Inside Information: Faron to present updated BEXMAB data in frontline HR-MDS to FDA; complete remission rate substantially increased to 43%

Inside Information: Complete remission rate in frontline HR-MDS patients rose from 28% to 43% in latest data cut, confirming the deepening of responses over time.

TURKU, FINLAND– Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunological pathways, today announced an increase in the complete remission (CR) rate in patients with frontline or treatment-naïve high-risk myelodysplastic syndrome (HR-MDS), based on updated efficacy data from its Phase 1/2 BEXMAB trial.

According to the investigator-assessed response using IWG 2006 criteria, as per protocol, the CR rate (as explained below) has increased to 43% (9 out of 21 patients), a substantial improvement from the 28% rate, seen in the earlier data cut. This data builds on the phase II results featured in recent oral presentation at the 2025 American Society of Clinical Oncology (ASCO) congress. This improvement in CR is a result of patient responses improving as they continue longer on the combination therapy of bexmarilimab and the standard-of-care, azacitidine. This updated efficacy data was prepared for an upcoming End-of-Phase 2 (EOP2) meeting with the US Food and Drug Administration (FDA).

CR signifies a return to normal blood cell counts and bone marrow cellularity. This rate was measured using the internationally recognized and stringent, protocol pre-specified criteria. The 43% CR rate achieved with the bexmarilimab combination is more than double the 16-17% historical rate seen in patients treated with azacitidine alone, representing a major therapeutic advance. Earlier data from the BEXMAB study had also reported an encouraging 50% composite CR rate (cCR) in frontline HR-MDS patients, and in essence more and more of these cCR responses are turning into CR over time.

“The continued maturation of the BEXMAB data demonstrates bexmarilimab’s profound impact as a disease-modifying agent," said Dr. Petri Bono, Chief Medical Officer of Faron. “Seeing the CR rate strengthen over time to 43%, which complements the robust 50% cCR we have already reported, is very encouraging. It provides us with two compelling and clinically meaningful data sets for discussion with the FDA and gives us confidence in proposing a randomized registrational trial designed for accelerated approval with either CR or cCR as the primary endpoint.”

About bexmarilimab

About Faron Pharmaceuticals Ltd.