On Jul. 1, 2021, HDT Bio announced the U.S. Food and Drug Administration had reviewed the companyﾒs Investigational New Drug Application and provided a notice to proceed for a US-based Phase 1 clinical trial of its HDT-301 COVID-19 RNA vaccine. HDT-301 was 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.