Initial Human Trials of OBX-115 Show Promise at 25-Week Milestone

Obsidian Therapeutics, Inc., an innovative biotech company advancing the field of synthetic cell and gene treatments, has recently shared progress from their Phase 1 human trial regarding OBX-115, a novel tumor-infiltrating lymphocyte cell treatment, targeted at individuals dealing with progressive or widely spread skin cancer. This announcement, which included details about the safety profile at a median duration of 25 weeks, as well as fresh insights into the treatment's effectiveness, was made at the American Association for Cancer Research Annual Meeting held in San Diego, CA.

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A presentation titled "Advancements in Melanoma Treatment: OBX-115 Engineered TILs Showing Sustained Efficacy Without the Need for Interleukin 2 in ICI-Refractory Metastatic Cases," was unveiled by Dr. Rodabe N. Amaria of The University of Texas MD Anderson Cancer Center. As a notable figure in Melanoma Medical Oncology, Dr. Amaria heads the research effort examining this innovative therapy.

The research in question, originating from a single institution, is focused on assessing OBX-115 with regards to patient safety, dose appropriateness, and its therapeutic impact on those battling metastatic melanoma not responding to ICIs. The treatment's preliminary evaluation was applied to 6 patients, all of whom initially showed resistance to anti–PD-1 treatment, and on average had undergone 2.5 previous treatments.

According to Dr. Amaria's insights, the initial group of 6 patients that underwent treatment with OBX-115 provided optimistic safety and efficacy profiles, revealing a significant rate of objective responses. She emphasized the importance of OBX-115's unique characteristic of not requiring concurrent IL2 usage, marking it as an innovative direction in engineered TIL therapy, and highlighting its potential to achieve sustained responses in cases of ICI-resistant metastatic melanoma sans the notorious IL2-related adverse effects.

Moreover, Exec. Chief Development Officer at Obsidian, Dr. Parameswaran Hari, expressed optimism regarding the new data on OBX-115. The information supports the effectiveness of Obsidian’s proprietary cytoDRiVE technology and suggests that the improved safety profile of OBX-115 could potentially make TIL cell therapies accessible to a broader range of patients, thus fulfilling a crucial need for those with advanced stages of melanoma who have not responded to ICIs.

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According to the data provided by the Synapse Database, As of April 10, 2024, there are 59 investigational drugs for the IL-15 target, including 103 indications, 74 R&D institutions involved, with related clinical trials reaching 120, and as many as 24762 patents.

OBX-115 is a TIL therapy drug that targets IL-15 and shows promise in treating various neoplasms, skin and musculoskeletal diseases, and respiratory diseases. It is indicated for advanced malignant solid neoplasms, metastatic melanoma, metastatic non-small cell lung cancer, secondary malignant neoplasm of the lung, melanoma, non-small cell lung cancer, and solid tumors. Developed by Obsidian Therapeutics, Inc., the drug has reached Phase 1/2 of clinical development.