Faron Pharmaceuticals has reported its half-year financial results for the period of January 1 to June 30, 2023. The company highlighted several key developments during this period. The US Food and Drug Administration (FDA) granted bexmarilimab Orphan Drug Designation (ODD) for the treatment of acute myeloid leukemia (AML). The latest data from the Phase I/II BEXMAB study showed promising results, with objective responses observed in three out of five patients in the 6 mg/kg bexmarilimab+ azacitidine doublet cohort. Eight out of fifteen objective responses were observed across all three doublet dosing cohorts. The company plans to advance to Phase II in Q4 2023 in relapsed/refractory AML and myelodysplastic syndromes (MDS) patients failing hypomethylating agents (HMAs). New biomarker data presented at the EHA2023 Congress indicated that bexmarilimab's mode of action in AML/MDS is supported by durable Clever-1 target engagement in the bone marrow, resulting in notable increases in T and NK cells and enhanced antigen presentation. The Phase II BEXCOMBO protocol has been approved by the FDA. The company also strengthened its leadership team and cash position through private placements, raising EUR 18.6 million.
Faron's CEO, Dr. Markku Jalkanen, expressed pride in the progress made during the first half of 2023. He highlighted the strong objective responses observed in the BEXMAB study and the FDA's Orphan Drug Designation for bexmarilimab in AML. He also mentioned the company's plans to advance to Phase II and prepare for regulatory submission in the first half of 2025.
The company's pipeline includes bexmarilimab, a novel precision cancer immunotherapy candidate in Phase I/II development for relapsed/refractory AML and MDS. The FDA has granted Orphan Drug Designation for bexmarilimab for the treatment of AML. Updated data from the BEXMAB study showed objective responses in three out of five patients in the 6 mg/kg bexmarilimab+ azacitidine cohort, with one patient achieving complete remission. Eight out of fifteen objective responses were observed across all three doublet dosing cohorts. The data supports the advancement to Phase II in relapsed/refractory AML and MDS patients failing HMAs. Biomarker data presented at the EHA2023 Congress showed that bexmarilimab's mode of action in AML/MDS is supported by durable Clever-1 target engagement in the bone marrow, resulting in increases in T and NK cells and enhanced antigen presentation.
The company also presented findings from its Phase I/II MATINS study of bexmarilimab in solid tumors at the American Association for Cancer Research Annual Meeting 2023. The study showed that bexmarilimab monotherapy facilitates macrophage conversion and induces changes in the tumor microenvironment, resulting in disease control and prolonged survival in late-stage cancer. Preparations are ongoing for the initiation of the Phase II BEXCOMBO trial, which will evaluate bexmarilimab with PD-1 blockade in head and neck cancer, bladder cancer, and non-small cell lung cancer patients.