December 07, 2013
Kite Pharma's Lead Program with the National Cancer Institute (NCI) Demonstrates Positive Results in Patients with Aggressive Non-Hodgkin's Lymphoma
- Findings Presented at 55th American Society of Hematology (ASH) Annual Meeting -
LOS ANGELES, CA (December 7, 2013) -- Kite Pharma, Inc. (Kite), a clinical-stage biotechnology company focused on engineered autologous T cell therapy (eACT) products for cancer, today announced positive clinical data demonstrating that Kite's most advanced product candidate can produce robust and durable tumor shrinkage in patients with an aggressive form of non-Hodgkin's lymphoma. In an oral presentation at the 55th ASH Annual Meeting, James N. Kochenderfer, MD from the NCI reported that an infusion of patients' own genetically modified T lymphocytes resulted in six complete remissions (CR) and six partial remissions (PR) among 13 patients with advanced B-cell malignancies who were eligible for response assessment.
Kite Pharma and the Surgery Branch of the NCI, led by Steven A. Rosenberg, MD, PhD, are collaborating under a Cooperative Research and Development Agreement (CRADA) for the development and commercialization of novel eACT products for the treatment of multiple cancer indications. This technology utilizes patients' peripheral blood T lymphocytes genetically engineered with either chimeric antigen receptors (CAR) or T cell receptors (TCR) that recognize tumor-specific molecules, traffic directly to the tumor, become activated upon engagement with the tumor antigen, and selectively eradicate tumors. The reported Phase 1/2a clinical trial is being conducted at the NCI with Dr. Rosenberg serving as principal investigator.
In the clinical trial, patients' T cells were modified to express a CAR targeting the B cell antigen CD19. Among the nine patients with either chemotherapy-refractory primary mediastinal B cell lymphoma (PMBCL) or diffuse large B cell lymphoma (DLBCL), seven patients were evaluable for response. Of these seven patients, six showed a response (three CR's and three PR's). This is the first report of successful treatment of these patients with CD19 CAR T cells. The majority of clinical responses were durable (up to 22 months ongoing). Acute toxicities, including fever, low blood pressure, focal neurological deficits, and delirium occurred in some patients after cell infusion, but resolved in less than three weeks.
"These clinical results are extremely encouraging and further validate both the CD19 target and the overall eACT approach," said Keith Nolop, MD, Chief Medical Officer of Kite Pharma. "These patients have aggressive disease that is resistant to chemotherapy, and they have no viable treatment options other than a clinical trial. Both the high overall response rate and the durability of the responses are noteworthy."
Arie Belldegrun, MD, Founder and Executive Chairman of the Board of Kite Pharma, added, "Our collaboration with the NCI has been highly productive and rewarding. Given the dramatic responses achieved so far, Kite is fully committed to rapidly advance the clinical development of
the CAR technology for multiple indications. We look forward to bringing this promising therapy to patients with advanced cancer."
About the eACT Platform
Clinical evidence has demonstrated that a patients' peripheral blood T cells, which have been engineered with T cell receptor (TCRs) and chimeric antigen receptors (CARs) that recognize tumor specific molecules, can traffic directly to the tumor, become activated upon engagement with the tumor antigen, and selectively eradicate tumors. Clinical studies performed at the National Cancer Institute (NCI) using these types of engineered peripheral blood T cells have been associated with significant and durable objective clinical responses in cancer patients with advanced metastatic disease, including those with refractory melanoma, sarcoma, lymphoma and leukemia. These encouraging results highlight eACT as an emerging therapeutic modality that could provide new personalized targeted therapy options for cancer patients spanning the spectrum of disease from its early stages to the salvage setting.
About Kite Pharma
Kite Pharma, Inc. (Kite) is a privately held development stage biotechnology company engaged in the development of novel cancer immunotherapeutic products, with a major focus on eACT therapy designed at restoring the patient's immune system to recognize and eradicate tumors. In partnership with the NCI Surgery Branch, Kite is advancing a pipeline of proprietary eACT product candidates, both CAR and TCR products, directed to a wide range of cancer indications. These novel personalized and targeted immunotherapies, which capitalize on the selectivity and potency of immune cells, are designed to provide significant and durable clinical benefit regardless of tumor origin, disease stage, and prior treatments. Kite's management team has a proven track record of building successful biotechnology companies and successfully developing cutting-edge immunotherapies and oncology treatments. Kite is based in Los Angeles, CA. For more information, visit the company's website at http://www.kitepharma.com.