Drugs / OBX-115
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05470283 | Sep 2022 → Apr 2027 expected | metastatic melanoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06060613 | Oct 2023 → Jun 2029 expected | metastatic melanoma, non-small cell lung carcinoma, skin neoplasm | Obsidian Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-06-02 | Obsidian Therapeutics, Inc. | Results 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 obsidiantx.com ↗
OBX-115 ORR was 67% at recommended Phase 2 dose (RP2D) (n=6), including 1 CR |
| 2025-04-25 | Obsidian Therapeutics, Inc. | Results Obsidian Therapeutics Announces Multiple Presentations at the American Association for Cancer Research Annual Meeting obsidiantx.com ↗
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. |
| 2024-11-05 | Obsidian Therapeutics, Inc. | Results Obsidian Therapeutics to Present Preclinical Data Supporting OBX-115 and cytoDRiVE® Platform at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2024 obsidiantx.com ↗
Preclinical data confirm the successful generation of OBX-115 using core needle biopsy tumor tissue procurement in NSCLC |
| 2024-09-03 | Obsidian Therapeutics, Inc. | Regulatory Obsidian Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for OBX-115 for the Treatment of Advanced Melanoma obsidiantx.com ↗ |
| 2024-07-09 | Obsidian Therapeutics, Inc. | Regulatory Obsidian Therapeutics Announces FDA Fast Track Designation for OBX-115 for the Treatment of Advanced Melanoma obsidiantx.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to OBX-115 |
| 2024-06-03 | Obsidian Therapeutics, Inc. | Results Obsidian Therapeutics Announces Additional OBX-115 Safety and Efficacy Data in Oral Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting obsidiantx.com ↗
OBX-115 continues to demonstrate a positively differentiated safety profile relative to IL2-dependent non-engineered TIL cell therapy: no DLTs, no Grade 4 or higher non-hematologic TEAEs observed. |
| 2024-05-23 | Obsidian Therapeutics, Inc. | Results Obsidian Therapeutics Announces Positive Clinical Data from OBX-115 in Patients with Advanced Melanoma at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting obsidiantx.com ↗
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. |
| 2024-04-09 | Obsidian Therapeutics, Inc. | Results Obsidian Therapeutics Presents Positive 25-Week Median Study Follow-Up Safety and Efficacy Data from First-in-Human Study of OBX-115 in Advanced Melanoma at the American Association for Cancer Research Annual Meeting obsidiantx.com ↗
OBX-115 induced deep and durable responses with a 50% objective response rate, including a 33% complete response rate. |
| 2023-12-12 | Obsidian Therapeutics, Inc. | Results Obsidian Therapeutics Announces Positive Interim Top-Line Clinical Data for OBX-115 Engineered TIL Cell Therapy in Advanced or Metastatic Melanoma Post-Anti-PD1 Therapy obsidiantx.com ↗
Positive results observed in patients with advanced or metastatic melanoma, including a 50% (3/6) objective response rate (ORR) with two complete responses (33%) at median follow-up of 18 weeks. |
| 2022-07-21 | Obsidian Therapeutics, Inc. | Regulatory MD Anderson and Obsidian Therapeutics announce FDA Clearance of IND application for novel TIL therapy OBX-115 obsidiantx.com ↗
The University of Texas MD Anderson Cancer Center and Obsidian Therapeutics, Inc. today announced Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for an MD Anderson-sponsored Phase I clinical study of OBX-115, Obsidian’s lead engineered tumor infiltrating lymphocyte (TIL) therapy candidate. |
| 2022-04-11 | Obsidian Therapeutics, Inc. | Results Obsidian Therapeutics to Present Preclinical Data from cytoTIL15™ Program at the American Associate of Cancer Research (AACR) Annual Meeting 2022 obsidiantx.com ↗
We are encouraged by the data demonstrating superior anti-tumor activity of cytoTIL15 cells in the absence of IL2 in a novel PDX tumor model. |
| 2021-11-09 | Obsidian Therapeutics, Inc. | Results Obsidian Therapeutics to Present In Vivo Anti-TumorEfficacy Data from Novel Engineered cytoTIL15 Program at SITC 2021 obsidiantx.com ↗
The abstract for the poster demonstrates enhanced in vivo potency of Obsidian’s cytoTIL15 product (TIL engineered with membrane-bound IL15) over conventional tumor-infiltrating lymphocytes (TILs) in PDX mouse models. |
All press releases naming this drug 16 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OBX-115 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06060613 ↗ |
| Modality | Cell therapy | “OBX-115 + acetazolamide cell therapy” NCT05470283 ↗ |
| Route | Intravenous | “Given by IV” NCT05470283 ↗ |