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ENOB-HV-01 is a novel, proprietary autologous cell therapy under pre-clinical development as a potentially curative gene therapy for HIV/AIDS. It involves harvesting hematopoietic stem cells (CD34+ cells) from the HIV-positive patient, genetically modifying them to silence the CCR5 gene—a receptor required for HIV to enter and infect CD4+ T cells—thus mimicking the naturally occurring CCR5 delta-32 mutation that renders cells resistant to HIV infection. The modified cells are then reinfused into the patient, where they are designed to engraft efficiently and outcompete non-modified cells, ultimately reducing or eliminating the need for antiretroviral therapy. Unlike allogeneic approaches, ENOB-HV-01 is intended to avoid myeloablative chemotherapy, potentially allowing outpatient administration and reducing risks associated with donor mismatch and graft-versus-host disease. The therapy is in advanced preclinical stages, with in vivo and in vitro proof-of-concept studies ongoing, and preparation for Investigational New Drug (IND) application with the FDA.
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