Business Wire

Celltrion’s Monoclonal Antibody Treatment for COVID-19, regdanvimab (CT-P59), Demonstrates Strong Neutralising Activity Against Delta Variant

Share

Celltrion Group today announced new results from an in vivo efficacy study showing that regdanvimab (CT-P59) has a strong neutralising effect against the rapidly spreading Delta variant (B.1.617.2, first identified in India).

According to the World Health Organization (WHO), the Delta variant has been reported in 96 countries becoming the most common variant.1

The pre- clinical in vivo study assessed the neutralisation effect of CT-P59 against the Delta variant, using a clinically relevant dose. The study demonstrated that CT-P59 treatment results in a 100% survival rate from COVID-19 compared to 0% for the placebo group, with significant protection against body weight loss shown after viral challenge also seen. In addition, a therapeutic dosage of CT-P59 significantly reduced the viral load of SARS-CoV-2 and inflammation in the lungs compared to non-treated controls with virus eradication from all animals treated with CT-P59.

Taken together, CT-P59 has shown in vivo efficacy against Delta variant following Beta (B.1.351, first identified in South Africa)2 and Gamma variant (P.1, first identified in Brazil)3, which was comparable to that against wild type SARS-CoV-2, thus demonstrating that despite the reduced in vitro neutralising activity against Variants of Concern (VOC), CT-P59 retained its therapeutic potency in in vivo setting.

The monoclonal antibody CT-P59 also demonstrated strong neutralising capability against the Lambda variant (C.37, first identified in Peru) in a cell-based pseudo- virus assay study performed by the National Institutes of Health (NIH), U.S.

“These new data are encouraging and reinforcing our body of both pre- clinical and clinical data,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “The Delta variant is a highly transmissible and contagious variant that could prompt further waves of infection around the world. It is important to expand the arsenal of monoclonal antibody therapies that are hoped to remain effective against the emerging COVID-19 variants.”

Celltrion announced its full Phase III data at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) which took place online from 9 -12 July 2021. During the oral session, data showed regdanvimab (CT-P59) significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high- risk of progressing to severe COVID-19 and 70% for all patients. In addition, patients who were treated with regdanvimab (CT-P59) reported a significantly shortened time to clinical recovery by at least 4.7 days for patients at high- risk of progressing to severe COVID-19 and by 4.9 days compared to placebo for all patients.

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 U.S. 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.

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 neutralise the wild type and mutant variants of concern including the Alpha variant (B.1.1.7, first identified in the UK). 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 II clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild- to- moderate symptoms of COVID-19.4 Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-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.

References


1 World Health Organization. Coronavirus disease (COVID-19)/Media resources/Science in 5/Episode #45 - Delta variant. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/science-in-5/episode-45---delta-variant [Last accessed July 2021]
2 Ryu DK., et al. Therapeutic effect of CT-P59 against SARS-CoV-2 South African variant. Biochemical and Biophysical Research Communications, Volume 566, 2021, Pages 135-140, https://doi.org/10.1016/j.bbrc.2021.06.016. [Last accessed July 2021]
3 Ryu DK., et al. Therapeutic efficacy of CT-P59 against P.1 variant of SARS-CoV-2. bioRxiv 2021.07.08.451696; doi: https://doi.org/10.1101/2021.07.08.451696
4 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) 7759 30162

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

Ipsen Strengthens Its Pre-clinical Oncology Pipeline With an Exclusive Worldwide-collaboration With BAKX Therapeutics Inc. for BKX-001, Targeting the Apoptosis Pathway27.7.2021 19:01:00 CEST | Press release

Regulatory News: Disclaimer: Intended for international media and investor audiences only Ipsen (Euronext: IPN; ADR: IPSEY) and BAKX Therapeutics Inc. have signed an exclusive worldwide-collaboration agreement to research, develop, manufacture and commercialize BKX-001 as a potential treatment for leukemia, lymphoma and solid tumors. Apoptosis is the naturally occurring process of programmed cell death. Deregulated apoptosis can lead to uncontrolled cell division and the development of a tumor.2 The apoptosis cell-signaling pathway has been proven to be a target for cancer therapy with the development and approval of BCL-2 inhibitors for the treatment of certain hematological malignancies.3 BAX is a novel target in this pathway that is downstream of all anti-apoptotic proteins like BCL-2, BCL-XL, MCL-1 etc.4 Direct activation of BAX has several possible outcomes as an investigational cancer therapy, potentially addressing multiple tumor types and the resistance encountered while target

Daikin Industries Becomes OCSiAl Shareholder27.7.2021 18:55:00 CEST | Press release

Japanese giant Daikin Industries, Ltd, has become a shareholder of the world’s largest producer of graphene nanotubes, OCSiAl, following three years of collaboration in developing graphene nanotube applications as a next-generation additive. Together, the companies are determined to develop high-performance materials and establish new markets. The signing of a share subscription agreement between Daikin Industries, a world-leading air conditioning company and a pioneer in fluorine technologies, and OCSiAl, the world’s largest producer of graphene nanotubes and related industrial solutions, was supported by prior joint developments and market evaluation. In accordance with the terms of the agreement, the valuation of OCSiAl is about USD $2 billion. Along with the subscription agreement, the two companies have signed a cooperation agreement to develop, produce, and market graphene nanotube solutions for next-generation Li-ion batteries and fluoropolymers, which comprise a substantial par

