Paradigm Shift in MDS Treatment: Faron Pharmaceuticals Unveils Landmark Phase II Trial Data at ASCO 2025

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.