Lyell Immunopharma, Inc. announced that the U.S. Food and Drug Administration has cleared an Investigational New Drug application to initiate a Phase 1 clinical trial for LYL132, an investigational T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1) that the company is developing in collaboration with GSK. LYL132 incorporates Epi-R, Lyell's epigenetic reprogramming technology and is under investigation as a potential next-generation enhancement to letetresgene autoleucel (lete-cel), a GSK TCR therapy targeting NY-ESO-1 currently in pivotal clinical development. The cell surface antigen NY-ESO-1 is a clinically validated target present on many aggressive solid tumors.

Lyell's Epi-R technology is designed to address a major barrier to successful Adoptive Cell Therapy (ACT) by creating populations of T cells with properties of durable stemness. T cells with properties of durable stemness are able to proliferate, persist, and self-renew with anti-tumor functionality. The planned Phase 1 trial will assess LYL132 in patients with NY-ESO-1+ advanced synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS).

Lyell will manufacture LYL132 in its LyFE™ Manufacturing Center and GSK will conduct the Phase 1 trial.