News Release

MD Anderson and Refuge Biotechnologies collaborate to advance next-generation cell therapies for treatment of solid tumors

Collaboration supports co-development of RB-340 CAR T cell therapy, application of Refuge's synthetic biology platform to MD Anderson TIL programs

Business Announcement

University of Texas M. D. Anderson Cancer Center

HOUSTON and MENLO PARK, Calif. ? The University of Texas MD Anderson Cancer Center and Refuge Biotechnologies, Inc. today announced a strategic collaboration to advance new cell therapies for potential treatment of solid tumors. The agreement pairs Refuge's innovative technologies with the experience and industrial capabilities of MD Anderson's Biologics Development platform, within the Therapeutics Discovery division.

Under the agreement, MD Anderson will possess exclusive rights to apply Refuge's proprietary platform for next-generation cell engineering to its tumor infiltrating lymphocyte (TIL) programs. MD Anderson also will co-develop Refuge's RB-340, a HER-2 targeted CAR T cell therapy with context dependent inducible down-regulation of PD-1, including Investigational New Drug (IND) filing, Good Manufacturing Practice (GMP) production and Phase I/II clinical trials.

"MD Anderson has extensive expertise in developing and manufacturing innovative cell therapies, including groundbreaking work with TILs," said Bing Wang, Ph.D., chief executive officer and co-founder of Refuge Biotechnologies. "We look forward to working closely with MD Anderson researchers to apply our technology to this promising field of research, while also advancing development of our lead intelligent cell therapy program."

Using Refuge's platform for programming cells to selectively react to tumor cells through direct modulation of gene expression utilizing CRISPR interference and activation, RB-340 is designed to conditionally and smartly down-regulate expression of PD-1 on approaching tumor cells, reducing T cell exhaustion and increasing T cell persistence and proliferation, thus creating better efficacy against solid tumors. Treatment with RB-340 in preclinical models has shown a clear survival benefit compared to conventional CAR T cell therapy. IND filing is anticipated in the first half of 2022, with clinical development of RB-340 focused in solid tumors.

Through its Biologics Development platform, MD Anderson is advancing research into therapeutic applications for TILs - naturally occurring lymphocytes that can recognize cancer cells and penetrate a tumor. MD Anderson and Refuge will explore the use of Refuge's platform to engineer TILs for enhanced anti-tumor activity.

"It is my belief that TILs are poised for a significant impact in the field of cancer therapy, and engineering improved TILs is a vital part of advancing this modality," said Jason Bock, Ph.D., vice president of Therapeutics Discovery and head of Biologics Development at MD Anderson. "We have been encouraged by the data coming from Refuge's applications of its next generation, context dependent and inducible cell engineering platform, and we look forward to incorporating its potential into our TIL programs."

MD Anderson's Biologics Development platform is built around an experienced team focused on pioneering impactful biologic therapeutics, including antibodies and cell therapies. With a state-of-the-art GMP cell therapy manufacturing facility, the platform unites MD Anderson research with industrial therapeutic development.

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