Celltrion to conduct tests on Omicron variant detected in Korea

Biopharmaceutical powerhouse Celltrion Inc. plans to use its treatments to test the Omicron variant detected in Korea, according to a high-level company official on Dec. 6.

The Incheon-based company's senior managing director Lee Soo-young discussed the company's plans during a presentation at the Korea Bio Investment Conference 2021 in Seoul on Monday. Lee is confident that the company's monoclonal antibody (mAb) treatment has widely encompassing virus-neutralizing capacity. 

Late last month, Celltrion announced it had accelerated the development of a nebulized formulation of its neutralizing antibody cocktail treatment to combat new variants of COVID-19.

Targeting newly emerging mutations of SARS-CoV-2 and using its already constructed antibody platform, Celltrion has developed a neutralizing antibody cocktail consisting of CT-P63 together with its monoclonal antibody treatment Regkirona, which was recently approved by the European Commission for the treatment of COVID-19.

CT-P63 is a monoclonal antibody targeting the SARS-CoV-2 spike receptor binding domain as a treatment for COVID-19 infection.

According to its press release, the company has enrolled 24 volunteers in its global Phase 1 trial to evaluate the safety, tolerability and pharmacokinetics of CT-P63.

The first clinical trial of the cocktail treatment is expected to be completed within this year. Once complete, Celltrion plans to discuss its adoption with Korean and European authorities. 

After verifying safety results in the first phase of its clinical trial, Celltrion plans to confirm the extensive neutralizing capacity of the cocktail therapy with Regkirona and CT-P63 on new variants as a follow-up trial, with a nebulized formulation of Regkirona.

Lee explained during the conference that inhalation treatment can be as effective as an intravenous administration method with a lower dosage. Thanks to this difference, Celltrion plans to be price competitive and make it easier for patients to receive the treatment.  

Last Tuesday, Celltrion's distribution arm signed supply deals with nine European countries for its monoclonal antibody COVID-19 treatment. 

The European Commission earlier this month approved Celltrion Healthcare's antibody therapy Regkirona, granting marketing authorization for use by adults with COVID-19 who are at increased risk of progressing in a severe manner. 

Lee said Regkirona has been effective against new variants of COVID-19, especially the Delta variant. 

In regards to the delay Regkirona is facing to receive the US Food and Drug Administration's emergency use authorization, Lee elaborated that the agency is being more particular than before as Washington has now acquired enough COVID-19 treatments from pharmaceutical companies globally.

Write to Do-hee Lee at tuxi0123@hankyung.com
Edited by Jee Abbey Lee