On October 31, 2022 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported that it has voluntarily paused enrollment in its ongoing clinical trials of ITIL-168 and ITIL-306 and has notified regulatory authorities in the United States, Canada, and the UK (Press release, Instil Bio, OCT 31, 2022, View Source [SID1234622638]). No regulatory agencies, including the FDA, have notified the Company of a clinical hold in any of its clinical trials.
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The voluntary pause by the Company was instituted following a recent decrease in the rate of 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 has been 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 and upon completion of this analysis, plans to take corrective actions to improve the rate of manufacturing success and resume the study. Although no manufacturing failures have been observed to date 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.
"We are committed to advancing TIL therapy for the treatment of patients with cancer," said Bronson Crouch, Chief Executive Officer of Instil Bio. "This pause in enrollment provides us an opportunity to refine our processes and enable us to manufacture and deliver TIL therapies to patients with no other treatment options. We have assembled a world-class technical operations organization and leadership team to address the challenges associated with manufacturing these therapies."
"With the quality of our technical operations staff and our significant experience in developing cell therapies, I am confident in our ability to overcome obstacles in manufacturing," said Tim Moore, Chief Operating Officer of Instil Bio. "Our end-to-end manufacturing analysis is being carried out to expeditiously identify contributing causes, design solutions, and implement corrective actions in order to resume clinical manufacturing."
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 upon the successful completion of a potential sale-leaseback transaction of its Tarzana manufacturing facility.