Latest news with #OBX-115
Business Wire
02-06-2025
- Business
- Business Wire
Obsidian Therapeutics Announces Positive Clinical Data from OBX-115 in Patients with Advanced Melanoma in Ongoing Multicenter Study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced initial Phase 1 safety and efficacy data from 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). These data, summarized below, will be presented in a rapid oral presentation (abstract 9517) delivered by Jason A. Chesney, M.D., Ph.D., Director and Chief Administrative Officer of UofL Health – Brown Cancer Center/Oncology Service Line at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Obsidian is also presenting a poster for abstract 9519 summarizing translational data from the Phase 1 first-in-human single-center study of OBX-115 (NCT05470283, enrollment completed) in ICI-resistant advanced melanoma. Summary of OBX-115 Safety and Efficacy Data (March 26, 2025 data cutoff): Advancing a More Patient-centric TIL Cell Therapy Regimen in Heavily Pre-treated Advanced Melanoma Patient Population Patients had disease that was predominantly ICI primary-resistant, with a median of 4 (range, 1–6) lines of prior systemic therapy, including a median of 2 (1–5) lines of prior ICI therapy (n=11). 10 patients received low-dose lymphodepletion (approximately 50% less Cyclophosphamide relative to non-engineered TIL), including 1 in the outpatient setting. Acetazolamide (ACZ) redosing following initial OBX-115 infusion to drive re-activation of OBX-115 cells was tolerable and safe enough to administer at home. OBX-115 Continues to Deliver Positively Differentiated Safety Profile Relative to Non-engineered TIL; No IL2, No Treatment-related Mortality: No dose-limiting toxicities were observed at any dose level. No Grade 4 or higher nonhematologic treatment-related adverse events (TRAEs) were reported; 5 patients experienced limited Grade 3 nonhematologic TRAEs. No confirmed events of cytokine release syndrome or infusion-related reaction higher than Grade 2; no capillary leak syndrome or immune effector cell-associated neurotoxicity syndrome were reported. No treatment-related ICU transfer, no treatment-related mortality. OBX-115 Maintains Consistent Efficacy Profile Without IL2 and With Low-dose Lymphodepletion in Anti-PD-1-resistant Advanced Melanoma; Dose Level 3 (RP2D) To Be Further Explored in Phase 2 Encouraging efficacy profile observed at the RP2D (n=6) 66.7% ORR, including 1 confirmed CR and 3 confirmed PRs (investigator-assessed RECIST 1.1 criteria) Durable clinical benefit, including 3 of 4 responses ongoing at week 24 / data cutoff (median duration of response not reached) 100% disease control rate, defined as stable disease or better for ≥12 weeks post-infusion 36.4% objective response rate (ORR) across all dose levels (n=11) Majority had reduction in tumor burden reduction: 83% at RP2D; 73% across all dose levels. Dr. Chesney commented, 'It is very encouraging to see the promising safety and efficacy profile for OBX-115, now observed in the Agni-01 multicenter study. As a highly differentiated, IL2-sparing TIL cell therapy that is compatible with low-dose lymphodepletion, OBX-115 has the potential to transform the treatment landscape and broaden the eligible population for patients with high unmet need.' 'The exciting results from OBX-115 in ICI-resistant advanced melanoma further indicate that OBX-115 has promising therapeutic potential, and that ACZ redosing is well-tolerated and has the potential to re-activate and re-expand persistent OBX-115 TIL,' commented Parameswaran Hari, M.D., Chief Development Officer of Obsidian. 'We look forward to exploring the go-forward melanoma RP2D in Phase 2, and continuing to evaluate OBX-115 in a Phase 1 cohort of patients with advanced non-small cell lung cancer, where we believe the potential impact from an IL2-sparing TIL cell therapy is clinically significant and may expand patient eligibility.' Obsidian is actively enrolling patients with advanced or metastatic melanoma and non-small cell lung cancer (NSCLC) at multiple sites in its ongoing Phase 1/2 Agni-01 multicenter study. Additional details may be found at using identifier: NCT06060613. 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. For more information, please visit and follow us on LinkedIn.
