Celltrion announces positive results for its cocktail therapy candidates including neutralisation data against Omicron variant

Celltrion Group announced today results for its cocktail therapy candidates including neutralisation data against the Omicron variant (B.1.1.529).

The Phase I clinical trial is a randomised, double- blind and placebo- controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of CT-P63 in 24 healthy subjects in Poland.¹ The study met its primary objectives with data showing CT-P63 to be safe and well tolerated, with no significant drug- related adverse events (AEs).

In an experiment conducted in partnership with the National Institutes of Health (NIH), CT-P63 showed strong neutralising activity against the Omicron variant based on structural analysis by X- ray crystallography and neutralisation data from pseudo- virus testing. Celltrion anticipates results of the SARS-CoV-2 Omicron variant assays and animal model studies by the end of the first quarter this year.

In order to elicit potent neutralising antibody response against the new emerging variants, Celltrion previously identified a total of 38 potent neutralising antibodies against SARS-CoV-2 in which antibody candidate No. 32 (CT-P63) produced high neutralisation titres against new emerging strains. CT-P63 has previously been demonstrated to have neutralising activity against the most common variants, including the Alpha, Beta, Gamma and Delta variants.

“The positive results demonstrate the potential of our cocktail therapy to retain neutralising ability against the Omicron variant” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We are confident that our antibody platform including Regkirona and CT-P63 will provide significant benefit for patients with COVID-19. Regkirona is given to a patient intravenously, so the drug could effectively treat patients hospitalised with COVID-19 at an early stage, while the nebulised cocktail therapy could address patients’ unmet needs for at- home treatment. We plan to discuss large- scale clinical trial for our nebulised cocktail therapy (CT-P63 in combination with Regkirona™) with regulatory agencies worldwide in the near future.”

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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-19.² 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 CT-P63

CT-P63 is a monoclonal antibody targeting SARS-CoV-2 spike receptor binding domain (RBD) as a treatment for COVID-19 infection. CT-P63 is currently being developed as a potential treatment for SARS-CoV-2 infection.

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. Nebulized 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

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

References

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¹ ClinicalTrials.gov. To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects. Available at: https://clinicaltrials.gov/ct2/show/NCT05017168#wrapper [Last Accessed January 2022]
² Celltrion Data on file

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