Bristol-Myers Squibb and Gritstone Oncology announced the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability of Gritstone’s personalized neoantigen immunotherapy, GRANITE-001, which comprises sequential delivery of neoantigens to patients within an adenovirus-based vector (prime) and a self-replicating RNA-based vector (boost), in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab), and Opdivo plus Yervoy (ipilimumab), in patients with advanced solid tumors.
The two-part Phase 1 dose escalation trial, which is anticipated to be initiated before the end of 2018, will evaluate the combination of GRANITE-001 with systemic Opdivo, and a localized subcutaneous injection of Yervoy. Subcutaneous administration of Yervoy is intended to maximize delivery of drug to the immunotherapy-draining lymph node.
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“The emergence of immunotherapies in the last decade has transformed the way we think about treating cancer, yet there remains a need for new therapies, which can initiate immune system recognition of tumors,” said Andrew Allen, Ph.D., president and chief executive officer, Gritstone Oncology. “We have developed our programs using insights from our proprietary tumor antigen discovery platform, EDGE™, together with an immunotherapy platform which has demonstrated the ability to elicit an enhanced antigen-directed T-cell response in preclinical primate models. We are excited to work closely with the experienced Bristol-Myers Squibb team to advance this novel combination approach into clinical trials.”
“Our innovative approach to translational medicine capabilities is fueled by the exploration of novel combinations of new assets with our oncology portfolio,” said Fouad Namouni, M.D., head of development, oncology, Bristol-Myers Squibb. “We look forward to working with the experienced Gritstone team and their neoantigen immunotherapy to gain a deeper understanding of the role of neoantigens as part of immunotherapy as we look to improve outcomes for patients with advanced cancer.”
Gritstone Oncology is the sponsor conducting the trial. Specific terms of the agreement were not disclosed.