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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