MD Anderson Cancer Center and Innovent Biologics Inc. signed an 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 conducting clinical trials of rare cancers.
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.
Innovent seeks to pursue approval of sintilimab by FDA for multiple rare cancer indications in addition to larger cancer indications for sintilimab.
TYVYT (sintilimab injection) was approved in 2018 by the National Medical Products Association in China for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, where it is being evaluated in additional clinical trials for solid tumors.
“We are conducting more than 20 related clinical trials including over 10 registration clinical trials,” Michael Yu, founder, chairman and CEO of Innovent, said in a statement.
