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Int'l Business Times
08-07-2025
- Business
- Int'l Business Times
Faron Pharmaceuticals To Earn Spotlight At IUIS 2025 With Its Bexmarilimab Data
In a year already marked by critical scientific milestones, Faron Pharmaceuticals is set to take center stage once again. The clinical-stage biopharmaceutical company has announced that detailed Phase II data from its BEXMAB study evaluating bexmarilimab (bex), a novel immunotherapy targeting Clever-1, has been accepted for oral presentation at the 19th International Congress of Immunology (IUIS) in Vienna, Austria, from August 17 to 22, 2025. This development is particularly significant given the current landscape of treatment for high-risk myelodysplastic syndromes (HR-MDS), a rare and aggressive group of bone marrow disorders with limited therapeutic options and poor prognoses, especially for patients who relapse or fail frontline hypomethylating agents (HMAs). Standard treatments have seen little advancement in recent decades, with response rates in the relapsed/refractory setting often below 10% and median overall survival typically less than six months. Immunotherapies targeting the tumor microenvironment, particularly macrophage-mediated immune resistance, represent a promising new frontier in hematology. Bex's ability to reprogram immunosuppressive macrophages and enhance anti-tumor immune responses marks a major shift from traditional cytotoxic approaches and has the potential to redefine the standard of care for HR-MDS and other difficult-to-treat malignancies. The company's inclusion in the oral sessions, one of the most prestigious scientific categories at IUIS, signals a rising recognition of bex's potential to change the treatment landscape for HR-MDS. This is the latest in a series of high-profile scientific endorsements for Faron, following similar honors at the American Society of Clinical Oncology (ASCO) and the International MDS Symposium earlier this year. Bex is Faron's first-in-class anti-Clever-1 monoclonal antibody designed to reprogram immunosuppressive macrophages in the bone marrow. When combined with azacitidine, a current standard-of-care hypomethylating agent, the therapy aims to overcome treatment resistance and restore the body's ability to combat cancerous cells, a vital advancement for a disease that has long been resistant to effective treatment. At IUIS 2025, Dr. Mika Kontro, MD, PhD, will deliver a presentation titled "Efficacy of Macrophage Checkpoint Clever-1 Inhibition with bexmarilimab plus Azacitidine in Myelodysplastic Syndrome: Results from the Ph1/2 BEXMAB Study." The talk will highlight both frontline HR-MDS patients and those with relapsed/refractory (r/r) disease who have failed prior HMA therapy. According to early disclosures, the data set includes impressive objective response rates and significant reductions in bone marrow blast counts, especially notable in a population where few therapeutic options remain. Acceptance into IUIS's oral presentation track is not just a ceremonial nod. It's a peer-reviewed endorsement from one of the most rigorous scientific communities in immunology. For Faron, it is another critical validation of its mission: to address treatment-resistant diseases through bold immunological strategies. "We are thrilled to see bex's data receive acceptance for oral presentation at IUIS, following similar recognition at MDS and ASCO," states Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals. "This continued momentum reinforces our belief that bex holds real promise as a much-needed therapeutic option for patients with higher-risk MDS, a rare and challenging condition with few effective treatments." The past year has been pivotal for Faron. Following its positive Phase II results announced at ASCO, where bex achieved a median overall survival of 13.4 months in r/r MDS patients, more than double historical norms, the company has rapidly accelerated its development roadmap. "We're not just excited by the numbers," Dr. Juho affirms. "We're driven by what this could mean for real people living with a devastating illness. If we can offer them a longer, better-quality life, we've done something truly meaningful." With preparations underway for a registrational trial and ongoing regulatory engagement, Faron is also eyeing accelerated approval pathways. According to the company, upcoming interactions with the U.S. Food and Drug Administration will focus on confirming the new composite complete response (cCR) endpoints outlined by the IWG 2023 criteria, which link closely to survival and long-term outcomes. Though much of the spotlight is on MDS, bex is part of a larger strategy: to harness the immune system's overlooked components to address immune resistance across a range of hard-to-treat cancers. Faron's broader pipeline reflects this ambition, with additional studies underway in acute myeloid leukemia (AML) and other indications where macrophage manipulation could yield significant benefits. But for now, all eyes are on Vienna, where the company's work will once again be put to the test, and, it hopes, further cement its place among the most exciting innovators in oncology.
