Apexigen and Yale Cancer Center announced a clinical trial collaboration to evaluate Apexigen's APX005M in combination with cabiralizumab and Opdivo in patients with advanced solid tumors. The Phase 1/2 clinical trial will evaluate the safety, tolerability, and preliminary activity of APX005M in combination with cabiralizumab and Opdivo in metastatic NSCLC, metastatic melanoma and RCC patients whose disease has progressed on prior anti-PD-1/PD-L1 therapy. In addition to providing funding, Bristol-Myers Squibb will supply Opdivo and cabiralizumab, an investigational antibody being developed in partnership with Five Prime Therapeutics.
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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. Cabiralizumab (FPA008) is an antibody that inhibits colony stimulating factor-1 receptor (CSF1R) and depletes immunosuppressive tumor associated macrophages (TAMs). Preclinical data from Yale researchers and others have demonstrated that treatment with a combination of CD40 activation and inhibition of CSF-1R modifies tumor-associated macrophages and activates T cells in tumors. This results in converting a "cold" into an "inflamed" tumor microenvironment capable of eliciting protective T cell responses in tumors that are either unresponsive or insensitive to immune checkpoint blockade.
"There is an urgent need to find effective therapies for the growing number of patients who have not responded to checkpoint inhibitors," said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. "CD40 has a fundamental role in the activation of both innate and adaptive immunity, and we believe that CD40 activation by APX005M will become a key component of a number of promising new I-O therapeutic regimens for treating cancer patients."