HDT Bio Receives Notice to Proceed from FDA for U.S. Phase 1 Clinical Trial of RNA COVID-19 Vaccine

July 1, 2021 11:00 UTC

The company’s RNA-based vaccine offers simpler manufacturing, easier deployment, and requires much lower doses than current RNA COVID-19 vaccines enabling global supply

SEATTLE--(BUSINESS WIRE)-- HDT Bio Corp., a developer of immunotherapies for oncology and infectious diseases, today announced the U.S. Food and Drug Administration (FDA) has reviewed the company’s Investigational New Drug Application (IND) and provided a notice to proceed for a U.S.-based Phase 1 clinical trial of its HDT-301 COVID-19 RNA vaccine. HDT-301 is also designed to provide protection against variants of SARS-CoV-2, the virus that causes COVID-19.

The trial will begin enrolling a total of 60 healthy volunteers in the coming month. It will evaluate the safety of two injections separated by 28 days at 1, 5, and 25 µg dose levels as a primary endpoint. Enrollment will be open to both unvaccinated and previously vaccinated individuals between 18 and 65 years of age. Additional metrics will include magnitude and longevity of antibody and T-cell responses to the injections.

HDT Bio has also developed HGCO19, a LION-based COVID-19 vaccine, in collaboration with Gennova Biopharmaceuticals of Pune, which is currently is being tested in India in a Phase 1/2 clinical trial. The company also has collaborations underway with partners in China, Korea, Brazil and Africa for its HDT-301 vaccine against COVID-19.

“Our company’s mission is to initiate value-sharing partnerships with drug developers around the world as part of our sustainable global health strategy,” said HDT Bio’s CEO Steve Reed. “The FDA’s notice to proceed with our U.S. Phase 1 trial is an important step forward in validating our LION technology and helping to lower international health security inequities.”

HDT Bio’s innovative vaccine uses a proprietary Lipid InOrganic Nanoparticle (LION) formulation to deliver immune-stimulating RNA fragments to targeted cells. The 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.

HDT-Bio also recently announced that the company was awarded a three-year, $2.9 million grant to develop an HIV-1 RNA vaccine with its LION delivery system.


HDT Bio is a Seattle-based 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

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Christopher M. Pirie, Ph.D.
(425) 241-4152

Source: HDT Bio Corp.

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