Enochian BioSciences 宣布其成功完成 FDA Pre-IND 以潜在治愈乙型肝

StephenW

Enochian BioSciences 宣布其成功完成 FDA Pre-IND 以潜在治愈乙型肝炎病毒感染

以诺生物科学
2021 年 9 月 27 日，星期一，晚上 9 点·4 分钟阅读
在本文中：

公司在审查 FDA 的 CBER 书面评论后受到明确的鼓励

洛杉矶，2021 年 9 月 27 日（环球通讯社）--（纳斯达克股票代码：ENOB）——以诺生物科学公司，一家专注于传染病和癌症的基因修饰细胞和免疫疗法的公司，今天宣布完成一项预- 在收到美国食品和药物管理局 (FDA) 生物制品评估与研究中心 (CBER) 组织和高级治疗办公室 (OTAT) 的书面评论后，新药研究 (IND) 流程。

全球约有 3.5 亿人因 HBV 感染慢性肝病，每年有近 100 万人死于慢性乙型肝炎。

ENOB-HB-01 是一种通过创新的“劫持 RNA”策略可能消除 HBV 感染的肝细胞的新方法，该策略利用病毒的机制来诱导受感染细胞的死亡，而不是繁殖并导致更多的感染和肝病. Enochian BioSciences 的发明者兼联合创始人 Serhat Gumrukçu 博士在科学会议（Hep Dart 2019 演讲和 ASGCT 2020 演讲）上展示了动物研究的有希望的结果。

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。”

“我曾在几家新的生物技术公司工作过。以诺生物科学正在进入一个新阶段。基于我对全球肝炎负担的经验，我对我们 HBV 产品的未来和全球潜在应用非常热情，”以诺董事会成员、吉利德科学公司前临时首席执行官兼首席患者官 Gregg Alton 说。

StephenW

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.

未济

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。

四十己过

基本结果 都不大好 慢慢 等吧