SANTA MONICA, Calif.—Carefully choosing strategic alliances with preeminent companies and academic institutions, Kite Pharma Inc., a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for cancer treatment, is working on “a paradigm shift approach toward treating cancer,” according to Dr. David D. Chang, executive vice president of research and development and chief medical officer.
Kite Pharma, which was founded in 2008, focused for the first few years on intellectual property positions for its T cell receptor (TCR) and new chimeric antigen receptor (CAR) product candidates to destroy difficult-to-treat tumors. Now the company is working on taking its programs to full development and commercialization, according to Chang, who is an oncologist, and is expanding work with the National Cancer Institute (NCI).
The eACT platform is the foundation for Kite Pharma’s lead programs in a collaboration with the NCI, which is advancing multiple clinical trials in patients with hematological and solid tumors. In this approach, a patient’s peripheral blood T cells are genetically modified ex vivo to express receptor molecules that render these T cells highly efficacious against cancer. The eACT platform involves the genetic engineering of T cells to express either CAR or TCR. Both these categories of products encompass extracellular tumor antigen recognition domains and endogenous or engineered intracellular T cell activating domains. Together, they ensure a broad coverage across intracellular and membrane targets, solid tumors and hematological malignancies.
“Through gene therapy engineering, T cells can identify and destroy tumor cells,” Chang explained. “We add a special ‘GPS’ against cancer cells onto the T cells and put them back into the patients.”
On March 2, the company announced that it had amended its Cooperative Research and Development Agreement (CRADA) with the NCI. The amendment will encompass emerging areas of research in the immune response to tumor neo-antigens, truly tumor-specific antigens generated as tumors accumulate genetic mutations. In addition, new TCR and CAR product candidates targeting solid tumors have been added to the collaboration.
The amendment broadens Kite’s ongoing research collaboration with the Surgery Branch at the NCI, led by Dr. Steven A. Rosenberg, and provides additional product candidates for Kite’s growing pipeline. The additional programs will encompass methods of rapidly identifying and developing TCR product candidates targeted against neo-antigens, optimizing new methods to manufacture this new class of individualized therapies and developing additional TCR product candidates retrovirally engineered to target tumor antigens, including for the treatment of colorectal and lung cancers.
As Chang explained, “This year, we have substantially broadened our plan and vision for clinical development, engaging in a strategic R&D collaboration with Amgen, combining Amgen’s cancer targets with our T cell platform technology, as well as expanding our 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.”
On March 17, Kite Pharma announced that it has further strengthened its TCR product platform and established a European presence through the acquisition of T-Cell Factory B.V. (TCF), a privately held Dutch company that has been renamed Kite Pharma EU. Founded by Dr. Ton N. M. Schumacher of the Netherlands Cancer Institute (NKI) and Dr. Dirk H. Busch of the Technische Universität München, TCF has the ability to discover and develop tumor-specific TCRs for broad application in cancer treatment based on its proprietary TCR-GENErator platform.
Through this acquisition, Kite Pharma has obtained license agreements with IBA GmbH, Sanquin Blood Supply Foundation and the NKI that include rights to certain new intellectual property in the TCR space developed by Schumacher at the NKI. In addition, the acquisition provides access to European clinical manufacturing facilities, launching a base for Kite Pharma to build its global presence and initiate clinical programs in the European Union.
“Cell-based immunotherapy is exciting,” Dr. Chang said. “Even with the most difficult-to-treat tumors, the response can be long-lasting. The commercial potential is huge.”
He concluded, “We’re looking forward to advancing our pipeline for patients in need. We are deeply committed to the rapid advancement of these programs for the benefit of people who may not respond to other forms of treatment.”