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Case Western Reserve and Sangamo Therapeutics Announce $11 Million NIH Grant for Study of Gene-Edited T Cells for Viral Eradication of HIV

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CLEVELAND and RICHMOND, Calif., Feb. 7, 2018 /PRNewswire/ — Case Western Reserve University and Sangamo Therapeutics, Inc. (Nasdaq: SGMO) today announced the award of an $11 million grant from the National Institutes of Health for a planned study of gene-edited T cells designed to eradicate persistent HIV infection in patients receiving anti-retroviral therapy, a combination of medicines that slows the rate at which HIV replicates.

Case Western Reserve University

The grant will fund a clinical trial to test the hypothesis that treating patients with their own gene-edited T cells may lead to a sustained increase in T cell counts and eradication of latent HIV reservoirs. T cells (so-called because they develop in the thymus gland) are responsible for a variety of immune responses. Currently available treatments do not completely cure infected individuals due to the persistence of a latent HIV virus population. As a result, if treatment is stopped, the dormant virus rapidly emerges and reestablishes the infection.

The principal investigator of the new study will be Rafick-Pierre Sekaly, PhD, Richard J. Fasenmyer Professor of Immunopathogenesis at CWRU School of Medicine and one of the world’s leading scientists in AIDS research, human immunology, and immunotherapy. Sangamo Therapeutics will be contributing materials, equipment, and manufacturing expertise for the study, which is expected to begin in 2018.

The new study is designed such that T cells from the blood of 20 subjects will have the CCR5 gene “knocked out” via zinc finger nuclease gene editing. The CCR5 gene allows HIV to enter host cells. In this process, zinc finger nucleases, which are engineered proteins akin to genetic “scissors,” are designed to enable targeted editing of genes by creating double-strand breaks in DNA at precise locations identified by researchers. The newly-edited, “repaired” cell population would be expanded and infused back into the patients. A second set of ten patients will receive an infusion of unmodified T cells.

“For patients with HIV, new treatments to permanently eradicate latent HIV reservoir and increase CD4+ T cell counts – potentially leading to a cure – are an important unmet need,” said Sekaly. “Although standard-of-care anti-retroviral HIV therapy does suppress viral replication, HIV infection persists, and patients must stay on treatment for life. Moreover, a large subset of HIV patients receiving the therapy fails to achieve sustained rebound in T

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