Therapy Areas: AIDS & HIV
First Healthy Volunteers Dosed in Phase I/II Trials of Unique COVID-19 RNA Vaccine in India
4 May 2021 - - US-based immunotherapies HDT Bio Corp's development partner in India, Gennova Biopharmaceuticals, has begun dosing the first volunteers in a Phase I/II COVID-19 vaccine trial, the company said.

HDT Bio's innovative vaccine uses a proprietary Lipid InOrganic Nanoparticle 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.

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 USD 8.2m 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 USD 6m in a seed round financing led by Zoic Capital.

HDT Bio is a biopharmaceutical company dedicated to providing immunotherapies to people around the world, including those in historically underserved areas.

The company seeks to harness the body's immune system to deliver therapies that narrowly target the specific areas of the body where they are needed.

HDT's work focuses on oncological and infectious disease applications. HDT Bio's founders are world leaders in the development of immune stimulants, including both therapeutics and therapy-enhancing adjuvants.

One of the company's core technologies, RNA/LION, combines formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses for therapy or vaccination. 

Gennova Biopharmaceuticals Ltd., headquartered in Pune, India, is a biotechnology company focused on the research, development, production, and commercialization of biotherapeutics to address life-threatening diseases across cardiovascular, neurology, nephrology, and oncology sectors.

As a part of its Global Health Initiative, Gennova has an intense vaccine research and development program.