Instil Bio is discontinuing the development of its unmodified tumor-infiltrating lymphocyte (TIL) therapeutic, ITIL-168, and laying off 60% of its staff.
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In a strategic shakeup, Instil Bio is discontinuing the development of its unmodified tumor-infiltrating lymphocyte (TIL) therapeutic, ITIL-168, and laying off 60% of its staff, the company announced Thursday.
Instead of continuing with ITIL-168, which was being investigated for a number of solid tumors, the company will prioritize the development of its CoStAR-TIL program, which is currently in Phase I studies in non-small cell lung cancer, ovarian cancer and renal cell carcinoma.
The announcement comes two months after Instil reported manufacturing issues with ITIL-168. It is unknown at this time if the decision to discontinue the development of ITIL-168 was related to those concerns.
Those manufacturing issues prompted Instil to voluntarily pause enrollment in its ongoing clinical trials following the discovery of what was described as a “decrease in the rate of successful manufacturing of ITIL-168.” That resulted in an inability to dose some patients. The company noted at the time there were no unexpected safety issues due to this issue.
After pausing enrollment, Instil initiated an end-to-end analysis of its manufacturing processes in order to correct the issue. Results of the analysis are expected by the first quarter of 2023, the company stated.
ITIL-168 was in a Phase II/III trial for melanoma at the time enrollment was paused. It was also being assessed in Phase I studies for non-small cell lung cancer and head and neck squamous cell carcinoma. In each of those studies, ITIL-168 had been paired with Merck’s Keytruda.
In its Thursday announcement, Instil stated it conducted an analysis of the scenarios required to restart and complete a registration-enabling cohort in the Phase II/III DELTA-1 trial in melanoma. The company did not specify what it discovered in that analysis, but it prompted the shift of focus to the CoStAR-TIL platform.
Although no manufacturing failures were observed in the ongoing Phase I trial of ITIL-306, Instil voluntarily paused enrollment in that study as part of its overall manufacturing analysis. That came days after the company announced it had dosed the first patient with ITIL-306.
In the Thursday announcement, Bronson Crouch, CEO of Instil, said the company looks forward to resuming dosing in the Phase I ITIL-306 study. Initial data readouts from the Phase I dose escalation trial are expected in 2023.
BioSpace has reached out to Instil for more information about the decision and will update this story accordingly.
TIL Technology
Instil is one of a number of companies focused on developing TIL-based therapeutics as a means of boosting the body’s natural immunity.
TIL technology is a form of cell therapy that uses lymphocytes found in the body to attack and eliminate cancerous tumors. Lymphocytes, which are made up of T cells and B cells, are removed from the tumor and amplified through genetic sequencing to recognize the threat. After external amplification, the TILs are reinserted into the tumor to attack and destroy the cancer.
TIL therapy is different from CAR-T therapies, which use T cells that are genetically engineered to recognize cancer.
Although there are no currently approved TIL therapies, a number of companies are exploring this therapeutic option for cancer.
One of those is Iovance, whose lead TIL therapeutic is in a registrational study in melanoma. And in July, Turnstone Biologics and the Moffitt Cancer Center expanded a TIL pact in cutaneous and non-cutaneous melanoma.
