The FDA has accepted a Pre-IND (Investigational New Drug) request for a potential functional cure or treatment of HIV, according to Enochian BioSciences, Inc., a firm focused on gene-modified cellular and immunological therapies in infectious illnesses and cancer. This fall, written comments are expected.
The Pre-IND was submitted by Dr. Serhat Gumrukçu, co-founder and developer of Enochian BioSciences and Director of Seraph Research Institute (SRI). The request was based on the results of an HIV-positive 54-year-old man who had been unable to suppress the virus with antiviral medication. With an unique treatment of Natural Killer (NK) and Gamma Delta T-cells (GDT) taken from another individual, the patient was able to maintain viral control for 255 days. Antiviral medicines were not administered at any point during the study. The GDT cells, a small group of immune cells that can be infected with HIV, are thought to be a significant element in HIV control.
The findings were presented at the American Society of Gene and Cell Therapy’s Conference in May. Presentation can be found at www.enochianbio.com/collaborations
The patented technology is licensed exclusively to Enochian BioSciences.
This novel cellular therapy could be a crucial step toward achieving an HIV “functional cure,” allowing people living with the infection to quit using antiviral medications for longer periods of time. The unique technique should be extended to people with HIV who have achieved viral suppression with antiviral treatment, according to the Pre-IND application.
“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. In addition, because many people achieve suppression with antiviral treatment, it is key to extend the evaluation to that specific group. Pre-IND is an important step to exploring the possibility of testing this novel NK-GDT treatment”
Dr. Mark Dybul – Executive Vice Chairperson of the Board of Enochian BioSciences
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.
Dr. Peter Piot – Former head of UNAIDS and Director of the London School of Hygiene and Tropical Medicine in London
