatology journals, ‘Annals of the Rheumatic Diseases'. CAN10 reduces both lung and skin fibrosis in multiple preclinical models of systemic sclerosis. The results are strengthened by the target of CAN10, IL1RAP and its signaling systems (IL-1, IL-33, and IL-36) being upregulated and disease-promoting in systemic sclerosis patient skin. CAN10 is an antibody in phase I clinical development. Systemic sclerosis is a life-threatening autoimmune disease resulting in fibrosis in the skin, lung, and other internal organs. Patients often have a severely impacted quality of life and there are no effective treatments today. Systemic sclerosis is one of the lead indications in the CAN10 development program. The published data demonstrate that the target for CAN10, IL1RAP, and the IL1RAP-dependent signaling molecules IL-1, IL-33 and IL-36, are upregulated in skin from systemic sclerosis patients and that IL-1, IL-33 and IL-36 have profibrotic effects on skin fibroblasts from systemic sclerosis patients, which can be reduced by CAN10. Moreover, therapeutic treatment with a surrogate of CAN10 (mCAN10) in three different preclinical models of systemic sclerosis potently reduced both skin and lung fibrosis. Gene expression analysis indicated a broad mode of action of mCAN10, which normalized the expression of a majority of the genes commonly dysregulated in systemic sclerosis. In summary, the published data show that CAN10 targets central processes important for systemic sclerosis and that CAN10 provides a novel and promising opportunity to treat this disease. The publication in this high-impact journal (impact factor 27.4) reflects the scientific significance of the data. This work was performed in collaboration with a world-leading research group headed by Prof. Dr. Jörg Distler at the Heinrich-Heine University, Düsseldorf, Germany. Key data from these studies were recently presented as a poster at the Systemic Sclerosis World Congress March 14-16, 2024. Announcement • Apr 03
Cantargia Publishes Data Highlighting the Potential of CAN10 in Atherosclerosis Cantargia AB (publ) reported publication of promising preclinical data supporting the potential of the anti-IL1RAP antibody CAN10 as treatment of atherosclerosis. The data, published in the journal 'Cardiovascular Research', shows that IL1RAP-blockade reduced the development of atherosclerotic plaques as well as reduced the plaque inflammation. Atherosclerosis is a huge future opportunity within the CAN10 project. Atherosclerosis is the main underlying cause of cardiovascular disease, including heart attack and stroke, and the leading cause of death in western societies. It is a chronic inflammatory vascular disease characterized by atherosclerotic plaque formation in the arterial wall. A high degree of inflammation in the atherosclerotic plaque is associated with an increased risk of heart attack and stroke, and molecules involved in plaque inflammation are therefore considered important therapeutic targets. The published data demonstrate that IL1RAP may be one such promising target that is expressed on various inflammatory cells in the atherosclerotic plaques. Therapeutic treatment with a CAN10 surrogate antibody resulted in a significant reduction in plaque burden and a reduced plaque inflammation, through both attenuated accumulation of inflammatory cells as well as a reduced expression of inflammatory mediators in the plaques of mCAN10 treated mice. Collectively, this strongly suggests that CAN10 treatment can have a positive effect on atherosclerosis and plaque inflammation, supporting the notion that IL1RAP represents a novel therapeutic target in this disease. These data were generated in collaboration with Dr. Daniel Engelbertsen's research group at Lund University. Key data from these studies have previously been presented as a poster at the European Atherosclerosis Society Congress in 2022. The article, titled "IL1RAP blockade limits development of atherosclerosis and reduces plaque inflammation", is published by Mulholland et al. and is available via the following link. Announcement • Mar 27
Cantargia AB (publ) Reports Progress Towards Start of DOT-Sponsored Clinical Trial of Nadunolimab in Leukemia Cantargia reported on the progress in the upcoming phase Ib/IIa clinical trial investigating nadunolimab in up to 40 patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This trial is financedthrough a grant from the US Department of Defense (DOD). With the upcoming submission to the US FDA, the current plan is to commence the trial during the summer of 2024, pending regulatory approval. In the context of cancer, IL1RAP was initially discovered as a therapeutic target in leukemia. Preclinical and translational results on IL-1 biology in various forms of leukemia as well as an overexpression of IL1RAP on both leukemia cells and leukemic stem cells indicate that nadunolimab has the potential to be used in the treatment of several different forms of the disease. The new phase Ib/IIa clinical trial is designed to investigate nadunolimab monotherapy as well as combination therapy, in up to 20 patients with AML and 20 with MDS. In addition to investigating anticancer effects, the study will include an extensive package of biomarker assessments using blood and bone marrow samples, including single cell multimodal analysis. The trial is sponsored by a grant from the DOD to The University of Texas MD Anderson Cancer Center which will be responsible for conducting the trial, with Dr Gautam Borthakur as principal investigator. More details on the trial will be disclosed once the trial has received regulatory approval from the US FDA and relevant IRB. Announcement • Mar 15
Cantargia Reports New Data Highlighting Potential of CAN10 Antibody, Currently in Phase I Clinical Development, as Therapy in Systemic Sclerosis Cantargia reported new data highlighting the potential of the CAN10 antibody, currently in phase I clinical development, as therapy in systemic sclerosis. All signaling systems targeted by CAN10 (IL-1, IL-33 and IL-36) were found to be highly upregulated in patient skin biopsies. These cytokines induce fibrosis in skin fibroblasts isolated from patients, and this manifestation of disease was blocked by CAN10. In mouse models, CAN10 reversed the aberrant expression of several genes involved in the systemic sclerosis pathogenesis in humans. The data is presented at the Systemic Sclerosis World Congress in Prague 14-16 March 2024. CAN10 is currently in phase I clinical development with transition from healthy volunteers to patients planned for Q3, 2024. One of the lead indications, systemic sclerosis, is a life-threatening autoimmune disease resulting in fibrosis in the skin, lung, and other internal organs. Current treatments focus on symptomatic treatment rather than addressing underlying disease mechanisms. It is estimated that in the US, approximately 100,000 patients suffer from the disease. CAN10 has orphan drug status in the US for treatment of systemic sclerosis. The new results demonstrate that both the target for CAN10, IL1RAP, and the IL1RAP-dependent signaling molecules IL-1, IL-33 and IL-36, are upregulated in skin from systemic sclerosis patients. This disease develops as fibroblasts promote the formation of an excessive buildup of connective tissue in skin and internal organs, so-called fibrosis. The results show that IL-1, IL-33 and IL-36 collagen production on skin fibroblasts from systemic sclerosis patients, leading to fibrosis. These disease-associated mechanisms can be reduced by CAN10. These new data strengthen previously reported beneficial effects of IL1RAP-blockade in three mouse models of systemic sclerosis, where treatment with a mouse surrogate of CAN10 reduced both skin and lung fibrosis. Additional gene expression analysis of mouse systemic sclerosis skin showed decreased expression of several key disease-related profibrotic factors in the skin by CAN10. In summary, the data show that CAN10 targets central processes important for systemic sclerosis and that CAN10 provides an opportunity to treat underserved systemic sclerosis patients. These data were generated in collaboration with a research group headed by Prof. Dr. Jörg Distler at the Heinrich-Heine University, Düsseldorf, Germany and will be presented as a poster at the 8th Systemic Sclerosis World CongressMarch 14-16, 2024 in Prague, Czech Republic. Announcement • Mar 08
Cantargia Reports New Preclinical Data on Antitumor Effects of nadunolimab in Pancreatic Cancer Cantargia reported new preclinical data highlighting how nadunolimab, an IL1RAP-targeting antibody currently in phase II clinical development, may induce antitumor activity in pancreatic cancer by blocking fibrosis. The data will be presented as a poster at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego and were generated in a collaboration with Nordic Bioscience A/S and the group of Dr. Marcus Järås at Lund University. Pancreatic ductal adenocarcinoma (PDAC) is a lethal disease with poor survival prognosis. Nadunolimab is currently in phase II clinical development in first line PDAC and has shown pronounced effects including a much longer survival than expected from historical controls. One factor that significantly contributes to the poor treatment response in PDAC is the high abundance of tumor-supporting stroma, driven by the excessive activity of cancer-associated fibroblasts (CAFs). The new data now show that in pancreatic cancer-associated fibroblasts, interleukin-1alpha (IL-1alpha) and IL-1beta both induce formation of type III collagen (as measured by PRO-C3), a biomarker which has been found to correlate with poor survival in PDAC. Similarly, formation of type III collagen could also be induced by pancreatic cancer cells when co-cultured with pancreatic CAFs. Notably, addition of nadunolimab to the in vitro co-cultures potently blocked the induction of type III collagen formation. Thus, the new data strengthen the role of IL-1alpha and IL-1beta in pancreatic tumor fibrosis and highlight the potential for nadunolimab to counter the detrimental, fibrotic microenvironment in PDAC tumors. Breakeven Date Change • Feb 25
Forecast to breakeven in 2026 The 2 analysts covering Cantargia expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr46.3m in 2026. Average annual earnings growth of 31% is required to achieve expected profit on schedule. New Risk • Feb 23
