Business Wire

Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate

Share

Celltrion Group announced today interim results from the Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The results showed a promising safety, tolerability and pharmacokinetics profile of CT-P59.

The Phase I clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of CT-P59 in healthy subjects.1 The results demonstrated no significant drug-related adverse events (AEs), and importantly there were no adverse events from the maximum tolerated dose cohort.

“Along with these promising safety results, we have launched commercial production of CT-P59 this month to ensure, if trials are successful, we can meet the urgent global demand for a safe and effective antiviral treatment against COVID-19,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “Should we receive positive results from our series of ongoing clinical trials, we intend to request emergency use authorisation for our drug.”

Celltrion has initiated an in-human, global, Phase I clinical trial of CT-P59 in mild COVID-19 patients and plans to conduct further global Phase II and III trials in 500 patients from 12 countries including Korea. Celltrion anticipates the enrolment of a total of 3,000 patients including those involved in the prevention clinical trial, investigating the use of CT-P59 as a preventative treatment for COVID-19 in those in close contact with COVID-19 patients. The company anticipates the development of the anti-COVID-19 monoclonal antibody treatment candidate will be complete by the first half of 2021.

-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 COVID-192,3

Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.

The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19.

Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1

About 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 including the mutated G-variant strain (D614G variant). 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.4

References


1 ClinicalTrials.gov. A Phase 1, randomized, double-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of CT-P59 in healthy subjects. Available at: https://clinicaltrials.gov/ct2/show/NCT04525079?term=celltrion&cond=covid+19&cntry=KR&draw=2&rank=1 Last accessed: September 2020
2 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: September 2020
3 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: September 2020
4 Celltrion. Data on file

Contact information

For further information please contact:

Preetika Ramjoorawon
pramjoorawon@hanovercomms.com
+44 (0) 20 3817 6766

Sophia Eminson
seminson@hanovercomms.com
+44 (0) 7751 116252

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

Call of Duty: Mobile World Championship Tournament Is Back – More Than $2 Million in Prizes Up For Grabs!14.4.2021 18:30:00 CEST | Press release

Activision today announced the return of the Call of Duty®: MobileWorld Championship. Presented by Sony, and starting June 3, 2021, eligible players in Call of Duty: Mobile Ranked Mode can compete for in-game rewards and a share of the more than $2 million (USD) total prize pool. “The momentum worldwide for Call of Duty: Mobile is incredible as our players continue to have a great time playing,” said Matt Lewis, vice president, mobile at Activision. “Picking up from last year’s competition, we’ve increased the prize money up for grabs and number of teams that can qualify, so there are even more reasons for fans to prove they’ve got what it takes to be the best.” The Call of Duty: Mobile World Championship 2021 Presented by Sony is open to eligible entrants across the world and will be conducted regionally in multiple stages. Sony’s newest flagship smartphone, Xperia 1 III, will be the official mobile device of the World Championship and will provide an 120FPS gaming experience*. Eligib

Verimatrix Chief Revenue Officer To Speak at StreamTV Sports Summit14.4.2021 17:45:00 CEST | Press release

Regulatory News: Verimatrix, (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced that Lu Bolden, Chief Revenue Officer, will participate in a virtual panel discussion from 1-1:45 p.m. Eastern Time on Monday, April 19 during the StreamTV Sports Summit. Titled, “Playing Defense – The Fight Against Piracy,” the five-person panel will share their experiences surrounding the need for media organizations and rights holders to protect expensive sports rights agreements. They’ll also discuss to what extent it’s possible to prevent footage from being shared and distributed on social platforms. Additionally, the panel will provide the latest insights regarding the actual anti-piracy tools and techniques organizations turn to for help. Alongside Bolden, the panel participants include: Tony Maroulis, Principal Analyst, Ampere Analysis (panel moderator) Mark Barron, Principal Solutions Engineer, Akamai William Mao, Vice President,

Valbiotis Launches a Capital Increase Through a Private Placement14.4.2021 17:40:00 CEST | Press release

