Designation includes early interactions with the FDA to facilitate development and discuss potential for expedited review.
Tessa Therapeutics, a clinical-stage cell therapy company developing next-generation cancer treatments announced in February 2020 the granting of Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for its investigational CD-30-directed autologous chimeric antigen receptor T cell (CD-30 CAR-T) therapy.
Tessa Therapeutics expect to initiate the pivotal Phase II multi-site trial in the fourth quarter of 2020.
“The RMAT designation speaks to the strength of the data in two independent Phase I/II trials, which show promising efficacy and a strong safety profile of the therapy in Hodgkin lymphoma patients whose disease had failed to respond to other available therapies,” said Ivan D. Horak, M.D., President of Research and Development at Tessa Therapeutics.
“We look forward to working closely with the FDA as we advance our trial at multiple sites in North America and work to bring this potentially transformative treatment option to patients.”
The designation followed positive proof-of-concept data from two independent Phase I/II clinical studies conducted in patients with relapse or refractory CD-30 positive classical Hodgkin Lymphoma. The two studies were performed by Baylor College of Medicine (NCT02917083) and University of North Carolina Lineberger Comprehensive Cancer Center (NCT02690545). Both studies demonstrated objective response rates of more than 70%, with 18 patients achieving complete response out of 27 patients treated with CD 30 CAR- T with lymphodepleting chemotherapy as of November 2019.
RMAT designation facilitates the development and expedite review of cell therapies and other qualifying regenerative medicines intended to treat a serious or life-threatening disease or condition; and preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition.
This designation grants the benefits of the FDA’s Fast Track and Breakthrough Therapy Designation programs. [APBN]