Pre-investigational new drug requests are very early stage communications between the Office of Infectious Diseases and creators of new treatments. The company expects comments from the administration sometime this fall.
Enochian Biosciences specializes in gene-modified cellular and immune therapies in infectious diseases and cancers.
Dr. Serhat Gumrukçu, co-founder of the company, submitted the request based on the findings of a 54-year-old man with HIV who achieved viral control for 255 days due to treatment with Natural Killer and Gamma Delta T-cells, according to a company press release. The man had not been able to suppress the virus with anti-viral drugs.
The company said that the Gamma Delta T-cells could be useful in controlling the virus.
Treatment could also help patients achieve a so-called “functional cure” that would allow people with HIV to go without anti-virals for lengths of time.
“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,” said Dr. Mark Dybul, executive vice-chairperson of the board of Enochian BioSciences, in the release. Dybul added that conducting the pre-investigational new drug request was a vital next step.
The former head of UNAIDS and director of the London School of Hygiene and Tropical Medicine in London, Dr. Peter Piot said it was important to explore potential treatments for people with HIV who want to safely stop anti-viral drugs but still 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,” Piot said.