Celltrion Confirms Neutralising Potency Against Emerging SARS-CoV-2 Variants With Anti-COVID-19 Monoclonal Antibody Treatment regdanvimab (CT-P59)

• CT-P59 demonstrated neutralising capability against key emerging mutations, including SARS-CoV-2 variants first identified in New York (B.1.526), Nigeria (B.1.525) and India (B.1.617)¹
• Evaluation of other emergent variants of concern (first identified in Brazil P.1)² is ongoing; data expected in the coming months
• Celltrion is committed to assess the therapeutic neutralising antibodies against a wide array of emerging variants to end the pandemic

INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced that CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, has confirmed neutralising potency against emerging variants first identified in New York (B.1.526), Nigeria (B.1.525) and India (B.1.617).¹

The Korea Disease Control and Prevention Agency (KDCA) has assessed the test by combining the antibody with recent emerging variants first identified in New York (B.1.526), Nigeria (B.1.525) and Brazil (P.1); infecting the host cell with this combination to identify neutralising effect against the variants with CT-P59. The monoclonal antibody candidate CT-P59 demonstrated strong neutralising capability against the New York (B.1.526) and Nigeria (B.1.525) variants and produced neutralising titers against the Indian variant (B.1.617) in an in-vitro pseudo virus assay.¹

The company plans to study neutralising titers against additional emerging strains, including the Brazil variant (P.1)², in order to proactively address the pandemic as the virus continues to evolve. CT-P59 is known to successfully neutralise the SARS-CoV-2 variants first identified in the UK (B.1.1.7), California (B.1.427/B.1.429), Brazil (P.2), in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR).

“The emergence of SARS-CoV-2 variants has created great concern across the globe. We are encouraged by these results, which reinforce our confidence that CT-P59 should be effective against these newly detected variants.” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Monoclonal antibodies have the potential to alleviate symptoms and prevent progression to severe disease in patients with mild to moderate COVID-19. It’s clear there is an urgent need to improve access to treatments like regdanvimab, as emerging variants continue to threaten efforts to curb the spread of the virus around the world.”

Celltrion has successfully enrolled more than 1,300 people and its global Phase III clinical trial to further evaluate the efficacy and safety of CT-P59 in 13 countries including the U.S., Spain and Romania is on track with data expected in the coming months.

As of May 2021, more than 3,000 people have been treated with regdanvimab in the Republic of Korea.

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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

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¹ Celltrion Data on file

² SARS-CoV-2 variants of concern as of 11 May 2021. European Centre for Disease Prevention and Control. Available from: https://www.ecdc.europa.eu/en/covid-19/variants-concern