Kite Pharma's CAR Therapy For Cancer Shows Positive Clinical Trial Results
By C. Rajan, contributing writer
Kite Pharma, a California based clinical-stage biopharmaceutical company, announced last Monday the positive results from a Phase 1-2 clinical study in patients with aggressive non-Hodgkin's lymphoma who were treated with an anti-CD19 chimeric antigen receptor (CAR) T- cell therapy.
The Phase 1-2 clinical trials were conducted by the Surgery Branch of the National Cancer Institute (NCI) and were funded by Kite. The results showed that, after administration of anti-CD19 CAR T-cells, or CARTs, to 12 patients with advanced B-cell malignancies, eight patients had complete remission and four patients had partial remission. Of seven evaluable patients with chemotherapy-refractory diffuse large B cell lymphoma (DLBCL), four achieved complete remission, with three patients’ treatment continuing for longer durations. The results of the clinical trial have been published in the August 25, 2014 Issue of the Journal of Clinical Oncology.
The trial was performed with Kite's most advanced product candidate, KTE-C19, which is prepared by genetically modifying a patient's T-cells to express a CAR designed to target the protein CD19, which is expressed on the cell surface of B cell lymphomas and leukemias. The NCI is conducting the Phase 1-2 clinical trials for Kite under a Cooperative Research and Development Agreement (CRADA) between Kite and the NCI.
"We are greatly encouraged by the strong results we have seen from our joint lead clinical program with the NCI," commented Arie Belldegrun, , Kite's President and CEO. "Based on this substantial progress, Kite plans to file an IND in the fourth quarter of this year to initiate a Phase 1-2 single-arm multicenter clinical trial of KTE-C19 in patients with DLBCL who have failed two or more lines of therapy. We are excited to advance this promising therapy and anticipate commencing patient enrollment in our DLBCL clinical trial in the first half of 2015."
Accordingly to Kite's press release, there are about 22,000 new cases of DLBCL diagnosed in the U.S. annually. DLBCL is an aggressive type of non-Hodgkin's lymphoma, and a significant proportion of patients have a form of the disease which is resistant to the standard chemotherapy or autologous transplant treatments. For these patients with relapsed/refractory DLBCL, there is an unmet need for more effective therapies.
In March 2014, the FDA granted orphan drug designation for Kite's anti-CD19 CAR T-cell therapy for the treatment of DLBCL. Since then, Kite has been actively pushing ahead with the CAR therapy development. In April, Kite secured $50 million in private funding to advance its clinical programs in CAR therapy for the treatment of cancer. In June this year, Kite entered into an exclusive, worldwide license with the NIH for certain intellectual property related to T-Cell Receptor (TCR)-based product candidates.
Several other companies are actively competing in the CAR therapy arena, with Novartis leading the pack. In July 2014, Novartis's anti-CD19 CAR therapy, CTL019, manufactured in collaboration with the University of Pennsylvania, received a breakthrough therapy designation from the FDA for acute lymphoblastic leukemia. Another company leading in this area is Juno Therapeutics, a biotech startup which has raised over $300 million in investments within a year. Juno is developing three different CAR therapies in partnerships with the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, and Seattle Children's Research Institute.