Aankondiging • Apr 18
TME Pharma N.V. Announces Publication Of NOX-A12 Triple Therapy Phase 1/2 Expansion Arm Findings from GLORIA Trial in Nature Communications TME Pharma N.V. announced a Nature Communications article on the results from the Phase 1/2 expansion Arm A cohort of the GLORIA trial testing NOX-A12 + radiotherapy + anti-VEGF triple therapy in glioblastoma patients. The article in the scientific peer-reviewed high-impact journal, Nature Communications, describes results of the expansion cohort Arm A in TME Pharma’s Phase 1/2 GLORIA trial. In this arm, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients with residual tumor after surgery received NOX-A12 + radiotherapy + anti-VEGF (bevacizumab) Triple Therapy. The authors noted that overall survival (OS) of patients receiving NOX-A12 Triple Therapy significantly outperformed two different cohorts of similar patients external to the trial who received standard of care treatment, and further noted that due to the conservative trial design, the study likely underestimates survival compared with most contemporary trials. As already disclosed in the March 5, 2024 press release, the GLORIA trial has been amended to allow inclusion of 100 additional patients in a randomized, controlled Phase 2 part of the trial composed of 5 additional arms (Expansion Group Arms D through H) to assess three different doses of NOX-A12 in the Triple Therapy, one dose of NOX-A12 + radiotherapy and standard of care. It is planned to initiate this Phase 2 part of the trial once appropriate partnerships are in place. The findings described in the publication demonstrate the potential and value of TME Pharma’s NOX-A12 asset. Aankondiging • Sep 22
TME Pharma N.V. to Report First Half, 2025 Results on Oct 30, 2025 TME Pharma N.V. announced that they will report first half, 2025 results on Oct 30, 2025 Aankondiging • Jun 25
Tme Pharma N.V. Appoints Diede Mink Van Den Ouden as Sole Member of the Board of Directors TME Pharma N.V. announced the unanimous approval of all resolutions submitted to its 2025 annual general meeting of shareholders (AGM), including the appointment of Diede Mink van den Ouden as sole member of the board of directors. Aankondiging • Dec 05
TME Pharma N.V. has filed a Follow-on Equity Offering in the amount of €2.6 million. TME Pharma N.V. has filed a Follow-on Equity Offering in the amount of €2.6 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 52,000,000
Price\Range: €0.05
Transaction Features: Rights Offering Aankondiging • Nov 01
TME Pharma Receives €2.4 Million German Federal Ministry of Education and Research Grant to Support NOX-A12 Phase 2 Trial in Brain Cancer TME Pharma N.V. announced that it is awarded a non-refundable grant of EUR2.4 million from the KMU-innovativ funding program run by the German Federal Ministry of Education and Research. The non-dilutive non-refundable funding will support TME Pharma's planned Phase 2 randomized controlled study evaluating its lead asset, the CXCL12 inhibitor NOX-A12, for use in the treatment of aggressive adult brain cancer, glioblastoma. In the Phase 2 study design, approved by the US Food and Drug Administration and the German regulator, glioblastoma patients will be treated in five different arms that will address questions of dosing and assess the contribution of the NOX-A12 and bevacizumab components to the overall efficacy of the combination therapy. TME Pharmawill be able to optimize late phase development by selecting the best performing treatment arm against standard of care. The Phase 2 results will serve as a basis for discussions with regulatory authorities on the design of the further development strategy, up to market approval, and for discussions with potential partners, such as pharmaceutical companies. Aankondiging • Oct 18
TME Pharma N.V. Provides Clinical Update TME Pharma N.V. provided clinical update. The GLORIA NOX-A12 clinical trial has achieved exceptional clinical results in newly diagnosed glioblastoma patients with extremely poor prognosis that have tumors resistant to standard chemotherapy plus incomplete surgical resection showing potential benefit as a therapy for glioblastoma. The study achieved a remarkable 19.9-month median overall survival (mOS) rate for patients receiving NOX-A12 in combination with the VEGF inhibitor bevacizumab and radiotherapy. This doubles the 9.5-month mOS rate demonstrated in the standard of care matched reference cohort, as presented by Dr. Frank Giordano, the lead investigator of the clinical trial, at the European Society for Medical Oncology (ESMO) conference in September 2024. The ESMO presentation further revealed statistically significant improvement in survival for this triple combination (NOX-A12 + bevacizumab + radiotherapy) over standard of care reference cohort as well as NOX-A12 + radiotherapy alone. Analysis of the competitive landscape has shown that the NOX-A12 survival results surpass those from what TME Pharma believes are all relevant therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy. NOX A12’s effectiveness is even more impressive considering the NOX-A12 GLORIA trial enrolled patients with a worse prognosis than those in the competitor trials. The NOX-A12 trial only enrolled patients with residual detectable tumor after surgery whereas competitor trials also included patients with no detectable tumor after surgery, i.e. patients that would be expected to have a better average survival outcome. This progress highlights the immense potential of NOX-A12 to transform the treatment of glioblastoma patients, who face a devastating prognosis from this highly aggressive form of brain cancer. Clear Path for Phase 2 Clinical Development with Open IND and Fast Track Designation Awarded by US FDA, and Protocol Approved in Germany . TME Pharma engaged in discussions with the US Food and Drug Administration (FDA) in late 2023 to establish a clear regulatory roadmap for the next stage of NOX-A12's clinical development. The FDA cleared in March 2024TME Pharma’s Investigational New Drug (IND) application on the basis of the protocol for a randomized, controlled Phase 2 clinical trial in glioblastoma, allowing the company to expand clinical development in the US. Subsequently, the Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) has also approved the protocol, enabling the company to conduct Phase 2 study in Germany. NOX-A12 was also granted Fast Track designation by the US FDA. This designation aims to facilitate the development and expedite the review of drugs addressing serious conditions like glioblastoma. Companies whose programs are granted Fast Track Designation can benefit from more frequent interactions with the FDA during the clinical development process, and thus potentially accelerated timelines. TME Pharma perceives the achievement of these two key regulatory milestones as the FDA's recognition not only of the urgent unmet medical need which glioblastoma represents, but also the potential of NOX-A12 to address it. This paves the way to accelerate NOX-A12's route to market while providing investors and potential partners with a clear development pathway for NOX-A12. Aankondiging • Oct 01
TME Pharma N.V. Announces Appointment of Alexandra Glucksmann to Supervisory Board TME Pharma N.V. announced that the nomination of Dr. Alexandra Glucksmann to the Supervisory Board was approved at the extraordinary general meeting of shareholders (EGM), which took place on September 30, 2024. Aankondiging • Jun 28
TME Pharma N.V. Appoints Lee Schalop as Member of the Supervisory Board TME Pharma N.V. announced that at its AGM held on June 27, 2024 the appointment of Lee Schalop as member of the supervisory board. New Risk • Apr 28
New major risk - Negative shareholders equity The company has negative equity. Total equity: -€294k This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. 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). Negative equity (-€294k). Earnings have declined by 12% per year over the past 5 years. Shareholders have been substantially diluted in the past year (436% increase in shares outstanding). Revenue is less than US$1m (€17k revenue, or US$18k). Market cap is less than US$10m (€7.08m market cap, or US$7.58m). Aankondiging • Apr 23
