Tillkännagivande • Jan 09
Alligator Bioscience to Present New Optimize-1 Data on Mitazalimab at ASCO Gastrointestinal Cancers Symposium Alligator Bioscience announced that new data from its Phase 1b/2 OPTIMIZE-1 study evaluating mitazalimab in combination with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) will be presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA, taking place 8-11 January 2026. The presentation will highlight new analyses from OPTIMIZE-1 further characterizing the clinical benefit observed with mitazalimab plus standard chemotherapy in metastatic pancreatic cancer. The data support Alligator's continued preparations for mitazalimab's pivotal development and reinforce the scientific and clinical rationale for CD40 agonism as an immunotherapy approach in this hard-to-treat disease. Tillkännagivande • Dec 20
Alligator Bioscience AB (publ) has completed a Composite Units Offering. Alligator Bioscience AB (publ) has completed a Composite Units Offering.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 198,725,144
Price\Range: SEK 0.4
Transaction Features: Rights Offering Tillkännagivande • Jul 11
Alligator Bioscience AB (Publ) Appoints Johan Giléus as Chief Financial Officer as of August 12, 2024 On June 14, Alligator Bioscience AB (publ) announced the appointment of Johan Giléus as the company's new Chief Financial Officer as of August 12, 2024, to oversee financial strategy and operations. Tillkännagivande • Jul 10
Alligator Bioscience Announces Completion of Enrollment in Mitazalimab Optimize-1 Study Alligator Bioscience announced an update on the on-going OPTIMIZE-1 clinical Phase 2 trial with the company's lead asset, mitazalimab. All patients in the 450 ug/kg back-fill cohort have been enrolled. The additional cohort was enrolled in order to provide further dose characterization following advice from the FDA, to ensure mitazalimab Phase 3 readiness. OPTIMIZE-1, an open-label, single-arm, multicenter, Phase 1b/2 study, assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX in 1st line pancreatic cancer. On June 26, the 18- was reported, demonstrating robust data with month follow-up analysis substantial survival benefits compared to standard of care chemotherapy. Tillkännagivande • Jun 26
Alligator Bioscience Announces Results from the Ongoing Optimize-1 Trial Alligator Bioscience announces positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve pancreatic cancer patients. The data demonstrated a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX alone. The updated Median Overall Survival (mOS) was 14.9 months, up from 14.3 months at the time of first analysis, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX and more recently by NALIRIFOX. Median follow-up duration for the updated analysis was 18.2 months, indicating the maturity of these outcomes. At the time of the analysis, a total of 17 (30%) patients were still alive, and of these 9 (16% overall) were still on treatment. The longest ongoing treatment duration was 24 months. The follow-up data further demonstrate: An additional late responding patient increased the confirmed Objective Response Rate (ORR; as per the Response Evaluation Criteria in Solid Tumors RECIST 1.1) to 42.1% from the 40.4% reported in the top-line readout, comparing favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone and an ORR of 42% reported by NALIRIFOX. An increase in the unconfirmed ORR to 54.4% was reported in 57 evaluable patients. The median Duration of Response (DoR) was 12.6 months, an unprecedented outcome in this aggressive disease and much longer compared to 5.9 months with FOLFIRINOX and 7.3 months with NALIRIFOX. Median Progression Free Survival (PFS) was 7.7 months, and a nearly 3-fold increase in the 12-month PFS rate was reported; 35.1% in OPTIMIZE-1 against 12.1% previously reported for FOLFIRINOX. Tillkännagivande • Jun 21
Alligator Bioscience AB (publ) to Present Positive Phase 2 Data on Mitazalimab in Pancreatic Cancer at ESMO GI 2024 Alligator Bioscience AB (publ) announced it will present positive Phase 2 data on its lead drug candidate mitazalimab in first line metastatic pancreatic cancer at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2024 (ESMO GI 2024), taking place in Munich, Germany from June 26-29. The oral presentation outlines OPTIMIZE-1, an open-label, multicenter, Phase 1b/2 study, assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX. The trial study met its primary endpoint, with mitazalimab showing a manageable safety profile and promising DoR associated with a clinically meaningful survival benefit. Furthermore, there was a significant