US Pharma Firm HDT Bio Begins Phase III Trial Of Covid Vaccine In India
US-based bio-pharmaceutical company HDT Bio Corp on Wednesday announced the start of Phase III trial of its COVID-19 vaccine in India.
The Phase III trial of the vaccine developed by HDT Bio in partnership with Gennova Biopharmaceuticals in India is expected to be an affordable one as compared to the existing vaccines in the west.
“This trial is a major milestone for Gennova and us,” HDT Bio CEO Steve Reed said.
An important part of the company’s mission is establishing value-sharing partnerships with drug firms in historically underserved countries, he said.
“Our goal is to empower our partners to produce and distribute innovative medicines at affordable prices,” Steve Reed said.
HDT Bio’s innovative vaccine uses a proprietary Lipid Inorganic Nanoparticle (LION) formulation to deliver immune-stimulating RNA fragments to targeted cells, a media release said.
The company said its 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 the 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, the release said.
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.
HDT Bio has also raised $6 million in a seed round financing led by Zoic Capital.
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