TME Pharma N.V. Announces 33% of Patients Receiving NOX-A12 in Combination With Bevacizumab and Radiotherapy Achieve Two-Year Survival in GLORIA Phase 1/2 Trial in Brain Cancer TME Pharma N.V. announced a positive update on survival at two years for newly diagnosed glioblastoma patients receiving NOX-A12, TME Pharma's CXCL12 inhibitor, with the VEGF inhibitor bevacizumab and radiotherapy. Two out of the six glioblastoma patients in this expansion arm of the GLORIA Phase 1/2 trial have survived for more than 24 months since the start of therapy. These two patibents had tumors which, at one point during treatment, either disappeared completely or reached near-complete reduction (>99%) in size. The first patient to cross the two-year survival milestone had maintained a physical and cognitive condition within the norm, displaying only minimal disease-specific symptoms at this timepoint. This translates to a preserved quality of life, as evidenced by the patient’s continued ability to engage in hobbies, leisure activities, and social interaction. The second patient’s clinical status at the last assessment at 23 months was stable, although certain neurological functions had been partially affected. This patient’s course is also remarkable in that they received no therapy expected to prolong survival in the last 18 months since they decided to end treatment with the NOX-A12 combination following a near-complete reduction of tumor as assessed by MRI. In February, TME Pharma announced the final median overall survival (mOS) for this NOX-A12 cohort had reached an unprecedented 19.9 months. This survival rate compares very favorably to a matched standard of care reference cohort, which achieved an mOS of approximately 10 months, and exceeds what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy. TME Pharma recently announced two key regulatory milestones with the clearance by the U.S Food and Drug Administration (FDA) in March of the company's Investigational New Drug (IND) application for NOX-A12 in glioblastoma, allowing TME Pharmato proceed with the continued clinical development of NOX-A12 in a new Phase 2 study. This was followed by the FDA's award of Fast Track designation to NOX-A12 in glioblastoma in April. Fast Track designation aims to facilitate the development of therapies intended to treat serious conditions and address unmet medical needs, and could support an accelerated pathway to U.S regulatory approval. Preparatory steps for the NOX-A12 Phase 2 in glioblastoma are ongoing, and TME Pharma is aiming to initiate the new study as soon as the necessary resources from financial and industrial partners have been secured. Aankondiging • Apr 03
TME Pharma N.V. Receives US FDA Fast Track Designation for Lead Asset NOX-A12 in Brain Cancer TME Pharma N.V. announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for NOX-A12 (olaptesed pegol), TME Pharma'sCXCL12 inhibitor, in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma, in the newly diagnosed setting where the tumor is resistant to chemotherapy and measurable tumor remains after surgery. The FDA's Fast Track designation aims to bring important new drugs to patients more quickly, facilitating the development and expediting the review of therapies intended to treat serious conditions and address unmet medical needs. Companies whose programs are granted Fast Track designation can benefit from more frequent interactions with the FDA during the clinical development process and potentially "accelerated approval" and "priority review" if the relevant criteria are met. TME Pharma continuously evaluates ways to advance the clinical development of NOX-A12 while remaining focused on identifying and securing financial resources from multiple sources, including those having no or minimalutive effect on its shareholders, such as governmental grants or free supply of combination drugs. The company would prioritize such programs that support financial compensation for therapies leading to revenue generation, thus potentially reducing the financial needs of late-stage clinical development and also helping to generate real-world clinical evidence. Recently announced clearance by the FDA of TME Pharma'sInvestigational New Drug (IND) application for a Phase 2 study with NOX-A12 in glioblastoma, that the company plans to initiate later this year, was a pre requisite to having Fast Track designation granted by the FDA. Having Fast Track designation in addition to an open IND with an FDA-approved study design that addresses questions of dosing and contribution of components optimizes late phase development and offers an economically efficient model which further de-risks TME Pharma's glioblastoma program. Following IND approval, this Fast Track designation is an external validation of NOX-A12's potential to address the unmet need for glioblastoma patients. The necessary preparatory steps for the NOX-A12 Phase 2 in glioblastoma are ongoing, and TME Pharmais aiming to initiate the new Phase 2 study as soon as the necessary resources from financial and industrial partners have been secured. Aankondiging • Mar 06
TME Pharma N.V. Announces FDA Clearance of Investigational New Drug (Ind) Application for Nox-A12 Phase 2 Trial in Brain Cancer TME Pharma N.V. announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND)1 application for NOX-A12, TME Pharma'sCXCL12 inhibitor, for use in the treatment of aggressive adult brain cancer, glioblastoma. With the IND now open at the FDA, TME Pharmaplans to proceed with the continued clinical development of NOX-A12 in a Phase 2 randomized controlled study in approximately 100 newly diagnosed, chemotherapy-resistant glioblastoma patients having residual measurable tumor remaining after surgery. The study is expected to be initiated later this year, starting first in Europe, once the necessary resources and preparations are in place. Sufficient NOX-A12 clinical grade material has already been manufactured to initiate the study. The study will address questions of dosing and contribution of components – NOX-A12 and bevacizumab – to overall efficacy of the combination therapy and will allow TME Pharma to optimize late phase development by testing multiple doses of NOX-A12 with bevacizumab in a patient population that is also randomized to standard of care. Together with the IND submission TME Pharmahas also submitted a Fast-Track Designation2 request to the FDA to secure an expedited regulatory pathway for NOX-A12 in glioblastoma and the company expects to receive the FDA's decision before the end of March 2024. Based on discussions with the FDA last year and further interaction during the IND application process, the FDA-approved study design includes five arms, with 20 patients per arm: Arm 1: NOX-A12 - 200mg/week + radiotherapy and bevacizumab, Arm 2: NOX-A12 - 400mg/week + radiotherapy and bevacizumab, Arm 3: NOX-A12 - 600mg/week + radiotherapy and bevacizumab, Arm 4: NOX-A12 - 600mg/week + radiotherapy and Arm 5: Standard of Care control (temozolomide + radiotherapy). TME Pharma'sregulatory interactions were supported by recent survival data from the GLORIA Phase 1/2 study in which NOX-A12 demonstrated an unprecedented median Overall Survival (mOS) of 19.9 months in combination with bevacizumab and radiotherapy in glioblastoma patients with measurable chemotherapy-resistant residual tumors after surgery. This survival rate compares very favorably to a matched standard of care reference cohort, which achieved an mOS of approx. 10 months, and exceeds what TME Pharmabelieves to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy. Aankondiging • Feb 09
TME Pharma N.V. announced that it expects to receive €1.479999 million in funding TME Pharma N.V. announces private placement of 6,727,270 ordinary shares at an issue price of €0.22 per share for gross proceeds of €1,479,999.4 on February 9, 2024. The transaction is expected to close on February 12, 2024. Aankondiging • Jan 10
TME Pharma Announces Successful Advice Meeting with US Food and Drug Administration on Nox-A12 Development in Brain Cancer TME Pharma N.V. announced that it successfully completed its pre-IND advice meeting with the US regulator, the Food and Drug Administration (FDA), discussing plans for the further clinical development of NOX-A12 as a treatment of aggressive adult brain cancer, glioblastoma. Based on the feedback received, TME Pharma confirms that it is on track with preparations to file its Investigational New Drug (IND) application and the expedited regulatory pathway request on a timeline that will allow successful completion of both by the end of First Quarter 2024. Aankondiging • Dec 14
TME Pharma N.V. announced that it has received €2.7 million in funding On December 14, 2023, TME Pharma N.V. closed the transaction. The company has issued preferential subscription rights through the issuance of new shares with associated warrants for an amount of €2.7 million. New Risk • Nov 29
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: -€9.7m 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 (-€9.7m free cash flow). Share price has been highly volatile over the past 3 months (29% average weekly change). Earnings have declined by 17% per year over the past 5 years. Shareholders have been substantially diluted in the past year (290% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (€1.33m market cap, or US$1.46m). Minor Risk Negative equity (-€163k). Aankondiging • Oct 10
