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July 23, 2018

Bristol-Myers Squibb and Gritstone to start Phase l trial for tumours

Bristol-Myers Squibb Company has entered a clinical trial collaboration with Gritstone Oncology to examine the safety and tolerability of GRANITE-001 in combination with Opdivo (nivolumab) and Opdivo plus Yervoy (ipilimumab) for the treatment of patients with advanced solid tumours.

Bristol-Myers Squibb Company has entered a clinical trial collaboration with Gritstone Oncology to examine the safety and tolerability of GRANITE-001 in combination with Opdivo (nivolumab) and Opdivo plus Yervoy (ipilimumab) for the treatment of patients with advanced solid tumours.

Under the collaboration, Gritstone Oncology will sponsor the two-part dose escalation trial, which is scheduled to begin later this year.

As a part of the trial, the combination of GRANITE-001 will be examined with systemic Opdivo and a localised subcutaneous injection of Yervoy.

The subcutaneous administration is expected to maximise drug delivery to the immunotherapy-draining lymph node.

Gritstone Oncology president and CEO Andrew Allen said: “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 tumours.

“The emergence of immunotherapies in the last decade has transformed the way we think about treating cancer.”

“We have developed our programmes using insights from our proprietary tumour 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.”

Gritstone has developed the GRANITE-001, which is a personalised tumour-specific immunotherapy product candidate designed to elicit the T-cell response, particularly CD8+ cytotoxic T-cells against mutation-derived tumour-specific neoantigens.

Opdivo has been developed by Bristol-Myers Squibb as a programmed death-1 (PD-1) immune checkpoint inhibitor that can harness the body’s own immune system to help restore anti-tumour immune response.

It has already become a treatment option for various cancers.

Yervoy is a recombinant, human monoclonal antibody capable of binding the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), a negative regulator of T-cell activity.

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