The US Food and Drug Administration (FDA) has issued a notice to HDT Bio to carry out a Phase I clinical trial of the company’s Covid-19 ribonucleic acid (RNA) vaccine, HDT-301, in the country.
This development comes after the regulatory agency reviewed HDT Bio’s investigational new drug (IND) application for conducting the trial.
Created to offer protection against SARS-CoV-2 variants, the vaccine leverages the company’s Lipid InOrganic Nanoparticle (LION) formulation to carry immune-stimulating RNA fragments to target cells.
HDT-301 needs lower doses compared with currently authorised RNA Covid-19 vaccines, aiding in potential supply worldwide.
This reduced dosing is possible as the vaccine’s RNA payload can augment itself in the body.
HDT-301 has simple production steps because the RNA binds to the LION system’s outside instead of encapsulation within it. HDT Bio added that the vaccine can also be deployed easily.
The Phase I trial will commence next month and enrol a total of 60 healthy subjects aged 18 to 65 years, who are unvaccinated or already vaccinated.
The primary goal of the trial is to assess the safety of two injections of 1µg, 5µg and 25µg doses of the vaccine administered 28 days apart.
The magnitude and durability of antibody and T-cell responses to the vaccine will also be assessed.
HDT Bio has also partnered with various companies in China, Korea, Brazil and Africa for the HDT-301 Covid-19 vaccine.
HDT Bio has also developed another LION-based Covid-19 vaccine, HGCO19, in collaboration with the Indian company Gennova Biopharmaceuticals.
This vaccine is currently being evaluated in a Phase I/II clinical trial in India.
HDT Bio CEO Steve Reed said: “Our company’s mission is to initiate value-sharing partnerships with drug developers around the world as part of our sustainable global health strategy.
“The FDA’s notice to proceed with our US Phase I trial is an important step forward in validating our LION technology and helping to lower international health security inequities.”
Earlier, HDT-Bio received an award of $2.9m for three years to develop a human immunodeficiency virus (HIV)-1 RNA vaccine leveraging its LION delivery system.