HDT Bio Receives Procedural Notice from FDA for US Phase 1 Clinical Trial of COVID-19 RNA Vaccine | Vaccines



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

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

SEATTLE, WA, USA I July 01, 2021 I HDT Bio Corp., a developer of immunotherapies for oncology and infectious diseases, today announced that the United States Food and Drug Administration (FDA) has reviewed the New Drug Investigation (IND) application of the company and provided notice to conduct a Phase 1 clinical trial of its HDT-301 COVID-19 RNA vaccine. HDT-301 is also designed to provide protection against SARS variants

The trial will begin recruiting a total of 60 healthy volunteers over the next month. It will assess the safety of two injections 28 days apart at doses of 1, 5 and 25 µg as the primary endpoint. Registration will be open to unvaccinated and previously vaccinated people between the ages of 18 and 65. Additional measures will include the magnitude and longevity of antibody and T cell responses to injections.

HDT Bio has also developed HGCO19, a LION-based COVID-19 vaccine, in collaboration with Gennova Biopharmaceuticals of Pune, which is currently being tested in India in a Phase 1/2 clinical trial. The company also has ongoing collaborations 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 Steve Reed, CEO of HDT Bio. “The FDA’s notice to proceed with our Phase 1 trial in the United States is an important step in the validation of our LION technology and helps reduce inequalities in international health security. “

HDT Bio’s innovative vaccine uses a proprietary formulation of inorganic lipid nanoparticles (LION) to deliver immune system-boosting 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 inside the body. As a result, the vaccine effectively activates the immune system at a much lower dose than current vaccines, thus improving safety and reducing manufacturing costs. Second, RNA binds to outside of the LION system rather than encapsulating within it, which simplifies manufacturing and improves stability.

HDT-Bio also recently announced that the company has received a $ 2.9 million grant over three years 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 living in historically underserved areas. The company seeks to harness the body’s immune system to provide therapies that narrowly target specific areas of the body where they are needed. HDT’s work focuses on applications in oncology and infectious diseases. The founders of HDT Bio are world leaders in the development of immune stimulants, comprising both therapeutic adjuvants and therapy enhancing. One of the company’s core technologies, RNA / LION â„¢, combines formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate therapeutic or vaccine responses. http://hdt.bio




Leave A Reply