Instil Bio has voluntarily halted subject enrolment in its clinical trials underway analysing ITIL-168 and ITIL-306 due to manufacturing-related issues.
The company alerted the regulatory agencies in the US, UK, and Canada about the issue.
Instil Bio has not received any clinical holds on its trials from any regulatory authorities, including the Food and Drug Administration (FDA).
The voluntary halt was placed as a result of a recent decline in the successful ITIL-168 manufacturing rate, which made it impossible to dose some participants whose individual therapy product was not successfully created.
A pre-specified safety assessment was carried out in the DELTA-1 trial on subjects treated with ITIL-168 and no unexpected safety problems were reported.
Instil Bio has begun an end-to-end assessment of its production processes and following its conclusion, the company will adopt corrective actions to boost the manufacturing success rate and restart the trial.
Even though no production failures were seen to date in Phase I trial of ITIL-306 underway, the company voluntarily paused subject enrolment in the trial as part of the overall manufacturing assessment.
The company plans to give an update on the manufacturing assessment by the first quarter of next year.
Instil Bio CEO Bronson Crouch said: “We are committed to advancing TIL therapy for the treatment of patients with cancer.
“This pause in enrolment 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 organisation and leadership team to address the challenges associated with manufacturing these therapies.”