Bristol-Myers Squibb Company and Celldex Therapeutics, Inc. announced today that they have entered into a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of nivolumab, Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, and varlilumab, Celldex’s CD27 targeting investigational antibody in a Phase 1/2 study. Multiple tumor types will be explored in the study, which could potentially include non-small cell lung cancer (NSCLC), metastatic melanoma, ovarian, colorectal (CRC) and squamous cell head and neck cancers.
Nivolumab and varlilumab are part of a new class of cancer treatments known as immunotherapies that are designed to harness the body’s own immune system to fight cancer through separate yet complementary mechanisms of action that result in T-cell mediated destruction of cancer cells. Preclinical data suggest the combination of these two mechanisms may enhance anti-tumor immune response compared to either agent alone.
“As leaders in immuno-oncology, Bristol-Myers Squibb 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. We are excited to begin this study and look forward to initiating additional combination studies of varlilumab that explore other important mechanisms outside of this collaboration in the near-future.”
Under the terms of this agreement, Bristol-Myers Squibb will make a one-time payment of $5 million to Celldex and the parties will share development costs. Celldex will be responsible for conducting the Ph 1/2 study, which is expected to begin in the fourth quarter of 2014. Additionally, the parties have re-structured an existing agreement between Celldex and Medarex related to Celldex’s CD27 program, and waived certain future milestone payments and reduced future royalty rates that would have been due from Celldex to Medarex. Medarex was acquired by Bristol-Myers Squibb in September of 2009. The companies will work exclusively with each other to explore anti-PD-1 antagonist antibody and anti-CD27 agonist antibody combination regimens. Bristol-Myers Squibb will have a time-limited right of first negotiation if Celldex wishes to out-license varlilumab.