Input 2021.02.04 10:36 | Revision 2021.02.04 10:50
Genexine “Development for emergency use approval within the year”
Response to mutant viruses such as Jinwon Life Science and GICELL
Ubiologics, the same way as’NovaVax’
Celid, aims to apply for emergency use this year
Domestic pharmaceutical companies have a shorter history of vaccine development and lack capital and R&D capabilities than global pharmaceutical companies. However, if Corona 19 does not end and you need to get a vaccine every season like the flu, the government and industry share that it is necessary to develop a domestic vaccine to secure stable vaccination and sovereignty. There is also an opinion that it is necessary to develop a’domestic vaccine’ in order to further increase the capacity to respond to the new infectious disease crisis and respond to the emerging strain virus. The industry is a latecomer in the development of the Corona 19 vaccine, but is developing it with the will to put meaning on completion.
According to the pharmaceutical industry on the 4th, SK Bioscience, a domestic pharmaceutical and biotech company that is developing a COVID-19 vaccine, Genexin (095700), Celide, Ubiologics (206650), Genexin (095700)Five companies, including those, are representative and are undergoing clinical trials with the aim of launching next year.
◇ SK Bioscience and Genexine “going to launch in the first half of next year”
SK Bioscience and Genexine are ahead of the development of the Corona 19 vaccine. SK Bioscience and Genexine, which have built vaccine factories and focused on R&D since 20 years ago, are developing each with the aim of launching in the first half of next year.
SK Bioscience predicts that the Corona 19 vaccine under development will be released in the first half of next year. The final candidate is selected from the vaccine candidates’NBP2001′ and’GBP510′, which are currently being developed, and plans to enter the 3rd clinical trial this year. Sang-mok Lee, head of the Strategic Development Department of SK Bioscience, said, “The independent candidate substance NBP2001 developed by SK is undergoing phase 1 clinical trials, and GBP510, a candidate substance developed with the Bill & Melinda Gates Foundation, is undergoing phase 1 and 2 clinical trials.” By about time, we will confirm the intermediate results and proceed with the large-scale phase 3 clinical trial.”
SK Bioscience is currently conducting clinical trials with two vaccine candidates, NBP2001 and GBP510. NBP2001 entered phase 2 clinical trials last November, and GBP510 entered phase 1 and 2 clinical trials from last month. NBP2001 is a vaccine that induces an immune response with the surface antigen protein of Corona 19. GBP510 is a vaccine that uses gene recombination technology to produce virus surface antigen proteins. Ahn Jae-yong, CEO of SK Bioscience, said, “Our goal is to create a Corona 19 vaccine that has proven safety and effectiveness even later than a global vaccine,” and said, “We are raising the possibility of success under government support.”
Genexine is confident in the success of developing a COVID-19 vaccine. The company aims to complete phase 1 clinical trials in March in Korea and proceed with phase 2a clinical trials to obtain emergency use approval within this year.
Genexine was expected to release the Corona 19 vaccine the fastest in Korea, but it suddenly changed the corona 19 vaccine candidate from’GX-19′ to’GX-19N’ and proceeded with clinical trials again from the beginning with a new vaccine candidate. In progress. GX-19N, a new vaccine candidate, secured safety by using the same platform as the existing vaccine candidate GX-19 of Genexin, and additionally loaded the Nucleocapsid antigen with high sequence integrity to the existing Spike antigen. The company explained that this is a vaccine designed to cope with the COVID-19 virus strain. Seong Young-cheol, chairman of Genexine, said, “We have confirmed a wide and strong T-cell immune response and improved antibody response through animal experiments.” “We will develop a vaccine.”
◇ UBio and Celid speed up vaccine development
UBiologics announced its plan to complete the clinical trial of the Corona 19 vaccine’Yukobac 19′, which is being developed in-house, within this year and obtain an early product license. This candidate is classified as a’genetically recombined vaccine’ similar to that of SK Bioscience and NovaVax, USA. The company predicted that the phase 1 clinical trial of Yukobaek 19 will be completed in the second quarter and the second clinical trial will be completed in the early third quarter of this year. Baek Young-ok, CEO of UBiologics, said, “The goal is to enter phase 3 clinical trials in the second half of this year.”
The Corona 19 vaccine developed by Celid is a vaccine using an adenovirus vector similar to that of AstraZeneca. Celide is currently in phase 1 and 2 clinical trials for adenovirus vector-based vaccine candidate AdCLD-CoV19. Kang Chang-yul, CEO of Celid, said, “We have developed through a platform using adenovirus and are conducting phase 1 and 2 clinical trials at the same time. After completing clinical 2a of 150 patients in March, we plan to conduct clinical 2b with 1,000 patients in early June.” “If safety and immunogenicity are confirmed in phase 2 clinical trials, we plan to apply for emergency use in August,” he said.
Jinwon Life Sciences is conducting a phase 1 clinical trial of the DNA vaccine candidate’GLS-5310′. The DNA vaccine’GLS-5310′ is scheduled to be released in the first half of next year. Recently, the company has also launched an attack-infected animal test to evaluate the ability of the Corona 19 vaccine’GLS-5310′ to defend against the South African mutant virus. GLS5310 is a COVID-19 vaccine with the addition of the’ORF3a’ antigen to prepare for a mutant virus. Jeong Moon-seop, head of Jinwon Life Science Research Institute, stressed, “We apply for emergency use approval in April next year, and we aim to ship the vaccine in May.”
In addition, GI Innovation’s subsidiary GI Cell also signed a memorandum of understanding (MOU) with the International Vaccine Research Institute (IVI) for the development of candidates for the COVID-19 vaccine, and began development. Currently, GICELL is developing the COVID-19 vaccine candidate’GIC-1114/1114m’ using its own protein vaccine development platform, GI-COV-VAX. The company expects that it will produce an improved preventive effect against the virus strain in the future by inducing a T cell response as well as the formation of neutralizing antibodies against the Corona 19 virus.
There is also an opinion that the success of domestic pharmaceutical companies in developing a vaccine for Corona 19 is close to a miracle. It is said that there is no guarantee that the vaccine development by these companies will lead to the final license gate. An industry official said, “It would be nice if the development of a vaccine that would respond to mutations next year would be successful, but it seems that it is still in the process of developing a vaccine that will respond to mutations in advanced countries,” and said, “We will have to watch until the final phase 3 clinical trials.”
Some argue that domestic pharmaceutical and bio companies, latecomers of vaccines, need to have differentiated vaccine development strategies to become’game changers’. This is why vaccine companies that will respond to mutant viruses are attracting attention. Pfizer, Modena, and AstraZeneca, who completed clinical trials before the mutant virus appeared, currently do not have data on the preventive effect of the mutant virus. Man-ki Song, Ph.D. at the International Vaccine Research Institute, said, “Because mutant viruses can come out anytime, anywhere, it is expected that responses such as development of new vaccines will be needed.