Business Wire

Celltrion accelerates development of nebulised cocktail therapy (CT-P63 in combination with CT-P59) using its antibody platform to tackle new COVID-19 variants

Share

Celltrion Group announced today that the company has accelerated development of a nebulised formulation of its neutralising antibody cocktail treatment, to respond to emerging mutants from SARS-CoV-2.

Targeting newly emerging mutations of SARS-CoV-2 and using its already constructed antibody platform, Celltrion has developed a neutralising antibody cocktail consisting of CT-P63 together with its monoclonal antibody treatment Regkirona (regdanvimab, CT-P59), which was recently approved by the European Commission (EC) for the treatment of COVID-19.

Celltrion enrolled 24 healthy volunteers in its global phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of CT-P63 and the company anticipates results by the end of the year.

CT-P63 is a monoclonal antibody targeting SARS-CoV-2 spike receptor binding domain (RBD) as a treatment for COVID-19 infection. Celltrion plans to evaluate neutralisation of new emerging variants tailored to specific regions and assess potential escape mutants by using in vitro pseudo-virus assay. After verifying safety results in phase I clinical trial, Celltrion plans to confirm the extensive neutralising capacity of the cocktail therapy with Regkirona and CT-P63 on new variants as a follow up trial, with a nebulised formulation of Regkirona.

“The mutations in Omicron, also known as B.1.1.529, could help the virus evade the body’s immune response and make it more transmissible” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Omicron has many mutations in the same regions of the spike protein, however we anticipate CT-P63 to maintain strong neutralising ability against Omicron based on structural analysis by X-ray crystallography and neutralisation data from pseudo-virus testing. By leveraging our antibody platform including Regkirona (CT-P59) and CT-P63, as well as patented formulation, the development of a nebulised cocktail therapy will be accelerated.”

Regkirona has previously demonstrated in vivo efficacy against the most common variants, including the Alpha, Beta, Gamma and Delta variants.

- 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-19.1 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 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. Nebulised 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 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

For further information please contact:
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



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

Altasciences Chosen by Virpax Pharmaceuticals, Inc. to Conduct First-in-Human Study of Epoladerm™ for Chronic Pain Associated with Osteoarthritis of the Knee21.1.2022 17:00:00 CET | Press release

Altasciences is pleased to have been chosen by Virpax® Pharmaceuticals, Inc. (“Virpax”) (NASDAQ:VRPX) to conduct a first-in-human study of Epoladerm™ (diclofenac epolamine) for chronic pain associated with osteoarthritis of the knee. This treatment is supplied in a pre-filled device for administration as a topical spray film. The study will be conducted in Q2 2022 at Altasciences’ clinical pharmacology unit in Montreal, Canada. “We look forward to working with Altasciences to accelerate the development of this analgesic treatment and provide robust data in support of the 505(b)(2) FDA approval pathway,” stated Virpax’s Chairman & CEO, Anthony P. Mack. Virpax’s proprietary technology provides a pre-filled canister for the therapeutic application of a clear, fast-drying spray film that is thinner than a standard liquid bandage. This technology offers convenience and eliminates the need for messy creams or gels. Altasciences leverages decades of experience conducting first-in-human clinic

OMRON Healthcare Remote Patient Monitoring Services Win “Best of” Honors at CES 202221.1.2022 16:21:00 CET | Press release

OMRON Healthcare, Inc., the global leader in remote blood pressure monitoring and personal health technology, spotlighted its new remote patient monitoring services at the 2022 Consumer Electronics Show (CES) and won “Best of” honors for its offerings in the U.K. and U.S: Hypertension Plus by OMRON in the U.K. was selected as a TWICE Picks Awards winner for the 2022 TWICE, Residential Systems and TechRadar Pro Picks Awards VitalSight™ by OMRON in the U.S. was recognised as an INSIDER “Best of” CES selection These remote patient monitoring services gained recognition at the world’s largest innovation show as breakthrough health technology designed to foster greater active health condition management, strengthen the patient-physician connection, and guide behavior change to reduce health risks, while advancing the company’s mission of Going for Zero heart attacks and strokes. “OMRON developed Hypertension Plus as the first step toward transforming chronic care in the U.K., while VitalSig

Schlumberger Announces Fourth-Quarter and Full-Year 2021 Results21.1.2022 12:50:00 CET | Press release

