December 20, 2021 -- Lyell Immunopharma announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to initiate a phase I clinical trial for LYL797. LYL797 is an investigational CAR T-cell therapy for patients with receptor tyrosine kinaselike orphan receptor 1-positive solid tumors.
LYL797 incorporates two Lyell technologies that are designed to address the barriers to successful adoptive cell therapy: Gen-R, a genetic reprogramming technology that endows T cells with the ability to resist exhaustion, and Epi-R, an epigenetic reprogramming technology that creates populations of T cells with the properties of durable stemness.
Lyell expects to begin screening patients with relapsed/refractory triple-negative breast cancer who have failed at least two lines of therapy by the end of the first quarter in 2022 for the phase I dose-escalation phase of the trial. The company plans to expand the trial to include patients with non-small cell lung cancer once a recommended dose is determined.