Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced presentations reporting initial clinical data from the ongoing first-in-human study of OBX-115 and preclinical data from our cytoDRiVE® platform demonstrating regulatable cytoTIL15 signal transduction in cis and trans, as well as the ability of a single drug-responsive domain (DRD) to coregulate two cytokines, LIGHT and mbIL15, in tumor-infiltrating lymphocytes (TIL) during the American Association of Cancer Research (AACR) Annual Meeting, which will be held April 5-10, 2024 in San Diego, CA.

These data follow the announcement of positive top-line results from the ongoing first-in-human, Phase 1 clinical trial evaluating the safety and efficacy of OBX-115, Obsidian’s lead engineered TIL cell therapy candidate, in patients with metastatic melanoma that has relapsed and/or is refractory to prior immune checkpoint inhibitor (ICI) therapy (NCT05470283).

The details of these posters are as follows:

Title: OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy induced deepening and durable responses without interleukin 2 (IL2) in patients (pts) with immune checkpoint inhibitor (ICI)-resistant unresectable or metastatic melanoma

Presenting Author: Rodabe N Amaria, The University of Texas MD Anderson Cancer Center, Houston, TX

Poster: CT176, Tuesday April 9, 9:00 AM-12:30 PM PDT

Title: Trial in progress: A phase 1/2 study to investigate the safety and efficacy of OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy in patients (pts) with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma

Presenting Author: Sajeve S Thomas, Orlando Health Cancer Institute, Orlando, FL

Poster: CT285, Tuesday April 9, 1:30 PM-5:00 PM PDT

Title: Tumor-infiltrating lymphocytes (TIL) engineered with membrane-bound IL15 (cytoTIL15 cells) exhibit pharmacologically regulatable signal transduction in cis and trans

Presenting Author: Rachel Burga, Obsidian Therapeutics, Inc., Cambridge, MA

Poster: LB072, Sunday April 7, 1:30-5:00 PM PDT

Title: Tumor-infiltrating lymphocytes (TIL) engineered with regulatable membrane-bound IL15 (mbIL15) and LIGHT (TNFSF14) show enhanced efficacy in fibroblast-containing cold tumors

Presenting Author: Balazs Koscso, Obsidian Therapeutics, Inc., Cambridge, MA

Poster: LB065, Sunday April 7, 1:30-5:00 PM PDT

About OBX-115

Obsidian’s lead investigational cytoTIL15™ program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, anti-tumor activity, and clinical safety of TIL cell therapy. OBX-115 is being investigated in two ongoing and enrolling clinical trials in advanced or metastatic melanoma and NSCLC (NCT05470283 and NCT06060613).

About Obsidian Therapeutics

Obsidian Therapeutics, Inc. is a clinical-stage biotechnology company pioneering engineered cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian’s proprietary cytoDRiVE® technology is designed to precisely regulate the timing and level of protein function by using FDA-approved small-molecule drugs. Obsidian is headquartered in Cambridge, MA. The Company has collaborations with Bristol Myers Squibb and Vertex Pharmaceuticals. For more information, please visit www.obsidiantx.com and follow us on LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240305665630/en/