FDA Clears Lyell Immunopharma' LYL132 Trial For Solid Tumors

The FDA has cleared Lyell Immunopharma Inc's LYEL Investigational New Drug (IND) application to initiate a Phase 1 trial for LYL132 in solid tumors.

• LYL132 is an investigational T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1).
• 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 GlaxoSmithKline Plc GSK TCR therapy targeting NY-ESO-1.
• "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," said Liz Homans, CEO of Lyell.
• 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.
• Price Action: LYEL shares are down 4.30% at $5.01 during the market session on the last check Monday.