On February 27, 2020, Tessa Therapeutics (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments, announced its investigational CD30-directed autologous CAR-T cell (CD30 CAR-T) therapy was granted a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA. The therapy is intended to treat patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma.
Tessa Therapeutics is now aiming to initiate its pivotal Phase II multi-site trial in the 4th quarter of 2020.
According to Ivan D. Horak, M.D., President of Research and Development at Tessa Therapeutics:
“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. 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.”
Dr. Horak added: “As part of our longer-term R&D program, we are also developing an allogeneic CD30-CAR Epstein-Bar Virus-Specific T cell (CD30-CAR EBVST) therapy product that combines the unique properties of VSTs and CD30 CARs, in an effort to develop off-the-shelf cell therapies intended to treat a range of hematologic malignancies and solid tumors.”
Tessa’s RMAT designation is supported by clinical data from two independent CD30 CAR-T Phase I/II studies in patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma conducted by Baylor College of Medicine and University of North Carolina Lineberger Comprehensive Cancer Center.
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.
The U.S. FDA RMAT Designation
An RMAT is an FDA designation that accelerates the development and review of cell therapies and other qualifying advanced therapies (AT) to treat serious or life-threatening conditions for which preliminary clinical evidence suggests the treatment could address unmet medical needs. The acronym stands for “Regenerative Medicine Advanced Therapy,” a framework introduced in late 2016 as part of the 21st Century Cures Act.
An RMAT submission request must be made in conjunction with an IND application, either concurrently or as an amendment to one.
Advantages include all the benefits of the FDA’s Fast Track and Breakthrough Therapy Designation programs, such as early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval and satisfy post-approval requirements.
More information on Tessa’s CD30 CAR-T therapy pivotal Phase II clinical trial is available at this link.
About Tessa Therapeutics
Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a diverse range of cancers.
The company’s fast-growing clinical pipeline includes two investigational autologous cell therapies in late-stage clinical development for nasopharyngeal cancer and classical Hodgkin lymphoma. Combining the unique properties of Virus-Specific T cells (VSTs) and CD-30 Chimeric Antigen Receptors (CD30-CARs), Tessa is also emerging with a new approach to cancer cell therapy through the development of a novel, allogeneic platform technology. The platform holds potential for the creation of off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.
Tessa’s strategic partnerships with leading US academic centers and manufacturing and supply chain capabilities across Asia and the U.S., are enabling the company to deliver cell therapies on a global scale.
Source: Tessa Therapeutics