secwatch.observer — SEC 8-K summary
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Issuer:     Instil Bio, Inc. (TIL)
CIK:        0001789769
Form:       8-K
Filed at:   2022-10-31T23:59:59+00:00
Accession:  0001193125-22-273131
Event type: other_material
Sentiment:  negative
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Instil Bio voluntarily pauses enrollment in three clinical trials over manufacturing issues
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- Voluntary pause in DELTA-1 Phase 2 trial of ITIL-168 for advanced melanoma due to decreased manufacturing success rate causing inability to dose some patients.
- No unexpected safety issues identified in DELTA-1 patients who received ITIL-168; pre-specified safety analysis completed.
- Also paused DELTA-2 Phase 1 trial of ITIL-168 with pembrolizumab and ITIL-306 Phase 1 trial as part of overall manufacturing analysis.
- Company will provide update on manufacturing analysis by early Q1 2023.
- No regulatory agency, including FDA, has notified the company of a clinical hold.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1789769/000119312522273131/0001193125-22-273131-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1789769/000119312522273131/d407219d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-273131

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