TME Pharma N.V. Provides Positive Update on 18-Month Survival for NOX-A12 Combination Regimen in Brain Cancer TME Pharma N.V. announced a positive update on survival at 18 months for patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy, and provides an overview on upcoming clinical development plans for NOX-A12 in the aggressive adult brain cancer, glioblastoma. The percentage of patients who were alive 18 months after start of therapy of NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy is currently 50% (with the possibility to increase to 67% with the next patient reaching 18 months) which exceeds by 10-fold the 18-month survival of 5% observed in the matched group of patients receiving standard of care1. Since neither bevacizumab (anti-VEGF) alone, nor bevacizumab plus radiotherapy have previously shown to extend survival, the strong increase in survival can be attributed to the complementary mechanism of action of NOX-A12 with bevacizumab and radiotherapy2. The survival rate of the NOX-A12 triple combination also exceeds the 18-month survival of 20% seen in the patients with high levels of the NOX-A12 predictive biomarker EG12 receiving NOX-A12 + radiotherapy alone3, which further supports NOX-A12’s potential to synergize with VEGF inhibition in glioblastoma . The median overall survival has now reached 18 months and is expected to improve further as the remaining patients continue to receive treatment or follow-up care4. Two of the three living patients are clinically stable despite radiographic tumor progression at last report from treating clinicians, including the patient who achieved complete response, now completing 22 months therapy. As a reminder, the matched standard of care reference cohort achieved a median overall survival of 10.5 months. The NOX-A12-based therapy has now delivered median overall survival exceeding all the relevant competitor studies conducted in the US or EU involving newly diagnosed, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients despite recruiting more difficult to treat patients whose tumors could not be fully removed by surgery5. NOX-A12 in combination with bevacizumab and radiotherapy continues to show an excellent safety and tolerability profile similar to that noted in previous publications. In the upcoming 6 months the key regulatory steps for NOX-A12 program in brain cancer will include the following: Fourth Quarter 2023 – Request advice in October from US Food and Drug Administration (FDA) on next trial design and eligibility for expedited regulatory pathways, such as Fast-Track Designation. Feedback expected in late December. First Quarter 2024 – Submit IND application for glioblastoma with the US FDA along with expedited regulatory pathway access request. Successful IND filing and feedback targeted by end of First Quarter 2024. TME Pharma plans to keep the market updated on the progress of these regulatory discussions. The goal is to have an FDA approved clinical trial protocol in glioblastoma with an expedited regulatory path by the beginning of April 2024 in order to secure the funding for the necessary clinical trial via partnership, investment or other strategic transaction types. Aankondiging • Sep 22
TME Pharma Announces Selection of Two Clinical Abstracts on the Ongoing NOX-A12 GLORIA Phase 1/2 Trial in Glioblastoma for Presentation at ESMO 2023 Congress and SNO 2023 Annual Meeting TME Pharma N.V. announced that two abstracts on the ongoing NOX-A12 GLORIA Phase 1/2 trial in first-line brain cancer (glioblastoma) were selected for presentation at upcoming international scientific conferences. The oral presentation at the European Society for Medical Oncology (ESMO) Congress taking place in Madrid, Spain, on October 20-24, 2023, will highlight an in-depth analysis of how the combination of radiotherapy and NOX-A12 remodels the immune tumor microenvironment in first-line glioblastoma patients, featuring clinical data from the GLORIA Phase 1/2 trial. The full abstract will be published online via the ESMO Congress website at 00.05 CEST on Monday, October 16, 2023. It will be available concurrently on the TME Pharma website. Title: Spatial remodeling of the immune tumor microenvironment after radiotherapy and CXCL12 inhibition in glioblastoma in the Phase 1/2 GLORIA trial. Speaker: Dr. Julian Layer Session: Mini Oral 508MO Lecture Time and Date:11.15-11.20 a.m. CEST, Saturday, October 21, 2023. The 2023 Society for Neuro-Oncology (SNO) Annual Meeting, taking place in Vancouver, Canada, on November 15-19, 2023, will feature a poster presentation with a clinical update from the ongoing GLORIA Phase 1/2 trial studying NOX-A12, TME Pharma’s CXCL12 inhibitor, in combination with radiotherapy and anti-VEGF (bevacizumab). The full abstract will be published and made available on the SNO official journal Neuro-Oncologyon Friday, November 10, 2023.Title: Interim data on dual inhibition of post-radiogenic angio-vasculogenesis by olaptesed pegol (NOX-A12) and bevacizumab in glioblastoma from the first expansion arm of the Phase 1/2 GLORIA trial. Presenter: Prof. Frank Giordano, MD Session: Poster Session Session Time and Date: 7.30-9.30 p.m. PT, Friday, November 17, 2023. GLORIA (NCT04121455) is TMEPharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 three additional arms combining NOX-A12 with: A. radiotherapy in patients with complete tumor resection; B. radiotherapy and bevacizumab; and C. radiotherapy and pembrolizumab. OPTIMUS (NCT04901741) is TMEPharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients. Aankondiging • Sep 13
Tme Pharma N.V. Announces NOX-A12 Combination Regimen with Bevacizumab: 17-Month Survival Rate Exceeds All Relevant Competitor Treatments Against Most Severe Form of Adult Brain Cancer TME Pharma N.V. announces that the median Overall Survival (mOS) and Overall Response Rate (ORR) for patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy has now exceeded what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy. After 17 months on study (median), 67% of GLORIA expansion arm patients (4 of 6) are still alive. The median Overall Survival is expected to improve further as the remaining patients continue to receive treatment or follow-up care. The milestone in survival at 17 months is a crucial landmark since it means the NOX-A12-based therapy has surpassed the survival rates achieved in what TME Pharma believes to be all the relevant competitor studies conducted in the US or EU involving newly diagnosed, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients. In addition, the NOX-A12-based therapy achieved this result despite having a more difficult population to treat since only patients with residual detectable tumor after surgery were included the NOX-A12 trial, while competing trials included patients with complete removal of detectable tumor. Aankondiging • Jul 13
TME Pharma N.V. Provides Positive Data Update on Best Response to Therapy with First Complete Response in Glioblastoma, Bringing 50% of Patients in Expansion Arm to Complete or Near- Complete Response TME Pharma N.V. announced a positive clinical update on the best response to therapy, reporting one patient achieving complete response in the GLORIA expansion arm evaluating NOX-A12, TME Pharma'sCXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab, in first-line glioblastoma. One patient (out of 6) in the expansion arm with a previous best response of 89.9% tumor shrinkage has achieved complete response, meaning the tumor disappeared completely and was no longer detectable by MRI. The complete response comes in addition to 2 patients with reported near-complete reductions (>99%) in tumor size, leading to 50% of patients in the GLORIA trial expansion arm achieving a complete or near-complete response. In November 2022, TME Pharma announced interim results from the GLORIA expansion arm [2] that demonstrated: 100% of target lesions treated with the triple combination of NOX-A12, radiotherapy and bevacizumab were reduced by more than 50% as measured by MRI. 5 of 6 patients (83%) achieved durable partial responses (PR) by mRANO criteria3, which take into account radiographic response as well as other factors such as the clinical condition of the patient. One patient experienced progressive disease (PD) due to distant failure while target lesion control was maintained. The triple combination was well tolerated and safe. No dose-limiting toxicities were observed. Aankondiging • Jun 30
TME Pharma N.V. Announces Positive 15-Month Survival Data from Gloria Expansion Arm Evaluating NOX-A12 in Combination with Radiotherapy and Bevacizumab in Glioblastoma TME Pharma N.V. announced a positive clinical update on the survival of first-line glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, TME Pharma'sCXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab. After 15 months on study (median), 83% of GLORIA expansion arm patients (5 of 6) remain alive. As long as treatment or follow-up for these patients is ongoing, median overall survival (mOS) will continue to improve. As a reference, the expected median overall survival for patients under current standard of care with chemotherapy refractory tumors (MGMT unmethylated) and whose tumor remains detectable after surgical intervention is approximately 10 months. Aankondiging • Jun 16
TME Pharma N.V. Receives Investigational New Drug (IND) Approval for NOX-A12 From the US FDA TME Pharma N.V. announced that the US Food and Drug Administration (FDA), after reviewing the comprehensive submission, has approved the company’s Investigational New Drug (IND) application to evaluate the company’s lead asset NOX-A12 in a Phase 2 study in pancreatic cancer (OPTIMUS) in the United States. OPTIMUS is an open-label Phase 2 study designed to evaluate the safety and efficacy of NOX-A12 combined with anti-PD-1 pembrolizumab (Keytruda® from Merck) and two different chemotherapy regimens (nanoliposomal irinotecan/5-FU/Leucovorin or gemcitabine/nab-paclitaxel) in second-line pancreatic cancer. The study is expected to enroll approximately 70 patients in clinical sites in the US, as well as France and Spain, where the study has been previously approved. As announced in June 2022, TME Pharma is currently focusing its capabilities on the development of NOX-A12 in glioblastoma. Therefore, the OPTIMUS Phase 2 trial in second-line pancreatic cancer will be initiated once appropriate funding becomes available. NOX-A12 is currently being developed in GLORIA, a Phase 1/2 study evaluating NOX-A12 in combination with radiotherapy and with or without bevacizumab in first-line glioblastoma brain cancer (glioblastoma) patients with tumors resistant to standard chemotherapy (with unmethylated MGMT promoter). Interim data reported to date from GLORIA demonstrate that NOX-A12 has an excellent safety profile with extremely encouraging signs of efficacy showing an 83% rate of survival at 14 months in patients with detectable chemotherapy refractory tumor remaining after surgery. Aankondiging • May 30
