NAV

Regdanvimab

Identification

Summary

Regdanvimab is a monoclonal antibody targeted against the SARS-CoV-2 spike protein used to treat patients with COVID-19 who are at risk of progressing to severe COVID-19.

Brand Names
Regkirona
Generic Name
Regdanvimab
DrugBank Accession Number
DB16405
Background

Regdanvimab (CT-P59) is a recombinant human IgG1 monoclonal antibody directed at the receptor binding domain (RBD) of the SARS-CoV-2 spike protein.4 It blocks the interaction between viral spike proteins and angiotensin-converting enzyme 2 (ACE2) that allows for viral entry into the cell, thereby inhibiting the virus' ability to replicate. Trials investigating the use of regdanvimab as a therapeutic candidate for the treatment of COVID-19 began in mid-2020.1,3 It received its first full approval in South Korea in September 2021,3 followed by the EU in November 2021.5

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
>Regdanvimab light chain:
ELVLTQPPSVSAAPGQKVTISCSGSSSNIGNNYVSWYQQLPGTAPKLLIYDNNKRPSGIP
DRFSGSKSGTSATLGITGLQTGDEADYYCGTWDSSLSAGVFGGGTELTVLGQPKAAPSVT
LFPPSSEELQANKATLVCLISDFYPGAVTVAWKADGSPVKAGVETTKPSKQSNNKYAASS
YLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
>Regdanvimab heavy chain:
QITLKESGPTLVKPTQTLTLTCSFSGFSLSTSGVGVGWIRQPPGKALEWLALIDWDDNKY
HTTSLKTRLTISKDTSKNQVVLTMTNMDPVDTATYYCARIPGFLRYRNRYYYYGMDVWGQ
GTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHT
FPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPC
PAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKT
KPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVY
TLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSK
LTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
References:
  1. Protein Data Bank: Crystal Structure of COVID-19 virus spike receptor-binding domain complexed with a neutralizing antibody CT-P59 [Link]
Download FASTA Format
Synonyms
  • Regdanvimab
External IDs
  • CT P59
  • CT-P59
  • CTP59
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Pharmacology

Indication

Regdanvimab is indicated in the EU for the treatment of adult patients with COVID-19 who do not require supplemental oxygen and who are at risk of progressing to severe COVID-19.4

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofCoronavirus disease 2019 (covid‑19)•••••••••••••••••••••••••• •••• •• ••••••••••• •• •••••• •••••••••••••••••• ••••••••• •••••••••••
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Pharmacodynamics

Regdanvimab exerts its antiviral activity by blocking the viral entry of SARS-CoV-2.4 It should be given within seven days of the onset of COVID-19 symptoms, and is administered as a single intravenous infusion. Hypersensitivity reactions, including infusion-related reactions and anaphylaxis, have been reported during and after the intravenous administration of regdanvimab - patients should be observed during administration and for one hour after its completion to monitor for symptoms of infusion-related reactions such as fever, difficulty breathing, arrhythmia, and chills.4

Mechanism of action

Regdanvimab is a recombinant human IgG1 monoclonal antibody that is targeted at the receptor binding domain (RBD) of the SARS-CoV-2 spike protein.4,7 The interaction between viral spike proteins and angiotensin-converting enzyme 2 (ACE2) receptors facilitates viral entry into host cells - in blocking this interaction, regdanvimab neutralizes SARS-CoV-2 by preventing cellular entry and subsequent viral replication. The binding interaction between regdanvimab and the spike protein RBD is different as compared to most other neutralizing antibodies, as it appears regdanvimab binds to the RBD protein trimer exclusively in its "up" conformation and in an orientation distinct from most other ACE2-blocking antibodies.2

TargetActionsOrganism
ASpike glycoprotein
antibody
SARS-CoV-2
Absorption

The mean Cmax and AUC0-infof regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 were 1017 µg/mL and 182095 μg⋅h/ml, respectively.4,6

Volume of distribution

The steady-state apparent volume of distribution following intravenous administration of regdanvimab 40 mg/kg in patients with COVID-19 was 83 mL/kg.4

Protein binding

Not Available

Metabolism

As regdanvimab is a recombinant IgG1 antibody, it is likely to be degraded into smaller peptides and amino acids in the same way as endogenous IgG1.4

Route of elimination

Regdanvimab is likely to be eliminated via normal immunoglobulin degradation pathways.4

Half-life

The mean terminal half-life of regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 was 17 days.4

Clearance

The mean clearance of regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 was 0.20 mL/hr/kg.4

Adverse Effects
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Toxicity

Single doses of up to 8000mg of ragdanvimab have been administered to patients in clinical trials without evidence of dose-limiting toxicities.4 In the event of a suspected overdose, employ general supportive measures as clinically indicated.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
Integrate drug-drug
interactions in your software
ImlifidaseThe therapeutic efficacy of Regdanvimab can be decreased when used in combination with Imlifidase.
Food Interactions
No interactions found.

