Obsidian Therapeutics has secured Fast Track Designation from the FDA for OBX-115, an engineered T-cell therapy targeting metastatic or locally advanced melanoma resistant to PD-1/PD-L1 inhibitors.
OBX-115, based on patient-derived tumor-infiltrating lymphocytes (TILs), is enhanced with membrane-bound interleukin-15 (mbIL15), enabling pharmacological regulation. This potentially addresses the unmet need for effective treatments for melanoma patients who have progressed after ICI therapy.
The Fast Track Designation expedites the development and review process for promising new drugs addressing serious conditions. It allows for frequent interactions between Obsidian and the FDA and, upon meeting specific criteria, potential eligibility for Priority and Rolling Review.
OBX-115 is undergoing clinical trials in melanoma and non-small cell lung cancer (NSCLC). The company’s proprietary manufacturing process aims to improve the persistence, antitumor activity, and safety of TIL cell therapy.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.