Regulatory News: Valbiotis (Paris:ALVAL) (FR0013254851 – ALVAL, PEA-PME eligible), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, today announces the launch of a capital increase within the context of a private placement through an accelerated bookbuilding process for an amount of approximately 12 million euros. This capital increase, with the removal of shareholders’ preferential subscription rights in favor of a category of persons, will be reserved exclusively for qualified investors as referred to in article 2(e) of Regulation (EU) 2017/1129 of June 14, 2017. Reasons for the offer The net proceeds of the capital increase are intended primarily to finance the acceleration of the development of TOTUM•854 (prevention of arterial hypertension) with the launch of three clinical trials at the end of this year including a Phase II/III clinical trial, prior to a health claim application. In partnership with a major healt

Lenovo Outlines Company Transformation Strategy - From Devices To Solutions Company14.4.2021 17:00:00 CEST | Press release

Today, during its annual global employee kickoff event broadcast to 63,000 employees, Lenovo unveiled its plans to drive transformation from a global devices company to a technology leader in global devices + solutions, services, and software. Lenovo CEO Yang Yuanqing and other executive leaders outlined the company’s strategy, structure, and goals that will fuel Lenovo’s next decade of growth and position it as one of the world’s most trusted and iconic technology leaders, delivering smarter technology for all. “Last year at this time, none of us knew how things would turn out for Lenovo,” said Lenovo CEO Yuanqing Yang. “But we did know this: we would support each other in an unpredictable journey ahead; we would fight for the best possible outcome in an uncertain world; and we would use our technology to connect and heal a wounded society.” During the past year the COVID pandemic drove many businesses and consumers around the world to adopt and use technology innovations in new ways,

Coded Agency Celebrates Continued Growth with Rebrand, Internal Promotions and Client Wins14.4.2021 16:00:00 CEST | Press release

Global modern communications company Coded Agency today announces a highly-anticipated, strategic overhaul of its branding and website following steady growth and innovation into new markets and industries. Coded Agency, formerly known as codedpr, was founded in 2015 and quickly grew to become a leading agency of record for a range of lifestyle, fashion, beauty, fitness and wellness brands. In 2020, the agency generated a net income increase of 35%, despite an unprecedented global pandemic. Its upward trajectory continues in 2021 with not only a 65% increase in revenue in Q1 and a 50% increase in clients between Q1 and Q2, but a bold, fresh new look, instrumental employee promotions and expansion into Europe with the agency founder’s relocation to France. The minority-owned, female-founded company renews its namesake as Coded Agency in tandem with a new website and branding designed by Designsake Studio, a San Francisco-based, award-winning and female founded design firm. “Coded Agency

Microsoft Azure Customers Now Able to Acquire beqom with Existing Azure Credit14.4.2021 15:20:00 CEST | Press release

beqom, provider of cloud-based compensation management software, announced that Microsoft has designated beqom as an eligible “Microsoft Transact” application for customers of the Microsoft Azure cloud platform. This means that Azure customers can use their existing Azure budget commitment to fund the purchase of the beqom compensation management solution. “This presents a huge opportunity for Azure customers,” says Francois D’Haegeleer, beqom Head of Business Development. “As an eligible application, if you purchase beqom directly through the Azure Marketplace, Microsoft will contribute 100% of qualifying offer purchases towards your organization’s Azure consumption commitment at each invoice period, including software/IP costs. So you can get beqom’s world-class compensation management platform, used by Global 2000 companies around the world, for no additional budget outlay.” “Our enterprise customers want to streamline their software procurement process,” says Andrew Reid, Microsoft

Boehringer Ingelheim and MD Anderson Expand Collaboration to Accelerate Development of KRAS and TRAILR2 Compounds in Lung Cancer14.4.2021 15:00:00 CEST | Press release

Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center today announced the extension and expansion of their joint Virtual Research and Development Center (VRDC) to explore new molecules from Boehringer Ingelheim’s KRAS (Kirsten rat sarcoma) and TRAILR2 (TNF-related apoptosis-inducing ligand receptor 2) portfolios for the potential treatment of lung cancer, particularly non-small cell lung cancer. The collaboration, launched in 2019, has successfully combined MD Anderson’s innovative clinical research infrastructure and the patient-driven drug development capabilities of the Therapeutics Discovery division with Boehringer Ingelheim’s pipeline of innovative cancer medicines and expertise in advancing breakthrough therapies. Under the new agreement, joint research will continue for five additional years. “Our collaboration with MD Anderson strengthens our determination to find solutions for the most difficult-to-treat cancers, and this latest commitment marks an import

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