Enochian BioSciences Announces FDA Acceptance of Pre-IND Request For Potential HIV Cure

LOS ANGELES, June 14, 2021 (GLOBE NEWSWIRE) -- Enochian BioSciences, Inc., a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, today announced that the FDA has accepted a Pre-IND (Investigational New Drug) request for a potential functional cure or treatment of HIV. Written comments are expected this Fall.

Dr. Serhat Gumrukçu, co-founder and inventor of Enochian BioSciences, and Director of Seraph Research Institute (SRI), submitted the Pre-IND. The request was based on the results of a 54-year old man living with HIV who had failed to suppress the virus with antiviral therapy. The patient subsequently achieved viral control for 255 days with an innovative treatment of Natural Killer (NK) and Gamma Delta T-cells (GDT) collected from another person. During the entire period, no antiviral drugs were given. It is believed that the GDT cells, a small subset of immune cells that can be infected with HIV, could be a key factor in controlling the virus.

The findings were presented during the Conference of the American Society of Gene and Cell Therapy this past May. Presentations can be found at Enochianbio.com/Collaborations

Enochian BioSciences holds the exclusive license for the proprietary technology.

This innovative cellular therapy could be an important approach to achieve a "functional cure” of HIV, potentially allowing persons with the virus to stop antiviral treatment for extended periods of time. The Pre-IND submission requested that the novel strategy be extended to persons with HIV who have achieved suppression of the virus with antiviral treatment.

Dr. Mark Dybul, a prominent expert in HIV and Executive Vice Chairperson of the Board of Enochian Biosciences said: "As an HIV researcher, clinician and past leader of large, global HIV programs, I am very excited by the FDA’s decision to provide responses to the Pre-IND submission. Because the promising early results are only in one person, it is important to study the approach in a larger population. In addition, because many people achieve suppression with antiviral treatment, it is key to extend the evaluation to that specific group. Pre-IND is an important step to exploring the possibility of testing this novel NK-GDT treatment.”

Dr. Peter Piot, the former head of UNAIDS and Director of the London School of Hygiene and Tropical Medicine in London, said: "It is important to explore any potential for persons with HIV to safely stop antiviral drugs and control the virus. Although the results so far are preliminary and in one person, if the NK-GDT therapy is proven to be effective in others, it could offer hope to many who experience significant side effects from, or have grown tired of, daily antiviral medication.”  

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 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 BioScience’s 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 BioScience undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.