Presentations to feature clinical data from a Phase II CD30 CAR-T therapy study and a Phase I CD30 CAR-EBVST therapy study targeting lymphomas

SINGAPORE, Nov 5 (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 that data from its ongoing autologous and allogeneic cell therapy studies targeting lymphomas has been accepted for two separate poster presentations at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition being held from December 11-14, 2021.

The presentations include clinical data from a Phase II multi-center study evaluating safety and efficacy of CD30 CAR-T therapy (TT11) in patients with relapsed / refractory classical Hodgkin Lymphoma (R/R cHL) and another Phase I investigator-initiated study testing allogeneic ‘off-the-shelf’ CD30 CAR EBVST therapy (TT11X) in patients with relapsed / refractory CD30+ lymphoma. Accepted abstracts will also be published online in the November supplemental issue of Blood, a publication of the American Society of Hematology.

Details of Presentations

Title: Safety and Efficacy Profile of Autologous CD30.CAR-T-Cell Therapy in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (CHARIOT Trial)
Session Name: 704. Cellular Immunotherapies: Clinical: Poster III
Abstract: #3847
Presenting Author: Sairah Ahmed, M.D., MD Anderson Cancer Centre
Date, Time and Location: December 13, 2021; 6:00 PM - 8:00 PM ET; Georgia World Congress Center, Hall B5

Title: Safety and efficacy of off-the-shelf CD30.CAR-modified Epstein-Barr virus-specific T cells in patients with CD30-positive lymphoma
Session Name: 704. Cellular Immunotherapies: Clinical: Poster I
Abstract: #1763
Presenting Author: David Hon Quach, Instructor, Center for Gene Therapy, Baylor College of Medicine, Houston, TX
Date, Time and Location: December 11, 2021; 5:30 PM - 7:30 PM ET; Georgia World Congress Center, Hall B5

About TT11 (CD30 CAR-T Therapy)

TT11 is a CAR-T therapy, which harvests a patient’s own T-cells and modifies them by introducing a CD30-directed Chimeric Antigen Receptor (CAR) to target and kill CD30+ cells in classical Hodgkin Lymphoma (cHL). CD30 is a well validated lymphoma target with homogeneous expression in 98% of cHL and a significant proportion of subsets of non-Hodgkin Lymphomas. Clinical data from two Phase 1/2 studies, published last year in the Journal of Clinical Oncology^a, showed TT11 demonstrated strong safety and efficacy as a monotherapy for heavily pre-treated R/R cHL patients. A Phase 2 study was subsequently conducted this year evaluating TT11 among R/R cHL patients, results for which will be presented at 2021 ASH annual meeting.

About TT11X (Allogeneic CD30 CAR-EBVST Therapy)

TT11X is an allogeneic ‘off-the-shelf’ therapy which augments Epstein bar virus-specific T-cells with CD30 CAR technology. The therapy is based on a proprietary allogeneic cell therapy platform developed from 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.

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). 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, visit www.tessacell.com.

Cautionary Note on Forward Looking Statements

This press release contains forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, to the fullest extent applicable) including, without limitation, with respect to various regulatory filings or clinical study developments of the Company. You can identify these statements by the fact that they use words such as “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, “may”, “assume” or similar expressions. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the Company’s financial results, the ability to raise capital, dependence on strategic partnerships and licensees, the applicability of patents and proprietary technology, the timing for completion of the clinical trials of its product candidates, whether and when, if at all, the Company’s product candidates will receive marketing approval, and competition from other biopharmaceutical companies. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made, and disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The Company’s products are expressly for investigational use pursuant to a relevant investigational device exemption granted by the U.S. Food & Drug Administration, or equivalent competent body.

References:
a. Ramos et al., J Clin Oncol 2020

Tessa Therapeutics Media Contact
Ritika Khetawat
+65 6384 0755
media@tessacell.com

Source: Tessa Therapeutics Ltd

--BERNAMA