CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Obsidian Therapeutics Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced positive updated safety and efficacy data from its first-in-human study of OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma (NCT05470283). The data will be presented at an oral poster presentation at the 2024 American Society of Clinical Oncology Annual Meeting, taking place in Chicago on June 3. The oral poster titled, “OBX-115, an interleukin 2 (IL2)-sparing engineered tumor-infiltrating lymphocyte (TIL) cell therapy, in patients (pts) with immune checkpoint inhibitor (ICI)-resistant unresectable or metastatic melanoma,” will be presented by Rodabe Amaria, M.D., professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center, and principal investigator of the study.

The single-center study is evaluating the safety, tolerability, dosing, and efficacy of OBX-115 in patients with ICI-resistant metastatic melanoma. As of January 2, 2024, all 9 patients had disease that was primary-resistant to anti–PD-1 therapy, with a median of 3 (range, 1–6) lines of prior therapy. Post-infusion safety results included no dose limiting toxicities and no Grade 4 or higher non-hematologic treatment emergent adverse events (TAEs), and 2 patients with Grade 3 nonhematologic TEAEs. Updated efficacy data on 9 patients with a minimum of a 12-week post-infusion follow-up will be presented by Dr. Amaria at the oral presentation on June 3 at 9:45 a.m. CT/10:45 a.m. ET.

In addition to the first-in-human study, Obsidian is actively enrolling patients with metastatic melanoma and non-small cell lung cancer (NSCLC) at multiple sites in the company’s ongoing Phase 1/2 multicenter study. Additional details may be found at clinicaltrials.gov, using identifier: NCT06060613. Obsidian is presenting a trials in progress poster at ASCO 2024:

Title: 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 advanced solid tumors.
Presenting Author: Adam J Schoenfeld, M.D., Memorial Sloan Kettering Cancer Center
Date and Time: June 1, 1:0 p.m. CT / 2:30 p.m. ET
Abstract #: TPS9599
Poster Bd: 383a

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, antitumor activity, and clinical safety of TIL cell therapy. OBX-115 is being investigated in two ongoing clinical trials in advanced or metastatic melanoma and non-small cell lung cancer (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.

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