Bristol-Myers Squibb, Celldex To Collaborate On Immuno-Oncology Drugs Trial
By Cyndi Root
Bristol-Myers Squibb Company announced in a press release that it will collaborate with Celldex Therapeutics on immuno-oncology drugs. The clinical trial partnership will evaluate Bristol-Myers Squibb’s nivolumab and Celldex’s varlilumab, as evidence suggests that the two may work in combination against certain types of cancer including head and neck, ovarian, colorectal, and metastatic melanoma. Phase I and II studies will establish doses, test tolerability, and evaluate safety and effectiveness of the combination drug treatment.
Anthony Marucci, President and CEO of Celldex Therapeutics said, “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.”
Bristol-Myers Squibb and Celldex Agreement
Bristol-Myers Squibb and Celldex have agreed to share the costs of development and clinical trials. Bristol Myers will also make a one-time payment of $5 million to Celldex. In return, Celldex will conduct the studies, which are expected to begin at the end of 2014.
The two companies have also restructured a prior agreement between Celldex and Medarex (acquired by Bristol-Myers Squibb in September of 2009), waiving milestone payments and royalties related to Celldex’s CD27 program. This restructuring positions Bristol-Myers and Celldex to work exclusively with each other, and it gives Bristol-Myers a limited right to negotiate the license of varlilumab from Celldex.
Nivolumab
Nivolumab is Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor. The investigational agent is part of a new class of drugs known as immunotherapy. This class of drugs manipulates the immune system to fight cancer. A human monoclonal antibody, Nivolumab blocks PD-1 activation, thereby activating T-cells and anti-tumor activity. Bristol-Myers’ collaboration with Celldex is part of its broad effort to develop nivolumab in multiple tumor types. Thus far, over 7,000 patients have participated in trials investigating nivolumab in monotherapy or in combination with other agents.
Varlilumab
Varlilumab (CDX-1127) is Celldex’s CD27 targeting investigational antibody. The human monoclonal antibody targets CD27, a molecule critical in the activation pathway of lymphocytes. Manipulating CD27 with antibodies produces anti-tumor responses. An in vitro study, presented at the 2013 American Association of Cancer Research Annual Meeting, showed how the antibody worked and encouraged Celldex to continue development.