Bristol-Myers Squibb Co. and Apexigen, Inc. have entered a clinical trial collaboration to evaluate BMS’ Opdivo (nivolumab) in combination with Apexigen’s APX005M in patients with advanced solid tumors. APX005M is an investigational compound designed to activate CD40, a key immune co-stimulatory receptor essential to regulating the activation of immune responses against cancer.
 
The companies 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 I-O therapy.
 
Preclinical data suggest that APX005M mimics the immune activation process through activation of CD40. Opdivo is designed to overcome PD-1 pathway related immune suppression. The companies will explore the potential of combining these two drugs with the goal of effectively activating antigen presenting cells (APC) in the tumor microenvironment, thus driving a more productive and sustained immune response against the tumor.
 
“Targeting the tumor microenvironment through activation of antigen-presenting cells is a novel approach that we are excited to add to our Immuno-Oncology strategy as we continue to advance research for cancers with limited treatment options,” said Fouad Namouni, M.D., head of Oncology Development, Bristol-Myers Squibb. “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 I study,” said Xiaodong Yang, M.D., Ph.D., president and chief executive officer of Apexigen. “Based on scientific rationale and demonstrated data, we are excited about the new combination studies with Opdivo and APX005M.”