Bristol-Myers Squibb and Celldex Therapeutics, Inc. have entered into a clinical trial collaboration to evaluate BMS’ nivolumab, an investigational PD-1 immune checkpoint inhibitor, and varlilumab, Celldex’s CD27 targeting investigational antibody in a Phase 1/2 study.
 
The trial will evaluate safety, tolerability and efficacy in multiple tumor types, potentially including non-small cell lung cancer (NSCLC), metastatic melanoma, ovarian, colorectal (CRC), and squamous cell head and neck cancers.
 
Nivolumab and varlilumab are immunotherapies, part of a new class of cancer treatments designed to use the body’s own immune system to fight cancer. Preclinical data suggest the combination of these two mechanisms may enhance anti-tumor immune response compared to either agent alone.
 
Celldex will receive a one-time payment of $5 million and the companies will share development costs. Celldex will be responsible for conducting the Phase 1/2 study. The companies will work exclusively with each other to explore anti-PD-1 antagonist antibody and anti-CD27 agonist antibody combination regimens. BMS will right of first negotiation if Celldex wants to out-license varlilumab.
 
“As leaders in immuno-oncology, BMS is advancing the science of how immunotherapy can harness the body’s immune system to fight multiple types of cancers,” said Michael Giordano, senior vice president, Oncology and Immunosciences Development. “The clinical collaboration with Celldex and the opportunity to explore the potential benefits of combination treatment with nivolumab and varlilumab adds to our robust clinical development program focused on delivering the promise of long-term survival benefits to a broader patient population.”
 
“Celldex believes the future of immunotherapy lies in combination regimens that further unlock the power of the immune system to deliver the greatest benefit to the largest population of patients possible,” said Anthony Marucci, president and chief executive officer of Celldex Therapeutics. “Based on our clinical data and preclinical models for both programs, we think the combination of varlilumab and nivolumab could play an important role in maximizing the body’s immune response to cancer.”