• Pre-clinical data for Celltrion�s monoclonal antibody treatment regdanvimab (CT-P59) shows significant reduction in viral load of SARS-CoV-2, with no significant difference observed in the neutralisation titres against wild type SARS-CoV-2
• Celltrion has completed patient enrolment of 1,300 people in a global Phase III clinical trial to evaluate the efficacy and safety of CT-P59
• Celltrion to commence further investigation into neutralisation activity of CT-P59 against other emerging COVID-19 variants

INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced preliminary pre-clinical results for regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment, with data demonstrating that CT-P59 has a neutralising effect against the South African variant in an in vivo model. The study demonstrated that CT-P59 treatment, at a clinically relevant dose, results in a significant reduction in viral load of SARS-CoV-2. The manuscript describing this pre-clinical data is available on the pre-print server bioRxiv and is concurrently undergoing scientific peer-review for potential publication.

This pre-clinical study assessed the neutralisation effect of CT-P59 against the South African variant, using a clinically relevant dose. CT-P59 demonstrated reduction in the binding affinity against the receptor binding domain (RBD) in the three mutations (K417N, E484K and N501Y substitutions) of the South African variant. In addition, CT-P59 showed a reduced susceptibility against the South African variant in a live virus and pseudo-virus assay in vitro study. However, there was no significant difference observed in the respiratory viral infection in the upper and lower respiratory tracts when exposed with SARS-CoV-2 wild type and the South African variants in the study. Taken together, the reduced effect in in vitro neutralisation of CT-P59 is unlikely to compromise the in vivo therapeutic potency against the variant in the respiratory tract, especially at a clinical dose.

�We are encouraged by the new data, which reinforces that Celltrion�s CT-P59 treatment could be effective against the South African variant and variant mutations,� said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. �Faced with the rapid spread of COVID-19 variants, global access to effective antibody treatment is fundamentally important to reduce the disease progression rate to severe COVID-19 and help outpatients avoid hospitalisation and alleviate the burden on the health care system. We have commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging strains in the UK and South Africa and we will continue to further investigate the neutralising antibodies and other responses to protect against current SARS-CoV-2 strains and emerging variants .�

Celltrion�s global Phase III clinical trial to further evaluate the efficacy and safety of CT-P59 is ongoing in 13 countries including the U.S., Spain and Romania, having recently completed patient enrolment of 1,300 people.

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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 neutralise the wild type and mutant variants of concern including the UK variant (B.1.17). 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 clinical trial of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.¹ Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.

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