HONG KONG – South Korea-based Genexine Inc. has started enrolling a phase I/II trial for a DNA vaccine targeting COVID-19 called GX-19. CEO Young Chul Sung said it’s the first domestic vaccine trial to be approved by South Korea’s Ministry of Food and Drug Safety. Company managers expect preliminary data from the initial trial in September and hope to complete all stages by the end of 2021.

The phase I trial will include 40 healthy participants at Gangnam Severance Hospital, while a subsequent phase IIa study, if merited, will be conducted in the second half of the year with participants from countries such as Indonesia and Thailand.

Genexine has joined with PT Kalbe Farma Tbk for the Indonesian trials, with whom it shares a joint venture company, PT Kalbe Genexine Biologic, that develops and makes raw materials for biotechnology medicines in Indonesia. The Thai trials are likely to go through Genexine’s joint venture partner Kingen Holdings, with whom it established Kingen Biotech in September 2019.

Indonesia’s Kalbe is banking on the collaboration to ensure a supply of the vaccine for the country. “The COVID-19 vaccine development collaboration is Kalbe's contribution to helping the government to overcome the COVID-19 pandemic in Indonesia,” said Sie Djohan, the director of Kalbe Farma. “Kalbe hopes that through these research and development efforts the vaccine will be able to get quick results, thus the availability of vaccines in Indonesia can be guaranteed,” he said.

“An equally important question is that once we prove that the vaccine works in a safe way, how will we then manufacture enough doses when there are seven billion people in the world and everybody or at least 60% to 70% of them needs to be vaccinated? And what if the vaccine requires two doses? Then you would need to make 14 billion doses of the vaccine. So, manufacturing the vaccine that works is just as important as proving that it works,” Jerome Kim, the director general of nonprofit organization the International Vaccine Institute, told BioWorld.

Genexine has said it is working to ensure a steady supply. "We are working with several domestic and foreign partners, including Binex, to secure vaccine supply, and we will accelerate our preparations to supply sufficient amounts not only in Korea but also in countries with insufficient vaccines," said Sung.

In March, Genexine began developing its vaccine candidate through the establishment of a COVID-19 DNA vaccine development consortium that consists of Genexine, Binex, International Vaccine Institute, Genbio, the Korea Advanced Institute of Science & Technology (KAIST) and Pohang University of Science & Technology (POSTECH).

Due to the close collaboration between the consortium members and the rapid evaluation of the Ministry of Food and Drug Safety, the trial was approved within three months.

Research on the vaccine thus far has been carried out in primates and has shown it able to produce antibodies capable of neutralizing the novel coronavirus.

Genexine is one of a few vaccine development companies supported by the South Korean government. Currently, the others are Geneone Life Science, Biopoa, LG Chem, Genexine, Sumagen, Gflas Lifesciences and SK Bioscience.

Though Genexine has a head start in the vaccines trial race in South Korea, others are quickly catching up. Incheon, South Korea-based Celltrion Inc. aims to move its own candidate into the clinic in July after it wraps up animal testing. The company is considering running clinical trials in South Korea or abroad.

Besides a vaccine, Genexine is also developing a treatment for COVID-19 by collaborating with Rockville, Maryland-based Neoimmunetech Inc. on U.S. trials of Hyleukin-7 (GX-I7) for COVID-19 patients. Hyleukin-7 was recently greenlighted by the FDA for a phase I study in the treatment of patients with mild COVID-19 infections.

“The severity of COVID-19 is related to the reduction and depletion of lymphocytes, which are essential for immune defense against infection. Hyleukin-7 is expected to more effectively combat viral infections by restoring lymphocytosis and the patient's immune function," said Sung.

“The joint development of Hyleukin-7 through close cooperation with Neoimmunetech is expected to greatly accelerate the commercialization of Hyleukin-7 as an anticancer and infectious treatment,” he said.