On January 20, 2021 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), reported 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 (Press release, T-Cure Bioscience, JAN 20, 2021, View Source [SID1234574146]). 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.

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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.