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CAR-Ts: The next generation
SEATTLE—Alpine Immune Sciences (AIS), an immunotherapy company focused on developing treatments for autoimmune diseases and cancer, announced Oct. 23 that it had extended the research term of its worldwide research and license agreement with Kite Pharma Inc.
The research collaboration and license agreement, which had its start in October 2015, grants Kite an exclusive license to two Alpine programs from Alpine’s Transmembrane Immunomodulatory Protein (TIP) program. The license allows Kite to further engineer these candidates into chimeric antigen receptor T cell (CAR-T) and T cell receptor (TCR) product candidates.
The research term extension does not change the upfront and potential regulatory milestone amounts payable to Alpine in the original agreement, or royalties Alpine may earn on potential future sales of Kite products incorporating Alpine’s TIP technology. Kite will continue to have access to two programs from Alpine’s TIP technology for use in CAR-T and TCRs during the extended research term.
Looking back at the original deal announcement two years ago, AIS noted that the deal would be working “to discover and develop protein-based immunotherapies targeting the immune synapse to treat cancer ... 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 microenvironment.”
“The field of immuno-oncology has the potential to significantly improve the outcome of patients with cancer,” Dr. Arie Belldegrun, chairman, president and CEO of Kite said at the time of the 2015 deal. “We believe the ability of AIS’ TIP technology to modulate the immune synapse can be incorporated into engineered T cell therapies to advance CAR and TCR product candidates into multiple tumor types. This collaboration is another example of Kite's continuing commitment to advancing our pipeline through transformative technologies grounded in innovative science.”
Under the terms of the original collaboration, Kite made an upfront payment to AIS of $5 million and additional payments to support AIS’ research. AIS is eligible to receive milestone payments based upon the successful achievement of pre-specified research, clinical and regulatory milestones—which could total $530 million—plus low single-digit royalty payments on product sales.
“AIS was established with a team of experienced scientists to capitalize on our keen understanding of immunology and protein engineering,” Dr. Mitchell H. Gold, AIS executive chair, said of the original deal at the time. “At AIS, we have a robust discovery platform to identify molecules capable of directly modulating the immune synapse. We look forward to working with Kite, a company that uniquely understands the complexities surrounding cancer biology.”
In somewhat related news, Gilead Sciences—Kite Pharma’s parent company—announced on Oct. 18 that the U.S. Food and Drug Administration (FDA) had granted regular approval to Kite’s compound Yescarta (axicabtagene ciloleucel), the first CAR-T therapy for the treatment of adult patients with relapsed or refractory large B cell lymphoma after two or more lines of systemic therapy, including diffuse large B cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B cell lymphoma, high-grade B cell lymphoma and DLBCL arising from follicular lymphoma (transformed follicular lymphoma). Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
“The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B cell lymphoma. This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite’s employees,” said Kite’s Belldegrun. “We must also recognize the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses. We believe this is only the beginning for CAR-T therapies.”
“Today is an important day for patients with relapsed or refractory large B cell lymphoma who have run out of options and have been waiting for new treatments that may help them in their fight against cancer,” added Dr. John Milligan, president and CEO of Gilead. “With the combined innovation, talent and drive of the Kite and Gilead teams, we will rapidly advance cell therapy research and aim to bring new options to patients with many other types of cancer.”