- Instil Bio Inc (NASDAQ: TIL) has voluntarily paused enrollment in its ongoing clinical trials of ITIL-168 and ITIL-306 and has notified regulatory authorities in the U.S., Canada, and the U.K.
- No regulatory agencies have notified the company of a clinical hold in its clinical trials.
- The voluntary pause was instituted following a recent decreased rate in the successful manufacturing of ITIL-168, resulting in the inability to dose some patients whose individual product of ITIL-168 was not successfully manufactured.
- A pre-specified safety analysis in the DELTA-1 trial was conducted on patients who received ITIL-168 and did not identify any unexpected safety issues.
- The company has commenced an end-to-end analysis of its manufacturing processes.
- Although no manufacturing failures have been observed in the ongoing Phase 1 trial of ITIL-306, the company has also voluntarily paused enrollment in this trial as part of its overall manufacturing analysis.
- The company intends to provide an update on the manufacturing analysis by early Q1 2023. The company confirms its previously disclosed cash runway into 2025.
- In May, the FDA signed off ITIL-306 Investigational New Drug (IND), an autologous TIL cell therapy for non-small cell lung cancer (NSCLC), ovarian cancer, and renal cell carcinoma (RCC).
- Price Action: TIL shares are down 26.70% at $3.85 on the last check Monday.
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