Gene-modified cellular and immune therapies company Enochian Biosciences Inc. (ENOB:NASDAQ) today announced "the completion of an Initial Targeted Engagement for Regulatory Advice (INTERACT) meeting with the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT)."
The company advised that the meeting included management and scientists from Enochian BioSciences together with CBER OTAT staff. The INTERACT meeting's purpose was said to discuss the direction forward for ENOB-HV-01; "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.".
Dr. Mark Dybul, executive vice-chair of Enochian BioSciences, remarked, "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."
The company's Scientific Advisory Board Chair and former Chief Medical Officer of Calimmune Dr. W. David Hardy commented, "The novel approach we are pursuing has the potential to overcome the challenges of engraftment commonly encountered by others in the field. While still early, thus far the data have exceeded my expectations, and I believe the FDA reviewer feedback was very much aligned with our development plan. After more than 30 years as an HIV clinician and researcher, it is a great privilege to be involved with an enterprise with the potential to cure HIV, offering hope to millions of people."
Enochian BioSciences is a biopharmaceutical company based in Los Angeles, Calif. The firm in engaged in developing and commercializing gene-modified cell therapies. The company noted that it gene-modified cell therapy platform can be utilized in many indications, including HBV, HIV/AIDS and oncology. The company states on its website that in 2017, 36,900,000 people throughout the world were living with HIV and 1,000,000 AIDS related deaths were reported in that same year worldwide.
Enochian started off the day with a market capitalization of around $191.6 million with approximately 46.5 million shares outstanding and a short interest of about 2.8%. ENOB shares opened greater than 220% higher today at $13.25 (+$9.13, +221.60%) over Friday's $4.12 closing price and reached a new 52-week high price this morning of $13.43. The stock has traded today between $6.39 and $13.43 per share and is currently trading at $6.20 (+$2.08, +50.49%).
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