HDT Bio Corp and Gennova Complete Phase 1 Trial of COVID-19 RNA Vaccine in India

HDT Bio Corp and Gennova Complete Phase 1 Trial of COVID-19 RNA Vaccine in India

HDT Bio Corp and Gennova Complete Phase 1 Trial of COVID-19 RNA Vaccine in India

Vaccine Would Be India’s First Indigenous RNA Vaccine, Exemplifying HDT Bio’s Mission of Addressing Global Health Inequity Through Global Partnerships to Develop Technology for Defeating COVID-19 and Future Pandemics

SEATTLE–(BUSINESS WIRE)–HDT Bio Corp., a developer of immunotherapies for oncology and infectious diseases, announced today that its development partner in India, Gennova Biopharmaceuticals, successfully completed a Phase 1 trial of its COVID-19 RNA vaccine candidate HGCO19 and Indian regulatory authorities have approved the start of pivotal Phase 2/3 trials. This vaccine uses HDT Bio’s proprietary LIONTM RNA-delivery technology.

“We are excited about Gennova’s progress,” said HDT Bio CEO Steve Reed. “This collaborative effort was seeded in part with funding from NIH under the Indo-US vaccine action program (VAP) and subsequently received major support from the Indian government. It demonstrates that our strategy of transferring our technology through value-sharing partnerships in developing nations can work. This is consistent with HDT’s mission to address global health inequities through commercially viable means.”

Reed explained, “The COVID-19 pandemic has demonstrated that massive centralized manufacture of vaccines is not working and is not keeping pace with rapid mutations of the virus. By providing partners in underserved nations with the tools to manufacture and distribute local vaccines to fight COVID-19 more effectively. This also is a major milestone toward having the foundations in place to strategically confront future pandemics.”

HDT Bio is actively commercializing its COVID-19 RNA vaccine technology in many countries, including its recent agreements with Korea’s Quratis Inc. for development and distribution in parts of Asia and Brazil’s SENAI CIMATEC for development and distribution in Brazil.

India’s Department of Biotechnology, Ministry of Science & Technology reported on Aug. 24, 2021, that its Phase 1 data demonstrated that Gennova’s COVID-19 RNA vaccine candidate HGCO19 was safe, tolerable, and immunogenic. It also reported that India’s Central Drugs Standard Control Organization has approved initiation of Phase 2 and Phase 3 trials. In addition, Pune-based Gennova said it will begin scaling up manufacturing capacity to meet India’s COVID-19 vaccine requirements.

Clinical trials of HDT Bio’s COVID-19 vaccine, called HDT-301, also 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.

HDT Bio’s innovative vaccine uses its proprietary LION, lipid-based carrier system for delivery of RNA. The vaccine is significantly different from currently commercially available RNA vaccines in two ways. First, its RNA payload is designed to amplify itself inside the body. As a result, the vaccine activates the immune system at a much lower dose than commercially available vaccines, enhancing safety and reducing manufacturing costs. Second, the RNA attaches to the outside of the LION system rather than being encapsulated within it, providing for enhanced stability.


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. http://hdt.bio


Christopher M. Pirie, Ph.D.