Enochian BioSciences announces Scientific Presentation of a Person with HIV Exhibiting Controlled Blood Levels of Virus for 255 Days Following Treatment with a Novel Cellular Therapy

LOS ANGELES, May 12, 2021 (GLOBE NEWSWIRE) -- Enochian BioSciences, Inc., a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, today announced the release of preliminary data relating to the use of a novel cell therapy approach in controlling human immunodeficiency virus (HIV) in humans. Dr. Serhat Gumrukçu, co-founder and inventor of Enochian Biosciences and Director of the Seraph Research Institute (SRI), presented the findings at the Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT). Presentation can be found at https://www.enochianbio.com/about-us/collaborations/

A 54-year-old man, diagnosed with HIV in 1986, had persistent HIV detected in his blood, despite antiretroviral therapy. With approval from an Institutional Review Board, this single patient was treated with a novel cellular therapy of natural killer (NK) and gamma delta T-cells (GDT) – a small subset of immune cells that can be infected with HIV but could also be a key factor in controlling the virus. The NK and GDT cells were collected from a person who does not have HIV. Because the patient stopped antiviral treatment and received some supportive medication before the cellular therapy, the level of HIV initially increased, as expected.

However, HIV levels began to decline after approximately three weeks, and after 100 days dropped below the detection level of routinely used blood tests (20 copies/ml). HIV levels in the patient’s blood have remained at or below detection for an additional 255 days, all while the patient has not been taking antiviral medication.

This innovative cell therapy could be a potential strategy to achieve a "functional cure” for HIV. This could potentially allow persons living with HIV to stop antiviral treatment for extended periods of time. Dr. Gumrukçu and SRI are currently pursuing a regulatory pathway with the FDA to study the approach in more patients. Enochian BioSciences holds the exclusive license for the proprietary technology.

Dr. Mark Dybul, a prominent global HIV expert and Executive Vice Chair of Enochian BioSciences said, "As an HIV researcher, clinician and former leader of large, global HIV treatment programs, I am excited by these results. Although antiviral treatment is very effective, it is expensive and some patients cannot, or do not want to receive it. This, combined with the fact that access to antiviral treatments is limited, creates a significant unmet medical need. While the findings presented are preliminary and in one person with HIV, I’m hopeful that with further testing in larger patient populations, SRI’s novel cell therapy approach could one day be an alternative HIV treatment to many.”

About Enochian BioSciences, Inc.
Enochian BioSciences, Inc. is a biopharmaceutical company dedicated to identifying, developing, manufacturing, and commercializing gene-modified cell therapy. The company’s gene-modified cell therapy platform can be applied to multiple indications, including HIV/AIDS and Oncology. For more information, please visit www.enochianbio.com

About Seraph Research Institute (SRI)
Seraph Research Institute is a Los Angeles-based non-profit research institution, which runs basic science, translational and clinical research in pursuit of cures and effective treatments for chronic viral infections, cancers, and genetic disorders. For more information, please visit Seraphinstitute.org

Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as "believes,” "plans,” "expects,” "aims,” "intends,” "potential,” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Enochian BioSciences’ most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The findings in this press release are preliminary and based on one person. There is no assurance the findings will result in an effective alternative treatment for HIV. All forward-looking statements are qualified in their entirety by this cautionary statement, and Enochian BioSciences undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.