TME Pharma N.V., Annual General Meeting, Jun 29, 2023 TME Pharma N.V., Annual General Meeting, Jun 29, 2023, at 13:30 Central European Standard Time. Location: At the offices of Freshfields Bruckhaus Deringer LLP, Strawinskylaan 10, 1077 XZ Amsterdam Netherlands Agenda: To consider the annual accounts for the year ending December 31, 2022, and the report of the board of directors for 2022. Aankondiging • May 26
TME Pharma N.V. Provides Positive Clinical Update and 14-Month Survival Data from Gloria Expansion Arm Evaluating Nox-A12 in Combination with Radiotherapy and Bevacizumab in Glioblastoma TME Pharma N.V. announced clinical update on survival of newly diagnosed glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, TME Pharma'sCXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab. After 14 months on study (median), 83% of GLORIA expansion arm patients (5 of 6) are still alive. As long as treatment or follow-up for these patients is ongoing, median overall survival (mOS) will continue to improve. As a reference, the expected median overall survival for patients under current standard of care with chemotherapy refractory tumors (MGMT unmethylated) and whose tumor remains detectable after surgical intervention is approximately 10 months. The latest survival data from the treatment combination of NOX-A12 with radiotherapy and bevacizumab continues to validate therapeutic approach, demonstrates a highly encouraging trend towards prolonged overall survival and underlines the potential for superior benefit of this treatment combination for glioblastoma patients. Aankondiging • Jan 23
Tme Pharma Provides Clinical Update on the Gloria Expansion Arm Testing Nox-A12 in Combination with Radiotherapy and Bevacizumab in Patients with Glioblastoma TME Pharma N.V. announced a clinical update on survival of first-line glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, the CXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab. With a median follow-up to date of 10 months in this arm of the trial median overall survival (mOS) has not yet been reached, and five of six patients (83%) remain alive. The 10-month timepoint is an important landmark for assessment since this is the expected survival for patients with MGMT unmethylated tumors and incomplete resection. Aankondiging • Nov 19
TME Pharma Announces Positive Updated Interim Results from NOX-A12 GLORIA Phase 1/2 in Brain Cancer Presented at the Society for Neuro-oncology 2022 Annual Meeting TME Pharma N.V. announced the presentation of updated interim results from the GLORIA Phase 1/2 clinical trial expansion arm with NOX-A12 combined with radiotherapy and bevacizumab (biosimilar Avastin®) in chemotherapy-refractory (MGMT unmethylated) brain cancer (glioblastoma) in a poster presentation at the Society for Neuro-Oncology (SNO) Annual Meeting, held in Tampa, Florida, US from November 16 – 20, 2022. The company additionally disclosed newer data from the expansion arm that became available after the presentation submission cut-off date, as well as results from the completed dose-escalation part of the same clinical trial. The poster as well as the most recent data highlight the following key points: 100% of target lesions treated with the triple combination of NOX-A12, radiotherapy and bevacizumab were reduced by more than 50%. 5 of 6 patients (83%) achieved durable partial responses (PR) by mRANO criteria1, which takes into account radiographic response as well as other factors such as clinical condition of the patient. One patient experienced progressive disease (PD) due to distant failure while target lesion control was maintained. 2 of 6 patients achieved almost complete tumor size reduction (>99%) where contrast enhancing lesions were detectable but too small to be measured. The data for the second patient achieving >99% decrease in tumor size was obtained shortly after the data cut-off for the poster and will be presented in the webinar on November 22, 2022. The mean best sum of perpendicular diameters (SPD) of the tumor response was -74.9% (-53.8% to -99.9%) for target lesion sums. The triple combination was well tolerated and safe. No dose-limiting toxicities were observed. Aankondiging • Nov 12
TME Pharma Announces Publication of Abstract Disclosing Positive Interim Results from Bevacizumab Expansion Arm of NOX-A12 Gloria Phase 1/2 Brain Cancer Clinical Trial TME Pharma N.V. announced publication of the submitted abstract by conference organizers of positive interim data from the GLORIA Phase 1/2 clinical trial expansion arm with NOX-A12 combined with radiotherapy and bevacizumab (biosimilar of Avastin®) in first-line MGMT unmethylated brain cancer (glioblastoma) patients. The interim data from the published abstract show that five out of six patients (83.3%) achieved radiographic partial responses, which remained durable at a median follow-up of 5.6 months (range 3.6 to 9.3 months). Patients with MGMT-unmethylated brain tumors (refractory to chemotherapy) are particularly challenging and respond only rarely to standard of care. The GLORIA data compare favorably to a matched historical reference cohort of 20 glioblastoma patients treated with standard of care, where only 10% of patients achieved partial responses. In the GLORIA Phase 1/2 brain cancer trial in combination with bevacizumab, the mean best response in tumor size reduction was -65.9% (-13.3% to -99.9%) for sum of target lesion and -92.1% (-76.2% to -100%) for sum of non-target lesions (NTL). In all three patients with NTL, at least one lesion disappeared. Advanced MRI parameters showed reduced blood flow to targeted tumor lesions vs. baseline in all patients, consistent with the anticipated mechanism of action of preventing tumor blood vessel regrowth. Importantly, the neurological function of patients receiving NOX-A12 + RT + bevacizumab remained stable during follow-up as assessed by a scale adapted to patients with brain tumors, the Neurologic Assessment in Neuro-Oncology (NANO) scale. Aankondiging • Aug 26
TME Pharma N.V. Announces Data Safety Monitoring Board Validated Safety Data from the Initial Four Weeks of Treatment of the First Patient Enrolled in the GLORIA Phase 1/2 Clinical Trial Expansion Arm with NOX A12 TME Pharma N.V. announced that the Data Safety Monitoring Board (DSMB) validated safety data from the initial four weeks of treatment of the first patient enrolled in the GLORIA Phase 1/2 clinical trial expansion arm with NOX A12 combined with radiotherapy and the PD-1 immune checkpoint inhibitor pembrolizumab, and concluded it is appropriate to continue with recruitment of the remaining 5 patients according to the study protocol. GLORIA is a Phase 1/2 dose-escalation study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). The pembrolizumab expansion arm is the second triple-combination arm of the GLORIA clinical trial. The company also evaluates NOX-A12 combined with radiotherapy and bevacizumab. The company reported promising initial data from the bevacizumab expansion arm on June 23, 2022, and plans to disclose more detailed data from the study at a scientific conference later this year. Aankondiging • Aug 04
TME Pharma Announces Enrollment of First Patient in Pembrolizumab Expansion Arm of NOX-A12 GLORIA Phase 1/2 Brain Cancer Clinical Trial TME Pharma N.V. announced that the first patient was enrolled and has received their first week of treatment in the GLORIA Phase 1/2 clinical trial expansion arm with NOX-A12 combined with radiotherapy and the PD-1 immune checkpoint inhibitor pembrolizumab. Once this first patient of this expansion arm has received a four-week treatment of NOX-A12, radiotherapy, and pembrolizumab, the Data Safety Monitoring Board will convene to determine whether it is safe to recruit the remaining five patients into the arm. The expansion arms of the GLORIA trial will each enroll 6 patients with recruitment ongoing at 6 clinical sites. The clinical sites are now focused on patient recruitment into the second expansion arm with pembrolizumab after having completed recruitment of patients in the expansion arm with bevacizumab. Initial data from the bevacizumab expansion arm exploring the triple combination of NOX-A12, radiotherapy and bevacizumab reported by the company on June 23, 2022, showed reduced tumor size and radiographic partial response (defined as tumor size reduction of more than 50%) in 100% of evaluable patients, with tumor size reductions ranging from -54.7% to -94.7%. Data from the NOX-A12 dose-escalation part of the clinical trial were reported at ASCO 2022 in June and showed that 90% of patients who received NOX-A12 and radiotherapy achieved tumor size reductions and 40% of patients achieved partial response. TME Pharma aims to disclose more detailed data, including longer follow-up at a scientific conference later this year. Aankondiging • Jul 13
NOXXON Pharma N.V. Announces Resignation of Gregory Weaver from its Supervisory Board, Effective September 30, 2022 NOXXON Pharma N.V. announced the resignation of Gregory Weaver from its Supervisory Board, effective September 30, 2022. Mr. Weaver is transitioning away from some of his professional commitments to allow room to focus on his Chief Financial Officer career, leading to scaling back on his other professional obligations. He has served as a member of NOXXON's Supervisory Board since June 2021. Aankondiging • Jun 23
