FDA OKs Study of Bexmarilimab in AML/MDS/CML

The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application for a phase I/II trial of bexmarilimab plus standard of care in patients with relapsed acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or chronic myelomonocytic leukemia (CML).

“Research has shown a clear survival benefit among certain blood cancer patients with low Clever-1 expression, a receptor known to be expressed on immunosuppressive macrophages in the tumor microenvironment,” said Marie-Louise Fjällskog, MD, PhD, Chief Medical Officer of Faron, the drug’s manufacturer. “By adding bexmarilimab to standard of care we expect to downregulate Clever-1 expression, thereby increasing antigen presentation and allowing the immune system to better identify and kill cancer cells.”

The primary objective of the study is to determine the safety and tolerability of bexmarilimab in combination with standard of care treatment with azacitidine and to identify the recommended phase II dose. Secondary objectives include characterizing the pharmacokinetic profile of bexmarilimab in combination with azacitidine and to assess the immunogenicity of bexmarilimab.

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 patients with AML who are not able to tolerate chemotherapy. Patient recruitment is expected to begin in the coming weeks.

Source: Faron Pharmaceuticals Ltd Press Release, May 2022