Celltrion’s New Antibody Is Effective against the Omicron Variant

Vaccines have been the most powerful weapon to combat the Covid-19 pandemic. However, breakthrough infections of the Delta and Omicron variants in double-vaccinated people suggest that we need a diverse arsenal of antivirals to offer protection from the SARS-CoV-2 virus. All major pharma companies are working on multiple candidates to develop treatments which are effective against existing and possibly emerging variants. 

South Korea- based Celltrion Healthcare introduced a cocktail therapy candidate for effective therapy against the Omicron variant. 

Combating the threat from emerging Covid variants

CT-P63, a monoclonal antibody against the viral spike’s receptor binding domain (RBD), was successfully tested for safety, efficacy and tolerance in Phase I randomised, double-blind and placebo-controlled clinical trial, without any significant adverse events. Crystal structure and cell-based analyses conducted in collaboration with the U.S National Institutes of Health studied the antibody’s interaction with the virus demonstrated strong neutralisation of the Omicron variant. Further data on animal models and neutralising titres in wider cell biology studies are expected in the next few months.  

The clinical trial, conducted in Poland, enrolled 24 healthy participants to test the pharmacokinetic profile of CT-P63. Previous studies showed that CT-P63 is effective in neutralising the Alpha, Beta, Gamma and Delta variants of SARS-CoV-2. 

Celltrion’s anti-Covid pipeline

Celltrion has a candidate list of 38 antibodies which are being tested for effective antiviral activity against Covid variants, with plans to evaluate them for neutralisation of new emerging variants tailored to specific regions and assess potential escape mutants by using in vitro pseudo-virus assay. At the Korea Bio Investment Conference 2021, Senior Managing Director, Lee Soo Young introduced  Regkirona (CT-P59), a monoclonal antibody therapy against coronavirus, which was approved by the European Medicines Agency (EMA) and is under review with the U.S. FDA. Previously, Celltrion bagged approval for its Covid rapid testing kit, DiaTrust and is available for at-home testing. 

Celltrion aims to develop cocktail therapy options by combining CT-P63 and Regkirona nebuliser treatments for at-home patients using their patented nebuliser formulation, while the monoclonal antibody treatments are recommended for hospitalised patients. “The positive results demonstrate the potential of our cocktail therapy to retain neutralising ability against the Omicron variant” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. 

Author

Sahana Shankar