TAbS







Regdanvimab Approved Naked monospecific

Antibody Information

Entry ID 57
INN Regdanvimab
Status Approved
Drug code(s) CT-P59
Brand name Regkirona
mAb sequence source mAb human
General Molecular Category Naked monospecific
Format, general category Full length Ab
Format details None
Isotype (Fc) IgG1
Light chain isotype lambda
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology Human B cells (Convalescent source)

Therapeutic information

Target(s) SARS-CoV-2 (spike protein)
Indications of clinical studies COVID-19
Primary therapeutic area Infectious diseases

Development stage information


Most advanced stage of development (global) Approved EU, Australia, South Korea
Status Active
Start of clinical phase (IND filing or first Phase 1) July 15, 2020
Start of Phase 2
Start of Phase 3 September 15, 2020
Date BLA/NDA submitted to FDA
Year of first approval (global) 2021
Date of first US approval
INN, US product name Regdanvimab
US or EU approved indications Extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition, with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19.

Company information

Company Celltrion
Licensee/Partner None
Comments about company or candidate October 05 2021: Celltrion Group announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19. On September 18, 2021, Celltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) approved regdanvimab for extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition, with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19. Conditional use authrorization granted on S. Korea on Feb 5, 2021. Dec 29, 2020: Celltrion Group has submitted today a formal Application for Conditional Marketing Authorisation (CMA) to the Korean Ministry of Food and Drug Safety (MFDS). This submission is based on the data from global Phase II/III clinical trial of CT-P59, meeting objectives of clinical endpoints. September 17, 2020 I Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase II/III pivotal clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The global trial will evaluate the safety and efficacy of CT-P59 in patients with mild-to-moderate symptoms of SARS-CoV-2 infection. The global Phase II/III trial is set to enrol 1,000 patients from up to 12 countries to investigate the safety and efficacy of CT-P59 Celltrion expects to apply for emergency use authorisation (EUA), conditional on the results July 17, 2020: Celltrion Group today announced the launch of its Phase I human clinical trial investigating a potential antiviral antibody treatment for patients with COVID-19. The in-human study follows positive pre-clinical results for the treatment candidate and subsequent approval of the Investigational New Drug application by the Korean Ministry of Food and Drug Safety (MFDS). The potential treatment will also be investigated for use as a preventative measure. The Phase I clinical trial aims to enroll 32 healthy volunteers in collaboration with Chungnam National University Hospital. The study will evaluate the safety of the antiviral antibody treatment candidate in healthy participants who have not been diagnosed with COVID-19. The trial’s completion is expected by Q3 of this year. Celltrion is set to conduct a further in-human Phase I clinical trial of the antiviral treatment candidate in mild COVID-19 patients across Europe, including the UK, which will be followed by global Phase II/III trials in patients with mild and moderate COVID-19. Celltrion anticipates promising preliminary results from pivotal studies by the end of the year. In addition, a clinical trial investigating the use of the potential antiviral antibody treatment as a preventative measure, by enrolling people in close contact with COVID-19 patients globally, is also planned. The topline data for this trial is anticipated in Q1 of 2021. Furthermore, Celltrion has previously demonstrated its antiviral antibody treatment to be effective in neutralising the mutated G-variant strain (D614G variant), which is associated with the increased viral transmission and wide spread of COVID-19. The ultimate goal is to complete all clinical trials and obtain a commercialization permits for CT-P59 by the first half of 2021. https://www.businesswire.com/news/home/20200322005024/en/Celltrion-Accelerates-Development-COVID-19-Antiviral-Treatment-Aims Celltrion aims to initiate a clinical trial in July 2020. May 13, 2020: Celltrion announced its anti-viral pipelines development for Middle East respiratory syndrome and COVID-19 have been selected as national projects.
Full address of company 23, Academy-ro, Yeonsu-gu, Incheon, Republic of Korea
Asia
Republic of Korea
https://www.celltrion.com/en-us

Description/comment

March 23, 2020: Celltrion has been selected as a preferred developer for a monoclonal antibody project to treat and prevent COVID-19 by the Korea Centers for Disease Control (KCDC). Korea was one of the first countries to be affected by the global pandemic.[3] Celltrion has identified the library of antibodies sourced from the blood of recovered patients in Korea, which are thought to be involved in neutralising the virus and may contribute to recovery from COVID-19. These antibodies are undergoing further screening processes to identify those that are most effective in neutralising the virus causing COVID-19. Once identified these will form the basis of the antiviral treatment to be tested through pre-clinical and clinical trials around the world in the third quarter of 2020. As of April 3 2020, Celltrion initiates the second stage; selecting the therapeutic antibodies which are most potent for neutralising the infection, after completing the first phase of screening 300 potential antibody candidates to treat COVID-19. APRIL 13 2020, Celltrion announced that the company has successfully selected the most potent antibody candidates to neutralize SARS-CoV-2, the virus causing COVID-19. Through a partnership with the Korea Centers for Disease Control and Prevention (KCDC), Celltrion initially identified and secured 300 different types of antibodies that bind to the SARS-CoV-2 antigen. These were then screened based on their ability to bind to the virus spike protein. Celltrion was then able to capture a total of 38 potent neutralizing antibodies, of which, 14 are powerful neutralizing antibodies against SARS-CoV-2. Following the selection of antibody candidates which demonstrate high potency in neutralizing SARS-CoV-2, Celltrion will begin cell-line development. Once this is completed, Celltrion aims to roll out mass production of the therapeutic antibody and, together with the KCDC, Celltrion will conduct efficacy and toxicity testing in mice and non-human primates.

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None