Tessa Therapeutics Announces Positive Early Clinical Data for Allogeneic, 'Off-the-Shelf' CD30-CAR EBVST Therapy TT11X in Relapsed/Refractory CD30+ Lymphoma

May 16, 2021 /BioonBIOON/ -- Tessa Therapeutics is an international biotechnology company headquartered in Singapore, dedicated to developing next-generation cell therapies for the treatment of cancer. Recently, the company announced at the 24th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT 2021) in 2021"Off-the-Shelf" T-Cell Therapy (TT11X)early clinical results.

TT11X is an allogeneic, CD30 chimeric antigen receptor, Epstein-Barr virus-specific T cell therapy (allogeneic CD30-CAR EBVST)., currently being co-developed by Baylor College of Medicine in the United States and Tessa Therapeutics, the data presented at the meeting are from an ongoing Phase 1 dose-escalation study (NCT04288726). This study is evaluating TT11X in patients with CD30-positive (CD30+) lymphoma.

Data from six patients treated with TT11X were presented at the conference. The results demonstrated that in patients with relapsed or refractory (R/R) CD30+ lymphoma who were heavily pre-treated (i.e., previously treated with multiple therapies), TT11X exhibited a favorable safety profile and promising clinical activity, even at lower dose levels. The dataset included three patients who received the lowest dose level (4 × 10^7 CD30-CAR EBVST) and three patients who received the second dose level (1 × 10^8 CD30-CAR EBVST).

“Off-the-Shelf” Allogeneic CD30-CAR EBVST Cell Therapy

Key findings are summarized as follows: (1)No serious adverse events or dose-limiting toxicities, including no evidence of graft-versus-host disease (GVHD), cytokine release syndrome (CRS), or neurotoxicity syndrome. (2) Among the 5 patients evaluable for efficacy, disease control was observed in 3, all of whom achieved partial response, namelyThe overall response rate (ORR) was 60% (3/5).。

This Phase I study aims to enroll 12–18 patients across three dose-escalation levels (4 × 10E7, 1 × 10E8, 4 × 10E8 CD30-CAR EBVST), with the final cohort's dose level roughly equivalent to that used in Tessa Therapeutics’ autologous CD30 program. Full results from this study are expected to be reported by the end of 2021.

`Principal Investigator of the study, Baylor College of Medicine Cellular and``Gene therapy`Dr. Carlos Ramos, Center Professor, stated: "We are encouraged by the early data generated from this study. TT11X was well tolerated, with no evidence of GVHD or any serious adverse events, and the clinical activity is encouraging. Although these are preliminary results, data collected from the first 5 patients suggest that allogeneic CD30-CAR EBVST may be able to overcome the safety and tolerability challenges commonly associated with allogeneic cell therapies. We look forward to completing enrollment in this trial and further advancing our understanding of this potential..."Tumorunderstanding of the new therapeutic platform."

Jeffrey H. Buchalter, President and Chief Executive Officer of Tessa Therapeutics, stated: “These are early but highly significant data supporting the development of Tessa Therapeutics’ ‘off-the-shelf’ allogeneic cell therapy. We believe that our allogeneic CD30-CAR EBVST platform holds tremendous potential, and we remain committed to our long-term plan to develop this platform to address hematologic malignancies and solid tumors.”Tumormajor needs in the field.”

Malcolm K. Brenner, Scientific Co-founder of Tessa Therapeutics, is a Member of the U.S. National Academy of Medicine, Baylor College of Medicine (BCM) Cell andGene therapyFounding Director of the Center (CAGT). Building upon decades of research by Dr. Malcolm Brenner and the Baylor College of Medicine team onVirus-specific T cells (Virus-specific T cell, VST)Focusing on the research and development of unique characteristics, Tessa Therapeutics is developing a proprietary allogeneic cell therapy platform.

VSTs are highly specialized T cells capable of recognizing and killing infected cells while simultaneously activating other components of the immune system to mount a coordinated response.Unmodified allogeneic VSTs demonstrated robust safety and efficacy in early-phase trials, exhibiting a minimal risk of GVHD. Preclinical studies further indicated that targeting CD30 has the potential to enhance the expansion and persistence of allogeneic cells. Through this platform approach, Tessa Therapeutics aims to overcome the current challenges faced by allogeneic cell therapies and develop more effective, reliable, and scalable treatments for a broad range of cancers.

Autologous CD30 CAR-T Cell Therapy

In addition to allogeneic cell therapies, Tessa Therapeutics is also developing multiple autologous therapies. TT11, the lead asset in the company's pipeline, is an autologous CD30 CAR-T cell therapy currently under development for the treatment of relapsed or refractory classical Hodgkin lymphoma (cHL, Phase 1) and CD30-positive non-Hodgkin lymphoma (NHL, Phase 2). Previously, TT11 has been by the U.S.FDAgrantedRegenerative MedicineRegenerative Medicine Advanced Therapy (RMAT) designation, and was granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).

inClinical TrialsIn China, TT11 demonstrates significant efficacy, a favorable safety profile, and minimal toxicity in patients with R/R cHL who have previously received multiple treatment regimens, and can meaningfully address the current unmet medical needs in the treatment of R/R cHL.

From 2 Phase 1/2 trialsClinical TrialData from (NCT02917083, NCT02690545) show that, in patients with relapsed/refractory classical Hodgkin lymphoma (R/R cHL) who had previously received multiple regimens, approximately 60% of patients at the highest dose levelTumorComplete disappearance. Furthermore, TT11 demonstrates a favorable safety profile and very limited toxicity, without the severe toxicities associated with several currently marketed CAR-T cell therapies. TT11 has the potential to meaningfully address the current unmet medical need in the treatment of R/R cHL. (Bioon.com)

Original Source: Tessa Therapeutics Announces Positive, Topline Data from Ongoing Phase 1 Trial of Allogeneic, “Off-the-Shelf” Cell Therapy, in Patients with Relapsed or Refractory CD30-Positive Lymphoma