correlation between treatment-induced increases in natural killer T (NKT) cells and T cells expressing CD38 and depth of response, strongly suggestive of a mitazalimab-dependent contribution to deep anti-tumor responses. The 5-year overall survival rate for metastatic pancreatic ductal adenocarcinoma (mPDAC) is less than 5%, and current systemic therapies are associated with poor outcomes. The OPTIMIZE-1 data have also recently been published in the peer-reviewed The Lancet Oncologyand presented in two posters at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Alligator expects to report 18-month survival follow-up data from OPTIMIZE-1 at the end of June 2024, and that these will provide further insights into the potential of mitazalimab. Results from the OPTIMIZE-1 trial showed mitazalimab in combination with mFOLFIRINOX had a confirmed ORR of 40.4% in 57 evaluable patients (unconfirmed ORR was 50.9%). Median DoR was 12.5 months and the median OS was 14.3 months. Median Progression Free Survival (PFS) was 7.7 months. These data compare favorably to the historically reported outcomes with FOLFIRINOX (ORR 31.6%, mDoR 5.9 months, mOS 11.1 months and mPFS 6.4 months). The recently approved new treatment regimen of NALIRIFOX was associated with an ORR of 42%, mDoR of 7.3 months, mPFS 7.4 months and a mOS of 11.1 months. Tillkännagivande • May 24
Alligator Bioscience to Present Positive Phase 2 Mitazalimab Data in Pancreatic Cancer at 2024 ASCO Annual Meeting Alligator Bioscience AB (publ) announced that two clinical abstracts on its lead drug candidate mitazalimab, a best- in-class CD40 agonist, in first line metastatic pancreatic cancer will be presented (abstracts 2569 and 4133) in a poster presentation session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL and online during May 31-June 4. Data presented at ASCO from the OPTIMIZE-1 study, of mitazalimab in combination with mFOLFIRINOX chemotherapy, showed that pharmacological analyses identified mitazalimab-induced expansion of CD4 effector T cells one week after first administration as a correlate of treatment outcomes. These data suggest the contribution of mitazalimab to tumor responses, and further supports the unique trial design of OPTIMIZE-1. OPTIMIZE-1 achieved its primary endpoint, demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone. Median Duration of Response (DoR) was 12.5 months, remarkably longer than reported so far with any other approved and investigational therapies. Median Overall Survival (OS) was 14.3 months and the survival estimate from the next planned analysis may further improve. The open-label, multi-center OPTIMIZE-1 study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve patients. More details can be found with the clinicaltrials.gov identifier NCT04888312. Tillkännagivande • May 15
Alligator Bioscience Announces Initiation of an Investigator-Initiated Phase 1 Clinical Study of Mitazalimab in Local Advanced Pancreatic Cancer Alligator Bioscience announced the initiation of an investigator initiated Phase 1 clinical study (NCT06205849) evaluating the safety and efficacy of the company's lead asset mitazalimab (CD40 mAb agonist) injected intratumorally at the time of surgical irreversible electroporation (IRE) in patients with locally advanced pancreatic cancer (LAPC). The NCI-funded Phase 1a/1b single-center study will enroll up to 18 patients, who will receive a single intratumoral injection of mitazalimab immediately after the surgical IRE, a form of non-thermal ablation that is currently in clinical use for selected patients with LAPC. The study is being conducted by researchers at Moores Cancer Center at UC San Diego. Alligator will supply mitazalimab for the study. Tillkännagivande • Apr 05
Alligator Bioscience AB (Publ) Announces Graham Dixon and Veronica Wallin Not Proposed for Re-Election on Board Alligator Bioscience AB (publ) at the annual general meeting to be held on 7 May 2024, Graham Dixon and Veronica Wallin are not proposed for re-election on the board. Tillkännagivande • Mar 07
