On December 12, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported that characterizations of T cell receptor candidates which it has licensed under the Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH) have been published in the December 8, 2016 New England Journal of Medicine (NEJM) (Press release, Kite Pharma, DEC 12, 2016, View Source [SID1234517047]).

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The research, led by Steven A. Rosenberg, M.D., Ph.D., chief of the Surgery Branch at NCI’s Center for Cancer Research, and a scientific collaborator with Kite, describes a patient with KRAS mutant metastatic colorectal cancer who was successfully treated with T cells that are reactive to KRAS G12D mutation. This work follows previously reported treatment of a patient with advanced cholangiocarcinoma with T cells targeting a mutated erbb2 interacting protein.

"We are very excited to see the results of this landmark study conducted by Dr. Rosenberg and his team at the NCI. These findings represent proof of concept that T-cell technology directed against neoantigens can be utilized to treat solid tumors," said David Chang, M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer of Kite.

As published in the NEJM publication, mutations in the KRAS gene are thought to drive 95 percent of all pancreatic cancers and 45 percent of all colorectal cancers. The G12D mutation is the most common KRAS mutation and is estimated to occur in more than 50,000 new cases of cancer in the United States each year.

In September 2016, Kite announced that it had entered into an exclusive, worldwide license with NIH for intellectual property related to multiple TCR-based product candidates for the treatment of tumors expressing mutated KRAS antigens. These TCR product candidates were developed in the laboratories of Steven A. Rosenberg, M.D., Ph.D., and James C. Yang, M.D., of the NCI.