SAN DIEGO--(BUSINESS WIRE)--Ichor Medical Systems, Inc. (Ichor) announced today the first in human dosing of JNJ-64300535 with its next generation investigational TriGrid® Delivery System. This DNA vaccine candidate is being developed by the Janssen Pharmaceutical Companies (Janssen) for patients with chronic hepatitis B virus (HBV) infection. This is both the first human administration using Ichor’s next generation TriGrid Delivery System, developed for use in HBV patients in collaboration with Janssen, and the first-in-human dose of JNJ-64300535, Janssen’s investigational DNA vaccine candidate for chronic HBV infection (NCT03463369).
Hepatitis B is a potentially life-threatening disease caused by the hepatitis B virus. More than two billion people have been infected with HBV. Presently, an estimated 240 million people worldwide carry the virus and remain chronically infected. Current treatments seldom eliminate the virus.
DNA vaccines are an emerging vaccine platform that stimulate production of antigen-specific antibodies and T cells, the latter being crucial for long-term resolution of HBV infection. Electroporation is a delivery method that uses brief electrical pulses to facilitate entry of a DNA vaccine into its intracellular site of action. The first generation of the patented TriGrid Delivery System has been utilized in >25 clinical studies, including randomized comparative studies, demonstrating that DNA vaccination with the TriGrid device significantly enhances immune responses to delivered vaccines compared to conventional injection. The next generation TriGrid System incorporates the same integrated and automated design features for clinical use as its predecessor, as well as additional features to comply with the U.S. and international device standards necessary to support worldwide commercial deployment of the device.
Robert Bernard, Ichor Founder and CEO, stated, “We are very pleased to be supporting the development of immunotherapies for patients suffering from chronic hepatitis B infection. With the start of this first clinical trial utilizing Ichor’s next generation TriGrid System, Ichor and its many partners enter an exciting time with the initiation of multiple additional clinical studies in oncology and chronic viral infection anticipated by the end of this year. Furthermore, Ichor’s device technology is now well-positioned to provide a pathway to commercialization for novel nucleic acid-based product candidates in both the prophylactic and therapeutic setting, including the expanding field of personalized medicine.”
About Ichor Medical Systems, Inc.
Ichor Medical Systems’ investigational TriGrid® Delivery System (TriGrid) is the first integrated and fully automated device for electroporation-mediated nucleic acid administration in humans. Ichor, a privately-held biotech company based in San Diego, CA, is collaborating with partners to provide its enabling TriGrid platform as a means for delivery of nucleic acid-based drugs and vaccines in disease indications such as cancer, hepatitis B virus (HBV) infection, human papillomavirus (HPV) infection, and human immunodeficiency virus (HIV) infection, as well as for multiple biodefense agents. The TriGrid platform is also being developed for nucleic acid-based antibody delivery as a rapid countermeasure in the event of an infectious disease outbreak or biological weapons attack. Visit http://www.ichorms.com.