K-COVID-19 vaccine developers will ‘power through till end'

With the 80% vaccination rate in Korea and the imminent introduction of oral COVID-19 vaccines, companies have diversified their development strategies

Cellid applies for Phase IIb/III trial… in line with development of a vaccine for COVID-19 variants

SK Bioscience will focus on supplying its vaccine to developing countries after Phase III trial… Genexine to develop vaccines as booster shot

Domestic vaccine developers have been accelerating the last phases of their clinical trials.

 

SK Bioscience and Genexine have started Phase III trials in Korea and abroad, and Cellid has submitted its Phase IIb/III clinical trial plan.

 

Domestic developers have come up with new strategies to continue the development of their vaccines with the value of latecomer vaccines lowering due to the domestic vaccination rate reaching nearly 80% in Korea and the introduction of oral COVID-19 treatments imminent.

 

◆Cellid applied for Phase 2b/3 trial… starts development of a vaccine against variants If the clinical trial protocol is approved, the Phase IIb clinical trial will be conducted on 125 participants, and Phase III on 4,100 participants.

 

The Phase III trial will compare AdCLD-CoV19-1 with AstraZeneca’s COVID-19 vaccine.

 

Cellid has started a new clinical trial for its existing candidate ‘AdCLD-CoV19' after revising its virus vector.

 

The production yield rate change has improved with the revision of the virus vector.

 

Upon completing the phase 2a trial, Cellid said in June that it would newly develop AdCLD-CoV19-1, a revised version of the virus vector vaccine, for mass production.

 

In addition, the company obtained the regulatory nod for a phase 1 study of AdCLD-CoV19.

 

Apart from this, Cellid is also concurrently developing a new vaccine candidate that responds to COVID-19 variants including the Delta variant.

 

Animal testing is currently underway for the new vaccine candidate.

 

Cellid expects it would be able to enter Phase I clinical trials for its variant vaccines next year at the earliest.

 

The company’s experience with its Phase IIb/III trial for AdCLD-CoV19-1 is expected help accelerate its development.

 

Cellid’s two-track development strategy is not unrelated to the COVID-19 vaccine and treatment development situation in Korea and abroad.

 

With the market value of latecomer vaccines decreasing, the companies have explained that the changes in their development strategies were inevitable.

 

As of midnight on the 12th, the domestic COVID-19 vaccination rate in Korea reached 77.6 % (full vaccination rate).

 

Therefore, the possibility of not many candidates being left for vaccination even if the company completes its vaccine development by the first half of next year as planned.

 

Remains.

 

In addition, the value of the latecomer vaccine has been rated even lower with the imminent introduction of oral coronavirus treatments.

 

◆SK Bioscience signs agreement to supply its vaccine to developing countries… Genexine to develop a vaccine as booster shot SK Bioscience and Genexine, which have started their Phase III trials ahead of Cellid, have also been facing the same dilemma.

 

SK Bioscience plans to finish development and expand its supply to developing countries around the world by early next year.

 

SK Bioscience signed a supply agreement with CEPI (The Coalition for Epidemic Preparedness Innovations) for the provision of its vaccines.

 

After GBP510 is developed and is selected for the “Wave 2” (next-generation COVID-19 vaccine) project, the vaccine will be supplied globally, in Africa, South America, and Southeast Asia through the COVAX Facility.

 

The global vaccination rate has reached around 51.3%.

 

In developing countries, the rate is around 10% or less.

 

Therefore, unlike in the domestic market, a sufficient supply market remains for the vaccines globally.

 

SK Bioscience initiated its Phase III trial in August.

 

The company expects the trial to be finalized and be approved by 1H next year.

 

In the case of Genexine, the company changed its vaccine development strategy to developing booster shots.

 

In August, the company applied to change its clinical trial plan for the global Phase II/III trial it has been conducting for ‘GX-19N’ in Indonesia in August.

 

The new strategy is to develop a booster vaccine with its vaccine candidate.

 

The clinical trial will confirm the protective efficacy of GX-19N in 1,000 participants who had been vaccinated with Sinovac or Sinopham’s inactivated vaccines 3 months earlier.

 

Genexine plans to expand the clinical trials in Indonesia to Argentina and other countries in 14,000 patients.

 

However, the analysts are that the decision may have been influenced by the fact that the drug, if developed, will not have much marketability, like other vaccine developers.