Obsidian Therapeutics Reports Positive OBX-115 Data in Advanced Melanoma at 2024 ASCO Annual Meeting

Obsidian Therapeutics Inc., a leading clinical-stage biotech firm specializing in engineered cell and gene therapies, has announced promising new data for its novel therapy, OBX-115. This announcement comes ahead of an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for June 3 in Chicago. The focus of the presentation will be the latest findings from the first-in-human study of OBX-115, a unique engineered tumor-derived autologous T cell immunotherapy designed to treat patients with advanced or metastatic melanoma resistant to immune checkpoint inhibitors (ICIs).

OBX-115 employs a sophisticated mechanism, utilizing pharmacologically regulatable membrane-bound IL15 (mbIL15) to enhance the effectiveness of tumor-infiltrating lymphocyte (TIL) cell therapy. This innovative approach aims to improve the persistence and antitumor activity of TIL cells, potentially offering a significant therapeutic option for patients with challenging cancer types.

The single-center study evaluates OBX-115's safety, tolerability, dosage, and efficacy in patients whose metastatic melanoma did not respond to anti–PD-1 therapy. By January 2, 2024, all nine study participants were primary-resistant to the anti–PD-1 therapy, having undergone a median of three prior treatment lines. The safety results post-infusion showed no dose-limiting toxicities and no Grade 4 or higher non-hematologic treatment-emergent adverse events (TEAEs). Two patients experienced Grade 3 non-hematologic TEAEs. Updated efficacy data, based on a minimum 12-week follow-up post-infusion, will be detailed by Dr. Rodabe Amaria from The University of Texas MD Anderson Cancer Center, who is also the study's principal investigator.

In addition to this single-center study, Obsidian Therapeutics is conducting a Phase 1/2 multicenter study enrolling patients with metastatic melanoma and non-small cell lung cancer (NSCLC). Details about this ongoing trial can be found on clinicaltrials.gov under identifier NCT06060613. Another presentation related to this study will occur at the ASCO 2024, led by Dr. Adam J. Schoenfeld from Memorial Sloan Kettering Cancer Center. This session, titled "A phase 1/2 study to investigate the safety and efficacy of OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced solid tumors," will be presented on June 1.

The OBX-115 program, part of Obsidian's cytoTIL15™ platform, shows promise for treating not only melanoma but potentially other solid tumors. By incorporating mbIL15, Obsidian aims to enhance the persistence, antitumor activity, and safety of TIL cell therapy, potentially transforming the treatment landscape for patients with advanced cancers.

Obsidian Therapeutics is headquartered in Cambridge, MA, and is recognized for its innovative cytoDRiVE® technology. This proprietary approach allows precise regulation of protein function using FDA-approved small-molecule drugs. The company is also engaged in collaborations with industry giants like Bristol Myers Squibb and Vertex Pharmaceuticals, further solidifying its position in the biotech field.

In conclusion, the latest data on OBX-115 underscores Obsidian Therapeutics' commitment to developing groundbreaking therapies for hard-to-treat cancers. The upcoming presentations at ASCO 2024 are highly anticipated, as they will provide deeper insights into the potential of OBX-115 and its impact on the future of cancer treatment.