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

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

Sensorion successfully raises approximately €31 (US$ 36.5) million in an oversubscribed private placement to US and European investors18.9.2020 09:00:00 EESTPress release

Regulatory News: Not for release, publication or distribution, directly or indirectly, in or into the United States, Canada, Australia or Japan. This press release is not intended as an offer and is for informational purpose only Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN – the “Company”) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders announces today the success of its previously announced capital increase. The Company has placed 18,236,000 new ordinary shares with a nominal value of €0.10 each (the “New Shares”), for total gross proceeds of approximately € 31 million by means of an accelerated bookbuild offering to the benefit of categories of persons (the “Reserved Offering”). The issue price of the New Shares is €1.70 per share, representing a 3.5% discount to the weighted average share price on the day preceding the date on which the issuance price

ESMO 2020: Phase II CLARINET FORTE Results Show Increasing Dose Frequencies of Somatuline® Autogel® (lanreotide) Allows Patients with NETs to Delay Treatment Escalation by up to 8.3 Months18.9.2020 08:00:00 EESTPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced the release of first efficacy and safety data from the CLARINET FORTE study, with the abstract to be presented as a mini-oral presentation at the 2020 European Society for Medical Oncology (ESMO) Congress, taking place virtually from 19-21 September 2020. The prospective single-arm, open-label, exploratory, international Phase II study investigated the efficacy and safety of increasing the dose frequency of Somatuline® Autogel ® (lanreotide) in patients with pancreatic or midgut NETs with centrally-assessed progression within the last two years while on a standard lanreotide regimen for ≥24 weeks. An extension of progression-free survival (PFS) rates and encouraging disease-control rates (DCR) were recorded in both tumor types, with no new safety signals. “These results support a clinically meaningful benefit to a population of patients with high unmet medical need by potentially delaying escalation to more toxic treatm

Vifor Pharma Group Announces Successful Sale of OM Pharma18.9.2020 08:00:00 EESTPress release

Regulatory News: Vifor Pharma has today announced the successful sale of 100% of the share capital of OM Pharma, a Vifor Pharma Group company to Optimus Holding Ltd. The terms of the deal include: A purchase consideration of MCHF 435 for 100% of the share capital An earn out related to potential future value gains on 20% of Optimus Holding Ltd. equity to be determined before the end of 2027 upon a trade sale, IPO or EBITDA multiple This earn out together with the purchase consideration could result in a total transaction value exceeding MCHF 500. The deal is expected to close within 30 days. OM Pharma is a Geneva-based company mainly active in the field of microbial derived immunotherapeutics and has developed strongly outside the core strategy of Vifor Pharma over the past few years. Optimus Holding Ltd. is a Swiss Group, founded by Etienne Jornod together with long-standing Swiss entrepreneurs and Abdi Ibrahim (28.5%), a Turkey-based pharmaceutical company operating in 12 countries a

A Continuous Journey of Digital Transformation, Alibaba Cloud and Its Global Customers at Apsara 202018.9.2020 06:00:00 EESTPress release

As the digital technology and intelligence backbone of Alibaba Group, Alibaba Cloud is experiencing continuous growth alongside its customers across different parts of the world. Over the years, it has made relentless efforts to serve clients from every industry, helping them accelerate their business development and navigate the challenges of these volatile times. Cloud computing and AI technology have been shown to be the cornerstone for businesses seeking to be fully equipped in the digital era, especially following the global outbreak of COVID-19. At the 12th Apsara Conference: Leap into the Future of Digital Intelligence, customers from various sectors, including aviation, leisure and hospitality, education, and e-commerce and retail, share their growth and success stories achieved together with Alibaba Cloud. “It is our utmost pleasure to see our customers experience a seamless transition into more digitalised operations,” said Selina Yuan, President for International Business, A

BeiGene Presents Data at ESMO Virtual Congress 2020 on Phase 3 Trial of Tislelizumab in First-Line Non-Squamous Non-Small Cell Lung Cancer and Phase 2 Trial of Pamiparib in Advanced Ovarian Cancer18.9.2020 01:05:00 EESTPress release

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced the first reported data from RATIONALE 304, the Phase 3 trial of its anti-PD-1 antibody tislelizumab in combination with chemotherapy as a potential first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), and the first reported data from the pivotal Phase 2 trial of its investigational PARP inhibitor pamiparib in advanced ovarian cancer (OC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which takes place on September 19-21. “We are pleased to share the promising RATIONALE 304 results, which were used to support our recently accepted supplemental new drug application in first-line non-squamous NSCLC in China,” commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “BeiGene is evaluating tislelizuma

Sensorion Launches a Capital Increase by Means of an Accelerated Bookbuild Offering17.9.2020 20:33:00 EESTPress release

Regulatory News: Not for release, publication or distribution, directly or indirectly, in or into the United States, Canada, Australia or Japan. This press release is not intended as an offer and is for informational purpose only Sensorion (FR0012596468 – ALSEN – the “Company”) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, intends to issue new ordinary shares of a nominal value of €0.10 (the “New Shares”) for a total capital increase of approximately €30 million (US$35 million), by means of an accelerated bookbuild offering to the benefit of categories of persons (the “Reserved Offering”). The New Shares will be issued through a share capital increase without shareholders’ preferential subscription rights pursuant to the 12th resolution of the extraordinary general meeting of shareholders of the Company held on May 20, 2020 and in accordance with Article

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