Study to evaluate potential of APX005M plus Opdivo to activate antigen-presenting cells in the tumour micro-environment to demonstrate enhanced anti-tumour activity.

Bristol-Myers Squibb (BMS) and Apexigen have announced a clinical trial collaboration to evaluate BMS’s Opdivo (nivolumab) in combination with Apexigen’s APX005M in patients with advanced solid tumours. APX005M is an investigational compound that is designed to activate CD40, a key immune co-stimulatory receptor essential to regulating the activation of both innate and adaptive immune responses against cancer.

The proposed collaboration will evaluate the safety, tolerability and preliminary efficacy of APX005M in combination with Opdivo in second-line metastatic NSCLC patients who have failed prior chemotherapy, and in metastatic melanoma patients who have failed prior Immuno-Oncology (I-O) therapy.

Preclinical data suggest that APX005M mimics the endogenous immune activation process through activation of CD40. A receptor on the surface of antigen presenting cells of the immune system, CD40 plays a fundamental role in the activation of both innate and adaptive immune system mechanisms. Opdivo is designed to overcome PD-1 pathway related immune suppression. The companies will explore the potential of combining these two agents with the goal of effectively activating antigen presenting cells (APC) in the tumour micro-environment, thus driving a more productive and sustained immune response against the tumour.

"Targeting the tumour micro-environment through activation of antigen-presenting cells is a novel approach that we are excited to add to our I-O strategy as we continue to advance research for cancers with limited treatment options," stated Fouad Namouni, head of Oncology Development, BMS. "Our agreement with Apexigen builds on our continued focus to bring forward potential novel combination treatment options for patients with cancer."

"APX005M has demonstrated immune stimulation in patients with solid tumors in a Phase 1 study," said Xiaodong Yang, President and CEO of Apexigen. "Based on scientific rationale and demonstrated data, we are excited about the new combination studies with Opdivo and APX005M."

Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 57 countries including the US, Japan, and in the European Union.

APX005M is a novel, humanized investigational monoclonal antibody designed to reverse the systemic immune suppression that typically affects cancer patients. APX005M is designed to activate CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems.