secwatch.observer — SEC 8-K summary
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Issuer:     Lyell Immunopharma, Inc. (LYEL)
CIK:        0001806952
Form:       8-K
Filed at:   2021-12-17T23:59:59+00:00
Accession:  0001193125-21-361060
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 1.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1806952/000119312521361060/0001193125-21-361060-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1806952/000119312521361060/d262325d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-361060

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer