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July 22, 2022

Obsidian receives FDA clearance to begin Phase I TIL therapy trial

The Phase I trial will assess OBX-115’s preliminary efficacy and safety to treat adult patients with metastatic melanoma.

Obsidian Therapeutics had its Investigational New Drug (IND) request granted by the US Food and Drug Administration (FDA) to begin a Phase I clinical study of its tumour infiltrating lymphocyte (TIL) therapy candidate, OBX-115.

Developed in partnership with the University of Texas MD Anderson Cancer Center, OBX-115 is armed with regulated membrane-bound IL15 (mbIL15) to drive improved efficacy, along with magnitude and response duration.

The therapy candidate replaces IL2 with mbIL15 and eliminates the need for concomitant IL2 therapy, which is required for conventional TILs.

Preclinical data showed enhanced potency, TIL persistence, and tumour control of OBX-115 compared to unengineered TILs.

The first-in-human, open-label, single-arm Phase I clinical trial has been designed to assess OBX-115’s preliminary efficacy and safety as monotherapy to treat metastatic melanoma adult patients who are relapsed or refractory to previous therapeutic regimens that contain anti-PD-1 antibodies.

Obsidian Therapeutics CEO Paul Wotton said: “The FDA clearance of the IND application for OBX-115 represents an important milestone for Obsidian and our colleagues at MD Anderson, and it is the result of years of commitment to developing a novel class of engineered TILs.

“We believe OBX-115 therapy has the potential to significantly transform the treatment landscape for patients, bringing broader access to TILs with the elimination of concomitant IL2 therapy, and the potential to achieve improved clinical outcomes.”

CTMC, a joint venture between MD Anderson and National Resilience, will be responsible for manufacturing the OBX-115 therapy for the Phase I study, which is sponsored by MD Anderson.

Formerly part of MD Anderson’s Therapeutics Discovery division, CTMC researchers were involved in the early development of OBX-115.

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