Schlumberger Limited (NYSE: SLB) today reported results for the fourth-quarter and full-year 2021. Fourth-Quarter Results (Stated in millions, except per share amounts)Three Months EndedChangeDec. 31, 2021Sept. 30, 2021Dec. 31, 2020SequentialYear-on-yearRevenue* $6,225 $5,847 $5,532 6% 13% Income before taxes - GAAP basis $755 $691 $471 9% 60% Net income - GAAP basis $601 $550 $374 9% 61% Diluted EPS - GAAP basis $0.42 $0.39 $0.27 8% 56% Adjusted EBITDA** $1,381 $1,296 $1,112 7% 24% Adjusted EBITDA margin** 22.2% 22.2% 20.1% 2 bps 208 bps Pretax segment operating income** $986 $908 $654 9% 51% Pretax segment operating margin** 15.8% 15.5% 11.8% 31 bps 401 bps Net income, excluding charges & credits** $587 $514 $309 14% 90% Diluted EPS, excluding charges & credits** $0.41 $0.36 $0.22 14% 86% Revenue by Geography International $4,898 $4,675 $4,343 5% 13% North America* 1,281 1,129 1,167 13% 10% Other 46 43 22 n/m n/m $6,225 $5,847 $5,532 6% 13% *Schlumberger divested certain businesses i

ZuluTrade - World’s Largest Social Trading Platform Joins the Finvasia Group21.1.2022 12:08:00 CET | Press release

ZuluTrade is strongly positioned to become the biggest and the largest broker neutral social trading platform with acquisition by Finvasia Group. 2022 will see ZuluTrade strengthening its current capabilities and widen its product line by venturing into different markets and financial instruments. The expansion will include contemporary asset classes like cryptocurrencies and traditional asset classes like stocks and bonds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220120005780/en/ ZuluTrade - World’s Largest Social Trading Platform Joins the Finvasia Group (Graphic: Business Wire) ZuluTrade has been at the forefront of copy trading for more than a decade and has helped over a million investors across more than 100 countries trade a volume of over USD 2 trillion. ZuluTrade 2.0 Future plans include launching a more engaging social investing platform with enhanced social and technology features, built on ZuluTrade’s curre

Ipsen Nominates Karen Witts as New Independent Board Member21.1.2022 07:00:00 CET | Press release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220120006035/en/ Karen Witts (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) announced today the nomination of Karen Witts to its Board of Directors as independent member. Karen Witts was Group CFO at Compass Group Plc until October 2021. Compass is the world’s leading food service company, operating in 43 countries and employing more than 500k people. She was responsible for corporate strategy and planning, business performance management and reporting, financial reporting and control, tax and treasury activities, M&A, internal audit and enterprise risk management, investor relations, and led the digital and technology function. Prior to this, Karen was Group CFO at Kingfisher Plc, the international home improvement company. She has also held various senior strategic finance positions at companies including Vodafone Group Services Ltd, and BT Plc. She

Peru Is Presenting Itself at FITUR 2022 as a Bio-safe Destination, Committed to Outdoor Experiences21.1.2022 02:48:00 CET | Press release

Peru is in attendance at the 42nd edition of FITUR 2022 to position itself as a safe and ready destination for international travellers, motivating them to rediscover the South American country, reported the Comisión de Promoción del Perú para la Exportación y el Turismo [Peruvian Export and Tourism Promotion Commission] (PROMPERÚ). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220119005812/en/ Inauguration of the Peru stand at FITUR 2022 by the executive president of PROMPERÚ, Amora Carbajal. ©PROMPERÚ In line with its promotion and recovery strategy, Peru is presenting a delegation made up of 19 co-exhibitors in order to show off the best of its tourist offering in the nature, adventure and culture segments. Likewise, it announced its collaboration with the Asociación Española de Agencias de Incentivos – IdeMICE, in order to enhance the attributes of the destination in this segment. In addition, the executive president of

McAfee Continues to Provide Leading Online Protection to Consumers21.1.2022 02:40:00 CET | Press release

Today, McAfee Corp. (NASDAQ: MCFE, “McAfee”), a global leader in online protection, provided an update regarding its pure-play consumer offering and the previously announced divestiture of its enterprise business. In July 2021, McAfee completed the sale of its enterprise business. This transaction allowed McAfee to singularly focus on its consumer business and accelerate its strategy to be the leader in online protection for consumers. “McAfee continues to safeguard the privacy, security and identity of our consumers as the digital world evolves rapidly,” said Gagan Singh, Executive Vice President & Chief Revenue and Product Officer, McAfee. “We continue to stand firm that meaningful protection is a personal right for consumers and have recently rolled out major updates and industry firsts, including McAfee Total Protection and Protection Score, that look out for consumers online, including their privacy and identity.” The McAfee Enterprise business was purchased by Symphony Technology

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom