• 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

INCHEON, South Korea--(BUSINESS WIRE)--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.

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Notes to Editors:

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients� access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us.

About regdanvimab (CT-P59)

CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. In vitro and in vivo pre- clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralises the wild type and mutant variants of concern. In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global phase I and phase II/III clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild-to-moderate symptoms of COVID-19.¹ The EC granted marketing authorisation for Celltrion�s regdanvimab following positive opinion by the European Medicines Agency�s (EMA) Committee for Medicinal Products for Human Use (CHMP) in November 2021.

About nebulised formulation

The nebulised formulation of the monoclonal antibody not only targets SARS-CoV-2 spike receptor binding domain (RBD) and elicit neutralising antibody response but it also has �trapping� mechanism of action and thereby neutralises and traps in mucus with exceptional potency. The muco-trapping antibody platform directly traps the virus in airway mucus, preventing the local spread of the infection, and quickly eliminating the virus from the lungs through the body's natural ability to clear mucus. Nebulised formulation can be readily self-administered by patients, extend critical drug supplies to more patients by reducing the dosage needed, and does not place excessive demands on healthcare staff and infusion clinic space that intravenous (IV) drugs do.

FORWARD LOOKING STATEMENT

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References

¹ Celltrion Data on file

Contacts

For further information please contact:

Holly Barber

[email protected]
+44 (0) 07759 301620

Donna Curran

[email protected]
+44 (0) 7984 550312