NAV

Bamlanivimab

Identification

Summary

Bamlanivimab is a neutralizing human IgG1κ monoclonal antibody against the SARS-CoV-2 spike (S) protein for use in patients aged 12 and over at high risk of developing severe COVID-19.

Generic Name
Bamlanivimab
DrugBank Accession Number
DB15718
Background

Bamlanivimab (LY-CoV555, also known as LY3819253), is a synthetic monoclonal antibody (mAb) derived from one of the first blood samples in the United States from a patient who recovered from COVID-19.1,3,4 Bamlanivimab is a neutralizing IgG1κ mAb directed against the SARS-CoV-2 spike (S) protein, which is described to block viral entry into human cells.1,3,4,7

AbCellera initially discovered bamlanivimab in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), and subsequently further developed it in collaboration with Eli Lilly and Company. Bamlanivimab consists of two identical light chains of 214 amino acids and two identical heavy chains of 455 amino acids each; the Fc region is unmodified.7 Bamlanivimab is produced in Chinese Hamster Ovary (CHO) cells.7 Based on phase 2 clinical trial (BLAZE-1) interim results, bamlanivimab was granted Emergency Use Authorization (EUA) by the FDA on November 10, 2020.2,6 It is set to enter phase 3 clinical trials.4,5

Under the EUA granted in February 2021, bamlanivimab is used in combination with etesevimab to treat mild to moderate COVID-19 in adults and pediatric patients who are at high risk for progressing to severe COVID-19:9 this EUA later expanded in December 2021 to include all younger children at high risk, including newborns.8 The EUA currently allows bamlanivimab and etesevimab for post-exposure prophylaxis of COVID-19 in adults and children.9

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Protein Chemical Formula
C6498H10068N1732O2032S46
Protein Average Weight
146000.0 Da
Sequences
Not Available
Synonyms
  • Bamlanivimab
External IDs
  • LY-3819253
  • LY-CoV555
  • LY3819253
  • LYCoV555

Pharmacology

Indication

Bamlanivimab is not currently approved for any indication by the FDA.6

Bamlanivimab is authorized under an Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 in patients aged 12 years and older weighing at least 40 kg who are at high risk for progressing to severe COVID-19 and/or hospitalization due to COVID-19. Patients should have confirmed COVID-19, with identification of SARS-CoV-2 viral load by an approved test.6,7

Under this EUA, bamlanivimab is not authorized in patients who are hospitalized due to COVID-19, who require oxygen due to COVID-19, or in patients on oxygen therapy for non-COVID-19-related comorbidity who require an increased oxygen flow rate due to COVID-19.6,7

Bamlanivimab in combination with etesevimab is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients, including neonates, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. This combination regimen is also used for post-exposure prophylaxis of COVID-19 in unvaccinated or immunocompromised adults and pediatric individuals, including neonates, who are at high risk of progression to severe COVID-19, including hospitalization or death.10

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Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics

Bamlanivimab is a recombinant human IgG1κ monoclonal antibody directed against the spike (S) surface protein of SARS-CoV-2. Patients in a phase 2 trial were administered up to 7000 mg (ten times the authorized dose) with no increase in treatment-related adverse effects and a flat exposure-response relationship over ranges of 700-7000 mg. Despite generally mild adverse effects noted in the phase 2 trial, there is a risk of serious infusion-related hypersensitivity reactions with bamlanivimab, including anaphylaxis, which may necessitate slowing the infusion rate or discontinuing treatment entirely.7

Mechanism of action

Bamlanivimab is a neutralizing recombinant human IgG1κ monoclonal antibody directed against the spike (S) surface protein of SARS-CoV-2 derived from screening antigen-specific B-cells from a convalescent COVID-19 patient.1,7 X-ray crystallography and cryo-EM structural determination suggest that bamlanivimab binds the receptor-binding domain (RBD) of the S protein at a position overlapping the ACE2 binding site and which is accessible in both the up and down conformations of the RBD.1 Specifically, bamlanivimab binds to the S protein with a KD of 0.071 nM and blocks S protein-ACE2 interactions with an IC50 value of 0.025 μg/mL.7

TargetActionsOrganism
ASpike glycoprotein
antagonist
SARS-CoV-2
Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism

As a monoclonal antibody, it is expected that bamlanivimab will be degraded by proteases in various locations throughout the body. Bamlanivimab is not metabolized by cytochrome P450 enzymes, making drug interactions unlikely.7

Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

Bamlanivimab has been administered at doses of 7000 mg (ten times the authorized dose) during phase 2 clinical trials without any observed dose-limiting toxicity. In the event of an overdose, the recommended treatment is symptomatic and supportive measures; there is no antidote for bamlanivimab overdose.7

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
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interactions in your software
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Bamlanivimab.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Bamlanivimab.
Adenovirus type 7 vaccine liveThe therapeutic efficacy of Adenovirus type 7 vaccine live can be decreased when used in combination with Bamlanivimab.
AducanumabThe risk or severity of adverse effects can be increased when Aducanumab is combined with Bamlanivimab.
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Bamlanivimab.
AlirocumabThe risk or severity of adverse effects can be increased when Alirocumab is combined with Bamlanivimab.
AmivantamabThe risk or severity of adverse effects can be increased when Bamlanivimab is combined with Amivantamab.
AnifrolumabThe risk or severity of adverse effects can be increased when Anifrolumab is combined with Bamlanivimab.
AnsuvimabThe risk or severity of adverse effects can be increased when Bamlanivimab is combined with Ansuvimab.
Anthrax immune globulin humanThe risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Bamlanivimab.
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Food Interactions
No interactions found.