Yahoo
12-05-2025
- Business
- Yahoo
Faron Pharmaceuticals Presents Promising Phase 1/2 Data from BEXMAB Study at MDS 2025 Plenary Session
TURKU, FI / / May 12, 2025 / Faron Pharmaceuticals (HEL:FARON)(LSE:FARN) - BEXMAB data highlights meaningful clinical benefit, with beneficial immunological and hematological impact in r/r MDS Encouraging survival; Median overall survival 13.4 months in 20 high and very high-risk r/r MDS patients treated with bexmarilimab + azacitidine; 4 patients successfully bridged to hematopoietic stem cell transplant 55% patients showed ≥50% reduction in bone marrow; 21% of transfusion-dependent patients became transfusion-independent Faron will be hosting a virtual webinar to discuss the full analysis of r/r MDS as well as new frontline HR MDS patient data on Monday, 2 June 2025. To register for the event visit: BEXMAB Phase II study results Turku, Finland - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company advancing next-generation immunotherapies, presented updated data from its ongoing BEXMAB Phase 1/2 trial at plenary oral session at the 18th International Congress on Myelodysplastic Syndromes (MDS 2025) on May 10, 2025, in Rotterdam, Netherlands. The presentation, led by Dr. Amer Zeidan, MBBS, MHS, focused on the preliminary efficacy, safety, and immune biomarker data from 20 first patients with relapsed or refractory high-risk myelodysplastic syndromes (r/r MDS) who had failed prior hypomethylating agent (HMA) therapies. 90% of the patients were very high/high risk at baseline and 50% had tp53 mutations. These patients represent a population with extremely limited treatment options and aggressive and difficult-to-treat disease. The BEXMAB Phase 1 & 2 MDS patients with prior HMA failure experienced an estimated median overall survival (mOS) of approximately 13.4 months, compared to the 5-6 months that would typically be expected under standard of care historically. The BEXMAB study evaluated bexmarilimab (1, 3, or 6 mg/kg weekly in 28-day cycles), a first-in-class monoclonal antibody targeting the Clever-1 receptor, in combination with azacitidine, a standard-of-care HMA. By blocking Clever-1, bexmarilimab reprograms macrophages in the bone marrow, enhancing anti-tumor immunity. The combination was well tolerated, with no Grade 3-5 adverse events attributed to bexmarilimab and no treatment discontinuations due to related toxicity. Clinically, the combination of bexmarilimab and azacitidine demonstrated encouraging efficacy in patients with r/r MDS. A reduction of 50% or more in bone marrow blast counts was observed in 55% of patients, indicating clinically significant disease control. Additionally, 21% of patients who were transfusion dependent at baseline achieved transfusion independence, reflecting a potential improvement in quality of life and a reduced need for supportive care. Importantly, four patients were able to proceed to hematopoietic stem cell transplantation, the only potentially curative treatment, suggesting that this regimen may serve as an effective bridge to transplant. Dr. Amer Zeidan, MBBS, MHS, Professor of Medicine and Chief of Hematologic Malignancies at Yale School of Medicine and Yale Cancer Center, and the lead presenter said, "While we have a small number of patients treated on trial to date, I am encouraged by the safety and efficacy data we are observing to date with the the combination of bexmarilimab and azacitidine in patients with higher risk MDS, especially after HMA failure. If these trends continue to hold, they would provide strong rationale for pursuing a registrational approach with a randomized phase 3 trial, and could potentially offer a new therapeutic option for this difficult-to-treat patient population." Biomarker analysis revealed that treatment with bexmarilimab plus azacitidine was associated with a rise in immune activation markers in the bone marrow, suggesting that Clever-1 blockade enhances immune activation and engagement. Additionally, despite all patients being Clever-1 positive responding patients had higher pre-treatment Clever-1 expression on monocytes/macrophages than non-responding patients confirming the importance of Clever-1 as a target and the mode of action of bexmarilimab in the treatment of MDS patients. Juho Jalkanen, MD, PhD, Chief Executive Officer of Faron Pharmaceuticals, said, " We are deeply encouraged by these results, which show that bexmarilimab has the potential to significantly alter the treatment landscape for patients with relapsed or refractory MDS that have no further treatment options. The combination's favorable safety profile and promising clinical activity in last line MDS strengthen our belief in the mechanism of action and therapeutic promise of Clever-1 inhibition. These results also support the company's plans toward initiating a randomized study in frontline HR-MDS patients as suggested by the FDA earlier. New frontline data together with the fully enrolled r/r MDS Phase 2 will also be presented soon at ASCO 2025 and followed up with a webcast hosted by the company." Details of the presentation Title : Preliminary efficacy of bexmarilimab with azacitidine in relapsed or refractory MDS in BEXMAB Ph1/2 study Session : Plenary Session 08: Treatment High Risk Presenter : Dr. Amer Zeidan, MBBS, MHS Date & Time : May 10, 2025 | 09:50 - 11:20 CEST Location : Rotterdam, Netherlands Abstract Number : 225 Faron Pharmaceuticals remains committed to accelerating the clinical development of bexmarilimab for patients with high-risk myeloid malignancies. Faron will be hosting a virtual webinar to discuss the full analysis of r/r MDS as well as new frontline HR MDS patient data on Monday, 2 June 2025 at 4pm EEST/9am ET. To register for the event visit: BEXMAB Phase II study results Amer Zeidan consulted and received honoraria from Faron. The views expressed represent his own and do not necessarily reflect those of his employer. For more information, please contact: IR Partners, Finland(Media)Riina TuominenKare Laukkanen +358 44 313 50 553 9535 / +44 7 469 766 FINN Partners, US(Media) Alyssa Paldo +1 847 791-8085 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 KarttunenJukka Järvelä +358 (0)40 555 4727+358 (0)50 553 8990 About BEXMABThe BEXMAB study is an open-label Phase I/II 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 bexmarilimabBexmarilimab 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 LtdFaron (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 I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at . SOURCE: Faron Pharmaceuticals View the original press release on ACCESS Newswire
