On December 10, 2022 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported that enhanced clinical data from an ongoing Phase 1 study (NCT04288726) of TT11X, an allogeneic "off the shelf" CD30 (Press release, Tessa Therapeutics, DEC 10, 2022, View Source [SID1234625033]).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) (Free ASH Whitepaper) 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.
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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-positve 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 (Free ASH Whitepaper) 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-positve 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."
Tessa is currently 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. 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 Allogeneic VSTs without genetic modification have demonstrated a strong safety profile and efficacy in early trials with minimal risk of GVHD.
"The safety and efficacy data presented at ASH (Free ASH Whitepaper) were very compelling and indicate that our "off-the-shelf" CD30.CAR EBVST allogeneic cell therapy platform could provide a potential leap forward in the treatment of CD30 positive lymphomas," stated Ivan Horak, M.D., Chief Medical Officer and Chief Scientific Officer of Tessa Therapeutics. "We look forward to continuing the development of TT11X as a potential treatment for CD30-positive lymphomas, while exploring opportunities to extend the EBVST platform to other cancer indications, including solid tumors where there is significant unmet medical need."
Details of the podium presentation are as follows:
Presentation Title: Evaluating Safety and Clinical Efficacy of Off-the-Shelf CD30.CAR-Modified Epstein-Barr Virus-Specific T cells in Patients with CD30+ Lymphoma
Presenting Author: David H. Quach, PhD, Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX
Session Date: Saturday, Dec. 10, 2022, at 1:00 PM CT; Ballroom AB
A second oral podium presentation scheduled for Monday, December 12 at 5:45 PM CT p.m. and a poster presentation scheduled for Sunday, December 11 will highlight data from the Phase 2 CHARIOT trial evaluating the safety and efficacy of TT11, Tessa’s autologous CD30.CAR-T-cell therapy in patients with relapsed or refractory classical Hodgkin lymphoma (cHL).