CelltrionHealthcare

Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), demonstrates high efficacy in neutralising against SARS-CoV-2 variant first identified in Brazil (P.1)

·        Pre-clinical data for Regdanvimab(CT-P59) shows significant reduction in viral load of SARS-CoV-2 and protected body weight loss against Gamma variant (P.1, formerly ‘Brazilian’ variant)

·        Celltrion simultaneously assessed therapeutic neutralising antibodies against the Delta variant(B.1.617.2, formerly ‘Indian’ variant); data expected shortly

July 5 2021, INCHEON, KOREA – Celltrion Group today announced preliminary pre- clinical results for regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19, with data showing that CT-P59 has a neutralising effect against the Gamma variant in an in vivo model.

The pre-clinical study assessed the neutralisation effect of CT-P59 against the Gamma variant, using a clinically relevant and lower dose in SARS-CoV-2 infected mice. The study demonstrated that CT-P59 treatment results in a significant reduction in viral load from lungs and 100% survival rate from COVID-19 compared to placebo animal model of 0%. In addition, significant protection was shown in body weight loss after viral challenge.

CT-P59 is known to successfully neutralise the SARS-CoV-2 Variants of Concerns (VoC) including Alpha variant (B.1.1.7, first identified in the UK) and Beta variant (B.1.351, first identified in South Africa)[1] as well as Variant of Interests (VOIs) including lineages B.1.427/B.1.429, B.1.526, P.2, B.1.525 and B.1.617.1 in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). The company plans to additionally study in vivo neutralising activity against the Delta variants (B.1.617.2, formerly ‘Indian’ variant) in the coming days.

"Treatment with regdanvimab, even at low doses than in human clinical trial design, led to reduction in viral load,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We are encouraged by the results with regdanvimab against SARS-CoV-2 variants as these findings add to the growing body of our pre-clinical data. We remain committed to continue with further testing for antiviral activity against other emerging variants including the Delta variant.”

In June, the European Commission (EC) announced Celltrion’s regdanvimab to be part of the COVID-19 therapeutics portfolio for authorization for the treatment of COVID-19 patients as part of its strategy for COVID- 19 therapeutics.

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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.

About regdanvimab (CT-P59) and clinical trials

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 Alpha variant (B.1.1.7, first identified in the UK). 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 II 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.[2] Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.

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