On April 8, 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 entered into an exclusive, worldwide license with the National Cancer Institute (NCI) for intellectual property related to a TCR-based product candidate for the treatment of tumors expressing Kita-Kyushu lung cancer antigen 1 (KK-LC-1), for the treatment of KK-LC-1-expressing malignancies, such as gastric, lung, and breast cancers (Press release, T-Cure Bioscience, APR 8, 2020, View Source [SID1234556216]). T-Cure anticipates the KK-LC-1 TCR therapy will enter a multi-site Phase 1 clinical study in the second quarter of 2020 under the direction of Christian S. Hinrichs, M.D., Principal Investigator at the Experimental Transplantation and Immunology Branch (ETIB) at NCI.
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To support the preclinical and clinical research to develop the TCR product and future products targeting KK-LC-1, T-Cure has entered into a Cooperative Research and Development Agreement (CRADA) with the NCI. Under the CRADA, T-Cure will work to identify additional therapy candidates targeting KK-LC-1 using the Company’s proprietary TCR discovery platform, iSORT. The Company also intends to conduct an independent Phase 1 clinical trial in 2021 to further assess the safety and efficacy of the licensed KK-LC-1 TCR.
"The KK-LC-1 TCR technology forms the foundation of a new treatment strategy for a certain common, difficult to treat cancers," stated NCI’s Dr. Hinrichs.
"We are extremely excited to work with Dr. Hinrichs and his team at NCI to advance this novel TCR product candidate through preclinical and clinical development," stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. "Dr. Hinrichs’ extensive experience in the discovery and development of novel adoptive T-cell therapies for cancer will be invaluable as we advance this program. Of note, the TCR was isolated from the tumor-infiltrating lymphocytes of a patient who had a complete response to an immunotherapy without any toxicities. As a result, we believe it holds great promise for engineering patients’ immune cells to effectively target and destroy cancer cells without harming healthy tissue."