Faron Pharmaceuticals CEO Dr. Juho Jalkanen joined Steve Darling from Proactive to discuss the company’s presentation of Phase II data from its BEXMAB study during a Rapid Oral Abstract Session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which has recently concluded.
The BEXMAB study is evaluating bexmarilimab, Faron’s novel humanized anti-Clever-1 antibody, in combination with azacitidine, the current standard-of-care, in patients with high-risk myelodysplastic syndromes (MDS). The Phase II data presented focused on two patient populations: frontline treatment-naïve (n=21) and relapsed/refractory (r/r) MDS (n=32), with the majority (66% and 80% respectively) classified as very high/high risk at baseline.
Jalkanen emphasized the unmet medical need in these populations, particularly for r/r MDS patients who have failed prior hypomethylating agent (HMA) therapies and have limited treatment options. In this context, the BEXMAB results are highly encouraging, showing an estimated median overall survival (mOS) of 13.4 months in r/r MDS patients — more than double the typical 5–6 months under current standard-of-care.
These findings not only validate the therapeutic potential of bexmarilimab but also support progression to a confirmatory registrational Phase III trial, which would evaluate bexmarilimab + azacitidine versus placebo + azacitidine in frontline high-risk MDS patients. The company has received prior FDA guidance on trial design and is preparing for an end-of-Phase II meeting to discuss key parameters, including the proposed primary endpoint of composite complete response (cCR), a measure strongly correlated with overall survival.
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