Products

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International/Other Brands
Regkirona (Celltrion Healthcare)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
RegkironaInjection, solution, concentrate60 mg/mlIntravenousCelltrion Healthcare Hungary Kft.2021-11-18Not applicableEU flag

Categories

ATC Codes
J06BD06 — Regdanvimab
Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
  • SARS-CoV-2

Chemical Identifiers

UNII
I0BGE6P6I6
CAS number
2444308-95-4

References

Synthesis Reference

Kim C, Ryu DK, Lee J, Kim YI, Seo JM, Kim YG, Jeong JH, Kim M, Kim JI, Kim P, Bae JS, Shim EY, Lee MS, Kim MS, Noh H, Park GS, Park JS, Son D, An Y, Lee JN, Kwon KS, Lee JY, Lee H, Yang JS, Kim KC, Kim SS, Woo HM, Kim JW, Park MS, Yu KM, Kim SM, Kim EH, Park SJ, Jeong ST, Yu CH, Song Y, Gu SH, Oh H, Koo BS, Hong JJ, Ryu CM, Park WB, Oh MD, Choi YK, Lee SY: A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein. Nat Commun. 2021 Jan 12;12(1):288. doi: 10.1038/s41467-020-20602-5.

General References
  1. Tuccori M, Ferraro S, Convertino I, Cappello E, Valdiserra G, Blandizzi C, Maggi F, Focosi D: Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline. MAbs. 2020 Jan-Dec;12(1):1854149. doi: 10.1080/19420862.2020.1854149. [Article]
  2. Kim C, Ryu DK, Lee J, Kim YI, Seo JM, Kim YG, Jeong JH, Kim M, Kim JI, Kim P, Bae JS, Shim EY, Lee MS, Kim MS, Noh H, Park GS, Park JS, Son D, An Y, Lee JN, Kwon KS, Lee JY, Lee H, Yang JS, Kim KC, Kim SS, Woo HM, Kim JW, Park MS, Yu KM, Kim SM, Kim EH, Park SJ, Jeong ST, Yu CH, Song Y, Gu SH, Oh H, Koo BS, Hong JJ, Ryu CM, Park WB, Oh MD, Choi YK, Lee SY: A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein. Nat Commun. 2021 Jan 12;12(1):288. doi: 10.1038/s41467-020-20602-5. [Article]
  3. Syed YY: Regdanvimab: First Approval. Drugs. 2021 Nov 1. pii: 10.1007/s40265-021-01626-7. doi: 10.1007/s40265-021-01626-7. [Article]
  4. EMA Summary of Product Characteristics: Regkirona (regdanvimab) concentrate for solution for intravenous infusion [Link]
  5. EMA COVID-19 News: EMA recommends authorisation of two monoclonal antibody medicines [Link]
  6. EMA CHMP Assessment Report: Celltrion use of regdanvimab for the treatment of COVID-19 [Link]
  7. Protein Data Bank: Crystal Structure of COVID-19 virus spike receptor-binding domain complexed with a neutralizing antibody CT-P59 [Link]
Wikipedia
Regdanvimab

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19) / Infections, Coronavirus1
2, 3CompletedTreatmentCoronavirus Disease 2019 (COVID‑19)1
1CompletedScreeningCoronavirus Disease 2019 (COVID‑19)1
1CompletedTreatmentCoronavirus Disease 2019 (COVID‑19)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solution, concentrateIntravenous60 mg/ml
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Targets

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Details1. Spike glycoprotein
Kind
Protein
Organism
SARS-CoV-2
Pharmacological action
Yes
Actions
Antibody
Curator comments
Regdanvimab binds to the receptor binding domain (RBD) of the spike(s) protein of SARS-CoV-2.
General Function
Spike protein S1 attaches the virion to the cell membrane by interacting with host receptor, initiating the infection. Binding to human ACE2 receptor and internalization of the virus into the endosomes of the host cell induces conformational changes in the Spike glycoprotein (PubMed:32142651, PubMed:32075877, PubMed:32155444). Uses also human TMPRSS2 for priming in human lung cells which is an essential step for viral entry (PubMed:32142651). Can be alternatively processed by host furin (PubMed:32362314). Proteolysis by cathepsin CTSL may unmask the fusion peptide of S2 and activate membranes fusion within endosomes.
Specific Function
Host cell surface receptor binding
Gene Name
S
Uniprot ID
P0DTC2
Uniprot Name
Spike glycoprotein
Molecular Weight
141177.29 Da
References
  1. EMA Summary of Product Characteristics: Regkirona (regdanvimab) concentrate for solution for intravenous infusion [Link]

Drug created at December 23, 2020 16:31 / Updated at November 16, 2021 19:41