Alligator Bioscience and Aptevo Therapeutics Announce Positive Interim Data of Dose Escalation Phase of ALG.APV-527 Phase 1 Study in Solid Tumor Cancers Expressing Tumor Antigen 5T4 Alligator Bioscience AB and Aptevo Therapeutics announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The multi-center, dose escalation trial is now more than 50% enrolled, and preliminary results include: Treatment was overall well-tolerated, and a maximum tolerated dose has not yet been determined, dose-escalation in higher-dose cohorts is ongoing, ALG.APV-527 could be measured in all patients with plasma concentration of ALG.APV-527 consistent with the administered dose, Biomarker analyses indicate the expression of the targets (4-1BB and 5T4) in tumor biopsies and confirm biological activity of ALG.APV-527. Of particular interest, signs of clinical activity were observed for both enrolled patients with heavily pre-treated breast cancer. These patients demonstrated measurable level of drug in circulation (pharmacokinetic) and reproducible elevation of serum pharmacodynamic markers with dosing, suggesting the drug is biologically active. One patient remained on study for seven months and a second remains on study beyond nine months. Both patients achieved best overall response of stable disease. The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label trial that will include six cohorts (dose levels) in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. among adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial will assess the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527. ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer. Tillkännagivande • Jan 29
Alligator Bioscience Announces Positive Top-Line Results from the Optimize-1 Phase 2 Study of the Company's Lead Asset Mitazalimab in 1st Line Metastatic Pancreatic Cancer Alligator Bioscience announced positive top-line results from the OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naive patients. The study achieved its primary endpoint with the top-line results demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone. The cut-off time for analysis was November 14, 2023 with a median follow-up duration of 12.7 months. At the time of the analysis, a total of 29 (51%) patients were still alive, of these 18 (32%) were still on treatment. The longest ongoing treatment duration was 23 months. Three patients demonstrated complete remission of their target lesions. The study further demonstrated: Median Overall Survival (mOS) of 14.3 months at the time of analysis and expected to improve as majority of the patients remain alive, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX[1], and more recently by NALIRIFOX in the NAPOLI 3 Phase 3 trial. An unprecedented median Duration of Response (DoR) of 12.5 months, compared to 5.9 months with FOLFIRINOX[1], and the 7.3 months demonstrated by NALIRIFOX The 12-month survival rate was 59.3% compared to 48.1% for FOLFIRINOX and 45.6% for NALIRIFOX Median Progression Free Survival (PFS) of 7.7 months, compared to 6.4 months with FOLFIRINOX[1], and the 7.4 months demonstrated by NALIRIFOX. Mitazalimab's manageable safety and tolerability profile supporting long-term administration in combination with mFOLFIRINOX was confirmed. As the majority of patients remain alive at the time of analysis, Overall Survival and Durability of Response are expected to improve further with ongoing treatment and follow-up. Alligator Bioscience has undertaken discussions with the US Food and Drug Administration (FDA) and has been able to establish a clear development and approval pathway for mitazalimab in pancreatic cancer. Based on the emerging data from the OPTIMIZE-1 study, FDA has provided additional guidance and has endorsed OPTIMIZE-1 as a Phase 3 enabling study. Consequently, mitazalimab can proceed directly to a global Phase 3 registration study, which Alligator is preparing to initiate in early 2025. Tillkännagivande • Nov 07
Alligator Bioscience AB (Publ) Appoints Bertil Brinck as Chairman of the Nomination Committee Alligator Bioscience AB (publ) announced that Bertil Brinck has been appointed Chairman of the Nomination Committee. Tillkännagivande • Oct 13
Alligator Bioscience Grants New Composition of Matter Patent in Europe for Mitazalimab Alligator Bioscience announced that the European Patent Office (EPO) has granted the company a new patent based on EP Patent No. 3323834 covering its lead drug candidate= mitazalimab, a CD40 monoclonal antibody currently being evaluated in a Phase 2 study in 1st line metastatic pancreatic cancer. Mitazalimab is being evaluated in combination with chemotherapy, mFOLFIRINOX, in the OPTIMIZE-1 Phase 2 study in 1st line metastatic pancreatic cancer. The study is progressing and is on track for top-line readout in early first quarter of 2024. Tillkännagivande • Aug 18
Alligator Bioscience AB (publ) Announces Resignation of Malin Carlsson as Chief Operating Officer At the End of October Alligator Bioscience AB (publ) announced the resignation of Malin Carlsson as the company's Chief Operating Officer (COO). Dr Carlsson will leave her role at the end of October to assume an executive role in a global pharma company. Dr Carlsson’s responsibilities will be transferred to other members of the Management team. Tillkännagivande • Jul 06
