Gene-modified cellular and immune therapies firm Enochian Biosciences Inc. (ENOB:NASDAQ), which focuses on developing treatments for infectious diseases and cancer, today announced that "the U.S. Food and Drug Administration (FDA) has accepted a Pre-IND (Investigational New Drug) request for a potential functional cure or treatment of human immunodeficiency virus (HIV)." The company stated that it expects for receive written comments back from the FDA in the fall of 2021.
Enochian Biosciences Co-Founder Dr. Serhat Gumrukçu, who also serves as a director of the Seraph Research Institute (SRI), submitted the Pre-IND to the FDA. The company advised that the request was filed utilizing the data collected from studying a 54-year-old male HIV patient who was unable to suppress the virus using antiviral therapy.
The firm commented that subsequently "the patient achieved viral control for 255 days with an innovative treatment of Natural Killer (NK) and Gamma Delta T-cells (GDT) collected from another person." The company indicated that no antiviral drugs had been administered throughout the entire treatment period and now believes 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 company explained that in May 2021 the findings were presented at the American Society of Gene and Cell Therapy conference.
Enochian stated in the report that it holds the exclusive license for the proprietary cellular therapy technology "that 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 firm noted that the Pre-IND submission it submitted to the FDA included a request for allowing the novel strategic approach to be extended to HIV infected individuals who have previously demonstrated to have successfully achieved HIV suppression with antiviral treatment.
Enochian's Executive Vice-Chair Dr. Mark Dybul remarked, "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."
"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," stated Dr. Peter Piot, the former head of UNAIDS and director of the London School of Hygiene and Tropical Medicine.
The company states on its website that in 2017, 36.9 million people throughout the world were living with HIV and 1 million AIDS related deaths were reported in that same year worldwide.
Enochian is a biopharmaceutical company based in Los Angeles, Calif. The firm focuses its efforts on discovering, developing, manufacturing and commercializing gene-modified cell therapies. The firm states on its website that "its clear mission is to develop definitive cures and provide effective prevention for infectious diseases and cancer." The company claimed that its gene-modified cell therapy platform can be used for multiple indications, including HBV, HIV/AIDS and solid tumors in oncology.
Seraph Research Institute (SRI) was described as a non-profit research institution based in Los Angeles, Calif., that conducts basic science, translational and clinical research. The organization is primarily focused on finding cures and treatments for cancers, genetic disorders and chronic viral infections.
Enochian Biosciences began the day with a market cap of around $210.8 million with approximately 47.8 million shares outstanding and a short interest of about 4%. ENOB shares opened nearly 170% higher today at $11.88 (+$7.47, 169.39%) over Friday’s $4.41 closing price and reached a new 52-week high this morning of $12.99. The stock traded today between $6.71 and $12.99 per share and closed for trading at $6.80 (+$2.39, +54.20%).[NLINSERT]
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