Articles from Obsidian Therapeutics, Inc.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced the publication of 3 abstracts for poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2025. In addition to a trial-in-progress study design update on the ongoing multicenter study Agni-01 (NCT06060613), Obsidian will share preclinical data from our cytoDRiVE® platform demonstrating spatiotemporal regulation of membrane-bound IL12 in syngeneic solid tumor models and preclinical data on OBX-115 TIL phenotype starting from NSCLC tumor tissue.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced two presentations, including an oral presentation on the Phase 1/2 Agni-01 multicenter 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 (NCT06060613), at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago on May 30–June 3.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced that Chief Executive Officer, Madan Jagasia, M.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference, on Wednesday, January 15, at 8:00 am PST (11:00 am EST).

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced the publication of 3 abstracts for poster presentations at the SITC Annual Meeting 2024, including sharing preclinical data supporting the potential of its cytoDRiVE platform to enable a more patient-centric, core needle biopsy tumor tissue procurement procedure for OBX-115 manufacturing in non-small cell lung cancer (NSCLC) and to potentially expand the therapeutic window and application of potent, immune-modulating cytokines for armored cell therapies.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to OBX-115 for the treatment of patients with unresectable or metastatic melanoma that is resistant to immune checkpoint inhibitor (ICI) therapy. OBX-115 is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with membrane-bound IL15 (mbIL15) that is pharmacologically regulated using FDA-approved small molecule drug acetazolamide. This second FDA designation follows a July 2024 announcement of Fast Track designation for OBX-115.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to 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), for the treatment of patients with metastatic or locally advanced melanoma that is refractory to or has relapsed after PD-1/PD-L1–based immune checkpoint inhibitors (ICI).

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced the appointment of William Pao, M.D., Ph.D., to the company’s Board of Directors as an independent member.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced updated data from the ongoing Phase 1 first-in-human, dose-escalation 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. These data were presented in an oral presentation delivered 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, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

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.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced the appointment of Dana Alexander as Chief Technical Officer.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced two presentations, including an oral presentation on the Phase 1 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), at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago on May 31–June 4.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced the appointment of Jeffrey Trigilio as Chief Financial Officer, effective May 1, 2024.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today provided an update on its Phase 1 first-in-human study of OBX-115 tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced or metastatic melanoma, including 25-week median study follow-up safety data and newly detailed efficacy data, during a presentation at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA. The poster, “OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy induced deepening and durable responses without interleukin 2 (IL2) in patients with immune checkpoint inhibitor (ICI)-resistant unresectable or metastatic melanoma,” was presented by Rodabe N. Amaria, M.D., professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced it has closed a significantly oversubscribed $160.5 million Series C financing with a top-tier syndicate of life science investors led by new investor, Wellington Management. Additional new investors participating in the financing include Foresite Capital, Janus Henderson Investors, Novo Holdings A/S, Paradigm BioCapital, RTW Investments, funds and accounts advised by T. Rowe Price Associates, Inc., and Woodline Partners LP. Existing investors Atlas Venture, Blue Owl Healthcare Opportunities, Bristol Myers Squibb, Deep Track Capital, Logos Capital, RA Capital Management, TCGX, Samsara BioCapital and Surveyor Capital (a Citadel company) also participated in the financing.

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.

Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, announced today 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 tumor-infiltrating lymphocyte (TIL) cell therapy candidate, in patients with metastatic melanoma that has relapsed and/or is refractory to prior immune checkpoint inhibitor (ICI) therapy (NCT05470283).