NOXXON Announces Updated Development Strategy Following Strong Clinical Benefit Observed With NOX-A12 in Combination With Radiotherapy and Bevacizumab in Brain Cancer NOXXON Pharma N.V. announced an updated strategy to focus its capabilities on NOX-A12 in brain cancer (glioblastoma) and in particular on the triple combination of NOX-A12, radiotherapy and bevacizumab. This decision follows positive data generated in the GLORIA Phase 1/2 study, consisting of a dose-escalation part with NOX-A12 plus radiotherapy and a triple combination part with NOX-A12, radiotherapy and bevacizumab of which initial results are announced. The data from the GLORIA dose-escalation part of the trial (reported at ASCO 2022) showed that 90% of patients treated with NOX-A12 and radiotherapy achieved tumor size reductions; 40% of all were even reaching radiographic partial response (defined as =50% reduction in tumor size). The interim results from the triple combination part now further validate the safety and suggest even deeper and more sustained responses. All five patients that completed radiotherapy and are under NOX-A12/bevacizumab therapy achieved radiographic partial responses in the initial MRI scan. In two patients that have already been assessed at 4 and 6 months, respectively, these radiographic partial responses were maintained. Reductions in tumor size at latest time-points as assessed by an independent central reader range from -54.7% to -94.7%. NOXXON targets disclosure of detailed data, including longer follow-up at a scientific conference later this year. With this strategy, NOXXON is aiming to maximize the opportunity to successfully develop NOX-A12 in glioblastoma, while also increasing potential returns to shareholders by considering fully self-financed clinical development, as well as global or partial geographic partnerships. Following this decision, all significant R&D activities on projects unrelated to glioblastoma will be placed on hold and alternative strategies will be defined over the coming months. Such alternatives include, without being limited to, Investigator Initiated Trials (IITs), local and global out-licensing, partnering for specific indications, and divestments. The planned Phase 2 OPTIMUS trial of NOX-A12 in pancreatic cancer has been fully approved in France and Spain and NOXXON aims to finalize discussions with the US Food and Drug Administration (FDA) on the design such that the trial could be initiated rapidly when appropriate financing is available. The GLORIA Phase 1/2 expansion arm in triple combination of NOX-A12, radiotherapy and bevacizumab in glioblastoma has completed recruitment of 6 patients and anticipates top line data on the six patients to be available in Fourth Quarter 2022. The recruitment of patients into the arm with pembrolizumab is ongoing. Data from the dose escalation and expansion arms will form the basis for discussions with the FDA and European regulators to discuss pathways to marketing authorization. Aankondiging • May 30
NOXXON Pharma N.V., Annual General Meeting, Jun 29, 2022 NOXXON Pharma N.V., Annual General Meeting, Jun 29, 2022, at 14:00 Central European Standard Time. Location: Freshfields Bruckhaus Deringer LLP Strawinskylaan 10, 1077 XZ Amsterdam Netherlands Aankondiging • May 27
NOXXON Announces Presentation of NOX-A12 Phase 1/2 Data in Glioblastoma at The 2022 ASCO Annual Meeting and Invitation to a Dedicated KOL Event NOXXON Pharma N.V. announced publication of the abstract of its poster presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting which will take place in Chicago, Illinois, US, from June 3 to June 7, 2022. The poster presentation entitled “Radiotherapy and olaptesed pegol (NOX-A12) in partially resected or biopsy-only MGMT-unmethylated glioblastoma: Interim data from the German multicenter phase 1/2 GLORIA trial” will be presented by Dr. Frank A. Giordano and will exhibit the top-line results of the Phase 1/2 GLORIA trial in brain cancer (glioblastoma). Specifically, the abstract highlights that: 40% of patients achieved partial response (PR defined as tumor size reduction over 50%), a considerable increase over the 22% previously disclosed and as reported in March 2022. In 3 out of 10 patients, one or more non-target lesions (smaller secondary lesions) completely disappeared. The combination of radiotherapy and NOX-A12 was safe and well-tolerated, with no dose limiting toxicities and no treatment-related deaths. Only 4% of the adverse events of Grade 2 or more were deemed solely NOX-A12-related. NOXXON’s oncology-focused pipeline acts on the tumor microenvironment (TME) and the cancer immunity cycle by breaking the tumor protection barrier and blocking tumor repair. By neutralizing chemokines in the TME, NOXXON’s approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. NOXXON’s lead program NOX-A12 has delivered final top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients published at the ESMO conference in September 2020 and in July 2021 the company announced its Phase 2 study, OPTIMUS, to further evaluate safety and efficacy of NOX-A12 in combination with Merck’s Keytruda® and two different chemotherapy regimens as second-line therapy in patients with metastatic pancreatic cancer. NOXXON is also studying NOX-A12 in brain cancer in combination with radiotherapy which has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. GLORIA, a trial of NOX-A12 in combination with radiotherapy in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy has delivered top-line data from all three dose-escalation cohorts showing consistent tumor reductions and objective tumor responses. Aankondiging • May 12
Noxxon Pharma N.V. Announces Scientific Advisory Board Appointments NOXXON Pharma N.V announced the appointment of two leading brain cancer experts to its Scientific Advisory Board. Prof. Monika Hegi and Dr. Michael Lim and will complement the current SAB and provide strategic and scientific counsel to NOXXON’s lead NOX-A12 program in brain cancer (glioblastoma). Monika E. Hegi is the Head of Laboratory of Brain Tumor Biology and Genetics, Department of Clinical Neurosciences, University Hospital Lausanne, Switzerland. Michael Lim is the Professor and Chair of the Department of Neurosurgery, Stanford University, California, USA. Aankondiging • Apr 06
Top-Line Results from NOXXON’S NOX-A12 Phase 1/2 GLORIA Trial in Brain Cancer to Be Presented during 2022 ASCO Annual Meeting NOXXON Pharma N.V. announced that top-line data from the ongoing NOX-A12 Phase 1/2 GLORIA trial in brain cancer will be presented in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, Illinois, US from June 3-7, 2022. ASCO is the world's leading professional organization for physicians and oncology professionals caring for people with cancer. Its flagship event, the Annual Meeting, promotes cutting-edge research and attracts more than 40,000 oncology professionals from around the world every year. OPTIMUS (NCT04901741) is NOXXON’s open-label two-arm phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients. GLORIA (NCT04121455) is NOXXON’s dose-escalation, phase 1/2 study of NOX-A12 in combination with irradiation in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 three additional arms combining NOX-A12 with: A. radiotherapy in patients with complete tumor resection; B. radiotherapy and bevacizumab in patients with incomplete tumor resection; and C. radiotherapy and pembrolizumab in patients with incomplete tumor resection. Aankondiging • Jan 07
NOXXON Provides Progress Update on the Expansion Arms of the Phase 1/2 GLORIA Trial With NOX-A12 in Brain Cancer Patients NOXXON Pharma N.V. announced that the Data Safety Monitoring Board (DSMB) positively evaluated safety data from the initial four weeks of treatment of the first patient enrolled in the GLORIA clinical trial expansion arm with NOX-A12 combined with radiotherapy and bevacizumab. The DSMB concluded that it is safe and appropriate to continue recruitment of five additional remaining patients into this arm according to the study protocol. NOXXON also announced that the German Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) approved the third expansion arm of the GLORIA clinical trial in which patients will receive the PD-1 immune checkpoint inhibitor pembrolizumab in combination with NOX-A12 and radiotherapy. The GLORIA Phase 1/2 clinical trial evaluates the safety and efficacy of NOX-A12 combined with radiotherapy in newly diagnosed brain cancer (glioblastoma) patients with unmethylated MGMT promoter. Three expansion arms, each intending to enrol six patients, will evaluate the benefit of NOX-A12 in other therapeutic settings: Arm A: NOX-A12 with radiotherapy in patients with complete tumor resection - Arm B: NOX-A12 with radiotherapy and bevacizumab in patients with incomplete tumor resection - Arm C: NOX-A12 with radiotherapy and pembrolizumab in patients with incomplete tumor resection. Aankondiging • Jan 04
NOXXON Pharma N.V. announced that it expects to receive €17 million in funding from Atlas Special Opportunities LLC NOXXON Pharma N.V. announced a private placement of common shares for gross proceeds of of up to €17,000,000 on January 3, 2022. Aankondiging • Dec 09