Alligator Bioscience AB (Publ) Announces Executive Changes Alligator Bioscience AB (publ) announced that Anette Sundstedt, PhD, Principal Scientist at Alligator, has been appointed as employee representative, and Karin Nordbladh, Director Clinical Operations at Alligator, as deputy employee representative at the Alligator Bioscience AB's Board of Directors, effective July 5, 2023. Anette Sundstedt, who joined Alligator in 2021, replaces Tova Landström, who resigned on May 26, 2023, for personals reasons. Tillkännagivande • Jul 01
Alligator Bioscience AB (publ) Announces Phase II Results Indicate Durability of Response for Alligator's CD40 Agonist Alligator Bioscience AB (publ) has presented a second round of interim results from a phase II trial with mitazalimab in pancreatic cancer patients. The follow-up evaluation on the first 23 patients shows an objective response rate of 57% - up from 52% at the first evaluation reported in January. The evaluation on the full set of 57 patients reveals an objective response rate of 44% - also susceptible to an increase as the study progresses. More data points indicate that mitazalimab provides a durable response in combination with standard of care chemotherapy. Tillkännagivande • Jun 27
Alligator Bioscience Announces Positive Second Interim Results from the Ongoing Optimize-1 Phase 2 Study of the Lead Asset Mitazalimab in 1st Line Metastatic Pancreatic Cancer Alligator Bioscience announced positive second interim results from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. The second interim analysis conducted on the 23 patients included in the interim analysis, with a follow-up period of nine to 17 months, reported in January 2023. demonstrated the following: Tumor responses deepened and the Objective Response Rate (ORR) increased to 57% (from 52%), suggesting a durable benefit for patients. Of the 13 patients achieving an objective response, seven (54%) were still ongoing in treatment for longer than 10 months with a maintained response, with the longest being 17 months. The interim analysis conducted on all 57 evaluable patients with a follow-up periodof two to 17 months demonstrated the following: 25 patients responded to treatment resulting in an interim ORR of 44%. Median Duration of Response (DoR) was 8.7 months compared to 5.9 reported for FOLFIRINOX alone in other studies, indicating an immunostimulatory effect of mitazalimab and potential Progression Free Survival (PFS) and survival benefits. In addition, 19 patients (33%) achieved stable disease resulting in a 77% disease control rate (DCR) Furthermore, mitazalimab's manageable safety and tolerability profile in combination with mFOLFIRINOX was confirmed. These data compare favorably to the ORR of 31.6%, mPFS of 6.4 months and DoR of 5.9 months reported in similar patient populations treated with standard of care FOLFIRINOX alone. Completion of, and patient enrolment in OPTIMIZE-1 was reported in April 2023 in May 2023, mitazalimab was granted Orphan Drug Designation by the U. S. Food and Drug Administration for the treatment of pancreatic cancer. Tillkännagivande • Jun 06
Alligator Bioscience to Present Latest Clinical Data from Mitazalimab Optimize-1 Phase 2 Trial in Pancreatic Cancer At Asco Annual Meeting 2023 Alligator Bioscience announces that data from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, June 2-6. The data presented at ASCO demonstrate that mitazalimab in combination with mFOLFIRINOX is a feasible treatment regimen for 1st line pancreatic cancer patients with encouraging interim efficacy and well-manageable safety profile, consistent with mFOLFIRINOX monotherapy. Combination with mFOLFIRINOX had no impact on mitazalimab pharmacokinetics and the pharmacodynamic biomarker profile in peripheral blood confirmed the immune activation profile typical of mitazalimab. When administered at 900 µg/kg in combination with mFOLFIRINOX, mitazalimab showed robust anti-tumor activity in 23 mPDAC patients, meriting continued development. An objective response rate (ORR) of 52% was demonstrated with clinically meaningful tumor reduction in 12 of the 23 evaluable patients, which compares favorably to the 31.6%[1] reported with FOLFIRINOX in a similar patient population. The analysis also revealed: 8 patients achieved stable disease resulting in a 91% disease control rate (DCR), 6 of the 7 patients who began treatment at least 6 months prior to the interim analysis cutoff were still on treatment, and of these, 2 patients had been receiving treatment for over 11 months.