Bexmarilimab

TURKU, FI / ACCESS Newswire / June 15, 2026 / Faron Pharmaceuticals (HEL:FARON)(LSE:FARN) - Data continue to demonstrate prolonged durability of response, with median duration of CR reaching 16.1 months in frontline HR‑MDS, supporting the upcoming initiation of the Phase 2b trial Median duration of Complete Remission (CR) in treatment-naïve higher-risk myelodysplastic syndrome (HR-MDS) extended to 16.1 months with bexmarilimab + azacitidine Frontline HR-MDS treatment achieved an 85% Overall Response Rate (ORR), with 60% of patients achieving full clearance of bone marrow blasts Translational data indicates bexmarilimab drives bone marrow progenitor recovery and adaptive immune recruitment TURKU, FINLAND - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunotherapies, today announced the poster presentation of updated translational insights and matured clinical efficacy data from its ongoing BEXMAB Phase 1/2 trial at the European Hematology Association (EHA) 2026 Congress, 11-14 June, Stockholm, Sweden. The poster highlights the steady accumulation of clinical and biological evidence validating bexmarilimab, Faron's first-in-class immunotherapy candidate currently under clinical development for myeloid malignancies. Enhanced remission durability and blast clearance in treatment-naïve HR-MDS Data from the treatment-naïve HR-MDS cohort continues to mature positively, reflecting an ORR of 85% and a CR rate of 45%. Following a longer median follow-up of 14.9 months, the trial achieved substantial improvements in the durability and depth of clinical responses. Specifically, median duration of CR reached 16.1 months, indicating durable and clinically meaningful responses. Furthermore, 60% of patients now demonstrate full clearance of bone marrow blasts, a positive increase from the 55% observed in the prior data cut. As previously disclosed, Faron has achieved alignment with the FDA on the use of CR as a key endpoint for the upcoming Phase 2b trial, making the observed CR rate in this study particularly encouraging. Dr. Mika Kontro, MD, PhD, Associate Professor at the Helsinki University Hospital Comprehensive Cancer Center and Principal Investigator of the BEXMAB trial, said , "These results reinforce the potential of bexmarilimab to deliver clinically meaningful benefit in HR-MDS. A median duration of CR of 16.1 months in frontline patients is an encouraging signal, and the translational data add important biological depth. We are seeing evidence of genuine immune reprogramming in the bone marrow, with recovery of healthy progenitor cells and activation of cytotoxic T cell responses. Together, these findings provide a compelling foundation for the randomized Phase 2b BEXERA trial." Pre-treatment immune status correlates with depth of clinical response Translational analyses further demonstrated that bexmarilimab + azacitidine drives meaningful changes in the bone marrow immune landscape. Increases in basophil/mast cell and erythroid progenitor populations were observed in the majority of responding patients, alongside activation of cytotoxic CD8+ T cell responses and reductions in exhausted TIM3+ CD4+ T cells, consistent with immune reprogramming compared to azacitidine activity alone. Baseline immune profiling differentiated responders from non-responders: patients who achieved CR had a higher proportion of CD4+ and CD8+ central memory T cells and a lower proportion of terminal effector memory (TEMRA) T cells prior to treatment, suggesting a more favorable pre-existing immune context in CR responders. "The findings presented at EHA 2026 represent a vital milestone in our disciplined generation of evidence for bexmarilimab ," said Dr. Juho Jalkanen, Chief Executive Officer of Faron . "The biological evidence of hematological recovery seen with bexmarilimab means that it reduces cancer cells and actively helps a patient's body rebuild its blood-producing system and capacity to fight the disease, providing hope for a durable recovery where options have been historically limited." The safety and tolerability pro stable and well tolerated in this elderly, high-risk patient demographic. Backed by this clear translational validation and strong regulatory alignment, the Company is fully on track to initiate its randomized, placebo-controlled Phase 2b clinical trial (designated as the BEXERA trial) in treatment-naïve higher-risk MDS patients during the second half of 2026. Post‑EHA webcast Faron will host a live webcast on Monday, 15 June 2026, following the EHA Congress. The webcast will be hosted by Faron management and will feature Dr. Mika Kontro, Principal Investigator of the BEXMAB trial and presenting author of Faron's EHA poster. The webcast will focus on the broader clinical and scientific context of the BEXMAB programme and will include a live Q&A session. Post‑EHA webcast registration: About BEXMAB The BEXMAB trial is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC ( azacitidine ) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes. 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 and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care. 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 in combination with other standard treatments. Further information is available at For more information, please contact: IR Partners, Finland (Media) Kare Laukkanen +358 50 553 9535 / +44 7 469 766 223 kare.laukkanen@irpartners.fi FINN Partners, US (Media) Alyssa Paldo +1 847 791-8085 alyssa.paldo@finnpartners.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