J&J partners with startup for DNA vaccine, hand-held device to treat HBV in $85M+ deal

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.

The TriGrid delivery system--Courtesy of Ichor Medical Systems

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.

- here is the release