Instil Bio voluntarily pauses enrollment in three clinical trials over manufacturing issues

Instil Bio, Inc.

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.

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