Celltrion, commercially produce CT-P59 starting in September

Announced plans to develop a solution for COVID-19 an online meeting on the 20th

Seo Jung-jin, Chairman at Celltrion from Youtube

Seo Jung-jin, Chairman at Celltrion Pharm, announced that the company will begin the production of COVID-19 antiviral antibody treatment that have entered the clinical stage.

 

It is intended to quickly enter the commercialization stage by completing the verification of the adequacy and validity of production facilities early on.

 

On the morning of the 20th, Celltrion held the 3rd online meeting on the new COVID-19 and introduced the progress of R&D.

 

This is an update according to the approval of the phase I clinical trial plan of the antibody 'CT-P59' for the treatment of COVID-19 from the MFDS on the 17th.

 

At the end of February, Celltrion discovered the antibody 'CT-P59', which shows the strongest neutralizing ability, through an antibody screening process that can neutralize the virus by securing the blood of a patient recovered from COVID-19 at the end of February.

 

The first animal experiment with Ferret last month confirmed that the level of COVID-19 in the body was reduced to one-hundredth.

 

Chairman Seo said, “As a result of the hamster experiment conducted in a similar way, the virus fell to less than 1/190.

 

No specificity was found in the toxicity test of monkeys.

 

"The MFDS has comprehensively judged the results of these animal experiments and approved the administration to human subjects," he said.

 

The Celltrion Group plans to focus its entire efforts on clinical development of 'CT-P59' this year.

 

According to Celltrion, there are currently 51 companies that have started developing COVID-19 antibodies similar to Celltrion.

 

Only Celltrion and Regeneron, are conducting their own processes from antibody selection.

 

Celltrion suggested the goal of starting trial administration at Chungbuk National University Hospital this week and completing phase I clinical trial within three quarters.

 

In addition to healthy subjects, consultations with several European countries such as the UK are ongoing in order to evaluate the therapeutic effect of 'CT-P59' in mild and moderate COVID-19 patients, On this day, Chairman Seo dismissed public concern about the risk of development failure due to the mutation of COVID-19.

 

Since it was developed by targeting the S1 region of COVID-19 surface projection protein from the beginning, it is judged that there is no problem with the therapeutic effect of 'CT-P59' at the current variation level.

 

Celltrion confirmed the strong neutralizing ability of 'CT-P59' both before and after mutation as a result of the recent antibody neutralization capacity test conducted by the KCDC.

 

As a plan to prepare for the newly developed mutant virus, the super antibody 'CT-P27', which binds to the S2 site, is being developed at the same time.

 

Celltrion officially announced the start of production of 'CT-P59' in September.

 

It means that about 10 batches are attempted to be used for validation purposes to verify the adequacy and effectiveness of production facilities.

 

It is also intended to review the availability of therapeutic supplies in the first half of next year as soon as they are developed.

 

"It is necessary to secure low cost and production capacity (CAPA) that can be supplied to countries around the world in order for commercial COVID-19 treatment to be commercially successful" said Seo.

 

It is a step that is closely examining how much to keep the inventory of existing products according to the clinical course of 'CT-P59'.

 

It is also considering whether to contract with a contract manufacturing company (CMO) for the smooth supply of COVID-19 antibody.

 

Chairman Seo said, "So far, we are confident of the treatment effect and safety of 'CT-P59' as animal test data.

 

I think it is possible to approve urgent use according to the results of phase II clinical trials." “we will do our best to complete the development and production of COVID-19 antiviral antibody treatment while contributing to the end of COVID-19 crisis."