TIL - Instil Bio slips 35% as manufacturing issue halts enrollment in trials
- Instil Bio, Inc. ( NASDAQ: TIL ), a cancer-focused biotech, dropped 35% pre-market Monday after announcing that the company voluntarily paused enrollment in its ongoing clinical trials of the lead TIL product candidates ITIL-168 and ITIL-306 after a production issue.
- The company decided to pause enrollment after finding that the rate of ITIL-168 manufacturing has declined to dose patients in the DELTA-1 trial adequately.
- However, an analysis of patients who received the experimental therapy didn’t indicate any unforeseen safety issues, the company said, adding that the FDA or other regulators did not issue a clinical hold in any of its studies.
- The company has informed the U.S., Canada, and U.K. regulators about the decision and has started evaluating its manufacturing processes to rectify the problem.
- While there was no manufacturing failure related to the Phase 1 trial for ITIL-306, Instil ( TIL ) has also paused enrollment in that study as part of the manufacturing analysis. An update of the manufacturing analysis is expected in early Q1 2023.
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Instil Bio slips 35% as manufacturing issue halts enrollment in trials