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.Ro, Sam (August 26, 2014). "Biotech Stock Kite Pharma Explodes Higher After Good News About Its Non-Hodgkin Lymphoma Drug" . Business Insider. Retrieved August 27, 2014.
2015 In January, Kite Pharma and Amgen entered into a strategic research collaboration and license agreement to develop and commercialize the next generation of novel Chimeric Antigen Receptor (CAR) T cell immunotherapies based on Kite's engineered autologous cell therapy platform and Amgen's extensive array of cancer targets.
Kite Pharma announced in May, that the first patient in its Phase 1/2 clinical trial of KTE-C19 in patients with refractory aggressive Non-Hodgkin Lymphoma has been treated."Kite Pharma Announces That the First Patient in Its Phase 1/2 Clinical Trial Has Been Treated With KTE-C19, Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, for Refractory Aggressive Non-Hodgkin's Lymphoma (NHL) " . MarketWatch. 21 May 2015. Retrieved 7 July 2015.
In June, Kite Pharma and bluebird bio, Inc. announced they have entered into a collaboration agreement to co-develop and co-commercialize second generation T cell receptor product candidates directed against the human papillomavirus type 16 E6 onco protein incorporating gene editing and lentiviral technologies."Kite Pharma & Bluebird Bio To Co-develop T Cell Cell Therapy Products" . NASDAQ. 22 June 2015. Retrieved 7 July 2015.
In July, Kite Pharma and the Leukemia & Lymphoma Society announced that they have entered into a partnership to enhance the development of Kite's lead product candidate, KTE-C19, for the treatment of patients with refractory aggressive Non-Hodgkin Lymphoma."Kite Pharma (KITE), Leukemia & Lymphoma Society Enter Into Collaboration" . StreetInsider.com. 1 July 2015. Retrieved 7 July 2015.
In September, Kite Pharma announced that it has expanded its collaboration with the Netherlands Cancer Institute (NKI). Kite and the NKI have entered into an agreement under which Kite will receive from the NKI the exclusive option to license multiple T cell receptor (TCR) gene sequences for the development and commercialization of cancer immunotherapy candidates targeting solid tumors. Kite has also expanded its access to additional resources and research facilities through a master services agreement with the NKI."Kite Pharma Expands Collaboration With Netherlands Cancer Institute (NKI)" . Kite Pharma. 14 September 2015. Retrieved 20 October 2015.
In October, Kite Pharma announced that it has entered into an exclusive, worldwide license with the National Institutes of Health (NIH) for intellectual property related to T cell receptor (TCR)-based product candidates directed against MAGE A3 and A3/A6 antigens for the treatment of tumors expressing MAGE, which include lung, pancreatic, gastric, and breast cancers, among others."Kite Pharma Announces Exclusive License with the National Institutes of Health for T Cell Receptor (TCR)-Based Products to Treat Tumors Expressing MAGE" . FiereceBiotech. 20 October 2015. Retrieved 20 October 2015. In the same month, Kite Pharma announced that it has entered into a worldwide research and license agreement with Alpine Immune Sciences (AIS), a privately held biotechnology startup, to discover and develop protein-based immunotherapies targeting the immune synapse to treat cancer. AIS will grant Kite an exclusive license to two programs from its Transmembrane immunomodulatory protein (TIP) technology, which Kite plans to further engineer into chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates. This collaboration will accelerate Kite's efforts to establish the next generation of engineered T cell therapies specifically designed to overcome the inhibitory mechanisms present in the tumor micro-environment."Kite to spend as much as $530 million on rights to AIS programs " . ThePharmaLetter. 28 October 2015. Retrieved 28 October 2015.Demmitt, Jacob (28 October 2015). "Seattle’s Alpine Immune Sciences licenses cancer treatment to Kite Pharma for up to $530M" . GeekWire. Retrieved 28 October 2015.
In December, Kite Pharma announced that it has initiated a phase 1/2 clinical study of KTE-C19 (ZUMA-3) for the treatment of adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL). KTE-C19 is an investigational therapy in which a patient's T cells are 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 leukemia's. In the same month, Kite Pharma and GE Global Research announced they will partner to develop a next-generation, functionally integrated and automated manufacturing system for engineered T-cell therapy. Kite and GE Global Research—GE's centralized R&D hub—said they aim to increase the availability of engineered T-cell therapies by speeding up development of automation technologies that have the potential to lower costs, operate faster, and minimize variability."Kite Pharma, GE Global Research Partner on T-Cell Therapy Manufacturing" . Genetic Engineering & Biotechnology News. 3 December 2015. Retrieved 7 December 2015. Also in December, Kite announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to the company's lead product candidate, KTE-C19, for the treatment of patients with refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL).
2016 In January, it was announced that Kite Pharma has entered into a Cooperative Research and Development Agreement (CRADA) with the NCI for the research and clinical development of a fully human anti-CD19 chimeric antigen receptor (CAR) product candidate for the treatment of B-cell lymphomas and leukemia."Kite Pharma (KITE), NCI Expand Clinical and Research Partnership" . TheStreet.com. 7 January 2015. Retrieved 7 January 2015. Moreover, Kite Pharma announced that its European subsidiary has entered into a research and license agreement with Leiden University Medical Center (LUMC) to identify and develop T cell receptor (TCR) product candidates targeting solid tumors that are associated with the human papillomavirus (HPV) type 16 infection."Kite Pharma and Leiden University Medical Center Sign Research and License Agreement for T Cell Receptors Targeting HPV-Associated Cancers" . FierceBiotech. 13 January 2016. Retrieved 13 January 2016.
In March, Kite Pharma has announced that it would be collaborating with Genentech, in order to evaluate the safety and efficacy of two of its novel therapies. The target population for the tests would be patients with non-Hodgkin Lymphoma. The therapies in question, KTE-C19 and atezolizumab, would be tested in combination with each other.Sandford, Miles (18 March 2016). "Kite Pharma Inc (NASDAQ:KITE) To Begin a Collaborative Study on KTE-C19" . Journal Transcript. Retrieved 18 March 2016.
In June, Kite Pharma and Cell Design Labs, Inc. announced a research collaboration and license agreement to develop next generation, precision-controlled chimeric antigen receptor (CAR) product candidates that incorporate Cell Design Labs' molecular “on/off switch” technology."Kite Pharma (KITE), Cell Design Labs Enter Research Collaboration for Next-Gen CAR Product Candidates" . StreetInsider.com. 2 June 2016. Retrieved 2 June 2016. Also in June, Kite Pharma announced that it has entered into a new Cooperative Research and Development Agreement (CRADA) with the Experimental Transplantation and Immunology Branch (ETIB) of the National Cancer Institute (NCI) for the research and clinical development of T-cell receptor (TCR) product candidates directed against human papillomavirus (HPV)-16 E6 and E7 onco-proteins for the treatment of HPV-associated cancers."Kite Pharma Expands Development of T-Cell Receptor (TCR) Therapies Targeting HPV-Associated Cancers in Partnership with the National Cancer Institute (NCI)" . BusinessWire. 20 June 2016. Retrieved 20 June 2016.