Bexmarilimab

Final data in PD-1 refractory metastatic melanoma underpin the rationale for the ongoing BLAZE trial of bexmarilimab in combination with nivolumab TURKU, FI / ACCESS Newswire / October 19, 2026 / Faron Pharmaceuticals Ltd. (HEL:FARON)(LSE:FARN), a global, clinical-stage biopharmaceutical company focused on creating innovative cancer treatments that leverage the patient's own immune system, today announces that final results from the metastatic melanoma cohort of its Phase 1/2 MATINS study have been accepted as an ePoster at the European Society for Medical Oncology (ESMO) Congress 2026, taking place in Madrid, Spain, 23-27 October 2026. These are the final results from the melanoma cohort of MATINS and the first report of complete survival data for all 25 patients, following interim results presented in 2022 and 2023. The melanoma cohort comprised 25 patients with checkpoint inhibitor-refractory metastatic melanoma who received single-agent bexmarilimab at doses of 0.3 to 10 mg/kg every three weeks. All patients had failed prior anti-PD-1 therapy and 48% had also failed anti-CTLA-4 therapy. Patients had received a median of three prior lines of treatment, with a range of one to seven. The disease control rate was 20% and median overall survival was 7.6 months (95% CI 5.3-14.9). Patients who achieved disease control had a median overall survival of 15.2 months, compared with 6.2 months in patients who did not (p=0.1545), and 12-month survival rates of 80% and 35% respectively. The duration of the previous line of therapy before entering the trial was similar in both groups (p=0.7275). Treatment-emergent adverse events were reported in 96% of patients, including grade 3 or higher events in 56% and serious events in 44%, consistent with a heavily pretreated metastatic population. Events assessed as related to bexmarilimab occurred in 36% of patients, most commonly fatigue (20%), with one patient (4%) experiencing a related event of grade 3 or higher. Exploratory biomarker analyses showed lower baseline serum interferon gamma (sIFNγ) in patients who achieved disease control than in those who did not (3.5 versus 13.5 pg/mL, p=0.002). Low baseline sIFNγ was associated with a trend toward longer overall survival (10.1 versus 5.2 months, p=0.1971), and patients with disease control showed a median peak increase in sIFNγ of 181% on treatment, consistent with treatment-induced immune activation. These analyses are exploratory and the survival differences did not reach statistical significance in a cohort of this size. Petri Bono, MD, PhD, Chief Medical Officer of Faron, stated, "These are the complete survival data for bexmarilimab in melanoma, in patients who had run out of options. One in five achieved disease control on a single agent, and those patients lived longer, although in 25 patients we cannot call that difference statistically significant. What interests us most is the biology underneath it. The patients who benefited started with lower interferon gamma and their levels rose on treatment, which is what we would expect if bexmarilimab is reactivating an immune response that had been switched off. That is the question the BLAZE trial is now asking in combination with a checkpoint inhibitor." MATINS evaluated bexmarilimab as a single agent. The BLAZE trial, led by The Institute of Cancer Research, London, operating in partnership with The Royal Marsden NHS Foundation Trust, is the first clinical evaluation of bexmarilimab in combination with a checkpoint inhibitor in patients with acquired resistance to immunotherapy. BLAZE enrolls patients with metastatic non-small cell lung cancer (NSCLC) and melanoma who have progressed on prior anti-PD-1 therapy, and uses a sequential priming design in which patients receive an initial run-in dose of bexmarilimab , aiming to reprogram the immunosuppressive tumor microenvironment, before transitioning to the combination of bexmarilimab and nivolumab. Faron announced the first patient dosed in BLAZE on 01 October 2026. Its Principal Investigator, Dr Anna Minchom, is also the presenting author of the MATINS melanoma data. For more information on the BLAZE trial: NCT07718243 . Abstract details: Title : Activity of bexmarilimab, a novel macrophage checkpoint inhibitor, in PD-1 refractory metastatic melanoma: final results from the phase I/II MATINS study Abstract number : FPN 1091eP Category : Developmental therapeutics Presenting author : Dr. Anna Minchom, The Institute of Cancer Research, London Presentation type : ePoster, available on the ESMO congress platform and on the ePoster screens in Hall 5 Clinical trial identification : NCT03733990 About bexmarilimab Bexmarilimab is Faron's wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes by targeting myeloid cell function. It binds to Clever-1, a receptor on immunosuppressive macrophages that helps cancer evade the immune system. By targeting Clever-1, bexmarilimab reprograms the tumor microenvironment to ignite a potent anti-tumor immune response. About MATINS The MATINS study was a first-in-human open label phase 1/2 clinical trial investigating the tolerability, safety and efficacy of bexmarilimab in ten different hard-to-treat metastatic or inoperable solid tumor cohorts, which are all known to host a significant number of Clever-1 positive tumor-associated macrophages (TAMs). The completed Part 1 of the trial dealt with tolerability, safety and dose escalation. The completed Part 2 focused on identifying patients who show an increased number of Clever-1 positive TAMs and exploring safety and efficacy. Data from MATINS showed bexmarilimab to be safe and well-tolerated, and demonstrated early signs of clinical benefit in patients who have exhausted all other treatment options. About Faron Pharmaceuticals Ltd Faron (AIM:FARN)(First North:FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company's lead asset is bexmarilimab , a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase 1/2 clinical trials as a potential therapy for patients with hematological cancers and solid tumors in combination with other standard treatments. Further information is available at . Forward-Looking Statements Certain statements in this announcement are, or may be deemed to be, forward-looking statements. Forward looking statements are identified by their use of terms and phrases such as "believe", "could", "should", "expect", "hope", "seek", "envisage", "estimate", "intend", "may", "plan", "potentially", "will" or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward-looking statements reflect the Directors' current beliefs and assumptions and are based on information currently available to the Directors. A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based. For more information, please contact: IR Partners, Finland (Media) Kare Laukkanen +358 50 553 9535 / +44 7 469 766 223 kare.laukkanen@irpartners.fi LifeSci Advisors, US (Investors) Daniel Ferry +1 617 430-7576 daniel@lifesciadvisors.com Cairn Financial Advisers LLP (Nominated Adviser and Broker) Sandy Jamieson, Jo Turner +44 (0) 207 213 0880 Sisu Partners Oy (Certified Adviser on Nasdaq First North) Juha Karttunen Jukka Järvelä +358 (0)40 555 4727 +358 (0)50 553 8990 SOURCE: Faron Pharmaceuticals View the original press release on ACCESS Newswire