Bristol-Myers Squibb, Celldex Partner in Immunotherapies

Bristol-Myers Squibb Company and the biopharmaceutical company Celldex Therapeutics have formed 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 I/II study. Multiple tumor types will be explored in the study, which could potentially include non-small cell lung cancer, metastatic melanoma, ovarian, colorectal, and squamous cell head and neck cancers. Nivolumab and varlilumab are both immunotherapies.

This is the second clinical-trial collaboration for combination therapies of immunotherapies announced this week by the large pharmaceutical companies. AstraZeneca’s MedImmune, its global biologics R&D arm, formed a clinical study collaboration with the biopharmaceutical company Incyte Corporation. The Phase I/II oncology study will evaluate the efficacy and safety of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Incyte's oral small-molecule indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360. Both MEDI4736 and INCB24360 are immunotherapies.

Under the agreement between Bristol-Myers Squibb and Celldex, 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 Phase I/II 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 2009. The companies will work exclusively with each other to explore anti-PD-1 antagonist antibody and anti-CD27 agonist antibody combination regimens.

Source; Bristol-Myers Squibb

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