•  ITIL-306 is a novel TIL therapy engineered with our CoStAR platform (CoStAR-TIL) targeting folate receptor alpha which is designed to boost TIL activity in the tumor microenvironment

•  CoStAR-T cells demonstrate enhanced proliferation and other effector function, which may increase TIL efficacy and eliminate the need for high-dose interleukin-2

•  Patient with non-small cell lung cancer that is refractory to standard therapies is first to receive ITIL-306

•  Initial clinical data from dose escalation cohorts expected in 2023

DALLAS, TX, USA I October 18, 2022 I Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today announced that the first patient has been dosed in a Phase 1 dose escalation study of ITIL-306 (NCT05397093) for the treatment of multiple solid tumors. ITIL-306 is Instil’s first genetically-engineered Costimulatory Antigen Receptor-TIL (CoStAR-TIL) therapy.

“The successful initiation of the Phase 1 study of ITIL-306 underscores our commitment to evolving TIL therapy, using strategies to enhance product efficacy and safety, with the goal to achieve durable remissions in patients with treatment-refractory solid tumors,” said Bronson Crouch, Chief Executive Officer of Instil Bio.

Instil’s first-in-human Phase 1 study of ITIL-306 is an open-label, multicenter study in patients with non-small cell lung cancer, ovarian cancer, and renal cell carcinoma. Patients in the first dose cohort will receive a target dose of one billion CoStAR-transduced TILs  after receiving a reduced intensity lymphodepletion regimen and no post-infusion interleukin-2. The study will evaluate safety of ITIL-306 in addition to efficacy and translational endpoints. The company anticipates reporting initial clinical data from the Phase 1 trial in 2023.

ITIL-306 is an autologous TIL cell therapy engineered with a novel and proprietary CoStAR molecule that is activated by folate receptor alpha (FRα) to provide robust costimulatory signals within the tumor microenvironment. CoStAR builds on the key advantages of native TILs to enhance the cytokine release, cytolytic activity, and proliferation of TILs in the tumor microenvironment. Previously published preclinical data demonstrates the ability of CoStAR-T cells to enhance tumor control in vivo in the absence of exogenous IL-2, supporting a treatment regimen free of IL-2 in the Phase 1 study of ITIL-306.

About Instil Bio

Instil Bio, Inc. (Nasdaq: TIL) is a clinical-stage biopharmaceutical company focused on developing TIL therapies for the treatment of patients with cancer. The Company has assembled an accomplished management team with a successful track record in the development, manufacture, and commercialization of cell therapies. Using the Company’s proprietary, optimized, and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors as well as ITIL-306, a next-generation, genetically engineered TIL therapy for multiple solid tumors. For more information visit www.instilbio.com and LinkedIn.

SOURCE: Instil Bio