Oncology immunotherapies company HDT Bio Corp announced on Tuesday that it dosed the first healthy volunteer under its US Phase 1 clinical trial of its next generation COVID-19 RNA vaccine, HDT-301, funded by National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH).
The company stated that the clinical trials in 60 healthy volunteers will evaluate the safety and efficacy (including antibody and cellular responses) of its RNA vaccine at dose levels much lower than currently approved RNA vaccines. The other metrics of focus will include magnitude and longevity of antibody and T-cell responses to the injections.
Under the company trial, the vaccinated subjects will receive either one or two injections, while the unvaccinated subjects will receive two injections. Dose levels under investigation are 1, 5, and 25 μg (microgram).
According to the company, the HDT-301 vaccine targets the Beta variant of SARS-CoV-2 and has a demonstrated ability to provide broad protection against multiple variants of the virus that causes COVID-19 and unique cellular immunity compared to existing mRNA vaccines.
Celltrion's OMLYCLO receives US FDA approval
Kenox Pharmaceuticals partners with Lactiga US
Health Canada approves ALK's ACARIZAX for young children with dust mite allergy
Allergy Therapeutics publishes positive Phase III data for Grass MATA MPL
CSL's ANDEMBRY receives European approval to prevent attacks of hereditary angioedema
NICE recommends ALK's ACARIZAX for house dust mite allergic rhinitis treatment in UK's NHS
European Commission approves Palforzia for toddlers with peanut allergy
Eli Lilly and Co receives approval from FDA for Zepbound
CSL gains EMA backing for Garadacimab as HAE prophylactic treatment