Tessa Therapeutics Shifts Focus to Allogeneic Therapies

Tessa Therapeutics will be shifting its focus primarily to allogeneic therapies based on its CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) therapy platform, according to a corporate update.¹

The decision comes following the company’s presentation of promising safety and efficacy data regarding TT11X at the 64th American Society of Hematology (ASH) Annual Meeting, held December 10-12, 2022, in New Orleans, Louisiana.² TT11X is an allogeneic chimeric antigen receptor T-cell (CAR-T) therapy being developed in a collaboration with Baylor College of Medicine, currently being evaluated in a phase 1 clinical trial (NCT04288726). Data from the trial showed the candidate was well-tolerated and demonstrated a 79% overall response rate and a 43% complete response rate in the 14 patients with heavily pre-treated CD30-positve Hodgkin lymphoma included in the data presented.¹

“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 graft-versus-host-disease (GVHD) and immediate rejection even after multiple infusions,” David H. Quach, PhD, instructor at Center for Cell and Gene Therapy, Baylor College of Medicine, said in a December 2022 statement.² “Importantly, CD30.CAR EBVSTs elicited a clinical response in 11 of 14 patients with advanced CD30-positve Hodgkin lymphoma including 6 complete responses. Based on these results, CD30.CAR EBVSTs appear to be a promising platform for off-the-shelf cancer immunotherapy.”

The patients in the trial were treated at 3 dose levels: 4×10⁷ CD30.CAR EBVSTs, 1×10⁸ CD30.CAR EBVSTs, and 4×10⁸ CD30.CAR EBVSTs. It was noted that higher dose levels and additional infusions were associated with stronger responses. In terms of safety, 2 patients experienced reversible cases of grade 4 cytopenia. No dose-limiting toxicities were reported, and there was no evidence of GVHD.

The company additionally announced intention to seek other companies to continue the development of TT11, its autologous CAR-T program.¹ TT11, a CD30-CAR-T therapy, is currently being evaluated as a monotherapy for the treatment of relapsed or refractory classical Hodgkin lymphoma in the phase 2 CHARIOT clinical trial (NCT04268706) and in combination with nivolumab in the phase 1b ACTION clinical trial (NCT05352828). According to the company’s website, the CHARIOT trial has been paused until Tessa Therapeutics identifies a partner to continue development.³

“I believe that this strategic refocus on our allogeneic platform positions the company at the forefront of CAR-T innovation during 2023 and beyond,” Thomas Willemsen, president and chief executive officer, Tessa Therapeutics, stated in the update.¹ “This optimism is based on the compelling safety and efficacy data that continue to be generated by our TT11X program and the potential patient benefit in treating CD30-positive lymphomas, and potentially solid tumors where there is significant unmet medical need.” Willemsen previously discussed TT11 in an interview with CGTLive late last year, which can be viewed below:

REFERENCES

1. Tessa Therapeutics provides strategic outlook and corporate update for 2023. News release. Tessa Therapeutics Ltd. January 3, 2023. https://www.tessacell.com/2023/01/03/tessa-therapeutics-provides-strategic-outlook-and-corporate-update-for-2023/ 

2. Tessa Therapeutics announces new clinical data from phase 1 allogeneic study presented at 2022 Annual Meeting of American Society of Hematology (ASH). News release. Tessa Therapeutics Ltd. December 10, 2022. https://www.tessacell.com/2022/12/10/tessa-therapeutics-announces-new-clinical-data-from-phase-1-allogeneic-study-presented-at-2022-annual-meeting-of-american-society-of-hematology-ash/ 

3. Tessa Therapeutics. Pipeline. Website Accessed January 3, 2023. https://www.tessacell.com/pipeline/#tt11-cd30-car-ts