Lyell Immunopharma Advances TCR Therapy LYL132 into Clinical Trials for NY-ESO-1-Positive Solid Tumors

On January 24, 2022, Lyell Immunopharma announced that the U.S. FDA had approved the IND application for a Phase 1 clinical trial of the investigational T-cell receptor (TCR) therapy LYL132, intended for the treatment of patients with solid tumors expressing the New York esophageal squamous cell carcinoma-1 (NY-ESO-1) antigen. NY-ESO-1 is a cancer-testis antigen (CTA) that is expressed in various solid tumors but rarely in normal tissues. The therapy is currently co-developed by Lyell and GlaxoSmithKline (GSK). According to the press release, this Phase 1 clinical trial will evaluate the efficacy and safety of LYL132 in patients with advanced synovial sarcoma (SS) and myxoid/round cell liposarcoma (MRCLS) expressing NY-ESO-1. Lyell is responsible for therapy manufacturing, while GSK will conduct the clinical trial.

NY-ESO-1 is a member of the CTA family of tumor-associated antigens and is a clinically validated therapeutic target. It is highly expressed in various types of solid tumors, including non-small cell lung cancer, bladder cancer, SS, and MRCLS. SS is a rare malignant tumor that occurs in soft tissue, accounting for approximately 5-10% of all soft tissue sarcomas. Patients often experience cancer metastasis, particularly to the lungs, resulting in a 10-year survival rate of less than 50%. MRCLS is one of the most common types of liposarcoma, accounting for about 30% of all cases. It is a rare soft connective tissue tumor that grows in the cells where fat is stored in the body, usually occurring in the arms and legs. When cancer metastasis occurs, the 5-year survival rate of patients is approximately 40%.

LYL132 Incorporates Lyell’s Ex Vivo Epigenetic Reprogramming Technology, Epi-R. This technology aims to overcome the main challenges of adoptive T-cell therapy by generating a population of T cells with durable stem cell properties, achieving clinically meaningful and long-term responses. The characteristic of durable stem cells refers to the ability of T cells to persist, self-renew, and proliferate while maintaining anti-cancer effects.

References:

[1] Lyell Immunopharma Announces FDA Clearance of IND for LYL132, a T-Cell Receptor Therapy for Solid Tumors Being Developed in Collaboration with GSK. Retrieved January 24, 2022, from https://www.globenewswire.com/news-release/2022/01/24/2371644/0/en/Lyell-Immunopharma-Announces-FDA-Clearance-of-IND-for-LYL132-a-T-Cell-Receptor-Therapy-for-Solid-Tumors-Being-Developed-in-Collaboration-with-GSK.html

(Original text has been abridged)

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