Celltrion Develops Tailored Neutralising Antibody Cocktail Treatment with CT-P59 to Tackle COVID-19 Variant Spread Using Its Antibody Development Platform
Celltrion Group today announced that CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, has confirmed neutralising potency against emerging virus mutations and that the company has initiated development of a neutralising antibody cocktail treatment with CT-P59.
The Korea Disease Control and Prevention Agency (KDCA) has assessed and independently confirmed that CT-P59 successfully neutralises the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). They also added that cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralising capability against the UK (B.1.1.7) and South African (B.1.351) variants.
As of 19 January 2021, according to media and official sources, approximately 2,000 cases of the variant VOC 202012/01 (Variant of Concern, year 2020, month 12, variant 01, previously designated VUI, Variant under Investigation) had been identified in 60 countries. In the EU/EEA, about 1,300 cases have been identified in 23 countries. Outside the EU/EEA, approximately 700 cases have been identified in 37 countries.1
In order to elicit potent neutralising antibodies against the new emerging variants and to minimise lead time for introducing cocktail treatments with CT-P59, Celltrion previously captured a total of 38 potent neutralising antibodies against SARS-CoV-2 in which antibody candidate No. 32 produced neutralising titres against new emerging strains in the UK and South Africa. Using an already constructed antibody portfolio and encouraged by confirmed potency on various mutants, Celltrion has commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.
To date, CT-P59 has been shown to significantly reduce the risk of COVID-19 related hospitalisation and oxygenation up to Day 28, reduce rate of progression to severe COVID-19 by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over, and significantly shorten the time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo. A global Phase III clinical trial is currently recruiting and is expected to enroll 1,172 patients with mild-to-moderate symptoms of COVID-19 at more than 10 global sites to evaluate the efficacy and safety of CT-P59.
Global Principal Investigator Professor Adrian Streinu-Cercel, MD, PhD, Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, said, “CT-P59 has demonstrated its ability to shorten time to clinical recovery and reduce rate of progression to severe COVID-19. From the clinical trial, one of my patients with COVID-19 aged 85 and with an underlying condition, has recovered from the virus within 48 hours of being treated with CT-P59. The antibody treatment candidate would be most useful within 3-5 days of testing positive for the virus. This will greatly aid efforts to address the current burden on healthcare systems and resources.”
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 CT-P59 (Regdanvimab)
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. The mutated G-variant strain (D614G variant) was later identified and confirmed to be inactivated by CT-P59. In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation. Results from the global Phase I clinical trial of CT-P59 demonstrated promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.2
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.
1 Risk related to the spread of new SARS-CoV-2 variants of concern in the EU/EEA – first update 21 January 2021, European Center for Disease Prevention and Control. [Last accessed February 2021]
2 Celltrion Data on file
+44 (0) 07759 301620
+44 (0) 7984 550312
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™* injection in hemodialysis patients with moderate-to-severe pruritus8.3.2021 09:00:00 EET | Press release
Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210307005039/en/ Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA™ is 23 August 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application. The FDA grants Priority Review to drug applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The NDA filing is supported by positive data from two pivotal phase-III trials KALM-1, condu
HD-PLC Alliance Develops Its Global Activities in High-speed Power Line Communications and High-speed Wired Communications8.3.2021 09:00:00 EET | Press release
Last year, HD-PLC Alliance *1, Fukuoka, Japan (Alliance) launched the “Global Strategy Preparatory Office”, a new ad-hoc working group, to support the advancement of IoT migration which is leading to a dramatic growth of the needs for high-speed PLC in various systems such as smart-meter, factory-automation (FA), building-automation (BA), solar power generation, smart-streetlight, smarter-city, smarter-home, etc. The Alliance announces today several initiatives as part of the development of its global activities. First, the Alliance will hold an HD-PLC *2 global web seminar (webinar) jointly with IEEE SA*3 on coming Thursday, 18th March to showcase its ecosystem footprint. Event title: [IEEE SA And HD-PLC Alliance Webinar March 2021] Home Networking, Industrial and Building Automation through HD-PLC (High Speed Powerline Communication) Official website: https://hd-plc.org/news/ , https://standards.ieee.org/events/index.html Topics covered/Agenda: HD-PLC technology and Standards, Buildi
Masimo Monitoring Solutions Promote Newborn and Maternal Safety8.3.2021 08:00:00 EET | Press release