Business Wire
25-04-2025
- Business
- Business Wire
Obsidian Therapeutics Announces Multiple Presentations at the American Association for Cancer Research Annual Meeting
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 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 is presenting new preclinical data from its cytoDRiVE regulation platform, further demonstrating the ability to unlock the therapeutic window of potent cytokines and broaden the reach of armored cell therapies. The poster for abstract LB025 demonstrates the application of Obsidian's regulatable cytoDRiVE platform to enhance antigen-responsive ('spatial') promoter-induced activation by adding a critical pharmacologically regulatable ('temporal') signal to exert tight 'spatiotemporal' control over IL12 expression 1, resulting in a positive impact on safety and tumor control in syngeneic solid tumor models. Obsidian will also present preclinical data from a multimodal phenotyping analysis comparing OBX-115 TIL generated with its proprietary manufacturing process to conventional, non-engineered TIL using NSCLC tumor samples. The poster for abstract LB359 provides evidence that, as observed with melanoma 2, the OBX-115 process generates a minimally exhausted, CD8+ enriched and memory 'stem-like' T-cell phenotype. Additionally, the tumor reactive gene signature analysis showed that the drug product is enriched for putative tumor-reactive T-cell clonotypes. Obsidian Posters at AACR 2025: Spatiotemporally regulated expression of membrane-bound interleukin 12 (mbIL12) for armored adoptive cell therapy (ACT) shows strong antitumor activity in syngeneic solid tumor models without overt toxicity (Abstract LB025) Presenting Author: Ross T, Obsidian Therapeutics Poster: Sunday, April 27, 2:00-5:00pm CT OBX -115 TIL from non-small cell lung cancer (NSCLC) are enriched for putative tumor-reactive, stem-like T cells with enhanced tumor cytotoxicity: Results from multimodal phenotyping analysis (Abstract LB359) Presenting Authors: Schoenfeld AJ, Memorial Sloan Kettering Cancer Center Poster: Tuesday, April 29, 2:00-5:00pm CT Trial in progress: Phase 1/2 study of OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced solid tumors (Abstract CT244) Presenting Author: Shoushtari AN, Memorial Sloan Kettering Cancer Center 1 Smith et al., SITC 2024 (Abstract 463). 2 Bernatchez et al., ISCT 2024 (Abstract 909). 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. For more information, please visit and follow us on LinkedIn.
Business Wire
23-04-2025
- Business
- Business Wire
Obsidian Therapeutics to Present Clinical Data from OBX-115, its Engineered TIL Cell Therapy, for Patients with Advanced Melanoma in Oral Presentation at the 2025 ASCO Annual Meeting
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- 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. Oral Presentation: Title: OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy with regulatable membrane-bound IL15 (mbIL15) in patients (pts) with immune checkpoint inhibitor (ICI)-resistant advanced melanoma: Phase 1 results of the Agni-01 multicenter study Session Title: Rapid Oral Abstract – Melanoma/Skin Cancers Date and Time: Monday, June 2, at 9:45 a.m. CT/10:45 a.m. ET Abstract Number: 9517 Speaker/Lead Author: Jason A. Chesney, UofL Health – Brown Cancer Center, Louisville, KY Clinical Trial Identifier: NCT06060613 (Multicenter study) Poster Presentation: Title: OBX-115 engineered tumor-infiltrating lymphocytes (TIL) with regulatable membrane-bound IL15 (mbIL15): Translational data from a single-center phase 1 trial in patients (pts) with immune checkpoint inhibitor (ICI)-resistant advanced melanoma. Session Title: Poster Session – Melanoma/Skin Cancers Date and Time: Sunday, June 1, at 9:00 a.m. CT/10:00 a.m. ET Abstract Number: 9519 Speaker/Lead Author: Rodabe N. Amaria, The University of Texas MD Anderson Cancer Center 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. For more information, please visit and follow us on LinkedIn.
Yahoo
23-04-2025
- Business
- Yahoo
Obsidian Therapeutics to Present Clinical Data from OBX-115, its Engineered TIL Cell Therapy, for Patients with Advanced Melanoma in Oral Presentation at the 2025 ASCO Annual Meeting
Oral presentation of Phase 1 results from Agni-01 multicenter study of OBX-115, a novel, IL2-sparing engineered TIL cell therapy armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), in patients with ICI-resistant advanced melanoma Additional poster presentation summarizing translational data from Phase 1 first-in-human single-center study of OBX-115 (enrollment completed) in ICI-resistant advanced melanoma CAMBRIDGE, Mass., April 23, 2025--(BUSINESS WIRE)--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. Oral Presentation: Title: OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy with regulatable membrane-bound IL15 (mbIL15) in patients (pts) with immune checkpoint inhibitor (ICI)-resistant advanced melanoma: Phase 1 results of the Agni-01 multicenter study Session Title: Rapid Oral Abstract – Melanoma/Skin Cancers Date and Time: Monday, June 2, at 9:45 a.m. CT/10:45 a.m. ET Abstract Number: 9517 Speaker/Lead Author: Jason A. Chesney, UofL Health – Brown Cancer Center, Louisville, KY Clinical Trial Identifier: NCT06060613 (Multicenter study) Poster Presentation: Title: OBX-115 engineered tumor-infiltrating lymphocytes (TIL) with regulatable membrane-bound IL15 (mbIL15): Translational data from a single-center phase 1 trial in patients (pts) with immune checkpoint inhibitor (ICI)-resistant advanced melanoma. Session Title: Poster Session – Melanoma/Skin Cancers Date and Time: Sunday, June 1, at 9:00 a.m. CT/10:00 a.m. ET Abstract Number: 9519 Speaker/Lead Author: Rodabe N. Amaria, The University of Texas MD Anderson Cancer Center About OBX-115Obsidian'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 TherapeuticsObsidian 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. For more information, please visit and follow us on LinkedIn. View source version on Contacts Inquiries: Jeffrey TrigilioChief Financial Officerjtrigilio@ Sign in to access your portfolio
