Obsidian Therapeutics, Inc.

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- 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 will present preclinical data supporting a more patient-centric tumor tissue procurement procedure using core needle biopsy for OBX-115 manufacturing in patients with NSCLC, which is enabled by Obsidian’s proprietary and optimized manufacturing process, including IL15-driven tumor-infiltrating lymphocyte (TIL) expansion. This poster for abstract 444 provides evidence that, as observed with melanoma, 1 core needle biopsy can be used in NSCLC to successfully generate OBX-115 product that is phenotypically and functionally similar to product manufactured using surgical excision, maintaining similar TCR clonotype repertoire and predominantly effector-memory, stem-like phenotype with low PD-1 expression. Obsidian has previously presented clinical data demonstrating clinical efficacy in patients with advanced melanoma receiving OBX-115 where tumor tissue was obtained with a core needle biopsy. 2 Core needle biopsy is minimally invasive and typically completed as a routine outpatient procedure, reducing time, logistical complexity and total cost of care compared to surgical excision, and has the potential to increase access to care. Obsidian is presenting two additional posters showcasing the ability of its novel cytoDRiVE regulation platform to unlock the therapeutic window of potent cytokines and broaden the reach of armored cell therapies. The poster for abstract 463 demonstrates the application of Obsidian’s drug-inducible cytoDRiVE platform to enhance antigen-responsive promoter-induced (“spatial”) activation by adding a critical pharmacologically regulatable second (“temporal”) signal to exert tight “spatiotemporal” control over IL12 expression, resulting in a positive impact on safety and tumor control in physiologically relevant animal models relative to methods from previous clinical experience. 3 This abstract has been selected by the SITC Communications Committee to be presented at the SITC 2024 Annual Meeting Press Conference, scheduled for Wednesday Nov. 6, 2024, from 12:00-1:30pm CT. To attend this press briefing, you must register as a member of the press for SITC 2024. To register, please visit https://www.sitcancer.org/2024/press/press-registration . After registration is confirmed, press will receive instructions for the briefing. The poster for abstract 457 demonstrates that cytoDRiVE can bring two potent cytokines, membrane-bound IL15 (mbIL15) and LIGHT (TNFSF14), a potent immune mediator that is part of the tumor necrosis factor family, under pharmacologic regulation using a single drug-responsive domain (DRD)-ligand pairing (the same pairing used in OBX-115). The engineered mbIL15-LIGHT cell therapy demonstrated in vivo antitumor activity and evidence of tumor microenvironment (TME) remodeling in fibroblast-rich models, supporting the potential for cytoDRiVE to address solid tumors marked with an immunosuppressive TME. Obsidian is also presenting at the Tumor Infiltrating Lymphocytes (TIL) Symposium on Wednesday November 6. Dr. Parameswaran Hari will deliver a talk titled, “ OBX-115: An engineered, pharmacologically regulatable membrane-bound IL15 TIL cell therapy for advanced solid tumors” at 9:40 am CT. Obsidian Posters at SITC 2024: Potential feasibility of core needle biopsy tumor tissue procurement method for TIL cell therapy with OBX-115 in non-small cell lung cancer (NSCLC) (Abstract 444) Presenting Authors: Matthew Bott, Memorial Sloan Kettering Cancer Center; Zheng Ao, Obsidian Therapeutics Poster: Thursday, Nov 7, 3:10-5:00 pm CT (Immune Engineering Workshop Poster Session) and Saturday, Nov 9 (Annual Meeting Poster Session) Antigen-responsive promoters coupled with cytoDRiVE® technology provide tight spatiotemporal regulation for tumor-infiltrating lymphocytes (TIL) expressing membrane-bound IL12 (Abstract 463) Presenting Author: Sean Smith, Obsidian Therapeutics Poster: Thursday, Nov 7, 3:10-5:00 pm CT (Immune Engineering Workshop Poster Session) and Friday, Nov 8 (Annual Meeting Poster Session) Engineered tumor-infiltrating lymphocytes (TIL) with co-regulated membrane-bound IL15 (mbIL15) and LIGHT (TNFSF14) generate significant antitumor efficacy in fibrotic tumor models (Abstract 457) Presenting Author: Benjamin Primack, Obsidian Therapeutics Poster: Friday, Nov 8 (Annual Meeting Poster Session) 1 Bernatchez et al., ISCT 2024 (Abstract 909). 2 Amaria et al., ASCO 2024 (Abstract 9515). 3 Zhang et al., Clin Cancer Res (2015) 21 (10): 2278–2288. 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. Obsidian is investigating OBX-115 in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumors ( 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.

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- 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. “RMAT designation for OBX-115 highlights the unmet need in ICI-resistant melanoma and OBX-115’s potential to provide patient-centric, transformative care in this setting,” said Parameswaran Hari, M.D., Chief Development Officer of Obsidian. “In an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, initial Phase 1 data showed that OBX-115 exhibited a favorable safety profile relative to what has been observed historically from IL2-dependent non-engineered TIL cell therapy, encouraging efficacy in patients with heavily pre-treated disease, and compatibility with non-surgical core needle biopsy tumor tissue procurement . We look forward to continued collaborative interaction with the FDA as we advance OBX-115 clinical development in both melanoma and non-small cell lung cancer (NSCLC).” Established under the 21st Century Cures Act, RMAT designation is a dedicated program that includes the benefits of Fast Track and Breakthrough Therapy designations and is designed to expedite the development and review processes for certain promising drug candidates, including cell therapies. An investigational cell therapy is eligible for RMAT designation if it meets the definition of regenerative medicine therapy, is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. RMAT designation provides early and frequent interactions with the FDA, including intensive guidance on efficient drug development. Candidates receiving RMAT designation may also be eligible for Accelerated Approval and Priority Review. 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. Obsidian is investigating OBX-115 in a multicenter trial in patients with advanced melanoma or relapsed / refractory NSCLC ( 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.

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- 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). “FDA Fast Track Designation underscores the ongoing unmet need for patients with melanoma that has progressed on or after ICI therapy, agnostic of mutational status, and that OBX-115 may have the potential to address that unmet need,” said Madan Jagasia, M.D., Chief Executive Officer of Obsidian. “OBX-115 is poised to be a transformative treatment option due to its patient-centric focus, including compatibility with core needle biopsy tumor tissue procurement and positively differentiated safety and tolerability pro to non-engineered TIL cell therapy. We are highly encouraged by the most recent safety and efficacy data presented at the 2024 American Society of Clinical Oncology Meeting. With this designation, we look forward to continued collaborative interaction with the FDA as we advance OBX-115 clinical development in the broad post-ICI setting.” Fast Track Designation is intended to facilitate development and expedite the review of new drug candidates that address serious and life-threatening conditions so that an approved product can reach the market expeditiously. Features of Fast Track Designation include frequent interactions with the FDA review team, and if relevant criteria are met, eligibility for Priority Review and Rolling Review. OBX-115 is being investigated in a multicenter trial in advanced or metastatic melanoma and non-small cell lung cancer (NSCLC) (NCT06060613). Enrollment has been completed for the first-in-human, single-center study of OBX-115 (NCT05470283). 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 and follow us on LinkedIn.