Data to be Presented Today at the ASGCT 24th Annual Meeting Demonstrated No Dose-Limiting Toxicity with Encouraging Clinical Activity in First 5 Patients Treated
Final Data Readout Expected by End of 2021
Date: 07 May 2021 | Download Press Release
BEDMINSTER, N.J. / SINGAPORE – May 14, 2021 – Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, today announced early clinical results for an allogeneic CD30-CAR EBVST therapy (TT11X), being co-developed by Baylor College Medicine and Tessa. The data is from an ongoing Phase 1 dose-escalation study (NCT04288726) testing TT11X in patients with CD30+ lymphomas. The results will be presented today at the 24th Annual Meeting of American Society of Gene and Cell Therapy (ASGCT 2021).
The presentation at ASGCT 2021 will highlight data from six patients treated with the therapy. The results demonstrated a favorable safety profile with encouraging clinical activity even at lower dose levels in heavily pre-treated relapsed / refractory (R/R) CD30+ lymphoma patients. The dataset includes three patients dosed at the lowest dosing level (4 × 107 CD30.CAR EBVSTs) and three at the second level (1 × 108 CD30.CAR EBVSTs). Key findings summarized below:
- No serious adverse events or dose-limiting toxicities, including no evidence of graft-versus-host disease (GVHD), cytokine release syndrome or neurotoxicity syndrome
- Of the 5 patients evaluable for efficacy, disease control was observed in 3 patients, who had partial responses
The Phase 1 study aims to enroll 12-18 patients at three escalating dose levels (4 × 107 CD30.CAR EBVSTs, 1 × 108 CD30.CAR EBVSTs and 4 × 108 CD30.CAR EBVSTs (with this last cohort being broadly equivalent to the dose level utilized in Tessa’s autologous CD30 program). Full findings from the trial are expected to be reported by end of 2021.
“We are encouraged by the early data generated on the study. The therapy has been well tolerated with no evidence of GVHD or any severe adverse events, with encouraging clinical activity,” stated Dr. Carlos Ramos, Lead Principal Investigator, Professor at the Center for Cell and Gene Therapy and member of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine. “While these are preliminary results, the data gleaned from the first five patients suggest that allogeneic CD30-CAR EBVSTs may be able to overcome the safety and tolerability challenges that are common to allogenic cell therapies. We look forward to completing enrollment on the trial and further developing our understanding of this potential new therapy platform for oncology.”
Tessa is developing a proprietary allogeneic cell therapy platform based on decades-long research and development on unique properties of Virus Specific T-cells (VSTs) by Tessa’s Scientific Co-Founder, Dr. Malcolm Brenner, and the team at Baylor College of Medicine. VSTs are highly specialized T cells with the ability to recognize and kill infected cells while activating other parts of the immune system for a coordinated response. Allogeneic VSTs without any form of genetic modification have demonstrated a strong safety profile and efficacy in early trials with minimal risk of GVHD. Preclinical studies have further demonstrated that CD30 targeting potentially helps improve allogeneic cell expansion and persistence. With this platform approach, Tessa aims to overcome the current challenges faced by allogeneic cell therapies and create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers.
‘This is early but significant data supporting development of Tessa’s ‘off-the-shelf,’ allogeneic cell therapy,” stated Jeffrey H. Buchalter, President and CEO of Tessa Therapeutics. “We believe there is an enormous potential for our allogeneic CD30-CAR EBVST platform, and we remain committed to our longer-term plan to develop this platform to tackle both hematologic malignancies and solid tumors where there is significant patient need.”
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 prevent graft rejection. A therapy using this platform, is currently the subject of a Phase 1 clinical trial in CD30-positive lymphoma. A third clinical asset evaluates novel combination therapy of HER2-CAR-T cells and binary oncolytic virus in an ongoing Phase 1 study 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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