Who will follow SK Bio with its homegrown COVID-19 vaccine?

Approval of first homegrown COVID-19 vaccine by SK Bioscience imminent

Important to secure comparator vaccines for clinical trials…global companies reluctant to cooperate

Eubiologics’ vaccine approved for Phase III trial in Africa… wasn’t able to secure comparator vaccines for trials in Korea

Cellid takes a two-track approach with basic vaccine·booster shot…GeneOne Life Science turns to booster shots

The marketing authorization for SK Bioscience’s homegrown COVID-19 vaccine 'GBP510' is nearing approval.

 

If the drug is approved within the first half of the year as planned, GBP510 will become the first homegrown vaccine to be ever approved.

 

With the developer of the first vaccine set, who will be the No.2 and No.3 in line is gaining attention.

 

Currently, Eubiologics, Cellid, and Geneone Life Science are speeding up trials for their COVID-19 vaccines.

 

The issue at hand is how the companies will secure a comparator vaccine for comparative trials.

 

SK Bioscience had been able to quickly conduct a Phase III trial after securing the necessary comparator vaccines early on, other companies are having trouble securing comparator vaccines.

 

◆Eubiologics secures comparator vaccines and prepares to initiate global Phase III trial According to the pharmaceutical industry on the 27th, Eubiologics received approval to initiate its Phase III trial for ‘EuCorVac-19’ in three countries in Africa.

 

Eubiologics’s COVID-19 vaccine in development is a synthetic antigen vaccine, the same as SK Bioscience’s GBP510 or Novavax’s Nuvaxovid.

 

The company’s procurement of comparator vaccines played a decisive role in the initiation of the company’s Phase III trial in Africa.

 

The latecomers in the COVID-19 vaccine development industry have been conducting Phase III trials by comparing the efficacy and safety of its vaccines with previously approved vaccines rather than with large-scale clinical trials.

 

SK Bioscience had also conducted a Phase III trial by comparing its vaccine with AstraZeneca’s vaccine.

 

The comparator vaccine secured by Eubiologics for the African trial is not one of the 5 vaccines (Pfizer, Moderna, AstraZeneca, Janssen, Novavax) that were approved in Korea.

 

Eubiologics plans to conduct a clinical trial that compares the efficacy and safety of its vaccine with a comparator vaccine and expects to receive approval for a trial in the Philippines as well.

 

An official from Eubiologics said, “The clinical trial will start at the local site within the month.

 

If the Phase III trial is completed in Africa, it will be listed for Emergency Use Listing by the WHO, and then be supplied around low-income countries after obtaining export approval.

 

◆Have entered Phase III trials in Korea but have trouble securing ‘comparator vaccines’ Securing comparator vaccines is an issue in conducting Phase III trials in Korea as well, as Korea requires ‘vaccines approved in Korea’ to be used as comparators for domestic trials.

 

A pharmaceutical industry official explained that although SK Bioscience was able to secure a comparator vaccine relatively easily because of its past CMO agreement with AstraZeneca, the situation is different for other vaccine developers.

 

Global vaccine developers are showing a lukewarm reaction to being selected as a comparator vaccine for domestic companies due to concerns over technology leakage.

 

However, if a comparator vaccine is not secured, the domestic companies’ concern is that it would take that much longer for the companies to develop their vaccines.

 

An official from EUbiologics said, “If SK Bioscience receives approval for GBP510, we may use the vaccine as a comparator, but this is not our immediate plan as we would need to change our clinical trial protocol to enable this.

 

We are working closely with the government to secure a comparator vaccine among those that are already approved in Korea.” ◆Companies change paths or give up development strategies due to difficulty securing comparatorvaccines Other companies are also having difficulty securing comparator vaccines.

 

Companies are changing the development strategy or abandoning the development itself due to difficulty in securing comparators and the increased global vaccination rates and the smooth supply of vaccines already available in the market.

 

Cellid received approval for a Phase IIb trial for 'AdCLD-CoV19-1' in Korea in January this year.

 

If the Phase IIb trial is completed, the company would also need to secure a comparator vaccine for comparative trials.

 

Its approval will depend on how well the company procures a comparator vaccine.

 

Cellid had applied for the Phase IIb and III trials at the same time in November last year but was only approved for the Phase IIb trial due to the lack of a comparator vaccine.

 

After failing to conduct the Phase III trial, Celid has developed a two-track strategy to continue clinical trials of the vaccine for primary inoculation that was in development while developing vaccines for booster shots (additional inoculation).

 

Geneone Life Science changed its strategy from developing a vaccine for primary inoculation to developing a booster vaccine.

 

Earlier this month, the company announced that the company completed the registration of subjects for the Phase IIa clinical trial of 'GLS-5310', which is being developed as a DNA vaccine.

 

After confirming the safety and efficacy of clinical trials in a Phase IIa trial, the company plans to continue studying its vaccine through Phase IIb and III trials exclusively as a booster vaccine.

 

HK Inno.N completed Phase I trials for its ‘IN-B009’ in development as a synthetic antigen vaccine.

 

However, the company is pondering whether to proceed with Phase II trials.

 

An official from HK Inno.N said, “We have completed Phase I trial for our vaccine but haven’t submitted a clinical trial protocol for Phase II trial plan yet.

 

We haven’t decided on our direction from there.” Genexine withdrew its development.

 

Genexine was the first among domestic companies to start the development of a COVID-19 vaccine in June 2020.

 

Although it has completed the Phase IIa trial for 'GX-19N' in Korea, the company gave up proceeding with Phase II and Phase III trials last month.

 

GX-19N was being developed through a DNA vaccine platform.

 

No other vaccine approved around the world had adopted the use of this platform.

 

As comparative clinical trials require the use of a control vaccine from similar platforms, it was virtually impossible to secure a control vaccine.

 

For this reason, a large-scale Phase III clinical trial was inevitable for the company, which was why Genexine decided to stop the development of its vaccine determining that its business feasibility was low.