FDA Announced Clearance To Instil Bio's Early-Stage ITIL-306 Study In Cancer Settings

The U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance to Instil Bio’s TIL ITIL-306 an autologous TIL cell therapy, for the treatment for patients with with non-small cell lung cancer (NSCLC), ovarian cancer, and renal cell carcinoma (RCC).

ITIL-306 is company’s first genetically-engineered Costimulatory Antigen Receptor TIL (CoStAR-TIL) therapy.

The Phase 1 clinical study investigating ITIL-306 will enroll first patient with non-small cell lung cancer (NSCLC).

Bronson Crouch, Chief Executive Officer, said, “TILs have shown the ability to achieve complete responses in patients with solid tumors that are refractory to approved therapies, making these cells both a meaningful therapy for patients and a platform for innovation and next-generation therapies”.

The company is planning to highlight vivo data with CoStAR T cells demonstrating enhanced expansion, persistence, and tumor control in a poster presentation at the 2022 ASCO Annual Meeting.

Price Check: Shares of Instil Bio are trading high at $8.00 in Friday’s pre-market session, according to Benzinga Pro.