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr287m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr287m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings are forecast to decline by an average of 51% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr720m net loss in 2 years). Shareholders have been diluted in the past year (10.0% increase in shares outstanding). Market cap is less than US$100m (€51.5m market cap, or US$55.8m). Announcement • Feb 22
Cantargia AB (publ) to Report Fiscal Year 2024 Results on Feb 21, 2025 Cantargia AB (publ) announced that they will report fiscal year 2024 results on Feb 21, 2025 Announcement • Feb 21
Cantargia Reports US Regulatory Approval to Start Pancreatic Cancer Phase IIB Trial with Nadunolimab Cantargia reported that after both FDA and IRB review, regulatory approval has been granted to start recruiting patients in a controlled phase IIb trial in metastatic pancreatic cancer investigating nadunolimab as first line combination therapy. The trial is planned to start mid-2024 with initial results 2025. The planned phase IIb trial (PANFOUR) in metastatic PDAC will investigate first line treatment of nadunolimab in combination with standard of care chemotherapy (gemcitabine/nab-paclitaxel). Two different dose levels of nadunolimab will be investigated and the study will include a control arm with chemotherapy only. Each arm will consist of approximately 50 patients, totaling 150 patients in the trial, with a data review after approximately 60 patients. Patients will be enrolled in the US and in a number of European countries where regulatory approval is awaited. The current plan is to start the trial during mid-2024 although the exact time point is pending ongoing financing discussions. Announcement • Feb 13
Cantargia Reports New Data Reinforcing Nadunolimab as Cancer Combination Therapy Cantargia AB reported new clinical and preclinical results from the nadunolimab (CAN04) program, providing a promising starting point for additional future opportunities. The data show that nadunolimab, currently in phase II clinical development for cancer treatment, has additional effects that could be of high value when combined with either standard chemotherapies or antibody drug conjugates (ADC). These effects relate to alleviation of neuropathy and counteraction of tumor promoting signals. Consequently, nadunolimab treatment has the potential to improve efficacy of such treatments as well as to reduce serious side effects such as neuropathy. Nadunolimab has been investigated as cancer therapy in about 300 patients. The most promising results reported are in combination with chemotherapy in pancreatic cancer (PDAC), non-small cell lung cancer and triple negative breast cancer with higher response rates followed by longer progression free survival and overall survival compared to historical data with chemotherapy alone. Neuropathy is a serious side effect of several cancer therapies, including traditional chemotherapies and ADCs, which effectively are a type of tumor-targeting chemotherapies. Neuropathy often leads to discontinuation of an otherwise effective therapy. Previously, top line data from clinical studies using nadunolimab in combination with gemcitabine/nab-paclitaxel in PDAC, have indicated lower incidence of grade 3 and 4 neuropathy than expected from historical data using this chemotherapy regimen alone. Further detailed evaluation of the clinical results has provided additional support for a neuroprotective effect of nadunolimab. Mechanistically, several chemotherapies can stimulate IL-1 driven neuroinflammation, which is linked to neuropathy and may be counteracted by nadunolimab. In line with this, a pronounced protective effect on chemotherapy-induced neuropathy has been documented in two different animal models. A number of ADC-s have recently been approved as cancer treatment which has generated significant commercial interest in this approach. The new data show that several cytotoxic payloads used in ADCs act like traditional chemotherapy by inducing both forms of IL-1 on tumor cells, known to act as a danger signal that can lead to tumor progression and potentially resistance. IL-1 mediated inflammatory processes can thus be induced by both chemotherapy and ADCs and may induce resistance to therapy as well as onset of neuropathy. The new results suggest that these can effectively be blocked by nadunolimab. The new results are planned to be presented at upcoming scientific conferences during 2024. Announcement • Jan 10
Cantargia Reports Phase I Clinical Progress in the CAN10 Project Cantargia reported encouraging progress in the ongoing phase I clinical trial of the CAN10 antibody. The study proceeds according to plan, with the four initial dose groups concluded without any safety concerns. In addition, as predicted from preclinical models, CAN10 binds to its target, IL1RAP, on immune cells from the study subjects in a dose dependent manner. CAN10 is one of two clinical projects in the Cantargia pipeline. The CAN10 antibody has been designed for treatment of autoimmune/inflammatory diseases with lead indications being systemic sclerosis and myocarditis. The phase I clinical trial initially investigates increasing levels of CAN10 as single dose administration in healthy subjects followed by studies of multiple dosing in patients with psoriasis. The primary endpoint relates to safety. The first four dose groups in healthy subjects have now concluded the treatment period. No safety concerns have been observed and the fifth dose group has started in accordance with the protocol. In addition, a receptor occupancy study shows that already at initial dose levels, the majority of IL1RAP molecules on immune cells are binding CAN10 in a dose dependent manner. This is in line with predictions from preclinical studies. Furthermore, biomarker samples taken during the study are currently analyzed to document blocking of IL-1 and IL-36 stimulation of immune cells. The first results from such studies are expected during second quarter 2024. Studies in patients with psoriasis are expected to start second quarter 2024. Announcement • Nov 25
Cantargia Reports New Preclinical Data Confirming the Potential of Nadunolimab and Can10 Cantargia reported new preclinical data providing further support for its lead assets, the IL1RAP-binding antibodies nadunolimab (CAN04) and CAN10, in both cancer and cardiovascular disease. The data shows that IL1RAP blockade results in reduced vascular inflammation and that levels of IL1RAP correlate with various inflammatory markers in inflamed tissue. Vascular inflammation is considered integral for both cardiovascular disease and tumor growth. The findings demonstrate that antibody blockade of IL1RAP in a cell-based system results in decreased levels of multipleinflammatory markers, including interleukin-6 (IL-6), produced by vascular cells. The data further indicates that these effects may lead to reduced recruitment of inflammatory immune cells. Notably, analyses of human atherosclerotic plaques show that the level of IL1RAP correlated with several of the inflammatory markers reduced by IL1RAP blockade, including IL-6. New Risk • Nov 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 53% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr299m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings are forecast to decline by an average of 53% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr730m net loss in 2 years). Shareholders have been diluted in the past year (10.0% increase in shares outstanding). Market cap is less than US$100m (€56.9m market cap, or US$61.7m). New Risk • Nov 12
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr299m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr299m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr253m net loss in 2 years). Shareholders have been diluted in the past year (10.0% increase in shares outstanding). Market cap is less than US$100m (€56.9m market cap, or US$60.8m). Announcement • Nov 04
Cantargia AB (publ), Annual General Meeting, May 23, 2024 Cantargia AB (publ), Annual General Meeting, May 23, 2024. Location: Ideon Gateway, Scheelevägen 27 Lund, Lund Sweden New Risk • Nov 02
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 10.0% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr295m). Currently unprofitable and not forecast to become profitable over next 2 years (kr257m net loss in 2 years). Shareholders have been diluted in the past year (10.0% increase in shares outstanding). Market cap is less than US$100m (€53.3m market cap, or US$56.3m). Announcement • Sep 28
Cantargia Presents New Clinical Data Further Supporting Nadunolimab's Antitumor Activity and A Key Role of Its Target IL1RAP in Pancreatic Cancer Cantargia reported new clinical and biomarker data in further support of nadunolimab (CAN04) for treatment of pancreatic cancer (PDAC). Updated results in first-line combination with chemotherapy, as well as new results in late-stage monotherapy, show the strongest efficacy in patients with high levels of IL1RAP, the target of nadunolimab. Biomarker data consolidate these observations as levels of IL1RAP increase during PDAC development and appear to be linked to specific KRAS mutations associated with aggressive disease. These data will be presented at the AACR Special Conference: Pancreatic Cancer 2023, 27-30 September. In the clinical phase I/IIa trial CANFOUR, a total of 23 late-stage PDAC patients received nadunolimab monotherapy, typically after failure on at least two previous chemotherapy regimens. Of these, IL1RAP levels were assessed in tumor biopsies taken before treatment from 17 patients, categorized as either IL1RAP high or IL1RAP low. Notably, IL1RAP high patients had stronger clinical benefit compared to IL1RAP low patients, including prolonged median overall survival (5.8 vs 2.6 months; p=0.078) and progression-free survival (iPFS 3.6 vs 1.6 months; p=0.0073), indicating target engagement by nadunolimab leading to antitumor activity. Similar observations were made for the 73 first-line patients treated with a combination of nadunolimab and gemcitabine/nab-paclitaxel in CANFOUR, although as expected the median survival was generally longer compared to the late-stage patients. Significantly prolonged median overall survival was observed in IL1RAP high compared to IL1RAP low patients (14.2 vs 10.6 months; p=0.026), with a trend for higher response rates, with deeper and more durable responses. These results are complemented by biomarker data obtained from publicly available gene databases, in collaboration with experts in PDAC, as well as molecular profiling data from pancreatic cancer patients included in the Know Your Tumor programme by Pancreatic Cancer Action Network (PanCAN). Collectively, the biomarker data show that levels of IL1RAP, as well as IL-1alpha and IL-1beta which signal via IL1RAP, are increased in PDAC tumors compared to healthy pancreas. Further, the highest levels of IL1RAP were observed in late-stage PDAC tumors, and patients with high IL1RAP levels had shorter overall survival. Notably, high IL1RAP levels also correlated with the presence of KRAS mutations, in particular G12D, which is the most common KRAS mutation in PDAC. This is a key finding as KRAS mutations are considered a crucial component for disease progression in PDAC, and few effective therapies for targeting such mutations have been developed. Announcement • Sep 21
