LYEL - Lyell Immunopharma gets FDA signoff for clinical trial for CAR-T candidate

Lyell Immunopharma (NASDAQ:LYEL) announced that the FDA cleared the company’s Investigational New Drug (IND) application to begin a Phase 1 clinical trial for its chimeric antigen receptor (CAR) T-cell candidate, LYL797. Therefore, LYL797, targeted at patients with receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) solid tumors, will undergo an early-stage trial involving patients with ROR1+ relapsed/refractory triple-negative breast cancer or non-small cell lung cancer. Patient screening is expected to start in Q1 2022, with initial data anticipated in 2023. “Submission and clearance of our first IND is an important milestone for Lyell,” CEO Liz Homans, detailing the company’s plans to submit three additional INDs by the end of 2022 for the company’s TIL and partnered TCR programs.

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Lyell Immunopharma gets FDA signoff for clinical trial for CAR-T candidate