Faron Pharmaceuticals has announced the publication of the full safety and anti-tumor efficacy results from the Phase 1/2 MATINS trial of bexmarilimab in patients with treatment-refractory late-stage solid tumors. The trial showed that bexmarilimab monotherapy was effective in achieving disease control and prolonged survival in late-stage metastatic solid tumors. The treatment was also found to be safe and well-tolerated with no serious adverse effects. The study demonstrated that bexmarilimab induced macrophage activation and increased IFN signaling in patients who achieved disease control and prolonged survival. The results validate the macrophage-targeted approach and highlight bexmarilimab's potential as a novel immunotherapy in late-stage cancers, especially those resistant to PD-1 blockade.

Bexmarilimab is a humanized monoclonal anti-CLEVER-1 antibody that activates the immune system and evokes anti-tumor responses. Clever-1 is highly expressed by immunosuppressive macrophages and contributes to impaired antigen presentation and suppression of anti-tumor immunity. The Phase 1/2 MATINS trial evaluated the safety and efficacy of CLEVER-1 blockade with bexmarilimab in patients with treatment-refractory solid tumors. The monotherapy showed no dose-limiting toxicities and exhibited excellent safety and tolerability in over 200 patients. Disease control rates were associated with improved survival and were consistent with higher pre-treatment intratumoral CLEVER-1 levels and low baseline IFN signaling that then increased during treatment. Transcriptomics profiling of the tumors demonstrated that bexmarilimab activates intra-tumoral macrophages and stimulates IFN and T-cell receptors in a proportion of patients, leading to disease control and prolonged survival.

The publication of these positive Phase 1/2 data in Cell Reports Medicine highlights bexmarilimab's potential to overcome cancer immune resistance by restoring macrophage immune function. The results are particularly compelling given the challenging context of the late-stage, treatment-refractory disease patient population and the inclusion of nonimmunogenic cold tumors in this first-in-human trial. Faron Pharmaceuticals looks forward to generating additional data with bexmarilimab as a novel and innovative macrophage-targeting immunotherapeutic antibody.

Bexmarilimab is Faron's investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes by targeting myeloid cell function and igniting the immune system. It binds to Clever-1, an immunosuppressive receptor found on macrophages, and alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive state to an immunostimulatory one. This upregulates interferon production and primes the immune system to attack tumors and sensitizes cancer cells to standard of care.

Faron Pharmaceuticals is a global, clinical-stage biopharmaceutical company focused on developing novel immunotherapies to tackle cancers. Its lead asset is bexmarilimab, which is being investigated in Phase I/II clinical trials as a potential therapy for patients with various types of cancer.