The amended CRADA will encompass emerging areas of research in the immune response to tumor neo-antigens, which are tumor-specific antigens generated as tumors accumulate genetic mutations. New T cell receptor (TCR) and new chimeric antigen receptor (CAR) product candidates targeting solid tumors have also been added to the collaboration.
In addition to identifying methods of developing TCR product candidates targeted against neo-antigens, as well as to develop additional TCR product candidates retrovirally engineered to target tumor antigens, including for the treatment of colorectal and lung cancers, the company will also optimize new methods to manufacture this new class of individualized therapies.
The manufacturing portion of the deal will help to fill a newly leased commercial manufacturing facility in El Segundo, California, which is adjacent to Los Angeles International Airport. Kite also recently secured a lease for a clinical manufacturing facility in Santa Monica, California. The two facilities will not only support the planned clinical trials of Kite's product candidates, but also will prepare Kite for the commercial launch and supply of its lead product candidate, KTE-C19, anticipated in 2017.
The Santa Monica facility has about 18,000 square feet and will provide space for clinical manufacturing, research and development, and offices upon completion. In addition, Kite plans to continue to utilize its contract manufacturer to support clinical trials of eACT [autologous T cell therapy]-based product candidates.
The El Segundo facility has approximately 44,500 square feet, and, under the lease agreement, Kite has an expansion option for an additional 17,000 square feet until July 1, 2017.
"Neo-antigen immunotherapy will allow us to design a cancer treatment that can modify a patient's T cells to recognize the unique genetic profile of the patient's own tumor. This offers a new paradigm in cancer care and extends the significant progress we have achieved in collaboration with Dr. Steven Rosenberg, Chief of Surgery, and his clinical research teams at the NCI," Arie Belldegrun, Kite's President and CEO, said in a statement.
The amendment also broadens Kite's ongoing research collaboration with the Surgery Branch at the NCI and provides additional product candidates for Kite's growing pipeline.
The expansion of the contract comes as Kite recently signed a collaboration agreement with Amgen wherein Kite will be responsible for conducting all preclinical research, and cell manufacturing and processing through IND (Investigational New Drug) filing.
David Chang, Kite's EVP of R&D and Chief Medical Officer, added that the company also recently expanded its “agreement with Tel Aviv Sourasky Medical Center to develop novel approaches to CAR T cell therapy. The new research under our CRADA with the NCI further extends our clinical programs, particularly in regard to new TCR approaches. We are deeply committed to the rapid advancement of these programs for the benefit of patients."