Although the speed is slower than that of global pharmaceutical companies, domestic Corona 19 vaccines are also stepping through the development process.
In order to proceed with phase 3 clinical trials requiring large-scale subjects, it is expected that the ability to conduct overseas clinical trials and securing overseas data will be important because it must be a place where Corona 19 is prevalent.
The fastest place is Genexin. Genexine is currently in phase 1 after being approved for clinical trials (phases 1 and 2a) of the corona 19 vaccine’GX-19′ in June. Phase 1 verifies the safety of drugs in healthy people.
Initially, 40 people were conducted using an electroporator, but a study of 20 people using a needleless syringe was added. Genexine candidates are DNA vaccines. The drug is injected into the muscle cells. Therefore, try using all of the electroporator or needleless syringes that are applied to the muscles with pressure without an electric shock or needle. After comparing the data of the two, we will select the dosage regimen to be used in phase 2a.
Unlike conventional vaccines that inject a virus that has weakened or inactivated toxicity into the body, a DNA vaccine induces an immune response by injecting a viral gene that makes an antigenic protein into the human body. Recombinant DNA is injected into the human body to produce a spike protein (antigen) on the surface of the Corona 19 virus.
Genexine officials said, “We are currently completing phase 1 patient administration and blood collection and data analysis. We are planning to enter Phase 2a, designing Phase 3, and entering Phase 3 overseas by next March. Next year 9 In the month, I will also apply for approval to sell.”
◇SK Bioscience·Jinwon Life Science 1st Prize Application
SK Bioscience and Jinwon Life Science are waiting for approval of Phase 1 clinical trial submitted to the Ministry of Food and Drug Safety. The two companies are expecting to enter phase 1 clinical trials within this year.
On the 7th of last month, SK Bioscience applied for a phase 1 clinical trial of the COVID-19 vaccine developed by the Ministry of Food and Drug Safety. Earlier, the company started cooperation with the National Institute of Health, the Korea Centers for Disease Control and Prevention, as it succeeded in expressing a candidate material for the COVID-19 synthetic antigen vaccine last March. It is developing a corona19 vaccine with 4.4 billion won support from the Bill & Melinda Gates Foundation, where Bill Gates is the chairman.
SK is developing a recombinant protein vaccine that selects viruses that cause immune responses and synthesizes them using gene recombination technology. It is a synthetic antigen vaccine that elicits an immune response by technically synthesizing an antigen and administering it to the body.
Jinwon Life Sciences, who applied for phase 1 and 2 clinical trials earlier this month, is also developing a DNA vaccine (codename GLS-5310). If approved, it will be conducted in 4 clinical institutions besides the ancient Guro Hospital. The company has added one antigen in addition to the spike antigen to increase the preventive efficacy than other corona vaccines.
◇Celid-Smagen, adenovirus vector vaccine development
Celid is also developing a corona vaccine (AdCLD-Cov19). As a result of the primate test, the antigen-specific antibody response and high level of antibody neutralization ability were confirmed.
This vaccine is based on an adenovirus vector. The mechanism of action of viral vector vaccines is as follows. After preparing the antigen gene for the corona 19 virus, it is added to the adenovirus. Adenovirus plays a role in carrying the antigen gene of the corona 19 virus into human cells. After that, the virus is multiplied, purified, and put into a vial to be commercialized.
When a person inoculates it, antigenic components of the vaccine that have entered the human body stimulate B cells. Neutralizing antibodies that can remove viruses from stimulated B cells are made and stored in the body. Then, when the corona virus invades through the respiratory tract, it is a mechanism by which neutralizing antibodies in the body remove the invading virus.
Last month, Celid signed a mutual cooperation agreement with LG Chem for development, mass production, and commercialization.
Following Celid, LG Chem signed an agreement with Smagen to develop a corona vaccine this month. LG Chem aims to develop, produce, and commercialize the Corona 19 vaccine using Smagen’s’VSV Vector System’. VSV vector technology uses adenovirus as a viral vector (carrier) to produce antibodies in the human body.
In addition, HK Innoen (formerly CJ Healthcare) imported vaccine candidates from the CEVI Convergence Research Team of the National Science and Technology Research Council under the Ministry of Science, ICT and Communication, and began joint research with the fusion group and preclinical studies.
Food and Drug Administration Chief Kim Kang-lip at a press conference to commemorate the inauguration on the 16th, “The first task after the appointment of the Ministry of Food and Drug Safety is to accelerate the development of a vaccine and treatment for Corona 19 as soon as possible,” he said. “Domestic vaccines have a significant time difference from overseas vaccine development. I can come out.”