Enochian BioSciences 首席执行官 Mark Dybul 博士说：“我们认为书面答复非常有用和重要，为我们希望在中期成功申请 IND 提供了一条清晰的道路。” “我要感谢 FDA CBER OTAT 的专家提供详细而有用的见解。我们特别受到鼓舞，因为 Hijack RNA 是我们正在为其他传染病开发的平台。例如，一种潜在治疗或预防 SARS-CoV 任何变体（包括 COVID-19 的病因）和流感的任何变体以及潜在治疗或治愈 HIV 的吸入产品。 FDA 书面意见中提供的信息也有助于我们加速这些潜在产品的开发。”
Carol Brosgart 博士是 Enochian 的董事会成员、加州大学旧金山分校的临床教授、Gilead Sciences 负责 HBV 和 HIV 药物开发的前临床研究副总裁，他说：“我参与了许多控制或治愈 HBV 的努力。 ，但劫持 RNA 方法是最具创新性的，具有最大的治愈潜力，而不仅仅是我所知道的控制 HBV 感染。我还参与了 FDA 的许多 Pre-IND，我认为他们的评论对加速我们的产品开发非常有用。在我看来，这是一次非常成功的 Pre-IND。”
Enochian BioSciences Announces Its Successful Completion of FDA Pre-IND for a Potential Cure for Hepatitis B Virus Infection
Enochian Bioscience
Mon, September 27, 2021, 9:00 PM·4 min read
In this article:
Company encouraged by clear path following review of FDA’s CBER written comments
LOS ANGELES, Sept. 27, 2021 (GLOBE NEWSWIRE) -- (NASDAQ: ENOB) − Enochian BioSciences, Inc., a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, today announced the completion of a Pre-Investigational New Drug (IND) process following receipt of written comments from the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT).
Globally, there are approximately 350 million people living with chronic liver disease due to HBV, and nearly 1 million people die each year from chronic hepatitis B.
ENOB-HB-01 is a novel approach to potentially eliminate HBV-infected liver cells with an innovative “Hijack RNA” strategy that co-opts the virus’ machinery to induce the death of infected cells rather than reproducing and causing more infection and liver disease. Promising results from animal studies have been presented at scientific meetings (Hep Dart 2019 Presentation and ASGCT 2020 Presentation) by Enochian BioSciences Inventor and Co-Founder, Dr. Serhat Gumrukçu.
“We considered the written response to be very useful and important, providing a clear path to pursuing what we hope will be a successful IND application in the medium-term,” said Dr. Mark Dybul, CEO of Enochian BioSciences. “I want to thank the experts from FDA CBER OTAT for their detailed and helpful insights. We are particularly encouraged because Hijack RNA is a platform that we are developing for other infectious diseases. For example, an inhaled product to potentially treat or prevent any variant of SARS-CoV, including the cause of COVID-19, and any variant of influenza as well as a potential treatment or cure of HIV. The information provided in the FDA’s written comments also help us to accelerate the development of those potential products.”
Dr. Carol Brosgart, member of Enochian’s Board of Directors, Clinical Professor, UCSF, and former Vice President of Clinical Research at Gilead Sciences responsible for HBV and HIV drug development, said, “I have been involved in many efforts to control or cure HBV, but the Hijack RNA approach is the most innovative, with the greatest potential to cure, rather than only control HBV infection that I know of. I have also been involved with many Pre-INDs with the FDA, and I consider their comments remarkably useful to accelerate our product development. In my view, this was a very successful Pre-IND.”
“I have been on the ground floor of several new Biotech companies. Enochian BioSciences is entering a new phase. Based on my experience with the burden of global Hepatitis, I am very enthusiastic about the future and the potential application of our HBV product worldwide,” said Gregg Alton, Enochian Board member and former interim CEO and Chief Patient Officer of Gilead Sciences.作者: 未济 时间: 2021-9-28 11:10