Enochian BioSciences, Inc., a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, today announced that the FDA has accepted a Pre-IND (Investigational New Drug) request for a potential cure of hepatitis B virus (HBV) infection. Written comments are expected this Fall.
The Pre-IND request was made based on promising data from a proof-of-concept study conducted in chimeric mice, considered by some scientific experts to be the ‘gold standard’ animal model to evaluate HBV cure.
Dr. Mark Dybul, a prominent expert in viruses and Executive Vice Chairperson of the Board of Enochian BioSciences, said, “As a long-time researcher, clinician, and leader of large global disease programs, I am very pleased that the FDA accepted our request to provide feedback to our Hepatitis B development program, and welcome the agency’s input. We are encouraged by the novel mechanism of action, called Hijack RNA that shows promise as a potential platform technology for coronaviruses (including the cause of COVID-19), influenza and HBV, and are exploring its use against HIV.”
https://finance.yahoo.com/news/enochian-biosciences-announces-fda-acceptance-110000334.html
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