On October 6, 2022 T-Cure Bioscience, Inc., a privately held company focused on developing T cell receptor (TCR) therapy products for the treatment of solid tumors, reported that the National Cancer Institute (NCI) and Rutgers University sites are open to recruit patients for the treatment of Kita-Kyushu lung cancer antigen 1 (KK-LC-1) expressing malignancies, including gastric, lung, cervical and triple negative breast cancers (Press release, T-Cure Bioscience, OCT 6, 2022, View Source [SID1234621836]). The investigator-initiated phase 1 trials are intended to evaluate the safety and tolerability with dose escalation of the autologous TCR-T cells targeting KK-LC-1. The investigators are now actively recruiting participants who have failed first-line therapy for the above-referenced solid tumors.
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T-Cure licensed the commercial rights of the KK-LC-1 TCR-T therapy and entered into a Cooperative Research and Development Agreement (CRADA) with the NCI in 2020. The Company also initiated pre-clinical and clinical studies on KK-LC-1 TCR-T with Rutgers University in 2021.
"We have been working with the principal investigator at Rutgers University, Dr. Christian Hinrichs, and the NCI, Drs. James Gulley and Scott Norberg for a couple of years. We are extremely excited to see both sites have received IND clearance from the FDA, and are now open for recruitment", stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. "Our investigators are key opinion leaders of the cell therapy field. We are fortunate to work together to advance this novel TCR product candidate through the first ever clinical development in the world."
Patients entering the trial are selected based on their expression of the KK-LC-1 antigen as determined by an immunohistochemistry assay. This assay was developed by T-Cure and validated for use in the ongoing trials.
Of note, the KK-LC-1 TCR was isolated from the tumor-infiltrating lymphocytes of a patient who had a complete response to immunotherapy without any toxicities. KK-LC-1 is a unique target and cannot be readily targeted by antibody, chimeric antigen receptor (CAR), or antibody drug conjugate (ADC) therapies. Trials at Rutgers University and NCI (clinicaltrials.gov link) are first-in-human targeting KK-LC-1 for multiple solid tumors.