Cantargia Reports New Preclinical Data on nadunolimab Potential to Enhance Anti-Tumor Effect of Immunotherapy Presented at CRI-ENCI-AACR Cantargia reported new preclinical data highlighting how nadunolimab, an IL1RAP-targeting antibody currently in phase II clinical development, can be used to block the activity of cancer-promoting immune cells and increase the anti-tumor efficacy of immunotherapy i.e. a cancer vaccine. The data were generated by Professor Douglas Hanahan's research group at the Lausanne Branch of the Ludwig Institute for Cancer Research and the Swiss Institute for Experimental Cancer Research (EPFL) and are presented in a poster session at the CRI-ENCI-AACR International Cancer Immunotherapy Conference 2023. Tumors possess a wide variety of strategies by which they can gain resistance to anti-tumor therapies. One such strategy is the expansion of immune cell populations known as myeloid-derived suppressor cells (MDSC). MDSC have immunosuppressive properties and can mediate resistance to immunotherapy, as well as chemotherapy and cancer vaccines. The new data demonstrate that IL-1 signaling molecules, including IL-1alpha, drive the in vivo expansion of MDSC which have high levels of IL1RAP, the target of nadunolimab. Nadunolimab can potently block signaling via IL-1alpha and IL-1beta. In a model of cervical cancer, shown to produce IL- 1 signaling molecules and trigger MDSC expansion, a nadunolimab surrogate was able to dampen the MDSC expansion and reduce tumor growth. Notably, the nadunolimab surrogate also improved the anti-tumor efficacy of a cancer vaccine, in parallel with increasing the number of tumor-reactive T cells generated in response to the vaccine. Thus, nadunolimab can alleviate immunosuppressive mechanisms used by tumors to provide resistance against anti-tumor therapies. These preclinical data are presented in detail in a poster session at the CRI-ENCI-AACR International Cancer Immunotherapy Conference 2023. Announcement • Sep 19
Cantargia AB (publ) Announces New Nadunolimab Clinical Trial in Leukemia Financed by External US Grant Cantargia AB (publ) announced award of a $1.1 million grant from the US Department of Defense for investigation of Cantargia's lead asset, the IL1RAP-binding antibody nadunolimab (CAN04), in a phase Ib/IIa clinical trial in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The grant is awarded to Professor Gautam Borthakur at The University of Texas MD Anderson Cancer Center who will lead the trial. The trial will investigate nadunolimab alone or in combination with the chemotherapy azacytidine in patients with intermediate or high-risk MDS. Nadunolimab will also be evaluated with azacytidine and the targeted therapy drug venetoclax in patients with relapsed/refractory AML. The primary objective of this investigator-initiated trial is to assess the safety of different dose levels of nadunolimab; early efficacy and various biomarkers will be evaluated as secondary objectives. The trial may include a total of 40 patients. The trial will be managed by MD Anderson who will submit a clinical trial application. IL1RAP (Interleukin-1 Receptor Accessory Protein), the target of nadunolimab, was originally discovered as a promising therapeutic target on leukemia stem cells by Dr. Marcus Järås and Dr. Thoas Fioretos and at Lund University, Sweden. The group has published strong therapeutic effects of IL1RAP-targeting antibodies in several advanced preclinical models of leukemia. Nadunolimab has also shown signals of clinical activity in combination with chemotherapy in pancreatic cancer, triple-negative breast cancer and non-small cell lung cancer, and clinical trials are ongoing in these diseases. Announcement • Sep 06
Cantargia AB (publ)Expands Clinical Pipeline and Starts Treatment in Second Program, CAN10, for Autoimmune Diseases Cantargia AB (publ) announced that the first subject has been treated with the IL1RAP-binding antibody CAN10, developed for treatment of autoimmune/inflammatory diseases. The phase I clinical trial, conducted in Germany, investigates the safety, pharmacokinetics and biomarkers of CAN10 in healthy volunteers and psoriasis patients. A total of 80 subjects may be included in the trial. Initial data from the trial are expected in 2024. The primary objective of this phase I trial is to investigate the safety and tolerability of CAN10. Further objectives include pharmacokinetics and effects on various immunological or disease-related biomarkers. Initially, single ascending doses will be given intravenously to up to 64 healthy volunteers. A subsequent part of the trial is designed to also generate an early proof-of-concept in up to 16 patients with mild to moderate psoriasis, who will receive multiple injections of CAN10 subcutaneously at two dose levels. Additional trial details will be disclosed on clinicaltrials.gov. The CAN10 antibody strongly binds IL1RAP and simultaneously blocks the function of the signaling molecules IL-1, IL-33 and IL-36, which play key roles in several autoimmune and inflammatory diseases. CAN10 has previously shown promising effects in several models of such diseases, including the lead indications systemic sclerosis and myocarditis. Pronounced effects have also been observed in models of psoriasis and these findings will form the basis for studying the effects of CAN10 in psoriasis patients in the phase I trial. Subsequent trials intend to focus on patients with systemic sclerosis or myocarditis. Breakeven Date Change • Aug 24
No longer forecast to breakeven The 3 analysts covering Cantargia no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr520.0m in 2024. New consensus forecast suggests the company will make a loss of kr249.6m in 2025. Announcement • Aug 22
Cantargia AB (publ) to Report Q1, 2024 Results on May 21, 2024 Cantargia AB (publ) announced that they will report Q1, 2024 results on May 21, 2024 Announcement • Aug 11
Cantargia AB (publ) Receives Regulatory Approval to Start Phase I Clinical Trial for CAN10 Cantargia announced that the application for a phase I clinical trial with the IL1RAP-binding antibody CAN10 has been approved. The trial will investigate the safety of various single and multiple dose levels of CAN10 given intravenously to healthy volunteers or subcutaneously to psoriasis patients. Up to 80 subjects may be included in the trial, which is expected to start in September 2023. Following the approval by both the regulatory authority as well as the ethics committee in Germany, the phase I trial will now be initiated. The CAN10 antibody strongly binds IL1RAP and simultaneously blocks the function of the signaling molecules IL-1, IL-33 and IL-36, which play key roles in several autoimmune and inflammatory diseases. Cantargia is initially focusing the development of CAN10 on systemic sclerosis and myocarditis, two diseases with a high medical need. CAN10 has shown promising effects in several models of these diseases. The primary objective of this phase I trial is to investigate the safety and tolerability of CAN10 using a standard design involving single ascending doses (SAD), followed by evaluation of multiple ascending doses (MAD). Further objectives include pharmacokinetics and effects on various immunological or disease-related biomarkers. Initially, single ascending doses will be given intravenously to healthy volunteers. A subsequent part of the trial is designed to generate an early proof-of-concept in up to 16 patients with mild to moderate psoriasis who will receive CAN10 subcutaneously at two dose levels. Indication of clinically relevant effects on biomarkers will also be evaluated throughout the study. Treatment is expected to start in September2023. Announcement • Jun 05
Cantargia Publishes ASCO 2023 Poster on Promising Nadunolimab Efficacy in Non-Small Cell Lung Cancer Cantargia presented interim efficacy data for 39 non-small cell lung cancer (NSCLC) patients treated with nadunolimab (CAN04) and platinum-based chemotherapy as a poster at the ASCO Annual Meeting 2023 (ASCO 2023), and on the Cantargia webpage. Efficacy of the combination therapy was well above historical data for chemotherapy alone, including two patients with complete response. The data presented at ASCO 2023 were communicated at the time of abstract release on May 25, 2023. In summary, the results show strong efficacy of nadunolimab combined with platinum-based chemotherapy in 39 NSCLC patients. Efficacy for the total 30 first- or second-line NSCLC patients treated with this combination in the CANFOUR trial is summarized below, as reported May 25, 2023: Efficacy parameter, All (n=30), Historical control, Non-squamous (n=16), Non-squamous, historical control, Median OS, 13.7 mo, 10.3 mo, 15.9 mo, 11.3 mo, Median PFS, 7.0 mo, 5.1 mo, 7.3 mo, 4.9 mo, ORR, 53%, 22-28%, 56%, 19%, Complete response, 6.7% (n=2), <1%. Consistently high response rates to nadunolimab Combined with platinum doublets in different lines of therapy were also reported. This includes a preliminary ORR of 60% in five first- or second-lineNSCLC patients with carboplatin/pemetrexed, and a preliminary ORR of 50% in four third-line or beyond NSCLC patients with cisplatin/gemcitabine. Announcement • May 17