NOXXON Pharma N.V. Announces Enrolment of First Patient in the Expansion of the NOX-A12 Phase 1/2 Trial in Brain Cancer NOXXON Pharma N.V. announced that the first patient was enrolled in an expansion arm of the GLORIA clinical trial of NOX-A12 in MGMT unmethylated brain cancer (glioblastoma, GBM). The patient has received their first week of treatment of NOX-A12 (600 mg/week) and the VEGF inhibitor bevacizumab combined with radiotherapy. The GLORIA Phase 1/2 clinical trial evaluates the safety and efficacy of NOX-A12 combined with radiotherapy. In three expansion arms, the synergistic benefit of NOX-A12 with other therapeutic settings will be evaluated: Arm A: NOX-A12 with radiotherapy in patients with complete tumor resection; Arm B: NOX-A12 with radiotherapy and bevacizumab in patients with incomplete tumor resection; Arm C: NOX-A12 with radiotherapy and anti-PD-1 in patients with incomplete tumor resection. Each expansion arm plans to evaluate 6 patients. Aankondiging • Nov 23
NOXXON Pharma N.V. Presents New Phase 1/2 Data On NOX-A12 & Radiotherapy Combination in Brain Cancer at the Society for Neuro-Oncology Annual Meeting 2021 NOXXON Pharma N.V. announced that new data from the ongoing Phase 1/2 GLORIA trial with NOX-A12 and radiotherapy in brain cancer (glioblastoma multiforme, GBM) were presented at the Society for Neuro-Oncology (SNO) Annual Meeting. The presentation was held by Frank A. Giordano, M.D., Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany, and lead investigator of the ongoing GLORIA study. The oral presentation, entitled “CXCL12 inhibition in MGMT unmethylated glioblastoma - results of an early proof-of-concept assessment in the multicentric phase I/II GLORIA trial”, included results from 9 chemotherapy refractory (MGMT promoter unmethylated) patients participating in the proof-of-concept study on CXCL12 inhibition during and after radiotherapy of glioblastoma. Eight of 9 patients (89%) receiving NOX-A12 showed reductions in tumor size (2 patients with objective responses [>50% reduction] and 6 patients with stable disease [<50% reduction], while one patient progressed. These results compare favorably with historic patient outcomes from a matched cohort that received standard of care, where only 1 out of 13 patients (8%) showed a reduction in tumor size with an objective response and 12 patients’ tumors progressed. Also, data from tissue analysis of a patient on NOX-A12 therapy shows a significant reduction of the NOX-A12 target, CXCL12, on tumor blood vessels, a significant decrease in tumor cell proliferation and an increase in tumor infiltration of activated killer immune cells. Interestingly and very importantly, such benefits were observed across all available tumor tissue and not only in small subsections. These benefits are strongly supportive of the dual mechanism of action of NOX-A12: inhibiting repair of blood vessels damaged by radiotherapy; promoting of immune-response. This dual mechanism of action could prove transformational since this is not consistently observed in historical samples including patients treated with immune checkpoint inhibitors. Aankondiging • Sep 23
NOXXON Pharma N.V Enrolls Last Brain Cancer Patient in Dose Escalation Portion of GLORIA Study and Confirms Phase 1/2 Read-Out NOXXON Pharma N.V announced that the tenthand last patient with newly diagnosed brain cancer was enrolled into the third cohort of the Phase 1/2 clinical study and has been receiving the high dose (600 mg/week) of NOX-A12 for one week now. This patient will receive treatment and be monitored for six months leading to Phase 1/2 data expected in First Quarter 2022, as previously guided. An expansion phase will be the next step in this trial to obtain clinical data in additional patients with brain cancer. The GLORIA study investigates a combined therapy of increasing doses of the CXCL12 inhibitor, NOX-A12, and external-beam radiotherapy in newly diagnosed brain cancer patients. Three dose regimens of NOX-A12 (200, 400 and 600 mg/week) are being tested and administrated for up to six months. Aankondiging • Aug 06
NOXXON Provides Update on NOX-A12 Clinical Programs NOXXON Pharma N.V. provided an update on the clinical development and timelines of its lead asset NOX-A12. As NOX-A12 recently reported promising data from the second cohort of patients with glioblastoma (brain cancer), NOXXON is advancing and broadening the clinical programs with the upcoming expansion of the ongoing GLORIA study in patients with brain cancer and the initiation of a Phase 2 study in pancreatic cancer patients over the coming 12 months: Brain cancer: the ongoing Phase 1/2 GLORIA trial (NCT04121455), evaluating NOX-A12 in combination with radiotherapy in first-line MGMT unmethylated brain cancer patients, has already reported positive data from the first 2 cohorts of 3 patients each treated with weekly doses of 200 and 400 mg of NOX-A12. The third cohort of 3 patients dosed at 600 mg per week has been fully recruited with data expected in Fourth Quarter 2021, but due to the drop out of one of the patients unrelated to NOX-A12, recruitment of a replacement patient has been initiated and the data from this third cohort are now expected in First Quarter 2022; the expansion of the Phase 1/2 GLORIA trial with NOX-A12 in MGMT unmethylated brain cancer patients is expected to be initiated in September 2021 at the 6 clinical sites in Germany which are already participating. First patients are expected to be recruited in fourth quarter of 2021. The trial will (i) expand the patient population to those with completely resected tumors for the combination of NOX-A12 with radiotherapy and (ii) evaluate a new NOX-A12 treatment combination in patients with incompletely resected tumors. Executive Departure • Jul 02
Member of Supervisory Board J. deBethizy has left the company On the 24th of June, J. deBethizy's tenure as Member of Supervisory Board ended. We don't have any record of a personal shareholding under deBethizy's name. A total of 2 executives have left over the last 12 months. Executive Departure • Jul 02
Independent Member of the Supervisory Board Bertram Köhler has left the company On the 25th of June, Bertram Köhler's tenure as Independent Member of the Supervisory Board ended. We don't have any record of a personal shareholding under Bertram's name. A total of 2 executives have left over the last 12 months. Aankondiging • Jun 09
NOXXON Pharma N.V. Announces Positive Results from the Second Cohort in its Phase 1/2 Study of Nox-A12 NOXXON Pharma N.V. announced positive results from the second cohort in its Phase 1/2 study of NOX-A12 in combination with radiotherapy in patients with brain cancer (Glioblastoma Multiforme). Data show that NOX-A12 at 400mg/week continues to be safe and well tolerated with apparent signals of reduction of tumor size. The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. The six patients in the first two cohorts (3 patients receiving 200 mg/week and 3 patients receiving 400 mg/week) have now completed NOX-A12 therapy, with over 83% of these patients showing reductions in tumor size during or after NOX-A12 treatment with maximal reductions from baseline ranging from 2% to 62%2 for patients treated at 200 mg/week (1st cohort), and 28% and 71%1,2 for two patients treated at 400 mg/week (2nd cohort). These patients tolerated combined radiotherapy and NOX-A12 therapy well without any signs of dose-limiting toxicities. Two patients, one in each of the first two cohorts, achieved objective responses with tumor reductions greater than 50%, one of which occurred after cessation of NOX-A12 therapy. In three of the six patients, smaller satellite lesions that were present before therapy around the primary tumor completely disappeared. In cohort 1 (200mg/week), two of three patients have survived past the expected average survival of 10 months. Further analysis of survival in each cohort is still pending follow-up. NOX-A12 targets CXCL12 (C-X-C Chemokine Ligand 12), a key chemokine protein that communicates between tumor cells and their environment, and is designed to 1) block repair of destroyed blood vessels and 2) break tumor protection against the immune system, enabling anti-cancer immune cells, such as killer T-cells, to enter tumor tissue and attack the cancer cells. Advanced MRI imaging techniques showed that five of six patients in the first two cohorts achieved reduced blood flow to the tumor compared with baseline3, suggesting that NOX-A12 combined with radiotherapy was able to prevent blood vessel regrowth, a key mechanism of action predicted by preclinical data. The pharmacologic effect was further supported by comparison of pre-treatment to on-therapy tumor tissue from one patient in cohort 1, revealing a disappearance of CXCL12 from the barrier cells that separate the blood from the tissue, suggesting that NOX-A12 was able to effectively suppress its target4. This tissue comparison also showed an extensive reduction in the number of actively dividing tumor cells, reaching almost zero in the on-therapy sample, and clusters of expanding cytotoxic immune cells throughout the under-treatment sample. This supports the notion that NOX-A12 can facilitate an entrance of immune cells into the tumor and an anti-tumoral immune response5, already at the lowest tested dose in the study. Aankondiging • Jun 01
