On August 4, 2020 T-Cure Bioscience, Inc., a privately held company focused on developing autologous T cell receptor (TCR) therapy products for the treatment of solid tumors, reported that the Company has extended its ongoing research collaboration with the National Heart Lung and Blood Institute (NHLBI), through a formal Collaborative Research and Development Agreement (CRADA) to advance the Company’s HERV-E targeting TCR therapy for renal cell cancer (Press release, T-Cure Bioscience, AUG 4, 2020, View Source [SID1234562835]). Additionally, T-Cure has amended an existing license to expand to worldwide rights for the intellectual property it licensed from NHBI related to the anti-HERV-E TCR product. This TCR therapy is currently 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. T-Cure has been actively collaborating for the past 18 months with NHLBI on the research and development of the HERV-E-specific TCR.

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Under the CRADA, T-Cure and NHLBI will collaborate to develop a companion test to identify HERV-E transcripts in patients’ tumors as well as to identify additional therapy candidates targeting HERV-E using the Company’s proprietary TCR discovery platform, iSORTTM. Additionally, NHLBI and T-Cure plan to conduct preclinical experiments characterizing novel TCR and will evaluate various drug and TCR combination anti-tumor therapeutic strategies.

"We are extremely excited to work with the NIH to advance this novel HERV-E TCR therapy candidate through preclinical and clinical development," stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. "Of note, the TCR was isolated from a dominant killer T cell clone of a late stage metastatic ccRCC patient who responded to an immunotherapy and survived 4 years. The HERV-E-specific TCR represents a rare opportunity for us to specifically target ccRCC, a potential T cell responsive solid tumor."

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. Its 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.