FDA clears IND application for MD Anderson-sponsored Phase I clinical study of OBX-115 therapy

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.

OBX-115 has been developed in collaboration with MD Anderson as part of an agreement announced in 2020. The planned first-in-human single-arm, open-label, Phase I study will evaluate the safety and preliminary efficacy of OBX-115 as monotherapy in adult patients with metastatic melanoma who are relapsed or refractory to prior therapeutic regimens containing anti-PD-1 antibodies.

There is a significant opportunity to improve the standard of care in melanoma, especially in later line patients and those who have not responded well to immune checkpoint therapies. Preclinical studies suggest OBX-115 has the potential to show efficacy in these patients, and OBX-115 does not require patients to receive concomitant IL2 therapy. We look forward to continuing our collaboration with Obsidian to advance this novel therapy for our patients in need of new treatment options."

Rodabe Amaria, M.D., associate professor of Melanoma Medical Oncology at MD Anderson and principal investigator of the OBX-115 study

The OBX-115 therapy for the Phase I trial is planned to be manufactured by CTMC, a joint venture between MD Anderson and National Resilience, Inc. CTMC was launched to speed the development and manufacturing of innovative cell therapies for patients with cancer. CTMC researchers, formerly part of MD Anderson's Therapeutics Discovery division, contributed to the early development of OBX-115.

"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," said Paul Wotton, Ph.D., chief executive officer of Obsidian Therapeutics. "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."

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