Business Wire

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

Share

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.”

- ENDS -

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

____________________________

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

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Holly Barber
hbarber@hanovercomms.com
+44 (0) 07759 301620 

Donna Curran
dcurran@hanovercomms.com
+44 (0) 7984 550312

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Advent Technologies and the Greek Natural Gas Company, DEPA Commercial, sign MoU to collaborate on Hydrogen Projects8.8.2022 15:00:00 CEST | Press release

Advent Technologies Holdings, Inc., an innovation-driven leader in the fuel cell and hydrogen technology space, today announced the signing of a Memorandum of Understanding ("MoU") with DEPA Commercial S.A., the leading importer of pipeline gas and liquefied natural gas (“LNG”) in Greece to enter into a strategic collaboration on hydrogen projects of common interest. The MoU sets out the framework for a forthcoming mutually binding agreement. The parties have preliminarily agreed to the following actions: Collaborate on the production of environmentally friendly hydrogen as a fuel with the participation of other major industrial partners. Co-develop a proprietary and highly differentiated CHP system ready for mass production with efficiency approaching 90% and with multi-fuel operating capabilities (hydrogen, natural gas, efuels) that can address the key current, future, and on-grid, off-grid operation modes and business cases. Create an innovation hub for the Greek hydrogen and fuel c

Pharma Tech Holdings SA Obtains a Capital Commitment Agreement of CHF 30 million from Global Investor LDA Capital8.8.2022 10:50:00 CEST | Press release

Pharma Tech Holding SA (“PTH”) announced today it has secured a CHF 30 million investment to support its portfolio investments from LDA Capital Ltd, a global investment group with expertise in cross border transactions including the agriculture, Agri-tech, and CBD industries. Established in 2019, PTH is a Swiss based holding company, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food. This investment will allow PTH to mainly invest and support its portfolio company Blue Sky Swisse SA (“BSS”) a JV between PTH and listed company IGEA PHARMA NV (“Igea”), IGPH - ISIN NL0012768675. BSS focuses on the extraction of natural active principles from vegetable matrices, vegetable waste, and renewable sources to deliver B2B products under the form of CBD oil, Terpenes and Waxes. The factory located in Biasca, will be built to the state of art of extractio

Smile Hair Clinic Named 'Hair Transplant Clinic of the Year'8.8.2022 09:30:00 CEST | Press release

The Smile Hair Clinic took two awards in the ‘Highest Quality Hair Transplantation Clinic’, and the 'Hair Clinic of the Year' categories at the 13th Annual Quality of Magazine Klass Award Ceremony. Dr. Gokay Bilgin and Dr. Mehmet Erdoğan founded the Smile Hair Clinic in 2018 and have since overseen its successful and award-winning growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220808005053/en/ Smile Hair Clinic named 'Hair Transplant Clinic of the Year' (Graphic: Business Wire) Award Ceremony: https://www.youtube.com/watch?v=0TvUp2FxRII Accepting the award Dr. Bilgin said, "Our country holds an important position in medicine globally; patients from all over the world come to Turkey for treatment." Award winners Dr. Bilgin and Dr. Erdoğan have many years of experience in follicular unit extraction (FUE) techniques. Located on Istanbul’s Anatolian neighborhood of Ataşehir, the clinic has more than 100 trained personnel

Teckro Partners with Reforestation Non-profit “One Tree Planted”5.8.2022 15:04:00 CEST | Press release

Teckro, creator of the only digitally interconnected clinical trial platform for real-time decision-making at the point of patient care, today announced a partnership with One Tree Planted to support native reforestation in Ireland. Teckro will plant trees quarterly to celebrate new clinical research sites and studies live on the Teckro platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220805005165/en/ “Working with One Tree Planted aligns with Teckro’s ethos of making an impact in the world,” said Gary Hughes, co-founder and chief executive officer. “Digitally interconnected clinical trials are good for the environment with less paper and a reduced need for in-person monitoring visits. This partnership enables us to plant trees in recognition of the sustainable gains achieved with our platform.” Planting trees is one of the best ways to combat the damaging effects of climate change. Trees help clean the air we breath

SES to Participate in Upcoming Investor Conferences5.8.2022 13:45:00 CEST | Press release

SES AI Corporation (NYSE: SES), a global leader in the development and manufacturing of high-performance lithium-metal (Li-Metal) rechargeable batteries for electric vehicles (EVs) and other applications, today announced that management will participate and host one-on-one meetings at the following investor conferences. J.P. Morgan Auto Conference Date: August 9, 2022 Location: New York City Jefferies Industrials Conference Date: August 10, 2022 Location: New York City Baird Newly Public Company Virtual Access Day Date: August 17, 2022 Location: Virtual Piper Sandler Energy Transition Leaders Summit Date: August 18, 2022 Location: Aspen, CO Cowen Global Transportation & Sustainable Mobility Conference Date: September 8, 2022 Location: Virtual RBC Capital Markets Global Industrials Conference Date: September 12, 2022 Location: Las Vegas, NV About SES SES is a global leader in development and production of high-performance Li-Metal rechargeable batteries for electric vehicles (EVs) and o