Enochian BioSciences Announces the Successful Completion of an FDA Pre-IND for a Potential Cure for HIV: The Second Pre-IND in 1 month

Rhea-AI Summary

Enochian BioSciences (NASDAQ: ENOB) is moving closer to submitting an Investigational New Drug (IND) application following favorable comments from the FDA. The firm completed a Pre-IND process, encouraged by results from a case study involving a 54-year-old HIV patient who managed to control their viral load off antiretroviral therapy (ART) for a full year using a novel treatment developed by the Seraph Research Institute. This treatment employs Natural Killer and Gamma Delta T-cells and may offer new hope for effective HIV management.

Positive

• FDA comments provide a clear path to submit an IND, facilitating progress towards clinical trials.
• Successful case study shows potential effectiveness of the new treatment in controlling HIV without ART.

Negative

• Results are preliminary and based on a single patient, raising concerns about broader applicability.
• Dependence on future studies to validate the treatment's efficacy presents inherent risks.

Company encouraged by clear path to IND in near-term following its review of the FDA’s Center for Biologics Evaluation and Research written comments

LOS ANGELES, Oct. 18, 2021 (GLOBE NEWSWIRE) -- (NASDAQ: ENOB) − Enochian BioSciences, Inc., a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, today announced the completion of an Investigator Pre-Investigational New Drug (IND) process following receipt of written comments from the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT).

Dr. Serhat Gumrukçu, co-founder and inventor of Enochian BioSciences, and Director of Seraph Research Institute (SRI), submitted an investigator-initiated 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 (ART). The patient subsequently stopped taking ART and received an innovative treatment developed by SRI.

Enochian BioSciences holds the exclusive license for the product.

The patient’s HIV infection blood levels were controlled more effectively for 365 consecutive days, off ART using this new innovative SRI treatment compared to what had previously been achieved with ART.

“We are grateful for the FDA’s insightful and useful comments, which now provide us with a clear path to submit an IND in the near-term. We are encouraged to know that we are one step closer to making this treatment available to more people living with HIV,” said Dr. Mark Dybul, CEO of Enochian BioSciences.

The proprietary therapy includes 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.

Dr. Peter Piot, the former head of UNAIDS and the London School of Hygiene and Tropical Medicine in London, said, “Although the results so far are preliminary and in one person, the sooner the approach can be studied in others, the better. If proven to be effective, it could offer hope to many who would like to have alternatives to daily treatment, which can be costly and difficult to maintain.”

About Enochian BioSciences, Inc.
Enochian BioSciences, Inc. is a biopharmaceutical company focused on developing innovative platforms for gene-modified cellular and immune therapies to potentially cure and treat deadly diseases. The company’s gene-modified cell and immune therapy platforms can potentially be applied to multiple indications, including HIV/AIDS, Hepatitis B, all Corona and Influenza viruses, and Oncology. For more information, please visit Enochianbio.com

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. 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.

FAQ

What is Enochian BioSciences' recent progress towards IND?

Enochian BioSciences has received favorable FDA comments and completed the Pre-IND process.

What treatment did the HIV patient receive in the Enochian BioSciences study?

The patient received an innovative therapy involving Natural Killer and Gamma Delta T-cells.

How long did the patient's HIV infection remain controlled off ART?

The patient's HIV levels were controlled for 365 consecutive days without ART.

What does Enochian BioSciences aim to achieve with its treatment?

The company aims to offer new alternatives for managing HIV, potentially reducing reliance on daily ART.