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Lyell Immunopharma's IND for T-Cell Receptor Therapy Gets FDA Clearance

NEW YORK – Lyell Immunopharma on Monday said the US Food and Drug Administration has accepted its investigational new drug application for the T-cell receptor therapy LYL132, allowing for the start of a Phase I trial.

GlaxoSmithKline, which is developing T-cell therapies with Lyell under a 2019 collaboration, will sponsor the study and assess the activity of the drug in patients with NY-ESO-1-expressing advanced synovial sarcoma and myxoid or round cell liposarcoma.

NY-ESO-1 is expressed at detectable levels in various tumor types, including synovial sarcoma and myxoid or round cell liposarcoma, and non-small cell lung, bladder, liver, and skin cancers. However, there is little or no NY-ESO-1 expression in healthy adult tissues.

LYL132 incorporates Lyell's ex vivo epigenetic reprogramming technology Epi-R. That platform is designed to generate T-cells with "durable stemness," which maintain the cells' ability to self-renew and proliferate after initial activation and proliferation. Lyell will manufacture LYL132 in its LyFE Manufacturing Center for the trial.

Lyell, based in South San Francisco, California, also announced an IND clearance for its CAR T-cell therapy LYL797 in December. The company plans to study that drug in a Phase I trial in ROR1-positive triple-negative breast cancer and non-small cell lung cancer patients.

The company plans to submit two more INDs in 2022, CEO Liz Homans said in a statement. Lyell's preclinical programs include another candidate targeting NY-ESO-1 and an autologous tumor-infiltrating lymphocyte therapy.

"Clearance of the second IND incorporating Lyell's novel reprogramming technologies is another important milestone for Lyell, especially coming within a month of FDA clearance of an IND for LYL797, our lead CAR program," Homans continued. "We are eager to start multiple clinical trials that utilize our technologies to assess the potential benefits for patients with solid tumor cancers."