Cantargia Extends Development of Nadunolimab in Pancreatic Cancer with New Controlled Phase IIb Clinical Trial Following Strong Phase IIb Efficacy Results Cantargia announced intensified development of its lead asset, the antibody nadunolimab (CAN04), in pancreatic cancer (PDAC), through a new randomized controlled phase IIb trial. This trial will build on the strong interim phase IIa efficacy results presented at the AACR Annual Meeting 2023. Regulatory submission is planned for H2 2023 with top line data planned for 2025. Financial resources previously earmarked for the Precision Promise trial, will be used for this phase IIb trial. The new phase IIb clinical trial will evaluate two different dose levels of nadunolimab in a randomized setting in combination with gemcitabine and nab-paclitaxel, with the chemotherapy as active control arm, and will in addition to standard endpoints further analyze the impact of tumor IL1RAP levels on efficacy. Promising interim efficacy results were recently presented from the phase I/IIa clinical trial CANFOUR which evaluates nadunolimab with gemcitabine and grab-paclitaxel in PDAC patients. The data demonstrated a strong overall efficacy of the combination therapy, particularly pronounced in a subgroup of patients with high tumor levels of IL1RAP which showed a significantly prolonged median overall survival compared to patients with low IL1RAP levels (14.2 vs 10.6 months; p=0.017; n=27 and 19, respectively). This validating signal of activity will be fundamental for the continued development in PDAC and will be confirmed in a larger patient cohort of 150-200 patients in Europe and the US in the new phase IIb trial. The results will be important for increasing the likelihood of success of a subsequent registrational trial. An application to start the trial, designed in line with Project Optimus, an initiative introduced by the US FDA to reform dose optimization and selection in oncology, is planned for submission in H2 2023, with the goal to start patient enrollment early 2024. Top-line data for the trial are expected in 2025. Cantargia previously entered a collaboration with the Pancreatic Cancer Action Network (PanCAN) with the ambition to include nadunolimab in PanCAN’s adaptive phase II/III trial Precision Promise. While Cantargia’s partnership with PanCAN will continue, the two have agreed to put on hold nadunolimab’s potential participation in Precision Promise until results from the new phase IIb trial are available. Announcement • Feb 02
Cantargia Appoints Patrik Renblad as Chief Financial Officer Cantargia announced it has appointed Patrik Renblad as its new Chief Financial Officer (CFO). Mr. Renblad will assume this role by August 2023, at the latest. Mr. Renblad has over 25 years of experience in the healthcare industry, including a number of senior financial positions across multiple geographies. He previously spent 10 years at LEO Pharma, holding senior roles including Finance Director of R&D Finance, and Director of Finance & Patient Access in China, and also worked for AstraZeneca. Currently, he is the CFO of the Swedish biotech company SynAct Pharma, where he was instrumental in the company's listing on Nasdaq Stockholm in 2022. Mr. Renblad holds a Master of Science in Business Administration and Economics from Lund University, Sweden. Announcement • Jan 14
Cantargia AB (publ) Successfully Concludes Toxicity Study with Can10 Antibody Ahead of Phase I Clinical Trial Application Cantargia AB (publ) announced that the Good Laboratory Practice (GLP) toxicity study for its anti-inflammatory IL1RAP-binding antibody CAN10 has been concluded. Data from the study show that CAN10 was well tolerated when administered over six weeks. Cantargia plans to initiate the phase I clinical trial for CAN10 during the first half of 2023. In the present GLP toxicity study, CAN10 was given intravenously once weekly for six weeks at doses up to 50 mg/kg, which is well above the intended clinical dose levels. CAN10 was also administered subcutaneously at 5 mg/kg. There were no adverse findings associated with the intravenous or subcutaneous administrations of CAN10. No safety signals were detected in body weight, or on respiratory, cardiovascular or neurological functions, attributed to the administration of the antibody. There were also no changes in clinical pathology (e.g. hematology, serum chemistry, coagulation, and urinalysis), anatomic pathology, or microscopic evaluation of selected tissue. Completion of the GLP toxicity study is required by regulatory authorities prior to initiation of clinical trials. As a next step in the development of CAN10, once additional administrative procedures have been finalized, Cantargia plans to submit an application to regulatory authorities to start the phase I clinical trial. The study start is dependent on timelines for regulatory review, but treatment of healthy volunteers could be initiated shortly following approval of the application, as early as the first half of 2023. CAN10 is Cantargia's second development program and extends the reach of Cantargia's IL1RAP platform beyond oncology to inflammatory and autoimmune disease, with initial focus on systemic sclerosis and myocarditis. During 2022, Cantargiapresented preclinical data demonstrating strong treatment effects of a CAN10 surrogate antibody in several different in vivo disease models. For example, the CAN10 surrogate antibody was shown to reduce skin and lung fibrosis and affect relevant proinflammatory markers in models of systemic sclerosis. It also reduced inflammation and disease severity in models of viral and autoimmune myocarditis. These effects are a consequence of the broad and specific mechanism by which CAN10 modifies the activity of the target molecule IL1RAP. Announcement • Jul 27
Cantargia Reports New Positive Preclinical Efficacy Data for CAN10 Supporting Development in Myocarditis Cantargia AB (publ) reported new preclinical data from a collaboration with Johns Hopkins University School of Medicine demonstrating efficacy of CAN10 in a viral myocarditis model. The results highlight the potential of CAN10 in the treatment of this common form of myocarditis ahead of planned clinical trials. The data will be presented in a poster session at one of the world's largest meetings on innovations in cardiac health, the Basic Cardiovascular Sciences (BCVS) Scientific Sessions 2022, being held in Chicago, July 25-28, 2022. The IL1RAP-binding antibody CAN10 previously showed efficacy in various inflammatory and autoimmune disease models, including autoimmune myocarditis. The data to be presented at BCVS Scientific Sessions 2022 also show efficacy of a CAN10 surrogate antibody in a model of viral myocarditis. Myocarditis is a life-threatening disease characterized by inflammation of the heart muscle and impaired heart function. It may result from autoimmunity, but is most commonly caused by viral infections, and rates of myocarditis have increased during the COVID-19 pandemic. In the viral myocarditis model, IL1RAP was detected on immune cells and stromal cells in the heart. Further analyses showed that the CAN10 surrogate antibody reduced disease severity and inflammation, evidenced by reduction in the number of immune cells in the heart. Echocardiography also confirmed that the CAN10 surrogate antibody preserved the heart function. These effects were not achieved by blocking IL-1 signaling alone. The data were generated in collaboration with the research group of Dr. Daniela Ciháková at Johns Hopkins University School of Medicine. Announcement • Jul 22
Cantargia Receives USPTO Notice of Allowance for Composition of Matter Patent on Antibody CAN10 Cantargia AB (publ) announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. patent application 17/559,227. This application describes composition of matter for the anti-inflammatory IL1RAP-binding antibody CAN10, which Cantargia plans to bring to phase I clinical development early 2023. The Notice of Allowance indicates that the USPTO intends to grant the application once standard procedural steps have been completed. The allowed application is directed to a composition of matter covering Cantargia's CAN10 antibody and is expected to issue within 1-2 months with validity until at least 2041. Once issued, the patent will strengthen Cantargia's extensive intellectual property portfolio on the composition and use of molecules binding IL1RAP. CAN10 is an antibody which strongly binds IL1RAP (Interleukin-1 Receptor Accessory Protein). CAN10 functions by simultaneous blockade of IL-1, IL-33 and IL-36 signaling, which has great potential in the treatment of several autoimmune and inflammatory diseases. These unique properties will initially be explored in the treatment of myocarditis and systemic sclerosis, life-threatening disorders which lack effective therapies. In addition to the CAN10 patent family, Cantargia has extensive patent protection for IL1RAP-targeting antibodies and their use in therapy and diagnostics of cancer, including leukemias and solid tumors. Cantargia's patent portfolio includes over 100 patents globally, granted in key commercial territories such as the US, Europe, Japan and China. Announcement • Jul 09
Cantargia AB (Publ) Announces Executive Changes Cantargia announced the strengthening of its management team through the appointment of Dr. Dominique Tersago as Chief Medical Officer (CMO) from 1 August 2022. Dr. Tersago brings broad experience at leading pharma and biotech companies and will advance Cantargia’s medical activities and provide strategic guidance as the company prepares for late-stage clinical development of its lead asset, the IL1RAP-binding antibody nadunolimab (CAN04), in pancreatic cancer (PDAC) and non-small cell lung cancer (NSCLC). Dr. Tersago has over 25 years of experience in clinical development and regulatory affairs, with a focus on immuno-oncology, virology, immunology and hematology. She joins Cantargia from antibody start-up ExeVir Bio and brings significant industry experience, having held senior positions at high-profile life science firms including Bristol-Myers Squibb and Ablynx. At Ablynx, where she was CMO between 2013 and 2016 before it was acquired by Sanofi in 2018, Dr. Tersago had a key role in the phase III study design of caplacizumab for thrombotic thrombocytopenic purpura, later approved by both the EMA and FDA. Dr. Tersago has a medical degree from University of Antwerp, Belgium. Dr. Roger Belusa, who had been acting as interim CMO, will remain at Cantargia and take up a role in the ongoing clinical trials. Another change to the management team is that VP CMC Peter Juul Madsen has decided to enter a new position outside Cantargia, and his role will be temporarily filled by Liselotte Larsson, COO. Announcement • May 28
