On December 8, 2022 Instil Bio, Inc. ("Instil" or the "Company") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing next-generation tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported a reprioritization of its clinical programs to focus on development of its CoStAR-TIL product candidates (Press release, Instil Bio, DEC 8, 2022, View Source [SID1234624929]).
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"From the beginning of Instil, we have been committed to advancing TIL therapy by enhancing the native activity of TILs with innovative strategies designed to improve product efficacy and safety," said Bronson Crouch, CEO of Instil Bio. "Although it was a difficult decision to discontinue the development of ITIL-168, this decision provides us the opportunity to accelerate the development of CoStAR and other novel technologies to enhance TIL therapies for patients. We are excited to resume dosing patients in the Phase 1 ITIL-306 study and anticipate providing initial data readouts next year."
Strategic Update
Instil has prioritized development of its proprietary, genetically-engineered CoStAR-TIL programs, which are designed to boost the efficacy of T cells by providing potent synthetic costimulatory signals within the tumor microenvironment (TME). Instil’s lead CoStAR-TIL program, ITIL-306, is in a Phase 1 dose escalation trial in non-small cell lung cancer ("NSCLC"), ovarian cancer, and renal cell carcinoma, with the first patient dosed earlier this year. The Company expects to report data from the dose escalation cohorts of the Phase 1 ITIL-306 study in 2023.
Instil is undertaking a reduction in its U.S. workforce of approximately 60% to re-align its operating model from a registration-focused company to a development-stage company.
ITIL-168 Program Update
Instil is discontinuing its ITIL-168 clinical programs, the DELTA-1 trial in advanced melanoma and the DELTA-2 trial in NSCLC, cervical cancer, and head and neck squamous cell carcinoma. After an analysis of the potential scenarios to restart and complete a registration-enabling cohort in advanced melanoma in the DELTA-1 trial, the Company has decided to prioritize the CoStAR-TIL platform.