Apexigen initiates APX005M Phase 1 clinical trial in adults with solid tumors

Apexigen, Inc., a biopharmaceutical company discovering and developing innovative antibody drugs for the treatment of cancer and other life-threatening diseases, announced today the initiation of a Phase 1 clinical trial of APX005M, the company's lead proprietary anticancer program. APX005M is an immuno-activating monoclonal antibody targeting CD40, a receptor that plays a central role in the regulation of antigen presentation functions and tumor-specific T cell response.

The trial is a Phase 1, open-label dose-escalation study of APX005M in adults with solid tumors that is intended to establish the maximum tolerated dose, the pharmacokinetic profile and the overall safety and tolerability of APX005M. The study will also seek evidence of activation of the immune system in response to treatment and preliminary assessment of clinical response.

"We believe that APX005M has already demonstrated best-in-class potential in preclinical evaluation and could become an essential component in immuno-oncology combinations with immune check point inhibitors, or other immunotherapies," said Xiaodong Yang, M.D., Ph.D., President and CEO of Apexigen. "Activation and establishment of a specific immune response against cancers is important for tumor eradication and in the creation of tumor-specific memory immune cells that can prevent tumors from recurring. APX005M could play a critical role in activating as well as maintaining the tumor-specific immunity."