RE: New Redeye Research Note following update19 Jul 2023 15:21
Faron Pharmaceuticals: Positive BEXMAB Study Update
RESEARCH NOTE
2023-07-19
10:55
Redeye leaves a note following Faron’s recent study update from the phase I/II BEXMAB study with its lead candidate, bexmarilimab. We are encouraged by the continued positive progress and the candidate’s favorable response to treatment in relapsed/refractory AML and MDS.
Kevin Sule
Earlier today, Faron released additional encouraging findings from their phase I/II BEXMAB study, which focuses on evaluating the potential of the company’s leading candidate, bexmarilimab, in combination with standard-of-care (SoC) treatment for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). This comprehensive study consists of two distinct arms: a doublet arm where patients receive bexmarilimab treatment combined with azacytidine, and a triplet arm where patients receive bexmarilimab treatment in conjunction with both azacytidine and venetoclax.
Each arm is structured into three dose cohorts, with five patients in each cohort, receiving different doses of bexmarilimab. The dose cohorts are as follows: the first receives 1mg/kg, the second receives 3mg/kg, and the third receives 6mg/kg. These investigations aim to assess the safety and effectiveness of the treatment regimens and potentially offer new avenues for managing AML and MDS in relapsed or refractory cases.
During the European Hematology Association (EHA) 2023 Hybrid Congress on 9 June 2023, Faron presented promising biomarker data, revealing sustained engagement of Clever-1 targets in the bone marrow tumor microenvironment. The data showed notable increases in key cell types, namely T and NK cells, which effectively curtailed cancer growth and spread. Additionally, treatment with bexmarilimab led to heightened human leucocyte antigen (HLA-DR) gene expression in leukemic blasts, signifying improved immune recognition and eradicating malignant cells. Excitingly, the updated preliminary efficacy data demonstrated objective responses (OR) in 5 out of 10 patients across the first and second dose cohorts (1 or 3mg/kg doublet cohort). This was evident by a reduction in bone marrow blasts, leading to complete (CR) or partial remissions (PR).
Building on these promising results, Faron shared new interim efficacy data from the BEXMAB study. Specifically, the preliminary data from the third dose cohort (6mg/kg bexmarilimab + azacytidine) in the doublet arm were examined. Three of five patients in this cohort achieved complete remission of blasts in the bone marrow (mCR). One of these patients also experienced a complete recovery of blood counts, indicating the enhanced efficacy of Bexmarilimab at higher dosages.
Across all three doublet dosing cohorts (1, 3, and 6 mg/kg), 15 objective responses (ORs) were observed, with eight patients demonstrating positive outcomes. Four of these eight patients had previously experienced treatment failure with standard-of-care (So
Sign In
Follow the stocks