Cantargia Announces ASCO 2022 Presentation Strengthens Positive Phase IIa interim results for nadunolimab in NSCLC Cantargia reported updated interim results for non-small cell lung cancer (NSCLC) patients treated with nadunolimab (CAN04) in combination with gemcitabine and cisplatin, showing efficacy well above historical controls. With 30 patients evaluable, overall response rate (ORR) was 53%, disease control rate 83%, median progression-free survival (PFS) 6.8 months and median overall survival (OS) 13.7 months. The strongest efficacy benefits were seen in patients with non-squamous NSCLC, particularly those treated previously with a checkpoint inhibitor. The safety profile was acceptable and in line with earlier data. The results will be presented at the ASCO 2022 Annual Meeting on 6 June 2022. In total, 33 NSCLC patients were included in the phase IIa part of the CANFOUR trial, of which 30 received treatment with 1, 2.5 or 5 mg/kg of the company's IL1RAP-binding antibody, nadunolimab, in combination with gemcitabine and cisplatin. Efficacy analyses across all 30 patients treated with the combination showed an ORR of 53%, which is well above historical data of 22-28% for chemotherapy only. Additionally, disease control rate was 83%, median PFS was 6.8 months and median OS was 13.7 months. PFS and OS were stronger than historical data which show a median PFS and OS of 5.1 months and 10.3 months, respectively2. The last patient in the trial started treatment in September 2021. At data cut-off in April 2022, seven patients were still being treated, with one patient on therapy for over 30 months. The safety profile of the combination was acceptable and readily managed. Rates of neutropenia and febrile neutropenia were more frequent primarily during the first cycle compared to historical data for chemotherapy alone2, but could be reduced by the granulocyte growth factor, G-CSF: only 33% of patients treated prophylactically with G-CSF developed grade 3-4 neutropenia, a level similar to chemotherapy alone, compared to 71% without prophylactic G-CSF. Thrombocytopenia and grade 1-2 infusion-related reactions following the first infusion were also more common compared to chemotherapy only. The infusion-related reactions could be efficiently managed by standard measures. Announcement • May 27
Cantargia AB (publ) Presents Clinical Interim Results At ASCO 2022 Highlighting the Potential of Nadunolimab in Combination with Checkpoint Inhibitor Cantargia AB (publ) reported new results from the phase Ib clinical trial CIRIFOUR in 15 solid tumor patients, no longer responding to PD-(L)1 inhibitor therapy, treated with nadunolimab (CAN04) as an add-on to Keytruda® (pembrolizumab). The results are positive, with favorable safety. Disease control for at least 30 weeks was also achieved by the combination in a patient subgroup, identified by lower levels of the biomarkers CRP and IL-6 and higher levels of immune cells in the tumor tissue at baseline. These results will be presented at the ASCO 2022 Annual Meeting on 5 June 2022. Nadunolimab, an antibody targeting IL1RAP (Interleukin-1 Receptor Accessory Protein), is Cantargia's most advanced program. CIRIFOUR (NCT04452214), conducted in the United States, evaluates nadunolimab with the checkpoint inhibitor pembrolizumab in cancer patients progressed on previous PD-(L)1 inhibitor therapy. The trial includes a total of 15 patients with head and neck cancer, non-small cell lung cancer or malignant melanoma, evaluating safety and efficacy of 5 mg/kg nadunolimab as an add-on to pembrolizumab. The last patient started therapy in August 2021. These data are based on a read-out of performed in April 2022. The safety results are positive with only few patients demonstrating any adverse events of grade 3 or higher, and no specific pattern raising potential safety concerns. Disease control for at least 30 weeks (up to 58 weeks) was achieved by the combination therapy in 6 of 15 patients, including one partial response. These six patients had a distinct biomarker profile with lower baseline levels of CRP and IL-6, factors previously linked to tumor progression. The combination reduced blood levels of CRP and IL-6 in these patients. Biopsies also revealed that these patients had higher levels of immune cells, such as CD8-positive T cells and NK cells, in the tumor tissue before start of treatment. Four patients are still being treated in the trial. Announcement • May 23
Cantargia AB (publ) Reports Positive Preclinical Effects in Atherosclerosis Demonstrating Potential of Can10 in Cardiovascular Disease Cantargia AB (publ) reported new preclinical results, demonstrating efficacy of the IL1RAP-binding antibody CAN10 in a preclinical disease model for atherosclerosis. Treatment with a CAN10 surrogate antibody reduced plaque burden and plaque inflammation in this model, supporting the potential of CAN10 as a potent therapeutic in cardiovascular disease. These findings will be presented at the European Atherosclerosis Society (EAS) Congress in Milan on 22-25 May. CAN10 is an antibody that has demonstrated potent anti-inflammatory effects by binding IL1RAP (Interleukin-1 Receptor Accessory Protein). Cantargia is developing CAN10 for treatment of inflammatory and autoimmune disease with an initial focus on myocarditis and systemic sclerosis. The data presented at the EAS Congress show high levels of IL1RAP in the atherosclerotic plaques in a preclinical model. Treatment with a CAN10 surrogate antibody reduced the aortic plaque burden and number of infiltrating inflammatory cells in the plaques in this model. This strongly suggests that IL1RAP blockade has a positive effect on atherosclerosis and plaque inflammation, supporting the idea that IL1RAP represents a novel therapeutic target in this disease. These latest data on CAN10 were generated in collaboration with the research group at Lund University Cardiovascular Research Unit led by Dr. Daniel Engelbertsen. CAN10 blocks the function of IL1RAP in a different manner than nadunolimab (CAN04), Cantargia's anti-cancer antibody asset. CAN10 strongly binds IL1RAP and functions by simultaneous blockade of IL-1, IL-33 and IL-36 signaling, which can be of significant value in the treatment of several autoimmune or inflammatory diseases. CAN10 has previously shown potent effects in several models of inflammation, including myocarditis and systemic sclerosis. Cantargia plans to initiate clinical phase I studies for CAN10 in early 2023. Breakeven Date Change • May 10
Forecast breakeven date pushed back to 2024 The 3 analysts covering Cantargia previously expected the company to break even in 2023. New consensus forecast suggests losses will reduce by 84% per year to 2023. The company is expected to make a profit of kr165.6m in 2024. Average annual earnings growth of 91% is required to achieve expected profit on schedule. Breakeven Date Change • Mar 13
Forecast breakeven date pushed back to 2024 The 2 analysts covering Cantargia previously expected the company to break even in 2023. New consensus forecast suggests losses will reduce by 71% per year to 2023. The company is expected to make a profit of kr165.6m in 2024. Average annual earnings growth of 82% is required to achieve expected profit on schedule. Announcement • Mar 03
Cantargia Reports Positive Preclinical Efficacy Data for CAN10 Demonstrating Anti-Fibrotic and Anti-Inflammatory Effects in Systemic Sclerosis Cantargia AB announced new preclinical data on its anti-inflammatory IL1RAP-binding antibody CAN10 showing that CAN10 reduced established fibrosis in the skin and lungs in an advanced model of systemic sclerosis, a life-threatening autoimmune disorder. CAN10 also normalized biological markers of inflammation and fibrosis, associated with the human disease. The data will be presented in a poster session at the 7thSystemic Sclerosis World Congress on 10-12 March, 2022.Current treatments for systemic sclerosis focus on symptomatic treatment rather than addressing underlying mechanisms. A collaboration with the world-leading research group headed by Prof. Dr. Jörg Distler at the Friedrich-Alexander University Erlangen-Nürnberg, allowed Cantargia access to an advanced disease model of systemic sclerosis that accurately reproduces key features of the disease, including skin and lung fibrosis. CAN10 potently blocks the disease-promoting IL-1, IL-33 and IL-36 pathways by its interaction with IL1RAP(Interleukin-1 Receptor Accessory Protein) and was able to reduce disease development in this model. A CAN10 surrogate antibody reduced the skin and lung fibrosis in the systemic sclerosis model. CAN10 decreased the thickening of the skin, reduced the level of collagen deposits that lead to fibrosis, and reduced the number of myofibroblast cells that synthesize the collagen. The safety was favorable, with a trend for counteractingdisease-associated weight loss.Skin biopsies from systemic sclerosis patients show increased levels of IL1RAP and IL1RAP signaling componentscompared to healthy skin. A wide range of biological markers related to inflammation or fibrosis are also dysregulated and a similar pattern was identified in the skin from the systemic sclerosis model. Notably, treatment with CAN10 normalized the levels of many of these markers in the model. Announcement • Feb 24
Cantargia AB (Publ) Reports Encouraging New CAN10 Toxicology Results and Schedules Phase I Trial for 2023 Cantargia AB (publ) reported new encouraging results from non-GLP toxicology and pharmacokinetic studies for its anti-inflammatory IL1RAP-binding antibody CAN10. Results show no toxicologically relevant changes using a new subcutaneous formulation, with high bioavailability and desirable pharmacological half-life. Further studies using intravenous administration show good safety by repeated dosing at 50 mg/kg. The GLP toxicology studies for CAN10 are scheduled to start Second Quarter 2022, with timelines slightly adjusted to fit with global capacity during the COVID pandemic. CAN10 is Cantargia's second major program and extends the reach of Cantargia's IL1RAP platform beyond oncology to inflammatory and autoimmune disease. The non-GLP toxicology studies reported demonstrate no abnormal clinical signs and no toxicologically relevant changes. Additionally, a newly developed subcutaneous formulation was shown to have high bioavailability and desirable pharmacological half-life. The subsequent GLP toxicology studies required by drug regulators have been scheduled to start in Second Quarter 2022 and are expected to lead to initiation of the phase I clinical trial for CAN10 early 2023. Previously reported non-GLP toxicology and pharmacokinetic studies have not shown any toxicologically relevant changes of CAN10 administered intravenously as a single dose. New studies confirm the favorable safety of CAN10 following repeated intravenous administration at 50 mg/kg and demonstrate that subcutaneously administered CAN10 has above 90% bioavailability and a pharmacological half-life in line with design criteria. Subcutaneous administration of antibody drugs allows treatment in doctors' offices or a patient's home environment rather than in a hospital or infusion center, providing flexibility, convenience and other commercial advantages. Obtaining data on the subcutaneous formulation at this early stage allows for these important findings to be incorporated in the phase I clinical development. In the next step of CAN10's development, Cantargia will undertake GLP toxicology studies, an integral part of the process leading to the initiation of clinical trials. The usual high demand for safety studies has been exacerbated by additional demand from developers of COVID-19 vaccines and therapies. Cantargia has successfully secured the complete capacity required for the CAN10 GLP toxicology studies involving both intravenous and subcutaneous administration. The study is planned to start in Second Quarter 2022 and the phase I clinical trial for CAN10 is now expected to start early 2023. In parallel, manufacture of CAN10 drug product, intended for use in clinical study, is ongoing and proceeding as planned. Announcement • Feb 05
