On May 18, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a 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 reported a strategic collaboration agreement to co-develop TYVYT (sintilimab injection), Innovent’s anti-PD-1 monoclonal antibody, in rare cancers in the U. S. (Press release, Innovent Biologics, MAY 18, 2020, View Source [SID1234558229]).
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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.
About TYVYT (Sintilimab Injection)
TYVYT (sintilimab injection), an innovative drug developed with global quality standards jointly developed by Innovent and Lilly in China, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the supplemental new drug application for TYVYT in combination with ALIMTA (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with Gemzar (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC, TYVYT monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well.
TYVYT is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.