Thursday, 15 December 2022

TESSA THERAPEUTICS ANNOUNCES NEW CLINICAL DATA FROM PHASE 1 ALLOGENEIC STUDY PRESENTED AT 2022 ANNUAL MEETING OF AMERICAN SOCIETY OF HEMATOLOGY (ASH)

Oral podium presentation highlights data demonstrating a 79% overall response rate and complete responses in 43% of relapsed or refractory CD30-positive lymphomas treated with Tessa’s “off the shelf” CD30.CAR EBVST cell therapy (TT1X)

Therapy well tolerated with no dose-limiting toxicities or evidence of graft-versus-host-disease (GVHD) observed

SINGAPORE, Dec 12 (Bernama-GLOBE NEWSWIRE) -- Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, today announced enhanced clinical data from an ongoing Phase 1 study (NCT04288726) of TT11X, an allogeneic “off the shelf” CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) therapy being co-developed by Baylor College of Medicine and Tessa. The results, detailed in an oral podium presentation at the 64th Annual Meeting of the American Society of Hematology (ASH) on December 10, demonstrated TT11X to be well-tolerated at all dosing levels, eliciting a 79% overall response rate and complete disappearance of tumor in six patients.

The podium presentation, entitled, “Evaluating Safety and Clinical Efficacy of Off-the-Shelf CD30.CAR-Modified Epstein-Barr Virus-Specific T cells in Patients with CD30+ Lymphoma,” reported data from 14 heavily pre-treated patients with advanced CD30-positive Hodgkin lymphoma who were administered TT11X across three dosing levels  (4 × 10⁷ CD30.CAR EBVSTs, 1 × 10⁸ CD30.CAR EBVSTs, and 4 × 10⁸ CD30.CAR EBVSTs). An overall response rate of 79% (11/14 patients) was observed across all three dose levels, including six complete responses and six partial responses. The strongest responses were achieved in patients treated at the higher dose levels with additional infusions resulting in increasing effectiveness.

TT11X was demonstrated to be well tolerated with no dose limiting toxicities observed, including no evidence of graft-versus-host disease (GVHD) and only two patients having reversible grade 4 cytopenia.

“The data reported at ASH suggest that allogeneic CD30.CAR EBVSTs provide a potentially safe and efficacious treatment for CD30-positive lymphomas and affirm previously reported data indicating the technology may avert GVHD and immediate rejection even after multiple infusions,” stated David H. Quach, Ph.D., Instructor at Center for Cell and Gene Therapy, Baylor College of Medicine, USA. “Importantly, CD30.CAR EBVSTs elicited a clinical response in 11 of 14 patients with advanced CD30-positive Hodgkin lymphoma including six complete responses. Based on these results, CD30.CAR EBVSTs appear to be a promising platform for off-the-shelf cancer immunotherapy.”  

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