MD Anderson and Obsidian Therapeutics Announce FDA Approval of IND Application for Novel Therapy TIL OBX-115

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FDA Grants IND Clearance for Obsidian’s Lead TIL Therapy, OBX-115, for the Treatment of Patients With Solid Tumors

HOUSTON and CAMBRIDGE, Mass., July 21, 2022 /PRNewswire/ — The University of Texas MD Anderson Cancer Center and Obsidian Therapeutics, Inc. today announced the 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, the main lymphocyte infiltrating the Obsidian tumor. (TIL) therapy candidate.

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

“There is a significant opportunity to improve the standard of care in melanoma, particularly in late-line patients and those who have not responded well to immune checkpoint therapies,” said Rodabe Amaria, MD, Associate Professor of Melanoma Medical Oncology at MD Anderson and Investigative Director of the OBX-115 study. “Preclinical studies suggest that 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 new therapy for our patients in need of new treatment options.”

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

“The FDA’s approval of the IND application for OBX-115 represents an important milestone for Obsidian and our colleagues at MD Anderson, and is the result of years of commitment to developing a new class of TIL d engineering,” said Paul Wotton, Ph.D., CEO of Obsidian Therapeutics. “We believe that OBX-115 therapy has the potential to significantly transform the treatment landscape for patients, expanding access to TILs with the elimination of concurrent IL2 therapy, and the potential to achieve better clinical results.”

Disclosure

MD Anderson implements an institutional plan for managing and monitoring conflicts of interest for any research related to this relationship.

About MD Anderson

The University of Texas MD Anderson Cancer Center in Houston ranks among the world’s most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families worldwide. MD Anderson is one of 53 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is #1 for cancer in US News & World Report’s “Best Hospitals” ranking. It has been named one of the top two hospitals in the nation for cancer since the rankings began in 1990. MD Anderson receives an NCI Cancer Center Support Grant from the National Institutes of Health (P30 CA016672).

About the OBX-115

OBX-115 is a novel tumor-infiltrating lymphocyte (TIL) therapy designed with membrane-bound regulated IL15 that is designed to eliminate the need for concurrent IL2 therapy, a toxic and costly requirement for conventional TILs. Preclinical data of OBX-115 demonstrated improved persistence, potency, and tumor control of TILs compared to unmodified TILs, which should improve clinical outcomes in patients with different types of solid tumors.

About Obsidian Therapeutics

Obsidian Therapeutics, Inc. is a clinical biotechnology company pioneering cell and gene therapies designed to deliver transformative results for patients with life-threatening diseases. Obsidian’s proprietary cytoDRiVE® technology provides a way to precisely control the timing and level of protein function using FDA-approved small molecules. Obsidian is headquartered in Cambridge, Mass. The company has collaborations with Bristol Myers Squibb and Vertex Pharmaceuticals. For more information, please visit www.obsidiantx.com and follow us on LinkedIn and Twitter.

Media contact for Obsidian Therapeutics:
Erica FioriniPh.D. or Liz Philips
Russo Partners, LLC
[email protected]
[email protected]
+1 (914) 310-8172

MD Anderson Media Contact:
Clayton Bolddoctorate
MD Anderson Public Relations
[email protected]
713-792-9518

SOURCE Obsidian Therapeutics

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