NEW YORK – MD Anderson Cancer Center and Obsidian Therapeutics on Thursday said they've gotten the US Food and Drug Administration's permission to begin evaluating their engineered tumor-infiltrating lymphocyte therapy OBX-115 in a Phase I trial for metastatic melanoma.
Following the FDA's clearance of their investigational new drug application, MD Anderson will sponsor a Phase I study to evaluate OBX-115 as a monotherapy in metastatic melanoma patients who have been previously treated, including with anti-PD-1 therapy. The investigational treatment is the product of a 2020 development deal between Cambridge, Massachusetts-based Obsidian and MD Anderson.
The partners believe that OBX-115 — also known as cytoTIL15 — could offer a therapeutic advantage over other TIL therapies in development because the TILs are engineered with membrane-bound IL15, which eliminates the need for patients to receive IL2 infusions alongside their TIL treatment.
The engineered TILs for the clinical trial will be made in the Cell Therapy Manufacturing Center, or CTMC, an MD Anderson-National Resilience joint venture launched in June. The CTMC is located in a 60,000-square-foot good manufacturing practice-compliant facility within the Texas Medical Center in Houston.
While academic centers and the National Cancer Institute have been treating patients with autologous TILs for years, no TIL therapy has been approved for commercial use due to the unchartered territory of regulating this type of therapy.