FDA clears IND application for T-cell receptor therapy to treat epithelial cancers
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The FDA cleared an investigational new drug application for a T-cell receptor therapy designed to treat adults with solid epithelial cancers that express Kita-Kyushu lung cancer antigen 1.
The agent is an autologous, gene-edited T-cell receptor (TCR) therapy that targets Kita-Kyushu lung cancer antigen 1 (KK-LC-1), a cancer germline antigen highly expressed on several epithelial tumors. These include gastrointestinal, lung, cervical and triple-negative breast cancers.
The adoptive cell therapy was developed by the NCI and acquired by T-Cure Bioscience as part of a worldwide exclusive licensing agreement in 2020.
The IND clearance will allow enrollment for a clinical trial that will evaluate KK-LC-1-directed TCR therapy for adults with metastatic, relapsed or refractory epithelial cancers that have greater than 25% expression of KK-LC-1.
The single-center, phase 1 clinical trial will be sponsored and conducted by the NCI under a cooperative research and development agreement it has with T-Cure. Primary investigators for the study include James L. Gulley, MD, PhD, chief of the genitourinary malignancies branch at the NCI, and Scott M. Norberg, DO, assistant research physician in the genitourinary malignancies branch of the NCI.
“TCR T-cell therapy is a promising new treatment modality that has demonstrated clinical activity in a subset of solid tumors,” Norberg said in a T-Cure-issued press release. “Our hope is that KK-LC-1 TCR-T cell therapy can be effective against common epithelial cancers, which account for 80% to 90% of all human malignancies.”
The primary objective of the dose-escalation study is to determine the maximum tolerated dose of KK-LC-1-directed TCR T cells.
“We are excited that NCI has obtained the regulatory approval from FDA to initiate a first-in-human trial against a very important target in multiple solid tumors,” Gang Zeng, PhD, CEO of T-Cure, said in the release. “Dr. Norberg and Dr. Gulley have extensive experience in developing novel adoptive T-cell therapies for cancer, and they will be invaluable as we advance this program.”
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