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Instil Bio to Begin Phase II Trial of TIL Therapy for Advanced Melanoma

NEW YORK – Instil Bio said on Monday that following the US Food and Drug Administration's clearance of its investigational new drug application for ITIL-168, it will begin a Phase II clinical trial evaluating the autologous tumor-infiltrating lymphocyte, or TIL, therapy for advanced melanoma patients.

Dallas-based Instil expects to file a biologics license application for ITIL-168 with the FDA in 2023 and a marketing authorization application with the European Medicines Agency the following year based on the safety and efficacy results from the trial, dubbed DELTA-1.

In the trial, researchers will assess melanoma patients' overall response rates on ITIL-168 across three cohorts. The first cohort will involve approximately 80 melanoma patients whose cancers have progressed following treatment with PD-1 inhibitors; the second cohort will comprise roughly 25 patients who previously discontinued treatment with PD-1 inhibitors due to toxicity; and the third cohort will include around 25 patients whose best response to prior PD-1 inhibition is stable disease.

Initially, Instil had planned to include only the first cohort of patients in the study, but the trial was expanded during the IND process to include the second and third cohorts. Across all three groups, patients with BRAF-mutated tumors must experience disease progression on a BRAF inhibitor in order to be eligible for the DELTA-1 trial.

"The development of the product release plan, encompassing the innovative potency assay as part of quality control release as well as the comprehensive characterization strategy, was built on expertise from our broad, cross-functional team including research, process development, analytical sciences and translational medicine," Vijay Chiruvolu, Instil's chief technical officer, said in a statement.

Instil said it will evaluate its TIL therapy in additional solid tumor types starting next year.