Type: DNA vaccine
Status: Genexine said June 11 that it won approval from South Korea’s Ministry of Food and Drug Safety for a Phase I/IIa trial (NCT04445389) designed to assess GX-19—the nation’s first home-based company to receive such authorization.
The trial will consist of a Phase I portion in 40 healthy volunteers, followed by a placebo-controlled Phase IIa evaluation of two dose levels for safety and efficacy in 150 patients. The Phase I portion will be completed within three months, to be followed in the second half of 2020 by the Phase II portion, which will be conducted in multiple nations, including countries where the spread of COVID-19 is severe.
On March 13, Genexine began development of GX-19 by forming a COVID-19 DNA vaccine development consortium with Binex, the nonprofit International Vaccine Institute, GeNBio, Korea Advanced Institute of Science and Technology (KAIST), and Pohang University of Science and Technology (POSTECH).
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: