Shares of Enochian BioSciences (NASDAQ:ENOB) soared on Monday after the biopharmaceutical company said the Food and Drug Administration (FDA) accepted its pre-investigational new drug request for a "potential functional cure" of HIV.
As of 2:45 p.m. EDT, the biotech stock's price was up more than 100%.
Enochian BioSciences said its cellular therapy could potentially allow people with HIV to stop antiviral treatment for long periods. Its request to the FDA was based on the results of a 54-year-old man who was unable to suppress the virus with antiviral therapy. A treatment of Natural Killer (NK) and Gamma Delta T-cells (GDT) collected from another person subsequently allowed the patient to achieve viral control for 255 days -- without the use of antiviral drugs.
Enochian BioSciences believes Gamma Delta T-cells -- a small subset of immune cells that can be infected with HIV -- could help to control the virus. The biotech has an exclusive license for this proprietary technology.
"It is important to explore any potential for persons with HIV to safely stop antiviral drugs and control the virus," Dr. Peter Piot, the Director of the London School of Hygiene and Tropical Medicine, said in a press release. "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."
Enochian BioSciences hopes to evaluate the approach in more people, including those with HIV who have suppressed the virus with antiviral treatment. The company expects to receive written comments from the FDA this fall.