强生携手Ichor Founder共同推动乙肝DNA疫苗开发

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随着吉利德公司的丙肝药物Sovaldi横空出世，让丙肝治疗领域受到了一次前所未有的洗礼。各大生物医药巨头纷纷跟风 进入，投入巨资希望在这一领域分得一杯羹。而最近，强生公司则开始将目光放到了另外一种极为普遍的肝病--乙肝的治疗中。

最近，强生公司旗下杨森公司和圣迭戈的生物医药器械公司Ichor Medical Systems达成了一项合作协议，共同开发用于治疗乙肝的DNA疫苗。根据协议，扬森公司将向Ichor Medical Systems公司支付包括预付款、研发款等资助在内共计8500万美元的费用，Ichor Medical Systems公司则授权扬森公司使用其独有的TriGrid 电转系统 。

近几年来，DNA疫苗的研究经历了大起大落，其中一个重要原因在于研究人员没有找到一个有效的方法输送DNA。传统方法一般是使用重组减毒的细菌或病毒作为载体输送DNA，一方面可能会导致较大的安全隐患，另一方面是这些方法并不能达到令人满意的DNA转运效率。而TriGrid 电转系统 是通过利用一种小型医疗器械产生的电脉冲打开待输送组织部位的细胞膜，并直接将DNA输送进入细胞内部，可谓"简单粗暴"。现有数据显示这种方法输送DNA效率比传统方法高出了近1000倍。

事实上，强生公司并不是第一个"觊觎"TriGrid的医药巨头。早在2014年2月，辉瑞公司就重金获得了这项技术用于其肿瘤疫苗的研发。

目前，全世界约有2亿4千万人携带有乙肝病毒，其中绝大部分携带者分布在亚洲和非洲等地区。与丙肝类似，乙肝病情严重时会导致肝硬化甚至肝癌的发生。可以说，防治乙肝已经成为了发展中国家重要的健康任务之一。

详细英文报道：

Janssen Pharmaceuticals has paired up with Ichor Medical Systems to develop and market DNA-based vaccine products to treat chronic hepatitis B (HBV). The partners will use the startup's TriGrid electroporation technology for clinical administration of a DNA vaccine.

Ichor will get about $85 million in a combination of upfront payment, R&D support, and development and sales milestone payments; it also stands to receive undisclosed royalty payments on any future licensed product sales. Janssen, a Johnson & Johnson ($JNJ) company, is responsible for certain device development costs, as well as commercialization costs including manufacturing and distribution.

The idea is to deliver a DNA vaccine that will generate a broad immune response and more effectively treat HBV; current treatments aren't particularly useful in eliminating the virus and can be associated with severe adverse reactions. More than 240 million people globally are infected with HBV, most of whom are in Asia or Africa. Chronic infection with the disease is associated with higher rates of cirrhosis and liver cancer.

"Janssen's decision to couple our clinically validated TriGrid electroporation technology with their DNA vaccine for HBV is extraordinarily exciting for Ichor," Ichor Founder and CEO Robert Bernard said in a statement.

The industry has been incredibly effective at delivering effective, convenient--and quite lucrative--treatments for hepatitis C (HCV) in recent years and some are speculating that a similar massive revamp of HBV treatment options also could be in the offering.

Research on DNA vaccines has been around for a while, but the technology has struggled to deliver sufficient efficacy in clinical trials when administered via a conventional injection. Ichor's hand-held device provides electroporation-mediated DNA administration. This uses short electrical pulses to temporarily alter cell membranes, thereby facilitating the entry of a DNA vaccine into cells.

The company says its TriGrid Delivery System is up to 1,000 times more effective as compared to conventional injection of DNA drugs. Unlike DNA vaccines that rely on the incorporation of specific, isolated genes, conventional vaccines use an entire, inactivated microbe, or one with reduced virulence, to inoculate the patient.

In February 2014, Ichor entered into a similar agreement with Pfizer ($PFE) to develop a next-gen TriGrid electroporation device for use with the pharma's preclinical cancer vaccine-based immunotherapies. The financial details of that deal were undisclosed.

More recently in November, the San Diego-based company got a 5-year contract worth up to $20.2 million through the Defense Advanced Research Projects Agency (DARPA) and supported by the U.S. Army Research Office. It includes an $8.6 million base award and follow-on option years. The project aims to fund the development and clinical assessment of TriGrid to deliver antibodies for passive immunoprophylaxis. The idea is to use the technology to provide rapid protection in the event of an infection outbreak or biological weapons attack.

Ichor was founded in 1994 and has gained more than $30 million in committed grant or contract financing. It's also raised equity financing from undisclosed private and institutional investors.

来源：生物谷