Inside information

Faron Announces Positive BEXMAB Study Update in Relapsed/Refractory AML and HMA-Refractory MDS Patients

• Bexmarilimab produces a 50% remission rate in doublet dose cohorts (11 out of 22 patients)
• Eight of the 11 patients are Complete Responders (CR) or CR with incomplete blood recovery (CRi)
• Highest overall response rate (ORR) of 80% observed in prior HMA-failure MDS group (4 out of 5 patients)
• Bexmarilimab continues to be well-tolerated with no dose-limiting toxicity observed
• Company to host virtual investor call to discuss data, today at 8:00 am EST
  

Company announcement, Inside Information

TURKU, Finland and BOSTON, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces updated data from the Phase 1/2 BEXMAB study investigating bexmarilimab in combination with standard of care (SoC) in relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients having failed hypomethylating agents (HMAs).

The updated data are consistent with the high objective response rate observed in the previous results. The most recent data includes read outs from a total of 22 patients (r/r AML with 12 patients, MDS frontline and MDS HMA-failed patients with five patients each) who have completed at least two or more treatment cycles. Eight of 11 patients achieved complete remission in the bone marrow with or without blood count recovery.

The highest single indication-specific ORR was observed among HMA-failed MDS patients (4 out of 5 patients; 80%). The combined study ORR continues to be high (11 out of 22 patients; 50%) across all patient groups having received two or more treatment cycles in the doublet. In most patients (75%), blast reduction was observed. A total of 29 patients have been recruited into the doublet cohort as of October 5, 2023.

Bexmarilimab continues to be well-tolerated at all tested dose levels as no dose-limiting toxicity has been observed. A total of 18 drug-related events were observed with the majority below Grade 3. Five drug-related events were reported as Grade 3 and above, including immune-related events (capillary leak syndrome, hemophagocytic lymphohistiocytosis and cryptogenic organizing pneumonia), as well as one event of increased liver enzymes.