On December 10, 2024 Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, reported full analysis of the positive Phase 2 interim readout presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Faron Pharmaceuticals, DEC 10, 2024, View Source [SID1234649010]).
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"The BEXMAB results continue to improve over time showing a remarkable 80% ORR in r/r MDS patients," said Dr. Juho Jalkanen, Chief Executive Officer of Faron. "The combination is well-tolerated and generates strong and durable cancer blast reduction and hematological improvements. This solidifies bexmarilimab’s unique and leading mechanism of action for the treatment of MDS and in the field of myeloid cell re-programming. With this compelling evidence, we are well positioned to advance to the full Phase 2 efficacy readout and actively pursue further regulatory interactions to navigate and refine the pivotal pathway for BLA filing."
Dr. Mika Kontro, MD, PhD, Associate Professor at the Helsinki University Hospital Comprehensive Cancer Center and Principal Investigator of the BEXMAB trial, said: "Addressing MDS remains a considerable therapeutic challenge due to the limited efficacy of the current standard of care, particularly in TP53 mutated and HMA-failed MDS patient populations. The data presented at ASH (Free ASH Whitepaper) are highly promising, showing notable improvements in overall response rate and overall survival. These findings highlight the meaningful strides Faron is making in improving treatment outcomes for r/r MDS."
The BEXMAB study is a multicenter study, taking place in Finland, UK and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with standard of care in patients with aggressive myeloid leukemias.
Faron will host a virtual webinar to discuss the full analysis of data today, 10 December 2024 at 16.00 EET/9am ET/6am PT.
To register for the event visit: BEXMAB Study Update
The ASH (Free ASH Whitepaper) Annual Meeting takes place from 7-10 December 2024, in San Diego, California and virtually.
ASH Poster presentation details:
Title: Encouraging Efficacy of Bexmarilimab with Azacitidine in Relapsed or Refractory MDS in Bexmab Ph1/2 Study
Session Time: Monday, 9 December 2024, 6:00 PM – 8:00 PM PT
Session Title: Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III
Location: San Diego Convention Center, Halls G-H
Lead Authors: Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki; Dr. Naval Daver, MD, Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center
Abstract Number: 4265
The full Poster is available on the Company’s website at View Source and contains updated clinical data from the BEXMAB trial.