Celltrion speeds cocktail therapy via antibody platform to tackle new COVID variants

 

• Celltrion previously completed phase I clinical trials with a nebulised formulation of Regkirona (regdanvimab, CT-P59), a monoclonal antibody treatment for COVID-19
• Celltrion anticipates CT-P63 to maintain strong neutralising ability against Omicron based on structural analysis by X-ray crystallography and neutralisation data from pseudo-virus testing
• A separate global phase I clinical trial is set to be completed for CT-P63 by the end of the year

 

Celltrion Group announced today that the company has accelerated development of a nebulised formulation of its neutralising antibody cocktail treatment, to respond to emerging mutants from SARS-CoV-2.

Targeting newly emerging mutations of SARS-CoV-2 and using its already constructed antibody platform, Celltrion has developed a neutralising antibody cocktail consisting of CT-P63 together with its monoclonal antibody treatment Regkirona (regdanvimab, CT-P59), which was recently approved by the European Commission (EC) for the treatment of COVID-19.

Celltrion enrolled 24 healthy volunteers in its global phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of CT-P63 and the company anticipates results by the end of the year.

CT-P63 is a monoclonal antibody targeting SARS-CoV-2 spike receptor binding domain (RBD) as a treatment for COVID-19 infection. Celltrion plans to evaluate neutralisation of new emerging variants tailored to specific regions and assess potential escape mutants by using in vitro pseudo-virus assay. After verifying safety results in phase I clinical trial, Celltrion plans to confirm the extensive neutralising capacity of the cocktail therapy with Regkirona and CT-P63 on new variants as a follow up trial, with a nebulised formulation of Regkirona.

“The mutations in Omicron, also known as B.1.1.529, could help the virus evade the body’s immune response and make it more transmissible” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Omicron has many mutations in the same regions of the spike protein, however we anticipate CT-P63 to maintain strong neutralising ability against Omicron based on structural analysis by X-ray crystallography and neutralisation data from pseudo-virus testing. By leveraging our antibody platform including Regkirona (CT-P59) and CT-P63, as well as patented formulation, the development of a nebulised cocktail therapy will be accelerated.”

Regkirona has previously demonstrated in vivo efficacy against the most common variants, including the Alpha, Beta, Gamma and Delta variants.

https://www.biospace.com/article/releases/celltrion-accelerates-development-of-nebulised-cocktail-therapy-ct-p63-in-combination-with-ct-p59-using-its-antibody-platform-to-tackle-new-covid-19-variants/