On March 8, 2023 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported entry into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health (NIH), to investigate TT11X, Tessa’s allogeneic "off-the-shelf" CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) therapy, in multiple subtypes of non-Hodgkin lymphoma (Press release, Tessa Therapeutics, MAR 8, 2023, View Source [SID1234628320]).
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Under terms of the CRADA, Tessa will collaborate with the NCI’s Division of Cancer Treatment and Diagnosis (DCTD) to identify potential opportunities to expand the applicability of TT11X as a treatment of non-Hodgkin lymphoma. In this collaboration, NCI Cancer Therapy Evaluation Program (CTEP) will serve as the regulatory sponsor and conduct mutually approved clinical trials through NCI funded clinical network groups and using drug supply and other necessary support provided by Tessa. Tessa is currently advancing a Phase 1 clinical trial in the United States investigating TT11X in CD30-positive lymphomas. Data from the Phase 1 study presented at the 64th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) demonstrated TT11X to be well-tolerated at all dosing levels, eliciting a 79% overall response rate and 43% complete response rate among 14 heavily pre-treated CD30-positve Hodgkin lymphoma patients.
"We are pleased to enter into a CRADA with NCI.," said Tessa President and CEO Thomas Willemsen. "The collaboration is a strong incentive and encouragement for us to continue developing our scientific platform and will significantly expand our ability to conduct clinical trials with TT11X in a wide number of indications. Based on compelling safety and efficacy data from the Phase 1 trial of TT11X in patients with CD30-positive Hodgkin lymphoma, we believe there is a substantial opportunity to direct our ‘off-the-shelf’ therapy to other CD30-positive subtypes of non-Hodgkin lymphoma, where there is high patient need. We look forward to working with the clinical research team at the DCTD as well as DCTD’s funded extramural clinical network groups and benefitting from their breadth of research experience and scientific resources."
Tessa is advancing a pipeline of products that utilize CD30.CAR-modified EBVSTs, including its lead allogeneic cell therapy, TT11X, which is being co-developed with the Baylor College of Medicine for the treatment of relapsed or refractory CD30-positive lymphomas (NCT04288726). Tessa plans to extend its allogeneic EBVST platform to other cancer indications, including solid tumors.
Tessa’s proprietary "off-the-shelf" CD30.CAR-EBVST allogeneic cell therapy platform is based on decades-long research and development by researchers at Baylor College of Medicine into the unique properties of virus-specific T-cells (VSTs). These highly specialized T cells have the ability to recognize and kill infected cells while activating other parts of the immune system for a coordinated response. CD30.CAR-modified allogeneic EBVSTs without gene editing have demonstrated a strong safety profile and efficacy in early trials with minimal risk of graft-versus-host disease (GVHD).