Kite Pharma, Inc. is an American biotechnology company that develops cancer immunotherapy products with a primary focus on genetically engineered autologous CAR T cell therapy - a cell-based therapy which relies on chimeric antigen receptors and T cells. Founded in 2009, and based in Santa Monica, California, it was acquired by Gilead Sciences in 2017.
History The company was founded in 2009 by Arie Belldegrun, an Israeli-American oncologist, who served as the company's chairman, president and chief executive officer. Belldegrun had a co-founder in Joshua Kazam, who took on the role of Director. On August 28, 2017, Gilead Sciences announced that it would acquire Kite Pharma for $11.9 billion in an all-cash deal, a 29% premium on the share price. Gilead made the purchase in large part to bolster sales in the face of the company's declining hepatitis C franchise revenues, a result of declining patient numbers as they were cured, as Kite's sales were anticipated to reach $2 billion per annum. The acquisition was completed in October 2017, when Kite Pharma's Yescarta became the first CAR-T therapy approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. This form of immunotherapy was originally developed by the U.S. National Cancer Institute and the company pays the government to support continuing research. In 2017, MIT Technology Review ranked Kite Pharma 7th in its annual list of the preceding year's 50 Smartest Companies.
Lead product Axicabtagene ciloleucel (KTE-C19, ZUMA-3, YESCARTA) was an investigational therapy (for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL)) in which a patient's T cells were genetically modified to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. It garnered a US FDA Breakthrough Therapy Designation (Dec 2015) for the treatment of patients with refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL). It was approved for use in the United States under the brand name YESCARTA in October 2017.
Development history
2012 In October, Kite Pharma entered into a Cooperative Research and Development Agreement with the National Cancer Institute (NCI) for the development and commercialization of products for the treatment of multiple cancer indications.
2013 In December, the company announced data in its lead clinical development program with the NCI, demonstrating that Kite's most advanced immunotherapy product candidate – KTE-C19 CAR – can produce robust and durable tumor shrinkage in patients with an aggressive form of non-Hodgkin's lymphoma, known as diffuse large B cell lymphoma (DLBCL). The clinical data were presented at the 55th American Society of Hematology Annual Meeting.
2014 The company announced in March, that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company's proposed therapy for DLBCL. In June, Kite Pharma entered into an exclusive, worldwide license with the National Institutes of Health (NIH) to certain intellectual property related to TCR-based product candidates that target the NY-ESO-1 antigen for the treatment of cancers expressing NY-ESO-1. Kite Pharma announced findings from its ongoing clinical trial in August: 12 of 13 evaluable patients with advanced B-cell malignancies had complete remissions (8 patients) or partial remissions (4 patients) resulting in a 92% objective response rate. The results support Kite Pharma's plan to file an Investigational New Drug (IND) application in the fourth quarter of 2014 to initiate a clinical trial of Kite Pharma's lead CAR-based product candidate, KTE-C19, in patients with DLBCL.
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