V.E, part of Moody’s ESG Solutions, provides Second Party Opinion on Colombia’s Sovereign Green Bond Framework and Inaugural Issuance27.7.2021 17:58:00 CEST | Press release

V.E, part of Moody’s ESG Solutions, published today a Second Party Opinion (SPO) on Colombia’s Sovereign Green Bond Framework and inaugural issuance. The SPO assesses four main components: the framework’s level of contribution to sustainability, its alignment with international standards, its coherence with Colombia’s strategic sustainability priorities, and Colombia’s environmental, social and governance (ESG) performance. “Proceeds from the green instruments issued under Colombia’s framework will provide a ‘robust’ contribution to sustainability, the second-highest level on our four-point scale,” said Adriana Cruz Felix, Head of Sustainable Finance Research at V.E. “The issuance will fund projects to protect biodiversity as well as build climate change resilience and adaptation, thereby reinforcing the capacity of Colombia’s institutions to address key environmental challenges.” In V.E’s opinion, the framework and portfolio of eligible expenditures are aligned with the four core comp

DYSIS Announces New Compact and Portable Colposcope Design with Computer-Aided Cervical Mapping27.7.2021 17:30:00 CEST | Press release

DYSIS Medical Inc. is excited to announce the launch of DYSIS® View, a compact and portable colposcope, which includes the company’s innovative computer-aided cervical mapping technology that helps healthcare professionals detect cervical lesions more clearly. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210727005846/en/ DYSIS View | Computer-Aided Colposcopy with Cervical Mapping (Photo: Business Wire) The DYSIS family of colposcopes include the novel DYSISmap, which is a color-coded summary of the acetowhitening effect of the patient’s cervix. Colors are allocated on the map depending on the acetowhitening changes measured by DYSIS during the examination. This data helps healthcare professionals improve biopsy selection. In the IMPROVE-COLPO study, when map-assisted biopsies were added to colposcopy exams, detection of patients with CIN2+ increased by 44%1. “We are thrilled to bring DYSIS View to market to complement our

Exchanger Industries Limited Acquires HRS Heat Exchangers27.7.2021 17:00:00 CEST | Press release

Exchanger Industries Limited (“EIL”), the Canadian market leader and globally recognized designer and manufacturer of heat transfer products for the energy, petrochemical, industrial and clean power generation sectors, has acquired HRS Heat Exchangers Ltd. ("HRS"). Financial terms were not disclosed. HRS is widely recognized as the pre-eminent, international specialist supplier of heat exchangers and custom process systems across the environmental, food, beverage, and pharmaceutical sectors. The seasoned HRS management team will be retained by EIL and play a critical role in executing plans for robust international expansion afforded by the strategic combination of two distinct, yet complementary industry leaders. “For decades, we’ve worked hard on behalf of our customers in Canada, the U.S. and 25 countries worldwide, consistently providing them with mission-critical, innovative solutions in some of the most demanding environments,” stated Mark el Baroudi, EIL’s CEO. “The HRS acquisit

Quanergy’s 3D LiDAR Helps Waste Incineration Plant Optimize Recycling Process and Reduce Environmental Impact in China27.7.2021 16:18:00 CEST | Press release

Quanergy Systems, Inc., a leading provider of OPA-based solid state LiDAR sensors and smart 3D solutions for automotive and IoT, today announced a new smart LiDAR deployment automating waste plant operations, to ensure process efficiency and minimize the environmental impact of a waste-to-energy incineration plant in China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210727005789/en/ Quanergy’s 3D LiDAR Helps Waste Incineration Plant Optimize Recycling Process and Reduce Environmental Impact in China (Graphic: Business Wire) Deployed in collaboration with Hunan University, one of China’s top engineering research universities, and Hunan Qiaokang Bridge Health Intelligent Technology for Puxiang Bioenergy, Quanergy’s high accuracy M-Series 3D LiDAR sensors were applied to scan the surface of the waste piles at the incineration plant and create a 3D point cloud image, to accurately calculate the volume of the waste. The LiDAR

Andersen Global Enhances Gambian Foothold with Payce Consulting27.7.2021 15:30:00 CEST | Press release

Andersen Global continues its Africa expansion with the addition of collaborating firm Payce Consulting, adding dimension to the organization’s existing presence in The Gambia. Payce Consulting, founded in 2014 by Partner Paul Gaye, serves the public and private sectors at the local and international level including financial institutions, education, industrial and commerce, transportation, fish processing and export, hotel and leisure, seaport, energy, agriculture, information technology and government agencies. The tax and advisory firm provides corporate finance, business advisory, business structuring and insolvency, outsourcing, financial services and portfolio management services to clients. “Our client-focused approach, extensive industry knowledge and commitment to best-in-class service have allowed us to develop and maintain strong client relationships,” Paul said. “Our collaboration with Andersen Global is the next step for our firm as we look to provide our clients with the