Phase 2 BEXMAB Trial Begins with First Dose for HMA-resistant MDS Patient

Faron Pharmaceuticals, a biopharmaceutical firm, has commenced Phase 2 of the BEXMAB trial, which is testing the safety and effectiveness of bexmarilimab combined with standard care in patients with myelodysplastic syndrome (MDS) who have not responded to hypomethylating agents (HMAs). MDS is a severe form of myeloid leukemia with limited treatment options.

The BEXMAB trial is currently enrolling 32 patients with HMA-resistant MDS to receive either 3 mg/kg or 6 mg/kg doses of bexmarilimab. The doses have been selected following the FDA's Project Optimus initiative, which aims to improve the process of dose optimization in oncology drug development. Participants are being randomly assigned to one of the two dose groups before proceeding to a Phase 2/3 trial expansion.

The company will review data from the initial 20 patients to evaluate the benefits of the two selected doses. Faron plans to discuss a potential registrational study plan with the FDA after final dosing is selected. Dr. Birge Berns, Faron's Chief Medical Officer, expressed gratitude to the clinical network for the swift progress of the program and highlighted the potential of bexmarilimab to improve the lives of patients with HMA-resistant MDS.

Faron is also exploring the possibility of using bexmarilimab in low-risk MDS and chronic myelomonocytic leukemia (CMML) patients, who are currently treated with HMA-based therapies. The company is considering further development opportunities for bexmarilimab in hematological cancers, potentially through partnerships.

Bexmarilimab is an investigational immunotherapy owned by Faron, designed to enhance clinical outcomes by targeting myeloid cell function and activating the immune system. It is being studied in Phase I/II clinical trials as a potential treatment for hematological cancer patients in combination with other standard treatments.

Faron Pharmaceuticals is a global clinical-stage biopharmaceutical company focused on developing novel immunotherapies to treat cancer. The company's lead asset, bexmarilimab, is an anti-Clever-1 humanized antibody that has the potential to counteract the immunosuppressive effects of cancer by reprogramming myeloid cell function.