South Korea’s biotech firm Genexine will be able to market vaccine to prevent COVID-19 in the second half of next year, given the pace of simultaneous clinical trials in multiple countries, said the company’s chairman Sung Young-chul.
He credited the government’s fast-tracking in regulatory approval and financial support to enable a phase 3 trial from the end of this year.
In an interview with Maeil Business Newspaper on Wednesday, Sung said he was confident that the company’s COVID-19 vaccine candidate GX-19 would go to market earlier than any others being developed overseas if supported with government funding and prompt approval of future clinical trials.
GX-19 is due to be tested in a phase 1 clinical trial in 40 adults at Gangnam Severance Hospital in Seoul this month. The trial will evaluate whether the formation and maintenance of neutralizing antibodies that kill the virus meet endpoints at week 2 and 4.
In order to start phase 2b and 3 trials within this year, it is necessary to receive approval for additional clinical trials in a fast manner based on even interim results from phase 1 and 2a trials considering priming procedures, said Sung, adding Britain and American health authorities grant approvals quickly by overlapping clinical trial stages in response to the COVID-19 pandemic.
Sung also said Genexine will conduct phase 2b and 3 clinical trials in a total of up to 10,000 people in high-prevalence countries such as Southeast Asia, the Middle East, South America, and Europe.
There are 15 coronavirus vaccine candidates under clinical trial around the world. Of these, Inovio Pharmaceuticals and Genexine vaccines are the only two DNA vaccine candidates whose clinical trial is approved by the Ministry of Food and Drug Safety in Korea. A DNA vaccine, which uses a gene from a virus to stimulate the human body’s immune system, has advantages in mass production thanks to simple and fast manufacturing.
Regarding the company’s investigational cancer immunotherapy Hyleukin-7 (GX-I7), Sung said the novel drug can lead to an out-licensing deal as it has demonstrated efficacy as a COVID-19 treatment as well as cancer therapy in combination with other regimens. GX-I7 was recently approved by the FDA for a phase 1 study in the treatment of patients with mild COVID-19 infections.
By Kim Byung-ho and Minu Kim
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]