FDA, Finnish Medicines Agency Approve Initiation of Phase I/II Study of Bexmarilimab

Faron Pharmaceuticals Ltd announced that the U.S. Food and Drug Administration (FDA) and Finnish Medicines Agency have cleared the investigational new drug (IND) application to begin a phase I/II trial of the investigational treatment bexmarilimab in combination with standard of care in patients with relapsed acute myeloid leukemia (AML), myelodysplastic syndromes, and chronic myelomonocytic leukemia. This will be the first time bexmarilimab is investigated in hematologic malignancies.

The primary objective of the study is to determine safety and tolerability, as well as identify a recommended phase II dose of bexmarilimab. Secondary objectives include the pharmacokinetics and immunogenicity of the drug.

Based on initial safety data, there is potential for phase II expansion and to include a first-line triplet therapy of bexmarilimab, azacitidine, and venetoclax in newly diagnosed AML patients who cannot tolerate chemotherapy. Patient recruitment is expected to begin soon.

Source: PR Newswire press release, May 2022