NOXXON Announces Positive Results From Second Cohort in Phase 1/2 NOX-A12 Brain Cancer Trial NOXXON Pharma N.V. announced positive results from the second cohort in its Phase 1/2 study of NOX-A12 in combination with radiotherapy in patients with brain cancer (Glioblastoma Multiforme). Data show that NOX-A12 at 400mg/week continues to be safe and well tolerated with apparent signals of reduction of tumor size. The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. The six patients in the first two cohorts (3 patients receiving 200 mg/week and 3 patients receiving 400 mg/week) have now completed NOX-A12 therapy, with over 83% of these patients showing reductions in tumor size during or after NOX-A12 treatment with maximal reductions from baseline ranging from 2% to 62%1. These patients tolerated combined radiotherapy and NOX-A12 therapy well without any signs of dose-limiting toxicities. Two patients, one in each of the first two cohorts, achieved objective responses with tumor reductions greater than 50%, one of which occurred after cessation of NOX-A12 therapy. In three of the six patients, smaller satellite lesions that were present before therapy around the primary tumor completely disappeared. In cohort 1 (200mg/week), two of three patients have survived past the expected average survival of 10 months. Further analysis of survival in each cohort is still pending follow-up. NOX-A12 targets CXCL12 (C-X-C Chemokine Ligand 12), a key chemokine protein that communicates between tumor cells and their environment, and is designed to 1) block repair of destroyed blood vessels and 2) break tumor protection against the immune system, enabling anti-cancer immune cells, such as killer T-cells, to enter tumor tissue and attack the cancer cells. Advanced MRI imaging techniques showed that five of six patients in the first two cohorts achieved reduced blood flow to the tumor compared with baseline2, suggesting that NOX-A12 combined with radiotherapy was able to prevent blood vessel regrowth, a key mechanism of action predicted by preclinical data. The pharmacologic effect was further supported by comparison of pre-treatment to on-therapy tumor tissue from one patient in cohort 1, revealing a disappearance of CXCL12 from the barrier cells that separate the blood from the tissue, suggesting that NOX-A12 was able to effectively suppress its target3. This tissue comparison also showed an extensive reduction in the number of actively dividing tumor cells, reaching almost zero in the on-therapy sample, and clusters of expanding cytotoxic immune cells throughout the under-treatment sample. This supports the notion that NOX-A12 can facilitate an entrance of immune cells into the tumor and an anti-tumoral immune response4, already at the lowest tested dose in the study. Aankondiging • May 11
Noxxon Pharma N.V. Announces Data Safety Monitoring Board Validates NOX-A12 Highest Dose in Phase 1/2 Brain Cancer Trial NOXXON Pharma N.V. announced that an independent Data Safety Monitoring Board (DSMB) has confirmed that the highest dose of NOX-A12 in combination with radiotherapy in the ongoing Phase 1/2 study in patients with brain cancer is safe and that the trial should continue as planned. The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. The DSMB recommendation to proceed followed the analysis of safety data stipulated in the study protocol after all three patients in the third – and last – cohort completed at least four weeks of treatment at the highest dose. Aankondiging • Mar 14
Noxxon Pharma N.V. Announces That the Data Safety Monitoring Board Analyzed Safety Data from the Initial Four Weeks of Treatment of the First Patient Enrolled in the Third and Final Dose Cohort of the NOX-A12 Plus NOXXON Pharma N.V. announced that the Data Safety Monitoring Board (DSMB) analyzed safety data from the initial four weeks of treatment of the first patient enrolled in the third and final dose cohort of the NOX-A12 plus radiotherapy brain cancer study. The DSMB concluded that it is safe and appropriate to continue patient recruitment according to the study protocol. The DSMB’s decision marks an important milestone in this trial as it enables the advancement and analysis of the final dose regimen, placing NOXXON on the path toward valuable data readouts anticipated later this year. The Phase 1/2 clinical study is testing three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy, in newly diagnosed brain cancer patients. Based on the DSMB’s confirmation, participating clinical centers have now initiated final patient recruitment for the last and dose group. After all patients in the third cohort have received four weeks of treatment with NOX-A12 and radiotherapy, the DSMB will reconvene for a final meeting to assess safety and tolerability. The outcome of this meeting will inform the recommended dose for the next randomized, controlled brain cancer trial which will lead to the registration of NOX-A12. Aankondiging • Feb 16
NOXXON Enrolls First Patient in the High Dose Cohort of Trial Combining NOX-A12 With Radiotherapy in Newly Diagnosed Brain Cancer NOXXON Pharma N.V. announced the enrollment and first week of treatment of the first patient in the third, high dose cohort of the Phase 1/2 clinical trial. The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients who would not benefit clinically from treatment with standard chemotherapy. Once the newly enrolled patient in the third cohort has received a four-week treatment of NOX-A12 and radiotherapy, the Data Safety Monitoring Board will convene to determine whether it is safe to recruit the remaining two patients into the cohort. Aankondiging • Feb 09
NOXXON Appoints Leading Pancreatic Cancer Experts to Scientific Advisory Board NOXXON Pharma N.V. announced the appointment of four leading pancreatic cancer experts to its Scientific Advisory Board (SAB). Led by the newly appointed Chair, Dr. Jose Saro, the SAB will provide strategic and scientific counsel to NOXXON’s clinical programs in this indication. The members of NOXXON’s SAB for pancreatic cancer are listed below. Chiorean, E. Gabriela, MD. O’Reilly, Eileen M., MD. Prof. Dr. Seufferlein, Thomas T. W. Von Hoff, Daniel D.,MD, FACP, FASCO, FAACR. Aankondiging • Feb 02
NOXXON Pharma N.V. Appoints Jose Saro as Chair of Scientific Advisory Board NOXXON Pharma N.V. announced the formation of a Scientific Advisory Board (SAB) and the appointment of Jose Saro, M.D. as its Chair. Dr. Saro and the SAB will provide scientific and strategic advice to the company regarding research and development of its programs in cancer. Dr. Jose Saro brings over 25 years of experience in the preclinical, translational and clinical development of oncology compounds to NOXXON. Throughout his career, he has developed an extensive global network among oncologic academic institutions and the pharmaceutical industry. Dr. Saro currently works at AstraZeneca where he leads the ceralasertib post-PARP inhibitor early clinical development program in solid tumors. Prior to that, he worked at Avacta as Chief Medical Officer driving the development strategy of Affimer® programs into the clinic. Is New 90 Day High Low • Dec 31
New 90-day high: €0.65 The company is up 24% from its price of €0.53 on 02 October 2020. The German market is up 9.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 2.0% over the same period. Aankondiging • Dec 30
NOXXON Pharma N.V. Announces Initiation of NOX-A12 Manufacturing for Future Clinical Studies NOXXON Pharma N.V. announced the initiation of manufacturing of NOX-A12, the company’s lead drug candidate, in preparation for upcoming clinical studies. As previously communicated, NOXXON’s clinical development strategy for NOX-A12 will focus on two indications: brain and pancreatic cancer. The company will evaluate different combination approaches enabling multiple avenues to successfully develop NOX-A12 and to advance the company’s pipeline in underserved indications. NOXXON is preparing to initiate a two-arm clinical trial in H2 2021 for pancreatic cancer. The study will test two different standard of care chemotherapy combinations with NOX-A12 plus anti-PD-1 immunotherapy in second-line patients. This strategic approach will enable NOXXON to choose the optimal combination therapy to move forward into a randomized, controlled pivotal study. In its clinical development strategy for brain cancer, the company plans to expand the ongoing Phase 1/2 dose escalation study of NOX-A12 combined with radiotherapy. The expansion of the dose cohort chosen for the anticipated pivotal trial would provide additional safety and efficacy data in a larger group of patients for discussions with regulatory agencies. The initiation of the expansion study is planned for 2021. In order to secure manufacturing commitments that will allow continued advancement of these programs, the company drew down tranches dedicated to drug manufacturing for a total amount of €2.5 million from the Atlas Special Opportunities, LLC (ASO) convertible bond vehicle and issued to ASO 2,546 convertible bonds (including 46 convertible bonds issued in relation to the transaction fee) with a nominal value of €1,000 each on December 29, 2020. The amended and improved conditions of this financing vehicle were disclosed on October 14, 2020. Aankondiging • Nov 09
NOXXON Pharma N.V. Announces That Data Safety Monitoring Board Validates Further Nox-A12 Dose Escalation in Phase 1/2 Brain Cancer Study NOXXON Pharma N.V. announced that an independent Data Safety Monitoring Board (DSMB) has confirmed that it is safe and appropriate to start patient recruitment for the highest planned dose cohort for the Phase 1/2 NOX-A12 plus radiotherapy brain cancer study. The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. The decision to proceed followed the analysis of safety data stipulated in the study protocol after all patients in the second cohort completed at least four weeks of treatment at the middle dose. The clinical study centers participating in the study have initiated patient recruitment for the high-dose group that will receive 600 mg NOX-A12 per week. Once the first patient in the third cohort completes four weeks of treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to recruit the remaining two patients in the cohort. Aankondiging • Oct 29
