Breaking News

2nd Generation mRNA Vaccine Candidate Confirms Phase 1 Study

July 2, 2021 • 4:10 am CDT
(Precision Vaccinations News)

Seattle-based HDT Bio Corp. announced the U.S. FDA has reviewed the company’s Investigational New Drug Application and provided a notice to proceed with a Phase 1 clinical trial of its HDT-301 COVID-19 RNA vaccine.

HDT-301 is also designed to protect against variants of SARS-CoV-2, the beta coronavirus that causes COVID-19.

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.

The phase 1 trial will begin enrolling a total of 60 healthy volunteers in the coming month. It will evaluate the safety of two vaccine 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 of this study include the magnitude and longevity of antibody and T-cell responses to the injections.

“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 in a press statement issued on July 1, 2021.

HDT Bio has also developed HGCO19, a LION-based COVID-19 vaccine, in collaboration with Gennova Biopharmaceuticals of Pune, currently 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.

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, WA-based biopharmaceutical company dedicated to providing immunotherapies to people worldwide, including those in historically underserved areas. 

Medical Review by

Our Trust Standards: Medical Advisory Committee

Share