Business
Instil Bio Reports Second Quarter 2021 Financial Results and Provides Corporate Update
- Presented compassionate use study in advanced melanoma demonstrating 67% of subjects achieved an objective response with 19% achieving a complete response -
About this update from Instil Bio, Inc.
[{"type":"text","content":"- Presented compassionate use study in advanced melanoma demonstrating 67% of subjects achieved an objective response with 19% achieving a complete response - Received orphan drug designation from the U.S. FDA for lead asset ITIL-168 - Developed 21-day manufacturing process for ITIL-306 with robust transduction efficiency DALLAS, Aug. 12, 2021 (GLOBE NEWSWIRE) -- 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 reported its second quarter 2021 financial results and provided a corporate update. “We confirm our commitment to initiating a Phase 2 trial of ITIL-168 in advanced melanoma in the second half of 2021,” said Bronson Crouch, Chief Executive Officer of Instil. “With the installation and ongoing qualification of modular clean room pods at our Tarzana, California facility and our progress toward activating additional manufacturing capabilities in Manchester, U.K., we expect increased clinical manufacturing capacity in late 2021 and early 2022 to support our clinical development plans for ITIL-168 and ITIL-306. Our commitment to innovation in manufacturing continues with the development of a shortened 21-day manufacturing process with robust levels of TIL transduction efficiency for ITIL-306, our first genetically engineered CoStAR-TIL. We expect to pursue further enhancements to both ITIL-168 and ITIL-306 manufacturing processes in the future.” Second Quarter 2021 Highlights and Anticipated Milestones: Clinical Development: Presented Clinical Data in Advanced Melanoma at AACR: Instil presented clinical data demonstrating a 67% objective response rate and 19% complete response rate from a compassionate use program of TILs for the treatment of metastatic melanoma as a late-breaking e-Poster at the AACR virtual meeting in April 2021.Orphan Drug Designation: On April 27, 2021, ITIL-168 received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV.Phase 2 Clinical Trial Initiation of ITIL-168: Instil expects to start a Phase 2 clinical trial of ITIL-168 for the treatment of advanced melanoma in the second half of 2021. Topline safety and efficacy data would be expected in 2023, followed by submission of a BLA t...