Masimo (NASDAQ: MASI) provides a variety of innovative monitoring solutions designed to improve maternal and newborn safety during childbirth and the critical first minutes of life. Masimo SET® pulse oximetry’s ability to measure during motion and low perfusion has helped newborns, neonates, and pediatric patients like no other pulse oximetry. Not only has Masimo SET® helped clinicians reduce retinopathy of prematurity (ROP)1 and improve screening for critical congenital heart disease (CCHD),2-10 but it has helped push the standard of care for babies to new heights—the evidence from CCHD studies with SET®, for example, has been used in the establishment of screening guidelines used around the world.11 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210307005058/en/ Masimo Newborn Sensor (Photo: Masimo) Today, on International Women’s Day, it is especially important to recognize that, as UNICEF reports, “newborns and mothers a
High-Quality Healthcare, Education Systems Highlighted in China's Two Sessions7.3.2021 06:41:00 EET | Press release
Building Healthy China and a high-quality education system are both important content in the draft outline of the 14th Five-Year Plan (2021-2025) for national economic and social development and the long-range objectives through the year 2035, which will be reviewed by lawmakers at the ongoing National People's Congress (NPC) session. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210306005020/en/ On the second day of this year's annual session of the NPC, China's national legislature, President Xi Jinping joined a group meeting with national political advisors from the education, medical and health sectors. He attended joint group meetings with national political advisors from various sectors during the Two Sessions eight times from 2013 to 2020, hearing their comments and suggestions. Ensuring people's health Talking about work in medical and health areas, Xi reiterated holding people's health as a strategic priority, call
CGTN: China Outlines Plan to Address Economic Challenges in Next 5 Years5.3.2021 16:02:00 EET | Press release
China has set a gross domestic product (GDP) growth target of over six percent for 2021 and outlined a plan to promote innovation, green development, and common prosperity in the next five years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005288/en/ Addressing the country's annual legislative session, Premier Li Keqiang on Friday explained how China is going to tackle the numerous challenges it faces in a new development stage. "China remains in an important period of strategic opportunity for development. Yet, there are changes in both the opportunities and challenges we face," Li said when delivering a government work report at the opening meeting of the fourth session of the 13th National People's Congress (NPC), China's top legislature. 'Extraordinary year' Describing 2020 as "an extraordinary year in the history of the People's Republic of China," the premier underscored China's "major strategic success" in fi
Everbridge Awarded Revolutionary New Public Warning Patent for Technology that Automates the Selection of the Optimal Communications Channels to Reach the Broadest, Hyper-Targeted Populations – as Fast as Possible – During a Crisis5.3.2021 15:30:00 EET | Press release
Everbridge, Inc. (NASDAQ: EVBG), the global leader in critical event management (CEM), today announced the company received a revolutionary new patent related to its world-class Public Warning system. The patent pertains to technology focused on hybrid population alerting systems and intelligent sending of messages in public mobile networks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005260/en/ Everbridge Awarded Revolutionary New Public Warning Patent (Photo: Business Wire) Everbridge represents the first population alerting provider to serve the entire populations of 11 countries in Europe, Asia, Oceania, the Middle East, Africa, and the Americas, supporting five European Union (EU) countries in conjunction with the EU mandate requiring member countries to have a population-wide alerting system in place by June 2022. In compliance with GDPR, Everbridge Public Warning neither collects nor stores personally identif
COVID-19’s Economic Pinch Drives More Nordic Enterprises Toward Business Process Automation for Competitive Edge5.3.2021 12:00:00 EET | Press release
Large enterprises in the Nordics have been implementing business process automation over the last three years, and more organizations now see the urgency of adopting these technologies to stay competitive as COVID-19 strains the regional economy, according to a new report published today by Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The 2020 ISG Provider Lens™ Intelligent Automation – Solutions and Services report for the Nordics finds banking, financial services and insurance companies have led the region in adopting business process automation, seeking higher productivity, cost savings and improved customer experience. Manufacturing, retail and other sectors are also embracing the technologies, which include conversational AI, natural-language processing and AI for IT operations (AIOps). “Early adopters of automation in the Nordics are stepping up digital transformation to gain an advantage when they need it most,” said Jan
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