Lyell gets FDA IND clearance for LYL797 CAR-T; cGMP facility qualified; amends GSK deal

Lyell Immunopharma, Inc.

FDA cleared IND for LYL797, a ROR1-targeted CAR-T incorporating Gen-R and Epi-R; Phase 1 trial to screen TNBC patients by Q1 2022, initial data in 2023.
Lyell's LyFE manufacturing center in Bothell, WA achieved cGMP qualification to support upcoming clinical trials for CAR, TIL, and TCR programs.
Amended GSK agreement: Lyell will manufacture NY-ESO-1+Epi-R TCR product for Phase 1 trial; GSK to conduct trial under FTIH protocol.
Lyell retains ownership of improvements to Epi-R and Gen-R technologies under amendment; eligible for milestones and royalties.

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