NOXXON Pharma N.V. Announces Completion of 6-Month Therapy for Low-Dose Cohort in Phase 1/2 Brain Cancer Study of NOX-A12 Plus Radiotherapy NOXXON Pharma N.V. announced that the last patient in the low-dose cohort has completed six months of NOX-A12 therapy in the Phase 1/2 brain cancer clinical trial. The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external beam radiotherapy in newly diagnosed MGMT1 promoter unmethylated glioblastoma patients, a difficult-to-treat brain cancer. Patients participating in the study would not have benefitted clinically from the standard of care chemotherapy due to their MGMT promoter methylation status. They also all had tumor tissue remaining after surgical resection before being recruited into the study. Tumor volume reductions were observed in two of three patients during the six-month treatment, and in the third patient in the period after a second surgery following continued NOX-A12 treatment. Maximum tumor volume reductions were 6% and 60% for the first two patients. The third patient experienced 23% tumor volume reduction relative to the post-second surgery baseline. Tumor volume reductions were reported as the average of two independent central MRI readers and results included unscheduled scans. Two of three patients had stable or decreasing tumor volumes for 16 weeks or longer (one following a second surgery) and both are currently in the treatment-free follow-up period. One patient deceased from tumor progression during the treatment period. NOX-A12 steady-state plasma levels were in the targeted range following administration of 200 mg per week. With a data cutoff date of October 23, 2020, the adverse event profile was similar to that expected from radiotherapy alone in glioblastoma patients. Eighteen of 90 adverse events were noted as being potentially related to NOX-A12 and disease or radiotherapy. There were five adverse events potentially related only to NOX-A12 which were all mild or moderate (grade 1 or 2), confirming the manageable safety and tolerability profile for NOX-A12 in combination with radiotherapy. Going forward NOXXON’s planned clinical development strategy for NOX-A12 will be focused on two indications: brain cancer and pancreatic cancer. Each indication will test a different combination strategy, thereby providing multiple possibilities to successfully advance the clinical development plan: NOX-A12 plus radiotherapy in brain cancer, and NOX-A12 plus immuno-/chemotherapy in pancreatic cancer. In brain cancer, NOXXON plans to complete the ongoing Phase 1/2 study testing three doses of NOX-A12 combined with radiotherapy. The company is considering expanding the dose cohort, which is finally chosen for the planned pivotal trial, in order to gain experience in a larger group of patients for discussions with regulatory agencies. The next planned trial will be a pivotal, randomized Phase 2 trial comparing NOX-A12 plus radiotherapy to standard of care in MGMT unmethylated first-line glioblastoma patients. MGMT unmethylated patients represent approximately 50% of all first-line glioblastoma patients, or approximately 6,000 patients per year in the EU and 5,000 patients per year in the US. NOXXON’s planned clinical development strategy for pancreatic cancer will initially involve a two-arm clinical trial testing the combination of NOX-A12 plus anti-PD-1 immunotherapy in second-line patients. In each arm, a different second-line standard of care chemotherapy regimen will be combined with NOX-A12 plus anti-PD1. This will allow NOXXON to choose the best combination therapy to move forward into a randomized, controlled pivotal trial. Aankondiging • Oct 20
Noxxon Pharma N.V. Announces Three Additional Clinical Centers to Recruit Patients for Nox-A12 Brain Cancer Trial NOXXON Pharma N.V. announced the collaboration with three additional clinical sites to increase recruitment capacity for the Phase 1/2 brain cancer study of NOX-A12 plus radiotherapy, as a measure to ensure the timely completion of the study under the current challenging conditions posed by the COVID-19 pandemic. Along with the hospitals in Mannheim, Essen and Bonn, which have been participating in the recruitment of patients for the study since mid-2019, NOXXON will also collaborate with investigators at three additional hospitals in Leipzig, Münster and Tübingen, Germany. The clinical Phase 1/2 trial investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. Having completed patient recruitment in the first and second dose cohort, all six centers will continue enrolling patients into the highest dose cohort. Top-line data from the study is expected in mid-2021. Is New 90 Day High Low • Oct 16
New 90-day low: €0.41 The company is down 13% from its price of €0.48 on 17 July 2020. The German market is flat over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 11% over the same period. Aankondiging • Oct 14
Noxxon Announces Successful Completion of Patient Recruitment for Second Dose Cohort in Phase 1/2 Brain Cancer Study of Nox-A12 Plus Radiotherapy NOXXON Pharma N.V announced that all three patients of the second dose cohort have been enrolled into the brain cancer clinical trial testing CXCL12 inhibitor, NOX-A12, and have already received the planned initial treatment. The Phase 1/2 clinical study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external beam radiotherapy in newly diagnosed brain cancer patients. Once the last patient in the second cohort completes four weeks of therapy of NOX-A12 and radiotherapy, the independent Data Safety Monitoring Board (DSMB) will determine whether it is safe to proceed from the middle to the highest dose level of NOX-A12. The approved protocol plans for each patient to be treated with NOX-A12 for up to six months. Aankondiging • Sep 17
NOXXON Pharma N.V. Presents Final Clinical Data from Phase 1/2 NOX-A12 / Keytruda® Combination Trial in Colorectal and Pancreatic Cancer at the ESMO Virtual Congress 2020 NOXXON Pharma N.V. presented final clinical results from the Phase 1/2 study with CXCL12 inhibitor, NOX-A12, and pembrolizumab in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer at the European Society for Medical Oncology Virtual Congress 2020. The enhanced immune response and long survival times for certain late-stage patients combined with the good overall safety profile confirmed in the final data support further development of the combinations containing NOX-A12 plus pembrolizumab and established standard of care regimens in earlier lines of therapy. The trial called for all patients to have a baseline biopsy of tumor tissue, two weeks of NOX-A12 monotherapy and then a second biopsy to assess changes induced in the tumor microenvironment by NOX-A12. After the second biopsy, it was planned to move all patients to a combination therapy of NOX-A12 plus pembrolizumab (MSD’s anti-PD-1 antibody) and continue combination therapy until tumor progression or safety issues. CXCL12, the target of NOX-A12 which is thought to exclude immune cells from the tumor microenvironment, was found to be abundantly present in all tumor samples at baseline. NOX-A12 penetrated cancer tissue in both pancreatic and colorectal cancer patients where it neutralized its target, CXCL12. NOX-A12 monotherapy resulted in induction of a Th1-like immune response in patients when baseline biopsies were compared to post-NOX-A12 monotherapy samples. The extent of CXCL12 neutralization in tumor tissue correlates with a Th1 immune response and disease stabilization and based on the obtained results, an optimized dosing strategy for NOX-A12 will be used for future studies. As would be expected if the immune system were better coordinating a response against the cancer, T cells in the cancer both moved together (aggregation) and moved towards the tumor cells in responding tissues. The combination of NOX-A12 plus pembrolizumab resulted in stable disease in 25% of patients, and prolonged time on treatment vs. prior therapy for 35% of patients. Overall survival was 39% at 6 months and 20% at 12 months. Three of the stable disease patients (15% of the starting study population) survived for more than a year. In addition, the combination of NOX-A12 with pembrolizumab appears to be safe and this allows exploration of further combination approaches in earlier line patients combining an optimized dose with standard of care. Taken together, these data thus support a role of CXCL12 in resistance to immunotherapy and suggest that NOX-A12 may be able to counter this effect by boosting the immune response in tumor tissue. Further studies of NOX-A12 in combination regimens are warranted and currently the company is exploring strategies with external experts to combine NOX-A12 with anti-PD1 agents and established standard of care regimens in earlier lines of therapy than those explored in this clinical trial. Aankondiging • Jul 23
NOXXON Pharma N.V. announced that it has received €0.499999 million in funding On January 27, 2020, NOXXON Pharma N.V. (ENXTPA:ALNOX) closed the transaction. 
