FDA Grants Fast Track Designation to OBX-115 for Advanced Melanoma


The drug is intended to treat individuals with metastatic or locally advanced melanoma.

This article was updated on July 9, 2024, at 11:30 AM.

The FDA has granted Fast Track Designation to the novel engineered tumor-derived autologous T cell immunotherapy OBX-115 (Obsidian Therapeutics Inc.) to treat individuals with metastatic or locally advanced melanoma. To receive treatment, individuals must have experienced a relapse after PD-1/PD-L1-based immune checkpoint inhibitors (ICI), or have refractory disease.

Image credit: LIGHTFIELD STUDIOS | stock.adobe.com

Image credit: LIGHTFIELD STUDIOS | stock.adobe.com

Study authors noted that in 2023, melanoma was the fifth most common malignancy in males and females. While typically detected in the early stages, some cases are diagnosed when already metastatic. According to the American Society of Clinical Oncology, about 4% of melanomas are metastatic. Metastatic melanoma occurs through the spread of primary melanoma cells to other organs, including the nonregional lymph nodes, lungs, liver, brain, and bones.2

Treatment for the disease has evolved with the advancement of immune checkpoint inhibitors (ICIs) and targeted therapy. Current treatments include surgery, immunotherapy, targeted therapy, and radiotherapy.2 Despite the ever-changing treatment options, unmet needs remain an issue.1 The fast track designation highlights the potential of OBX-115 to fill some of those gaps in care.

“FDA Fast Track Designation underscores the ongoing unmet need for patients with melanoma that has progressed on or after ICI therapy, agnostic of mutational status, and that OBX-115 may have the potential to address that unmet need,” said Madan Jagasia, MD, Chief Executive Officer of Obsidian, in a news release.1

OBX-115 is reinforced with pharmacologically regulatable membrane-bound IL15 (mbIL15) that could provide aid for individuals with advanced or metastatic melanoma or other solid tumors, according to study authors. The drug is intended to use benefits from mbIL15 to “enhance persistence, antitumor activity, and clinical safety of TIL cell therapy.”1

To test the efficacy of OBX-115, the drug is currently being assessed in 2 ongoing clinical trials among individuals with advanced or metastatic melanoma (NCT05470283) and among individuals with non-small cell lung cancer (NCT06060613). The study authors noted that enrollment has been completed in the melanoma study—the first-in-human, single-center study evaluating OBX-115.1

“OBX-115 is poised to be a transformative treatment option due to its patient-centric focus, including compatibility with core needle biopsy tumor tissue procurement and positively differentiated safety and tolerability profile relative to non-engineered TIL cell therapy. We are highly encouraged by the most recent safety and efficacy data presented at the 2024 American Society of Clinical Oncology Meeting. With this designation, we look forward to continued collaborative interaction with the FDA as we advance OBX-115 clinical development in the broad post-ICI setting.”1

1. Obsidian Therapeutics Announces FDA Fast Track Designation for OBX-115 for the Treatment of Advanced Melanoma. Business Wire. News release. July 9, 2024. Accessed July 9, 2024. https://www.businesswire.com/news/home/20240709459610/en/Obsidian-Therapeutics-Announces-FDA-Fast-Track-Designation-for-OBX-115-for-the-Treatment-of-Advanced-Melanoma.
2. Metastatic Melanoma. National Library of Medicine. News release. February 17, 2024. Accessed July 9, 2024. https://www.ncbi.nlm.nih.gov/books/NBK470358/.
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