Cantargia AB Reports Treatment of First Non-Squamous Non-Small Cell Lung Cancer Patient in New Arm of CANFOUR Study Cantargia AB reported that the first patient in the new non-squamous non-small cell lung cancer (NSCLC) therapy arm of the CANFOUR study has received treatment with nadunolimab and chemotherapy. Interim clinical data has shown encouraging efficacy in patients with non-squamous histology, the large NSCLC subgroup. Up to 40 patients will be treated with nadunolimab and carboplatin/pemetrexed and recruitment is expected to take 12-15 months. In parallel, preparations are ongoing for a randomized trial in this patient group with an anticipated start in early 2023. Nadunolimab, an antibody binding interleukin-1 receptor accessory protein (IL1RAP) is Cantargia's most advanced program and is investigated in multiple clinical trials. CANFOUR, the first clinical trial for nadunolimab, is a combined phase I/IIa study (NCT03267316). The current focus of CANFOUR is to evaluate nadunolimab in combination with chemotherapy regimens for treatment of pancreatic cancer and NSCLC. Recently, an additional arm was included in CANFOUR where nadunolimab is evaluated with platinum-based chemotherapy, carboplatin/pemetrexed, in first line chemotherapy treatment of non-squamous NSCLC, the most common form of lung cancer. The first patient in this arm has now received treatment. Initially, a run-in phase is performed to document the safety of different dose levels of nadunolimab in combination with standard doses of carboplatin/pemetrexed. Combination with the high safe dose of nadunolimab will subsequently be evaluated with the objective to confirm safety and assess antitumor activity and effects on biomarkers. Patient recruitment will be performed in seven countries in Europe and is expected to take up to 12-15 months. Preclinical results have shown that nadunolimab can potentiate chemotherapy. To date, more than 100 patients have been treated with such combinations with encouraging results. At the recent ESMO Congress, Cantargia presented positive interim efficacy data based on 27 NSCLC patients treated with nadunolimab and chemotherapy in CANFOUR (Awada et al). Based on these results, the next steps in the development within NSCLC will focus on the non-squamous form, while development in the squamous form will be performed separately. Announcement • Feb 04
Cantargia Reports Positive Safety Data from Cirifour Clinical Study on Nadunolimab and Pembrolizumab Combination Cantargia AB reported an interim update on the first part of the phase Ib clinical study CIRIFOUR. Fifteen cancer patients no longer responding to checkpoint inhibitor therapy received nadunolimab as an add-on to Keytruda® (pembrolizumab) with the primary objective to evaluate safety. The results show a very favorable safety profile, with only one treatment-related grade 3 toxicity identified. As one third of patients are still on therapy, efficacy is planned to be reported in the second quarter 2022. The next stage of CIRIFOUR will investigate this combination with chemotherapy in non-small cell lung cancer (NSCLC). Nadunolimab, an antibody targeting interleukin-1 receptor accessory protein (IL1RAP), is Cantargia's most advanced program. CIRIFOUR, a phase Ib clinical study conducted in the US, evaluates nadunolimab with pembrolizumab in cancer patients progressing on previous checkpoint inhibitor therapy. A total of 15 patients with head and neck cancer, NSCLC or malignant melanoma were enrolled in the first part of CIRIFOUR, evaluating safety of 5 mg/kg nadunolimab as an add-on to pembrolizumab in patients no longer responding to immune checkpoint inhibitors. The safety results are very encouraging with only one patient having a treatment-related side effect of grade 3 (febrile neutropenia). No patient has terminated treatment due to side effects. The last patient started treatment in August 2021 and treatment of five patients is still ongoing. Among these, two patients have been on therapy for over 31 weeks and another two for over 49 weeks. Efficacy analyses are still premature but are planned for reporting in the second quarter 2022. Biomarker analyses of tumor biopsies and blood samples are ongoing. The favorable safety profile reported in CIRIFOUR is the basis for the addition of further therapies to the combination of nadunolimab and pembrolizumab. CIRIFOUR will therefore expand to study safety, biomarkers, and efficacy of this combination with carboplatin/pemetrexed in non-squamous NSCLC as first line treatment. Treatment in this new arm is expected to start in the first quarter 2022. Announcement • Jan 16
Cantargia AB (Publ) Reports Treatment of First Triple Negative Breast Cancer Patient in TRIFOUR Study Cantargia AB (publ) reported treatment of the first triple negative breast cancer (TNBC) patient with nadunolimab and chemotherapy in the phase Ib/II clinical trial TRIFOUR. This trial, performed in collaboration with the Spanish Breast Cancer Group, GEICAM, will evaluate nadunolimab in combination with gemcitabine and carboplatin in up to 113 patients. Initially, the trial will focus on the safety of this combination and the first part is expected to be completed within 6-9 months. The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody nadunolimab is Cantargia's most advanced program and is investigated in multiple clinical trials. Approval to start the phase Ib/II clinical trial TRIFOUR, which evaluates nadunolimab combined with chemotherapy in TNBC, was recently obtained. The first patient has now started treatment in the TRIFOUR trial. In the most advanced clinical programs, nadunolimab is evaluated in non-small cell lung cancer or pancreatic cancer patients in combination with chemotherapy. As these programs are advancing and have shown positive interim results, Cantargia's goal is to gain a better understanding of the applicability of nadunolimab in other forms of cancer. For this reason, the clinical development of nadunolimab has been broadened to include other types of cancer, including TNBC, an aggressive and difficult to treat form of cancer that expresses IL1RAP at higher levels compared to other types of breast cancer. In TRIFOUR, TNBC patients are treated with nadunolimab in combination with gemcitabine and carboplatin. The primary objective in the initial stage is to evaluate safety and tolerability of nadunolimab in combination with this chemotherapy regimen. Biomarkers and early signs of efficacy will also be evaluated at this stage. This part is estimated to be carried out over 6-9 months. If prespecified objectives are reached, the trial will be expanded into a randomized phase II part, which will investigate the efficacy of nadunolimab combination with gemcitabine and carboplatin in comparison to a control group receiving the same chemotherapy alone. The trial is estimated to include up to 113 patients at approximately 24 clinical centers in Spain. More information on the study can be found at clinicaltrials.gov (NCT05181462). Announcement • Jan 04
Cantargia Advances Nadunolimab Against Pancreatic Cancer in the Pancan Precision Promise[Sm] Phase 2/3 Clinical Trial Cantargia AB announced that the Pancreatic Cancer Action Network's (PanCAN) Precision PromiseSM phase 2/3 clinical trial, carried out at leading clinical US centers, plans to include nadunolimab in combination with chemotherapy as first-line experimental therapy in metastatic pancreatic cancer (PDAC). The trial utilizes a Bayesian platform designed by PanCAN in collaboration with the US Food and Drug Administration (FDA) to provide a basis for marketing approval of therapies in PDAC. The primary endpoint for the trial is overall survival. PanCAN's plan is to submit a Pre-IND application to the FDA in Second Quarter 2022 for including the nadunolimab treatment arm as an experimental arm in Precision Promise. The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody nadunolimab is Cantargia's lead program and is investigated in five clinical trials evaluating combination therapy regimens in various forms of cancer, with PDAC being the most extensively studied. To date, more than 70 PDAC patients have received treatment with nadunolimab in combination with gemcitabine and nab-paclitaxel in the phase 1/2a clinical study CANFOUR. Interim results from 33 PDAC patients, presented at the ESMO Congress in September 2021 and updated in December 2021, show that both median progression-free survival (iPFS) and overall survival are longer than expected for chemotherapy alone, based on historical control data. Cantargia has reviewed several opportunities to advance the clinical development of nadunolimab in PDAC and are announcing the decision to take part in PanCAN's adaptive clinical phase 2/3 trial, Precision Promise. In addition to advancing the clinical development in PDAC, ongoing activities for nadunolimab in non-small cell lung cancer will continue according to plan with the aim to start a randomized clinical study late 2022. PanCAN's Precision Promise adaptive clinical trial platform is currently being conducted in the US at 15 leading clinical centers, with additional sites added as the trial progresses. In the trial, patients will be randomized to receive experimental therapy of nadunolimab combined with gemcitabine and nab-paclitaxel, or a standard of care chemotherapy regime alone. Also, consistent with the platform nature of Precision Promise, other experimental arms will be evaluated simultaneously with the nadunolimab arm. The Bayesian trial design involves enrolling up to 175 patients on each experimental arm while randomizing patients to standard of care control arms. Depending on the arm's results at the time, successful completion of a 100-patient adaptively randomized Stage 1 of the trial may be followed seamlessly by a transition to a 75-patient fixed-randomized Stage 2. Should a transition to Stage 2 of the nadunolimab arm occur, enrollment will continue with no announcements of any of the trial results until the final analysis of the arm's comparison with control. Trial results for the nadunolimab arm are expected to be available in 2027 or earlier. Announcement • Dec 30
