82 Patient Pivotal cohort expected to commence in second half of 2021
BEDMINSTER, N.J. and SINGAPORE, April 30, 2021 /PRNewswire/ -- Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, today announced enrollment of 12 patient Pilot cohort of its Phase 2 trial (NCT04268706) in relapsed / refractory Classical Hodgkin Lymphoma (R/R cHL). The next step in the two-part study is enrollment of the 82 patient Pivotal cohort to assess the safety and antitumor efficacy of Tessa's autologous CD30 CAR-T in R/R cHL, which is planned to commence in 2H 2021.
"Tessa's CD30 CAR-Ts previously demonstrated excellent safety and efficacy in heavily pre-treated R/R cHL patients across two independent Phase 1/2 studies. It is exciting to see the rapid enrollment of the Pilot cohort, and we look forward to working with Tessa in the pivotal cohort of this trial. There is a high unmet need for effective treatments in R/R cHL and we are pleased to be able to advance this novel CD30 directed CAR-T cell therapy for our patients," said Sairah Ahmed, M.D., Associate Professor, The University of Texas MD Anderson, Cancer Center.
CD30 is a well validated lymphoma target with homogeneous expression in 98% of classical Hodgkin Lymphoma (cHL) and a significant proportion of subsets of non-Hodgkin Lymphomas. Tessa's technology modifies the patient's T-cells by introducing a CD30 directed Chimeric Antigen Receptor, or CAR, to target and kill cHL. Tessa's CD30 CAR-T therapy, previously induced a Complete Response in 59% of heavily pretreated R/R cHL patients, with no instance of neurotoxicity or grade 3 Cytokine release syndrome (CRS) (and published in Journal of Clinical Oncology[1]). Tessa's therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration and PRIority MEdicines (PRIME) designation by European Medicines Agency.
"The speed of enrollment of our 12 patient Pilot cohort, in less than 3 months, is testament to the strong physician and patient interest in our CD30 CAR-T therapy, and further endorses the clinical data generated under the dual Phase 1/2 studies. This marks a critical milestone as Tessa gears up to commence our Pivotal cohort in second half of the year," said Jeffrey H. Buchalter, President and CEO of Tessa Therapeutics. "We believe that Tessa's CD30 CAR-T therapy, with its promising efficacy and excellent safety profile, addresses current gaps in the treatment of cHL, and has the potential to rapidly move to earlier lines of therapy."
[1]Ramos et al. "Anti-CD30 CAR-T Cell Therapy in Relapsed and Refractory Hodgkin Lymphoma" J Clin Oncol (2020) |
About Tessa Therapeutics
Tessa Therapeutics is a clinical-stage biotechnology company developing next-generation cell therapies for the treatment of hematological cancers and solid tumors. Tessa's lead clinical asset, TT11, is an autologous CD30 targeting CAR-T therapy currently being investigated as a potential treatment for relapsed or refractory classical Hodgkin lymphoma (Phase 2) and CD30-positive non-Hodgkin lymphoma (Phase 1). TT11 has been granted RMAT designation by the FDA and PRIME designation by European Medicine Agency. Tessa is also advancing an allogeneic "off-the shelf" cell therapy platform targeting a broad range of cancers in which Epstein Barr Virus Specific T Cells (EBVSTs) are augmented with CD30-CAR technology to potentially increase their cell performance. A therapy using this platform, TT11X, is currently the subject of a Phase 1 clinical trial in CD30-positive lymphoma. A third clinical asset, TT16, which is a novel combination therapy of HER2-CAR-T cells and binary oncolytic virus therapy, is being evaluated in a Phase 1 clinical trial targeting HER2 positive solid tumors. Tessa has its global headquarters in Singapore, where the company has built a state of the art, commercial cell therapy manufacturing facility. Tessa's United States headquarters are in New Jersey. For more information on Tessa, please visit www.tessacell.com.
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