Apexigen and the Pediatric Brain Tumor Consortium (PBTC), announced a clinical trial collaboration to evaluate Apexigen's APX005M, an investigational immune activating compound that targets CD40, in pediatric patients with recurrent or refractory brain tumors. CD40 is an immune co-stimulatory receptor essential to the activation of both innate and adaptive immune responses against cancer. There is an unmet need in pediatric oncology for effective treatments for Central Nervous System (CNS) tumors. Immunotherapy is currently considered a promising area of investigation in clinical oncology and it is expected that novel immune-activating agents such as APX005M will provide additional benefit to complement the currently used immune checkpoint inhibitors.
The PBTC will conduct a Phase 1 dose escalation trial of APX005M in children at its participating academic medical centers and children's hospitals across the United States. Objectives of the study include establishing the safety, tolerability, pharmacokinetics and preliminary evidence of activity for APX005M in the pediatric population.
"In a Phase 1 study, APX005M has demonstrated immune stimulation in adult patients with solid tumors," said Xiaodong Yang, M.D., Ph.D., President and CEO of Apexigen. "We are excited about the opportunity to collaborate with the PBTC to explore the effects of treatment with APX005M in this underserved pediatric population."
APX005M is a novel, humanized investigational monoclonal antibody designed to overcome the systemic immune suppression that typically affects cancer patients through activation of CD40, a co-stimulatory receptor on the antigen presenting cells that is essential for activating both innate and adaptive immunity.