Obsidian Therapeutics Gets FDA Fast Track for Advanced Melanoma Treatment

Obsidian Therapeutics, Inc., a clinical-stage biotechnology firm specializing in innovative cell and gene therapies, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to their experimental treatment, OBX-115. This advanced therapy is an engineered tumor-derived autologous T cell immunotherapy, also known as tumor-infiltrating lymphocyte (TIL) cell therapy, which includes a pharmacologically controllable membrane-bound IL15 (mbIL15). The treatment is aimed at patients suffering from metastatic or locally advanced melanoma that has become resistant to or has recurred after treatment with PD-1/PD-L1-based immune checkpoint inhibitors (ICI).

Dr. Madan Jagasia, CEO of Obsidian, highlighted the significance of the FDA's designation, noting that it reflects the urgent, unmet medical needs of melanoma patients who have not responded to ICI therapies. He emphasized that OBX-115 could potentially address these needs and become a transformative treatment. Dr. Jagasia pointed out the patient-centric approach of OBX-115, which includes compatibility with core needle biopsy tumor tissue procurement and a favorable safety and tolerability profile compared to non-engineered TIL cell therapies. Encouraged by recent positive safety and efficacy data presented at the 2024 American Society of Clinical Oncology Meeting, Obsidian is eager to continue working closely with the FDA to advance the clinical development of OBX-115 in a post-ICI setting.

The Fast Track Designation by the FDA is designed to speed up the development and review of new drugs aimed at treating serious and potentially life-threatening conditions, thereby helping approved products reach the market more quickly. This designation includes frequent interactions with the FDA review team and, if certain criteria are met, eligibility for Priority Review and Rolling Review.

Obsidian's OBX-115 is currently under investigation in a multicenter clinical trial for advanced or metastatic melanoma and non-small cell lung cancer (NSCLC) (NCT06060613). The first-in-human, single-center study of OBX-115 has already completed enrollment (NCT05470283).

OBX-115, the leading candidate in Obsidian’s cytoTIL15™ program, represents a pioneering approach in tumor-derived autologous T cell immunotherapy. By incorporating pharmacologically regulatable mbIL15, OBX-115 aims to be a significant therapeutic option for patients with advanced or metastatic melanoma and other solid tumors. The therapy leverages the expected benefits of mbIL15 along with Obsidian’s unique manufacturing process to enhance the persistence, antitumor activity, and clinical safety of TIL cell therapy. OBX-115 is being evaluated in two ongoing clinical trials for advanced or metastatic melanoma and NSCLC (NCT05470283 and NCT06060613).

Obsidian Therapeutics, based in Cambridge, Massachusetts, is at the forefront of developing engineered cell and gene therapies with the potential to deliver transformative results for patients with difficult-to-treat diseases. The company’s proprietary cytoDRiVE® technology is designed to precisely control the timing and level of protein function using FDA-approved small-molecule drugs. Obsidian has established collaborations with major pharmaceutical companies such as Bristol Myers Squibb and Vertex Pharmaceuticals.