HDT Bio, Gennova Biopharmaceuticals Announce First Healthy Volunteers Dosed in Phase I/II Trials Of Unique COVID-19 RNA Vaccine in India

HDT Bio Corp., a developer of immunotherapies for oncology and infectious diseases, announced that its development partner in India, Gennova Biopharmaceuticals, has begun dosing the first volunteers in a Phase I/II COVID-19 vaccine trial. HDT Bio’s innovative vaccine uses a proprietary Lipid InOrganic Nanoparticle (LION) formulation to deliver immune-stimulating RNA fragments to targeted cells.

HDT Bio’s vaccine is significantly different from current mRNA vaccines in two ways. First, its RNA payload is designed to amplify itself inside the body. As a result, the vaccine effectively activates the immune system at a much lower dose than current vaccines, enhancing safety and reducing manufacturing costs. Second, the RNA attaches to the outside of the LION system rather than becoming encapsulated within it, simplifying manufacture and enhancing stability.

“This trial is a major milestone for Gennova and us,” said HDT Bio CEO Steve Reed. “An important part of HDT’s mission is establishing value-sharing partnerships with drug companies in historically underserved countries. Our goal is to empower our partners to produce and distribute innovative medicines at affordable prices.”

In July 2020, HDT Bio and Gennova formed a partnership to co-develop the COVID-19 vaccine. As part of the deal, Gennova received rights to market the vaccine in India. In return, Gennova agreed to provide doses for use in US clinical development and to improve the scalability of the LION technology.

Clinical trials of HDT Bio’s COVID-19 vaccine are expected to begin this year in the US and Brazil. HDT Bio received an $8.2 million grant from the National Institute of Allergy and Infectious Disease at the National Institutes of Health to accelerate the vaccine’s development.

The company also raised $6 million in a seed round financing led by Zoic Capital.