Apexigen and Yale Cancer Center Announce Clinical Collaboration to Evaluate APX005M, Cabiralizumab, and Opdivo (Nivolumab) in Patients whose Disease has Progressed on Anti-PD-1/PD-L1 Therapy
- Phase 1/2 clinical trial in patients with advanced solid tumors that have progressed on anti-PD-1/PD-L1 therapy to evaluate APX005M in combination with cabiralizumab and Opdivo
- Study to enroll metastatic non-small cell lung cancer (NSCLC), metastatic melanoma and renal cell carcinoma (RCC) patients whose disease has progressed on prior anti-PD-1/PD-L1 containing regimens
San Carlos, CA, and New Haven, CT – June 14, 2018 – Apexigen, Inc., and Yale Cancer Center today 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 (www.clinicaltrials.gov: NCT03502330). In addition to providing funding, Bristol-Myers Squibb will supply Opdivo and cabiralizumab, an investigational antibody being developed in partnership with Five Prime Therapeutics.
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.”
“This most exciting collaboration between Apexigen and Yale is a result of studies with tumor bearing mice that are poorly responsive to inhibitors of PD-1/PD-L1. Based on these studies, we believe that activation of the innate immune system by APX005M in combination with cabiralizumab will enhance the activity of nivolumab, leading to a novel therapeutic approach for the increasing population of cancer patients who progress on currently approved immune checkpoint inhibitors. This is the first time this combination of drugs has been given to patients and we are eager to initiate this new clinical trial,” said Harriet Kluger, M.D., Professor of Medicine at Yale Cancer Center and Principal Investigator of the trial.
Apexigen is a clinical-stage biopharmaceutical company discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents that could harness the patient’s immune system to combat and eradicate cancer. APX005M and the Company’s additional preclinical programs were discovered using APXiMAB™, Apexigen’s proprietary product discovery platform. This platform has enabled the Company and its collaboration partners to discover and develop high-quality therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. Seven product candidates discovered using APXiMAB™ are currently in clinical development, either internally by Apexigen or by its partners. For more information, please visit www.apexigen.com.
Yale Cancer Center