secwatch.observer — SEC 8-K summary ====================================== Issuer: Lyell Immunopharma, Inc. (LYEL) CIK: 0001806952 Form: 8-K Filed at: 2022-10-06T23:59:59+00:00 Accession: 0001193125-22-258907 Event type: regulatory Sentiment: positive Materiality: 0.65 Item codes: 7.01, 9.01 LLM model: deepseek-v4-flash:cloud@v2 Lyell Immunopharma receives FDA IND clearance for LYL845 TIL therapy for solid tumors -------------------------------------------------------------------------------- - FDA cleared IND for LYL845, an autologous TIL therapy enhanced with Epi-R reprogramming technology. - Phase 1 trial initially enrolling relapsed/refractory metastatic or locally advanced melanoma; expansion into NSCLC and colorectal cancer. - Initial clinical data expected in 2024; patient screening to begin in coming months. - LYL845 is Lyell's first TIL product candidate and second wholly owned IND clearance within the past year. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1806952/000119312522258907/0001193125-22-258907-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1806952/000119312522258907/d407382d8k.htm HTML page: https://secwatch.observer/filing/0001193125-22-258907 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer