Obsidian Therapeutics

Obsidian Therapeutics, established in 2015, is a clinical-stage biotechnology firm focused on developing engineered cell and gene therapies. The company was founded by Michael Gilman, Steve Shamah, and Tariq Kassum and is headquartered in Cambridge, Massachusetts. The scientific foundation of the company's technology was pioneered by Professor Thomas Wandless of Stanford University, a leading researcher in chemical and systems biology.

The company's core business revolves around its proprietary cytoDRiVE® platform, which functions as a pharmacologic operating system for cell therapies. This technology utilizes drug-responsive domains (DRDs) to precisely control the timing and level of protein function within the body. By using FDA-approved small-molecule drugs as an on/off switch, physicians can regulate the activity of engineered cells, enhancing their therapeutic effect while mitigating potential toxicity. This approach is designed to improve the safety and efficacy of powerful treatments like cytokine-based therapies.

Obsidian's primary market is oncology, specifically targeting solid tumors. Their clients are patients with intractable diseases, such as advanced or metastatic melanoma and non-small cell lung cancer (NSCLC). The company's business model is centered on the clinical development and potential commercialization of its therapeutic pipeline, funded through substantial venture capital financing. Obsidian has successfully raised hundreds of millions in funding from investors including GV (formerly Google Ventures), Wellington Management, and Bristol Myers Squibb.

The lead product candidate is OBX-115, an engineered tumor-infiltrating lymphocyte (TIL) therapy. This therapy arms a patient's own T cells with regulated membrane-bound IL15 (mbIL15), a cytokine that promotes the persistence and potency of the therapeutic cells. A key benefit of OBX-115 is that it is designed to eliminate the need for concomitant high-dose IL2 therapy, a treatment required for conventional TIL therapies that is associated with significant toxicity and cost. Clinical trial data has shown promising objective response rates in patients with advanced melanoma. The company is actively enrolling patients in a Phase 1/2 multicenter study for melanoma and NSCLC.

Keywords: cell therapy, gene therapy, oncology, tumor-infiltrating lymphocytes, TIL therapy, cytoDRiVE, drug-responsive domains, immunotherapy, cancer treatment, OBX-115, IL15, solid tumors, metastatic melanoma, non-small cell lung cancer, clinical-stage biotechnology, controllable therapeutics, precision medicine, pharmacologic operating system, engineered T cells, cytokine regulation