Enochian Bio's HIV Treatment Is on Its Way With the FDA
Enochian BioSciences Inc. (NASDAQ: ENOB) shares more than doubled to start out the week after the company received a critical update from the U.S. Food and Drug Administration (FDA). This update was specifically for the company’s HIV treatment.
The company announced that it completed an Initial Targeted Engagement for Regulatory Advice (INTERACT) meeting with the FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT).
The meeting, which included management and scientists from Enochian BioSciences, together with CBER OTAT staff, focused on the pathway forward for ENOB-HV-01.
Some quick background: ENOB-HV-01 is a novel approach to autologous stem cell transplantation, with the potential to cure HIV by increasing engraftment of gene-modified cells that are resistant to HIV infection. Failure to achieve engraftment has limited the success of other attempts to cure HIV with autologous transplantation.
Interact is the first available FDA interaction in the process toward a potential Investigational New Drug (IND) to study first-in-human products potentially leading to marketing authorization.
CBER has numerous Interact requests and only grants meetings that are deemed appropriate for this early FDA engagement.
Dr. Mark Dybul, executive vice-chair of Enochian BioSciences, commented:
We considered the meeting to be very successful, with strong alignment between Enochian’s approach to developing ENOB-HV-01 and the comments of the FDA reviewers. I want to thank the reviewers from FDA CBER OTAT for their time and helpful insight during our meeting. We look forward to advancing our thoughtful and deliberate pre-clinical work during the remainder of this year and into early next, leading to a pre-IND submission in 2021.
Enochian Biosciences stock traded up 130% Monday morning to $9.50, in a 52-week range of $1.95 to $13.43.