Cantargia AB (publ) Reports Updated Encouraging Survival Data from CANFOUR Trial with Nadunolimab and Chemotherapy in Pancreatic Cancer Cantargia AB announced updated interim results from the CANFOUR phase I/IIa clinical trial investigating nadunolimab in first line therapy of pancreatic cancer (PDAC) in combination with chemotherapy. The updated dataset from the initial 33 patients eligible for efficacy analysis continue to show stronger results than expected from chemotherapy only. Median survival is 12.7 months, median immune progression-free survival (iPFS) is 7.2 months, and 1-year survival rate is 55%. At the time of analysis, 12 patients were still alive and two patients were on therapy. Safety and response rates are similar to the previous update from May 2021. The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody nadunolimab is Cantargia's lead program and is investigated in multiple clinical trials evaluating various combination therapy regimens in different forms of cancer, with PDAC being the most extensively studied. To date, more than 70 PDAC patients have received treatment with nadunolimab in combination with gemcitabine and nab-paclitaxel in the phase I/IIa clinical study CANFOUR. The update reported is based on the first group of 33 patients evaluated for efficacy. In the updated interim analysis, with a longer follow-up period than previous readouts resulting in a more robust analysis, median survival is 12.7 months and 1-year survival rate is 55%. Median iPFS is 7.2 months with a 6-month iPFS of 56%. In comparison, historical data in first line treatment of PDAC patients with gemcitabine and nab-paclitaxel show median survival of 8.5 months with a 1-year survival rate of 35%, and median PFS of 5.5 months with a 6 month PFS of 44%. At the time of analysis, two patients were still receiving treatment and 12 patients were still alive. Interestingly, 6 patients (18%) in the trial have received treatment for longer than one year. The safety profile is essentially unchanged from the previous update with incidence of neutropenia and febrile neutropenia being higher than expected from chemotherapy alone. Notably, febrile neutropenia is observed only during the first cycle of therapy and can be largely prevented with prophylactic treatment by the granulocyte growth factor G-CSF. Interestingly, no cases of severe (grade 3 or higher) neuropathy, a common side effect of gemcitabine and nab-paclitaxel, have been observed. Furthermore, 40 additional PDAC patients are investigated in an extension of the CANFOUR trial. Results from this part of the trial are expected to mature for presentation during H1 2022. Cantargia is currently preparing for a randomized and potentially pivotal trial in first line pancreatic cancer. Design and timelines will be disclosed once preparatory discussions with major regulatory authorities have been concluded. Announcement • Dec 15
Cantargia AB (publ) Reports Positive Results for Can10 Antibody in Preclinical Systemic Sclerosis Model Cantargia AB reported new preclinical results demonstrating efficacy of the CAN10 antibody in a systemic sclerosis disease model where CAN10 counteracted disease development in the skin and lungs. Notably, the levels of several biomarkers affected in systemic sclerosis patients were normalized by CAN10 in this model. These results support clinical development of CAN10 in systemic sclerosis and results are planned to be presented at a scientific conference during First Quarter 2022. The CAN10 antibody binds interleukin-1 receptor accessory protein with high affinity and functions through simultaneous blockade of IL-1, IL-33 and IL-36 signaling. Development of CAN10 is initially planned to focus on two severe diseases: myocarditis and systemic sclerosis. Systemic sclerosis is a life-threatening autoimmune disease involving inflammation and subsequent fibrosis, i.e. uncontrolled scar tissue formation, in skin and internal organs. In an in vivo systemic sclerosis model, a surrogate CAN10 antibody reduced disease development in both skin and lungs. Further analyses of the skin also revealed that CAN10 normalized several biomarkers, i.e. gene signatures, which were dysregulated in skin biopsies from systemic sclerosis patients, suggesting that IL1RAP inhibition by CAN10 may lead to the same benefits in human disease as well. Together, these results support the clinical development of CAN10 as a new first-in-class treatment of systemic sclerosis and results are planned to be presented at a scientific conference during First Quarter 2022. The CAN10 antibody is in late-stage preclinical development. Cantargia plans to initiate a clinical phase I study for CAN10 in Third Quarter 2022. Breakeven Date Change • Oct 31
Forecast to breakeven in 2023 The 2 analysts covering Cantargia expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr758.5m in 2023. Average annual earnings growth of 65% is required to achieve expected profit on schedule. Breakeven Date Change • Sep 23
Forecast to breakeven in 2023 The 3 analysts covering Cantargia expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr758.5m in 2023. Average annual earnings growth of 67% is required to achieve expected profit on schedule. Announcement • Sep 13
Cantargia AB (Publ) Announces New Positive Interim Results on Nadunolimab Combination Therapy in NSCLC Published in Abstract for the Annual ESMO Congress Cantargia AB (publ) announced the publication of an abstract disclosing novel clinical interim data from the CANFOUR study. The abstract was submitted in May 2021 for the upcoming ESMO Congress starting 16 September, 2021. In 15 non-small cell lung cancer (NSCLC) patients evaluated for efficacy, nadunolimab (CAN04) combined with gemcitabine/cisplatin showed an overall response rate (ORR) of 60%, a median duration of response (DOR) of 6.2 months and a median progression-free survival (PFS) of 8.2 months. All these efficacy parameters compare favorably to historical control data from gemcitabine/cisplatin only. The safety profile was good. The most notable adverse event was neutropenia occurring more frequently than expected from chemotherapy alone. The neutropenia can be managed with the use of G-CSF and/or by dose reductions. Interim results from the phase II part of the ongoing CANFOUR study have been published in an abstract submitted to the upcoming ESMO Congress. In the abstract, new NSCLC data are disclosed and these are based on 22 patients, with 15 treated long enough to be included in an interim efficacy analysis. In summary, the efficacy of nadunolimab combination therapy is favorable compared to historical data for chemotherapy only. The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody nadunolimab is Cantargia's most advanced program and is investigated in multiple clinical trials evaluating nadunolimab in combination with various chemotherapy regimens in NSCLC, PDAC and other forms of cancer. CANFOUR, a phase I/IIa clinical study, investigates nadunolimab with gemcitabine and cisplatin as first line combination or on progression after pembrolizumab in NSCLC patients, or with gemcitabine and nab-paclitaxel as first line combination in patients with advanced PDAC. Announcement • Aug 31
Cantargia AB Reports Preclinical Data Highlighting Advantages of Nadunolimab Mechanism of Action Cantargia AB reported new preclinical data on the antibody nadunolimab (CAN04) in combination with the chemotherapy docetaxel. CAN04 increased the anti-tumor effect of docetaxel, but notably, this was not achieved by blocking only one of the pathways targeted by CAN04, using an antibody against IL-1ß signaling. Additionally, docetaxel and other chemotherapies induce the release of the other form of IL-1, IL-1a, by tumor cells. These data highlight the potential of CAN04, which blocks both IL-1a and IL-1ß, to increase chemotherapy efficacy. CAN04 is entering clinical development in combination with docetaxel for the treatment of non-small cell lung cancer (NSCLC). Cantargia develops antibody-based pharmaceuticals against interleukin-1 receptor accessory protein (IL1RAP). The IL1RAP-binding antibody CAN04 is Cantargia's most advanced program and is currently investigated in multiple clinical trials in combination with chemotherapy for treatment of cancer. CAN04 is unique compared to other IL-1-targeting concepts as it has a broader mechanism of action. CAN04 mediates killing of IL1RAP-expressing tumor cells via Antibody-Dependent Cellular Cytotoxicity (ADCC) and blocks tumor-promoting signals from both IL-1a and IL-1ß. While IL-1ß is known to be capable of stimulating tumor growth by various mechanisms, studies have indicated that IL-1a is essential for maintaining a tumor-promoting inflammatory state and may induce resistance to chemotherapy. Several approaches to block the activity of the individual components of the IL-1 system are assessed clinically. Clinical studies investigating treatment of cancer combining such agents with various chemotherapies are ongoing. A standard therapy for cancer treatment, including late-stage NSCLC, is the chemotherapy docetaxel. The new preclinical data show that CAN04 potentiates the efficacy of docetaxel in mice with established subcutaneous MC38 tumors. The potentiating effect was also compared to antibody blockade of only IL-1ß, which in this model did not add any benefit to docetaxel. Furthermore, in vitro data also demonstrate that addition of chemotherapy to tumor cells increases both the gene expression as well as the release of IL-1a by these cells. Turning to previous observations on the role of IL-1a in mediating resistance to chemotherapy2, these data could indicate that blocking signals from both forms of IL-1 by CAN04 is a key feature of its mode of action for improving chemotherapeutic sensitivity of tumors. Announcement • Aug 27
