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The FDA (Food and Drug Administration) has evaluated HDT Bio Corp’s Investigational New Drug  (IND) Application and given the company the green light for a Phase 1 clinical trial of its HDT-301 COVID-19 RNA vaccine. HDT Bio, a developer of immunotherapies for oncology and infectious diseases, also intends for its HDT-301 vaccine to provide protection against COVID-19 variants. The trials for HDT Bio’s HDT-301 vaccine are set to begin enrolling 60 volunteers aged 18-65 years old and will assess the safety and efficacy of the two injections, 28 days apart, as well as examine the antibodies produced and the T-cell responses to both doses. In addition to its HDT-301 vaccine, HDT Bio, in collaboration with Gennova Biopharmaceuticals of Pune, has also designed a LION-based COVID-19 vaccine which is undergoing testing in its Phase 1/2 clinical trial in India. HDT Bio’s innovative Lipid InOrganic Nanoparticle (LION) vaccine efficiently stimulates the immune system at a lower dosage than other vaccines currently in use and mitigates manufacturing expenses.

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