SANTA MONICA, Calif. and CAMBRIDGE, Mass.—Kite Pharma, Inc. and bluebird bio, Inc. today announced that they have entered into a collaboration agreement to co-develop and co-commercialize second generation T cell receptor (TCR) product candidates directed against the human papillomavirus type 16 E6 (HPV-16 E6) oncoprotein incorporating gene editing and lentiviral technologies. Bluebird bio has a platform comprised of lentiviral gene-delivery and gene-editing capabilities, with a focus on rare diseases and cancer immunotherapies. Kite has a broad existing pipeline of TCR product candidates and will continue to develop its existing and wholly owned TCR programs directed against high-risk HPV, which are unaffected by this collaboration, including HPV-16 E6 TCR, currently in a Phase 1 study, and HPV-16 E7 TCR.
Under the terms of the agreement, both companies will jointly develop and commercialize second generation TCR product candidates directed against the HPV-16 E6 oncoprotein, incorporating gene editing to efficiently modify certain genes to enhance T cell function. In addition, the companies will explore using lentiviral vectors to optimize delivery of HPV-16 E6 TCRs into patient T cells.
Kite will lead the program in the U.S., and bluebird bio will have the option to lead the program in the European Union. Both companies will share overall costs, including research and development and sales and marketing expenses, and profits will be equally split between the companies. Additionally, Kite will have a co-promotion option in the European Union, and bluebird will have a co-promotion option in the U.S.
Biotech entrepreneur and investor Nick Leschly has served as president and chief executive of bluebird bio Inc. in Cambridge since September 2010 after a six-month stint as its interim chief executive, noted an article by Robert Weisman that appeared in the Boston Globe earlier this year. Previously a partner at Boston venture capital firm Third Rock Ventures, the 42-year-old Leschly helped launch several of the firm’s portfolio companies, including Agios Pharmaceuticals Inc. and Edimer Pharmaceuticals Inc.
Noting that his company’s initial target is treating children with the rare blood disorder beta-thalassemia, Leschly said the company chose its unusual name—which it spells as lowercase bluebird bio for marketing purposes—with the patients in mind. “We wanted a name that wasn’t just a reflection on the sector,” he said. “The eastern bluebird is loyal, family oriented, and competitive. A ‘bluebird day’ is an ideal day.”
"As we continue to build a differentiated immuno-oncology portfolio, we are delighted to partner with Kite in a collaboration that combines their leadership in T cell-based immunotherapies with our expertise in gene editing and industry-leading lentiviral vector platform," said Leschly, who is also known as chief bluebird. "We believe partnering with Kite will allow us to deliver game-changing T cell therapies to patients through great science and great capabilities."
"This partnership is a natural fit with our mission to develop and deliver novel immunotherapies for cancer patients, and collaborating globally with bluebird bio will allow us to benefit from the strengths and capabilities of both companies in immuno-oncology. Through this collaboration, we will have access to our partner's strong science expertise and enabling technologies to further enhance one of our key TCR programs and to evaluate gene editing technology in the context of T cell therapy," said Arie Belldegrun, M.D., FACS, Kite's chairman, president and CEO.
Human papillomavirus (HPV) is the most common viral infection of the reproductive tract, with two viral strains, HPV type 16 and type 18, believed to cause 70 percent of cervical cancers and precancerous cervical lesions, as well as other urogenital cancers. There were over 500,000 new cases and about 270,000 deaths attributable to cervical cancer worldwide in 2012 according to the World Health Organization.
Additionally, HPV infection has become established as an etiologic risk factor for oropharyngeal head and neck cancers. The incidence of HPV-associated oropharyngeal cancers has been increasing for at least the past decade, and recent studies show that about 70 percent of oropharyngeal cancers may be linked to HPV. According to the CDC, there are over 12,000 new cases of oropharyngeal cancers in the U.S. annually, of which an estimated 7,500 new cases are attributable to HPV-16.
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on eACT™ designed to restore the immune system's ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA.
With its lentiviral-based gene-therapy and gene-editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and T cell-based immunotherapy. Bluebird bio's clinical programs include Lenti-D™, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of childhood cerebral adrenoleukodystrophy, and LentiGlobin®, currently in three clinical studies: a global Phase 1/2 study, called the Northstar Study, for the treatment of beta-thalassemia major; a single-center Phase 1/2 study in France (HGB-205) for the treatment of beta-thalassemia major or severe sickle cell disease; and a separate U.S. Phase 1 study for the treatment of sickle cell disease (HGB-206). Bluebird bio also has ongoing preclinical CAR T immuno-oncology programs, as well as discovery research programs utilizing megaTALs/homing endonuclease gene editing technologies. The company has operations in Cambridge, Mass., Seattle and Paris, France.