[Exclusive] "Developing Domestic COVID DNA Vaccine to the End... Competing on Safety"

Genexine Chairman Sung Young-chul "Indonesia Phase 3 Clinical Trial to Proceed in Two Stages"

[Asia Economy Reporter Seo Sojeong] "We will conduct the overseas Phase 3 clinical trial in two stages. First, we plan to conduct it on 10,000 people to reduce risk."

Recently, at the headquarters in Pangyo, Seongnam-si, Gyeonggi Province, Seong Young-cheol, chairman of Genexine (pictured), revealed that the plan to conduct a Phase 3 clinical trial on 30,000 people at once in Indonesia has been changed to be conducted in two stages.

The plan is to first verify whether the T cell-based DNA vaccine (GX-19N), which is being developed in-house, is effective against variant viruses on 10,000 people, and if proven in the first stage, to expand it to 20,000 people.

Chairman Seong explained, "If Genexine were to conduct the Phase 3 clinical trial on 30,000 people by itself, the cost burden would be too high," adding, "By dividing the Phase 3 clinical trial into two stages, we can reduce the cost burden and also reduce the risk of failure in the future." He said, "Even for 10,000 people, the clinical trial cost is about 50 billion KRW," and added, "Since the government plans to strengthen support for domestic vaccine development in the second half of the year, we plan to apply for government projects to lessen the financial burden."

Genexine will proceed with Phase 2 and 3 clinical trials for the COVID-19 vaccine next month in collaboration with Kalbe Farma, Indonesia's largest pharmaceutical company. The clinical trial costs will be shared equally between Genexine and Kalbe Farma. Genexine has recently been considering various funding options, including issuing convertible bonds (CB) worth 120 billion KRW ahead of Phase 3 clinical trials. Chairman Seong added, "Including 30 billion KRW in cash, the investable assets that can be liquidated amount to 900 billion KRW."

He also mentioned that funds could be raised through the sale of shares in five listed companies, including two U.S. companies listed on NASDAQ?iApp Biopharma and Resolute?two KOSDAQ companies (NeoImmuneTech and ZenenBio), and one KONEX company (ToolGen), as well as three domestic companies in total. However, Chairman Seong emphasized, "Since the companies in which Genexine holds shares have future growth potential, we cannot just sell the shares by putting all our focus on COVID-19 vaccine development," adding, "We will sell the shares that can be sold at the right time and manage risks."

Regarding the possibility of development discontinuation raised by some, Chairman Seong drew a clear line. He said, "It is expected that a market worth about 25 trillion KRW will be formed annually related to COVID-19 vaccines, and if we give up this opportunity, we may miss a great future opportunity." He explained that although some misunderstand that Genexine is solely focused on COVID-19 development, major pipelines in Phase 2 and 3 clinical trials such as immuno-oncology drugs, cervical precancer DNA vaccines, and sustained-release growth hormones are progressing smoothly, and the COVID-19 vaccine is just one of them.

Chairman Seong also expressed a different perspective on the trend where COVID-19 vaccines are being reorganized mainly around messenger RNA (mRNA) vaccines. He said, "Once the whole world takes a breather after vaccination, safety will become the biggest issue," and pointed out, "The safety issue is being overlooked."

Recently, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) warned that mRNA-based Pfizer and Moderna vaccines might be associated with myocarditis and other heart diseases in people under 30 years old. Chairman Seong emphasized, "It is that the association between the vaccine and adverse reactions is 'unknown,' not that there is 'no' association," adding, "DNA vaccines have relatively higher safety and can be an alternative."

He added, "DNA vaccines produce fewer antibodies compared to mRNA vaccines, and improving this is an urgent task," and "For future administration at local hospitals, it is also necessary to work on miniaturization and portability of equipment."

He continued, "For K-bio to leap forward, 'future-marking' is now more important than the past practice of 'benchmarking,'" and added, "For innovative companies like Germany's BioNTech to emerge, government support for bio companies that constantly look to the future and take on challenges must be further expanded." Chairman Seong is a first-generation domestic bio entrepreneur who founded Genexine in 1999 as a venture company within POSTECH.