Cantargia AB Reports First Patient Treated in CAPAFOUR Study Investigating Combination of Nadunolimab with FOLFIRINOX in Pancreatic Cancer Cantargia AB announced that the first patient has received treatment with nadunolimab (CAN04) and FOLFIRINOX in the phase Ib study, CAPAFOUR, investigating treatment of patients with metastatic pancreatic cancer (PDAC). The study will include approximately 30 patients at multiple sites in France and Spain. The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody CAN04 is the company’s most advanced program. The first patient has now been dosed in the phase Ib study CAPAFOUR, investigating CAN04 in combination with one of the two most commonly used first line chemotherapy regimens in metastatic PDAC, FOLFIRINOX. CAPAFOUR will be conducted at three sites in France and five sites in Spain. Approximately 30 patients are planned to be enrolled and recruitment is estimated to take 18-24 months. CAN04 is currently evaluated in several clinical trials, including a phase I/IIa study, CANFOUR, which is examining first line combination with gemcitabine and nab-paclitaxel in patients with advanced PDAC, and gemcitabine and cisplatin in non-small cell lung cancer (NSCLC). Additional clinical studies investigating CAN04 combination with chemotherapy for treatment of various forms of cancer will initiate during 2021. Further, CAN04 is evaluated in combination with a checkpoint inhibitor, pembrolizumab, in four different solid tumor indications in the phase Ib study CIRIFOUR. The primary objective of CAPAFOUR is to assess the safety and tolerability of CAN04 combined with FOLFIRINOX. The patients will receive CAN04 and FOLFIRINOX for up to 12 cycles. The initial part of the study, a dose escalation phase with increasing doses of CAN04 in combination with FOLFIRINOX, will include up to 15 patients. The second part, an expansion phase, will explore the high safe dose of CAN04 in up to 15 additional patients. Secondary endpoints include effects on serum biomarkers, such as IL-6 and CRP, biopsy analysis and antitumor efficacy. Announcement • Aug 20
Cantargia Expands CIRIFOUR Trial After Successful Completion of Recruitment in the Pembrolizumab Combination Arm Cantargia AB announced that the last patient in the initial treatment arm of the phase Ib clinical study CIRIFOUR has started treatment. A total of 15 patients have so far been recruited to this study, which evaluates nadunolimab (CAN04) in combination with Keytruda® (pembrolizumab), and preliminary data indicate a good safety profile. The CIRIFOUR study protocol will now be expanded to include the next combination therapy arm where CAN04 is evaluated with pembrolizumab and platinum-based chemotherapy in patients with non-small cell lung cancer (NSCLC). The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody CAN04 is Cantargia's most advanced program and is investigated in multiple clinical trials evaluating CAN04 in combination with different chemotherapy regimens in NSCLC, pancreatic cancer and other forms of cancer. CIRIFOUR is a phase Ib study conducted in the US with the aim to assess CAN04 in combination with the checkpoint inhibitor pembrolizumab in patients with NSCLC, head and neck cancer, bladder cancer or malignant melanoma, who progressed on previous therapy with immune checkpoint inhibition. The patient recruitment to the initial treatment arm of CIRIFOUR has now been finalized and a total of 15 patients have started treatment. These include 7 NSCLC patients, 7 head and neck cancer patients and 1 malignant melanoma patient. The primary objective of this study is to assess the safety and tolerability of CAN04 in combination with pembrolizumab and to establish a recommended dose of CAN04 in this combination. Secondary objectives include assessment of clinical activity and biomarkers. The preliminary results show that the combination is well-tolerated and are planned to be reported in Fourth Quarter 2021. Pembrolizumab is frequently utilized for first line combination with the platinum-based chemotherapy regime carboplatin/pemetrexed for treatment of non-squamous NSCLC. As both clinical and preclinical data indicate the ability of CAN04 to potentiate platinum-based chemotherapy, the data obtained in the CIRIFOUR study form the basis for further evaluation of CAN04 in combination with pembrolizumab and platinum doublets. Therefore, the CIRIFOUR study will now be expanded to include an additional arm to study safety, biomarkers and efficacy of such a combination in first line non-squamous NSCLC patients. The treatment of the first patient in this new arm is expected to start in Fourth Quarter 2021 and the plan is to recruit up to 30 patients. Announcement • Jul 02
Cantargia Advances Development of Nadunolimab in Triple Negative Breast Cancer Through Submission of Clinical Protocol for TRIFOUR Study Cantargia AB announced the submission of the clinical trial application for TRIFOUR, a phase Ib/II trial investigating nadunolimab (CAN04) combined with gemcitabine and carboplatin for treatment of triple negative breast cancer (TNBC). After an initial safety lead in, the study will include a randomized phase II part. This trial will be performed in Spain in collaboration with the Spanish Breast Cancer Group, GEICAM. Up to 120 patients may be included and the first patient is estimated to be enrolled in November 2021. The antibody CAN04, binding to interleukin-1 receptor accessory protein (IL1RAP), is Cantargia's most advanced program and is investigated in multiple clinical trials. CANFOUR, a phase I/IIa trial, investigates CAN04 first line combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer (PDAC), as well as with gemcitabine and cisplatin in non-small cell lung cancer. In CAPAFOUR, a phase Ib trial, CAN04 in combination with FOLFIRINOX is evaluated for first line treatment of metastatic PDAC. CESTAFOUR, a phase I/ll trial, will also investigate CAN04 with chemotherapy in three forms of solid tumors; biliary tract cancer, colorectal cancer and NSCLC. Additionally, CAN04 is investigated in the phase Ib trial CIRIFOUR, in combination with the checkpoint inhibitor pembrolizumab, in four solid tumor indications. The clinical trial application for a fifth study, called TRIFOUR, has now been submitted to the regulatory authorities in Spain. This study will be conducted in collaboration with GEICAM and the submission follows the previously communicated letter of intent with GEICAM. TRIFOUR is a phase Ib/II trial designed to evaluate CAN04 in combination with gemcitabine and carboplatin as first or second line treatment in patients with advanced TNBC. TNBC is an aggressive and difficult to treat form of breast cancer that expresses IL1RAP at higher levels than other forms of breast cancer. The primary objective in the initial stage is to evaluate the safety and tolerability of CAN04 in combination with this chemotherapy regimen. Biomarkers and early signs of efficacy will also be evaluated at this stage. If prespecified milestones are reached in the initial open label part, the trial will be expanded into a randomized phase II part, to investigate the efficacy of CAN04 combination with gemcitabine and carboplatin, compared to a control group receiving gemcitabine and carboplatin alone. The trial is estimated to include up to 120 patients at approximately 24 sites in Spain. The first patient is expected to be enrolled in the study in November 2021. Announcement • Jun 30
Cantargia AB (publ) Broadens the Development of Nadunolimab in Three Forms of Cancer and Submits Application for the Phase I/II Clinical Trial CESTAFOUR Cantargia AB (publ) announced that the development of nadunolimab (CAN04) has been broadened following the submission of an application of a phase I/II clinical trial to evaluate combination with chemotherapy in three different forms of solid tumors. Thus, the development of CAN04 is expanded to biliary tract cancer and colorectal cancer, and extended to new patient populations in non-small cell lung cancer. The study, called CESTAFOUR, will be conducted at approximately 20 clinical centres in Europe. The first patient is estimated to be enrolled in September 2021. The antibody CAN04, binding to interleukin-1 receptor accessory protein, is the company's most advanced program and is investigated in multiple clinical trials. CANFOUR, a phase I/IIa trial, investigates CAN04 first line combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer (PDAC), as well as with gemcitabine and cisplatin in NSCLC. In the phase Ib trial CAPAFOUR, CAN04 is also evaluated for treatment of metastatic PDAC in combination with the first line chemotherapy option FOLFIRINOX. Additionally, CAN04 is investigated in a phase Ib trial, CIRIFOUR, in combination with the checkpoint inhibitor pembrolizumab in four different forms of solid tumors. The clinical trial application for a fourth study, called CESTAFOUR, has now been submitted. This is an open label phase I/II clinical trial, which will evaluate CAN04 in combination with chemotherapy frequently used for treatment of three forms of solid tumors. This includes first line treatment of advanced BTC in combination with gemcitabine and cisplatin, CRC in combination with FOLFOX as third line therapy, and NSCLC in combination with docetaxel as second or third line therapy. The format originates from a basket-like design with selected combinations based on previous preclinical and clinical data for CAN04. A cornerstone in the trial is the previously reported synergy between CAN04 and platinum-based chemotherapy. The basket-like design also creates an opportunity for broadening the program into new diseases, such as BTC and CRC, where platinum-based chemotherapy is routinely used. Furthermore, broadening to a later stage patient group in NSCLC is based on previously communicated positive results in this disease. With an expected median survival of less than a year, the medical need in each of the chosen patient segments is very high. In the initial dose escalation phase, performed in approximately 15 patients for each indication/combination, the primary objective is to assess the safety and tolerability of CAN04, in combination with each of the three chemotherapy regimens. In the phase II part, the primary objective is to assess the antitumor efficacy. The phase II part will include approximately 40 patients for each of the three indications. The phase I part of the study will be performed in France, Spain and the United Kingdom and the first patient is estimated to be enrolled in September 2021. Trial details will be disclosed on clinicaltrials.gov during third quarter of 2021.