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Entrepreneur
02-06-2025
- Business
- Entrepreneur
Paradigm Shift in MDS Treatment: Faron Pharmaceuticals Unveils Landmark Phase II Trial Data at ASCO 2025
The ability to not only extend life but also improve quality of life by reducing transfusion needs and infection rates is what sets this treatment apart You're reading Entrepreneur United Kingdom, an international franchise of Entrepreneur Media. In a field long hindered by stagnation, Faron Pharmaceuticals may have just turned a critical corner in the fight against high-risk myelodysplastic syndromes (HR-MDS). The Finnish clinical-stage biopharmaceutical company unveiled highly promising results from its Phase II BEXMAB trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The updated data, presented during a Rapid Oral Abstract Session by Dr. Naval Daver of MD Anderson Cancer Center, revealed that Faron's investigational immunotherapy, bexmarilimab (bex), when combined with the standard-of-care drug azacitidine, achieved a median overall survival (mOS) of 13.4 months in patients with relapsed/refractory (r/r) MDS, which is more than double the typical 5-6 months expected under current treatments. "These are patients who historically have had virtually no effective options after standard HMA therapies fail," said Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals. "To see such meaningful survival and response rates gives us real hope that we're on the path to a true therapeutic breakthrough." The study reported an objective response rate (ORR) of 63% in r/r MDS patients (n=32) and an even higher ORR of 72% in treatment-naïve, frontline HR-MDS patients (n=18). Moreover, 56% experienced a complete (100%) reduction. Under the recently updated 2023 International Working Group (IWG) criteria, the composite complete response (cCR) rate was 56%, more than double the typical 25% response seen with azacitidine alone. Bex is a first-in-class monoclonal antibody targeting the Clever-1 receptor, a key mediator in immune suppression within the tumor microenvironment. By blocking Clever-1, the drug reprograms macrophages in the bone marrow, enabling them to mount a more effective anti-tumor immune response. "The ability to not only extend life but also improve quality of life by reducing transfusion needs and infection rates is what sets this treatment apart," confirmed Dr. Juho. "This is especially critical for a patient population that is often elderly and frail." Indeed, the therapy has demonstrated a favorable safety profile. No new safety concerns were reported, and the treatment was well-tolerated even among patients with severe anemia and recurrent infections. The impressive data from the BEXMAB study supports Faron's plan to move forward with a registrational Phase III trial comparing bex + azacitidine versus placebo + azacitidine in frontline HR-MDS. Discussions with the FDA are scheduled for an upcoming end-of-Phase II meeting. "Given the strong correlation between cCR and survival under the new IWG 2023 guidelines, we believe this could form the basis for accelerated approval," Dr. Juho stated. As the oncology community digests the implications of this data, one thing is clear: Faron Pharmaceuticals has taken a bold step forward in its mission to reshape cancer treatment through immune reprogramming.
Yahoo
15-05-2025
- Business
- Yahoo
Faron Announces Acceptance of Bexmarilimab Data for Oral Presentation at EHA 2025 Congress
TURKU, FI / / May 15, 2025 / Faron Pharmaceuticals (HEL:FARON)(LSE:FARN) - Overcoming immune resistance in HR-MDS: Detailed safety and efficacy Phase II data on bexmarilimab to be presented at EHA 2025 TURKU, FINLAND - Faron Pharmaceuticals Ltd. (AIM:FARN)(First North:FARON), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, today announced that data from its ongoing BEXMAB study evaluating bexmarilimab in patients with high-risk myelodysplastic syndromes (HR-MDS) have been accepted for an oral presentation at the 30th European Hematology Association's (EHA 2025) Congress, taking place in Milan from June 12-15, 2025. The oral presentation will feature detailed efficacy and safety results from the study of bexmarilimab in combination with standard-of-care (azacitidine) in frontline with HR-MDS and those with refractory or relapsed HR-MDS who have failed hypomethylating agent (HMA) therapies (r/r MDS). This follows the recent positive findings of the Phase II data f rom the BEXMAB study, and reaffirms bexmarilimab's mechanism of action and its potential in improving outcomes for patients with MDS. Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals, said:"We are thrilled to see bexmarilimab's data receive acceptance for oral presentation at EHA, following similar recognition at MDS and ASCO. This continued momentum reinforces our belief that bexmarilimab holds real promise as a much-needed therapeutic option for patients with higher-risk MDS, a rare and challenging condition with few effective treatments. We remain deeply committed to advancing its development and bringing meaningful innovation to those who need it most." The details of the oral presentation are as follows: Presentation title: Efficacy of Macrophage Checkpoint Clever-1 Inhibition with bexmarilimab plus Azacitidine in Myelodysplastic Syndrome: Results from the Ph1/2 BEXMAB Study Session: Oral presentation Presenter: Dr. Mika Kontro, MD, PhD Date and Time: 15 June 2025 11:00 - 12:15 CEST Location: Milan, Italy Abstract no: S178 Further details will be shared closer to the conference dates. 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 Sign in to access your portfolio
