A decrease in manufacturing success rates has led Instil Bio to pause trials and assess the production processes for its tumor infiltrating lymphocyte (TIL) cell therapy candidates.
Dallas, Texas-based cell therapy developer Instil‚Äôs lead candidate ITIL-168 is an autologous cell therapy product derived from a participant’s own TILs.
The product is on Phase II/III trials for melanoma but after reporting a decrease in the rate of successful manufacturing of the product resulting in the inability to dose some patients in its so-called DELTA-1 trial, the firm has placed the trial on a voluntary hold.
‚ÄúA 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,‚ÄĚ Instil said in a press release.
‚ÄúThe 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.‚ÄĚ
Instil has also placed a hold on a Phase I study of its solid tumor candidate ITIL-306, which only began two weeks back. No manufacturing failures have been observed to date in the trial, the firm said, but the pause will ensure an overall analysis of its cell therapy manufacturing process can take place. The candidate, which is Instil‚Äôs first genetically-engineered Costimulatory Antigen Receptor-TIL (CoStAR-TIL) therapy.
‚ÄúWith 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,‚ÄĚ said Tim Moore, COO of Instil. ‚ÄúOur 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.‚ÄĚ
Instil‚Äôs share price fell 26% following the clinical hold.
The news comes four months after Instil secured an $85 million loan to construct a 102,000 square-foot laboratory and manufacturing plant on a site in Tarzana, California that the firm acquired in 2020 for an undisclosed fee.