By Chris Wack

Enochian BioSciences Inc. shares doubled to $8.97 after the company said the U.S. Food and Drug Administration accepted a pre-investigational new drug request for a potential functional cure or treatment for HIV.

The company said written comments are expected this fall.

Volume for the stock was 83 million shares at 12:55 p.m. ET, compared with its 65-day average volume of 258,000 shares. The stock, which has 47.8 million shares outstanding, hit its 52-week high of $12.99 earlier in the session.

Enochian BioSciences said 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 and Gamma Delta T-cells collected from another person.

During the entire period, no antiviral drugs were given, the company said. 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.

Enochian BioSciences, which holds the exclusive license for the proprietary technology, said the 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.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

June 14, 2021 13:15 ET (17:15 GMT)