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T-Cure Bioscience and Immunotech Biopharm Ltd Announce License Agreement for Novel HERV-E T Cell Receptor Therapy

·6-min read
  • Immunotech Biopharm Ltd will have rights to develop and commercialize 800TCR, a HERV-E targeting T cell receptor (TCR) therapy for the treatment of kidney cancer, in China

  • T- Cure Bioscience to receive an upfront payment and future development milestones and royalties

T-Cure Bioscience, Inc., a privately held clinical-stage immuno-oncology company developing the next generation of T cell receptor (TCR) therapies for patients with solid tumors, and Immunotech Biopharm Ltd ("Immunotech"), a leading cellular immunotherapy biopharmaceutical company focused on the research, development, and commercialization of T cell immunotherapies (HKEX: 6978), today announced that they have entered into a license agreement for the research and development of T-Cure's 800TCR product candidate, a HERV-E targeting TCR therapy for renal cell cancer (RCC), in China. Under the terms of the agreement, Immunotech will make an upfront payment with T-Cure being eligible to receive additional future development milestone payments and tiered royalties on net sales of the product.

T-Cure is currently developing 800TCR in the U.S. in collaboration with the National Heart Lung and Blood Institute (NHLBI), through a formal Collaborative Research and Development Agreement (CRADA). This TCR therapy is currently being evaluated in a Phase 1 trial at NHLBI for the treatment of metastatic clear cell Renal Cell Carcinoma (ccRCC) that failed an angiogenic inhibitor and a checkpoint inhibitor.

"We are extremely pleased to have entered into this agreement with Immunotech," stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. "China represents a large opportunity for the 800TCR given the high prevalence of the haplotype, A11, which the TCR targets. With its advanced research, manufacturing, clinical operations, and marketing, Immunotech represents an ideal partner to help us advance the 800TCR in China."

"Our Company made a strong debut last year as the first pre-revenue cellular immunotherapy firm to trade on the Hong Kong Stock Exchange," added Dr. Wang Yu, Executive Director, CEO and co-CTO of Immunotech. "We see the addition of 800TCR as a natural expansion of our cell therapy product pipeline which currently consists of a number of product candidates. Moreover, the extensive experience of our management team with the research and clinical development of T cell immunotherapies will be extremely beneficial as we look to initiate clinical trials for 800TCR."

The HERV-E target is one of the quiescent Human Endogenous Retrovirus (HERV) sequences that are activated during tumor development. A growing number of HERV genes and proteins are expressed in different cancers raising the possibility that HERV derived antigens might represent excellent targets for tumor immunotherapy. HERV-E expression in renal cell carcinoma (RCC) is highly selective, with no transcripts detected in any normal tissues. In contrast to well-studied antigens such as NY-ESO-1 and MAGE, HERV-E represents a new frontier of TCR targets with significant clinical potential for immunotherapy.

About T-Cure Bioscience, Inc.

T-Cure Bioscience, Inc. is an innovative immuno-oncology company committed to delivering effective and durable cell therapies for the treatment of cancer. The Company focuses on isolating high avidity TCR that can be used to engineer a patient's T cells to effectively target and destroy solid tumors. The Company maintains a pipeline of TCR under clinical and pre-clinical development targeting HERV-E, KK-LC-1, NY-ESO-1 and other antigens associated with solid tumors of significant unmet medical needs, including kidney cancer, breast cancer, lung cancer, gastric cancer, ovarian cancer, liver cancer, pancreatic cancer, sarcoma, and glioblastoma. More information is available at www.T-Cure.com.

About Immunotech Biopharm Ltd (HKEX: 6978) and its founder, Dr. Wang Yu

Immunotech is a China-based leading cellular immunotherapy biopharmaceutical company focusing on the research, development, and commercialization of T cell immunotherapy. Its pipeline features major classes of cellular immunotherapy products, including both non-genetically-modified and genetically-modified products, as well as both multi-target and single-target products. Immunotech's core product candidate, EAL®, a multi-target cellular immunotherapy product, is the first cellular immunotherapy product in China approved for entry into a Phase II clinical trial for solid tumor treatment. EAL® has demonstrated efficacy in the treatment of various types of cancer. In its history of clinical applications, EAL® has shown efficacy in preventing tumor recurrence and maintaining long-term survival of patients, and when used in combination with chemotherapy, has shown better therapeutic efficacy than chemotherapy alone. In addition to EAL®, main product candidates include other CAR and TCR cell therapies.

Dr. Wang Yu, the founder of Immunotech, has more than 20 years of experience in the fields of tumor immunotherapy and cellular medication research, focusing on the R&D of safe and effective immune cell drugs, as well as the standardized and scale production process and quality research in relation to individualized cell products.

Forward Looking Statements

T-Cure cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as "may", "might", "will", "should", "could", "expect", "plan", "anticipate", "believe", "estimate", "project", "intend", "future", "potential" or "continue", and other similar expressions are intended to identify forward looking statements. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that we expected. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210120005131/en/

Contacts

T-Cure Bioscience, Inc. IR & Media Contact
Rutland Baker
(IR@T-cure.com)