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Friday, December 17, 2021

-=Lyell Immunopharma (LYEL) : FDA clears IND application to initiate Phase 1 trial for LYL797

  • IPO: 6/17/21 


Lyell Immunopharma's Investigational New Drug application to initiate Phase 1 trial for LYL797 cleared by the FDA
  • Co announces that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to initiate a Phase 1 clinical trial for LYL797, Lyell's first therapeutic candidate incorporating T-cell reprogramming technologies for the treatment of solid tumors. LYL797 is an investigational chimeric antigen receptor (CAR) T-cell therapy for patients with receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) solid tumors.
  • Lyell expects to begin screening patients with relapsed/refractory triple-negative breast cancer who have failed at least two lines of therapy by the end of the first quarter for the Phase 1 dose escalation phase of the trial and plans to expand the trial to include patients with non-small cell lung cancer when a recommended dose is determined.

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