world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic and other major diseases, and The University of Texas MD Anderson Cancer Center today announced a strategic collaboration agreement to co-develop TYVYT® (sintilimab injection), Innovent's anti-PD-1 monoclonal antibody, in rare cancers in the U. S..
The joint development will focus on advancing sintilimab as an effective immune checkpoint inhibitor for patients with rare cancer types. This research will be enabled by MD Anderson's experience in conducting clinical trials for even the rarest cancers not often seen by other centers. These studies will provide opportunities for Innovent to pursue approval of sintilimab by the U.S. Food and Drug Administration for multiple rare cancer indications in addition to larger cancer indications for sintilimab that Innovent is independently pursuing for approval as well.
"TYVYT® (sintilimab injection) was approved in 2018 by the National Medical Products Association (NMPA) in China for the treatment of relapsed or refractory classic Hodgkin's lymphoma after second-line or later systemic chemotherapy, where it is currently being evaluated in additional clinical trials for solid tumors" said Dr. Michael Yu, Founder, Chairman and CEO of Innovent. "We believe TYVYT® has great potential in various tumor types, both as a single agent and in combination with other inhibiting agents, and currently we are conducting more than 20 related clinical trials including over 10 registration clinical trials. Through this new co-development collaboration, we will work to advance TYVYT® into rare tumors, where we hope it will continue to demonstrate its efficacy across multiple tumor types."
"We look forward to working with Innovent and utilizing our unique expertise in treating rare cancers to advance sintilimab toward potential FDA approval," said Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Relations at MD Anderson. "The introduction of sintilimab to the U.S. would broaden the treatment options available to patients with rare cancer types, many of whom do not currently have an effective standard of care available."
Under the agreement, Innovent and MD Anderson will co-fund the development activities for sintilimab, which may include multiple clinical research studies to be conducted by MD Anderson. MD Anderson plans to develop an approach, upon commercialization in rare diseases, to allow royalty payments it receives on sales of the product in the U.S. to be used to fund care for uninsured patients.