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
BamlanivimabSolution700 mg / 20 mLIntravenousEli Lilly & Co. Ltd.2020-12-24Not applicableCanada flag
BamlanivimabInjection, solution35 mg/1mLIntravenousEli Lilly and Company2020-11-09Not applicableUS flag

Categories

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
45I6OFJ8QH
CAS number
2423943-37-5

References

General References
  1. Jones BE, Brown-Augsburger PL, Corbett KS, Westendorf K, Davies J, Cujec TP, Wiethoff CM, Blackbourne JL, Heinz BA, Foster D, Higgs RE, Balasubramaniam D, Wang L, Bidshahri R, Kraft L, Hwang Y, Zentelis S, Jepson KR, Goya R, Smith MA, Collins DW, Hinshaw SJ, Tycho SA, Pellacani D, Xiang P, Muthuraman K, Sobhanifar S, Piper MH, Triana FJ, Hendle J, Pustilnik A, Adams AC, Berens SJ, Baric RS, Martinez DR, Cross RW, Geisbert TW, Borisevich V, Abiona O, Belli HM, de Vries M, Mohamed A, Dittmann M, Samanovic M, Mulligan MJ, Goldsmith JA, Hsieh CL, Johnson NV, Wrapp D, McLellan JS, Barnhart BC, Graham BS, Mascola JR, Hansen CL, Falconer E: LY-CoV555, a rapidly isolated potent neutralizing antibody, provides protection in a non-human primate model of SARS-CoV-2 infection. bioRxiv. 2020 Oct 1. doi: 10.1101/2020.09.30.318972. [Article]
  2. Chen P, Nirula A, Heller B, Gottlieb RL, Boscia J, Morris J, Huhn G, Cardona J, Mocherla B, Stosor V, Shawa I, Adams AC, Van Naarden J, Custer KL, Shen L, Durante M, Oakley G, Schade AE, Sabo J, Patel DR, Klekotka P, Skovronsky DM: SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. N Engl J Med. 2020 Oct 28. doi: 10.1056/NEJMoa2029849. [Article]
  3. Eli Lilly: Initial LY-CoV555 statement [Link]
  4. Eli Lilly: LY-CoV555 phase three statement [Link]
  5. NIH: LYCoV555 phase three statement [Link]
  6. FDA Emergency Use Authorization Letter: Bamlanivimab [Link]
  7. FDA Emergency Use Authorization Fact Sheet: Bamlanivimab [Link]
  8. FDA Press Announcements: FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns [Link]
  9. Emergency Use Authorization (EUA) Letter of Authorization (January 24, 2022): Bamlanivimab and Etesevimab [Link]
  10. FDA: Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Bamlanivimab and Etesevimab [Link]
RxNav
2463114
Wikipedia
Bamlanivimab

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)1
4CompletedOtherCoronavirus Disease 2019 (COVID‑19)1
4SuspendedTreatmentCoronavirus Disease 2019 (COVID‑19) / Hospital Acquired Infections1
4TerminatedTreatmentCoronavirus Disease 2019 (COVID‑19)1
3Active Not RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)1
3CompletedPreventionCoronavirus Disease 2019 (COVID‑19)1
3TerminatedTreatmentCoronavirus Disease 2019 (COVID‑19)1
2CompletedTreatmentCoronavirus Disease 2019 (COVID‑19)2
2RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)1
2, 3Active Not RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19) / Infections, Coronavirus1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solutionIntravenous35 mg/1mL
SolutionIntravenous700 mg / 20 mL
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Targets

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Details1. Spike glycoprotein
Kind
Protein
Organism
SARS-CoV-2
Pharmacological action
Yes
Actions
Antagonist
Curator comments
Bamlanivimab binds the spike glycoprotein with a dissociation constant of 0.071 nM.
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. Jones BE, Brown-Augsburger PL, Corbett KS, Westendorf K, Davies J, Cujec TP, Wiethoff CM, Blackbourne JL, Heinz BA, Foster D, Higgs RE, Balasubramaniam D, Wang L, Bidshahri R, Kraft L, Hwang Y, Zentelis S, Jepson KR, Goya R, Smith MA, Collins DW, Hinshaw SJ, Tycho SA, Pellacani D, Xiang P, Muthuraman K, Sobhanifar S, Piper MH, Triana FJ, Hendle J, Pustilnik A, Adams AC, Berens SJ, Baric RS, Martinez DR, Cross RW, Geisbert TW, Borisevich V, Abiona O, Belli HM, de Vries M, Mohamed A, Dittmann M, Samanovic M, Mulligan MJ, Goldsmith JA, Hsieh CL, Johnson NV, Wrapp D, McLellan JS, Barnhart BC, Graham BS, Mascola JR, Hansen CL, Falconer E: LY-CoV555, a rapidly isolated potent neutralizing antibody, provides protection in a non-human primate model of SARS-CoV-2 infection. bioRxiv. 2020 Oct 1. doi: 10.1101/2020.09.30.318972. [Article]
  2. Eli Lilly: Initial LY-CoV555 statement [Link]
  3. FDA Emergency Use Authorization Fact Sheet: Bamlanivimab [Link]

Drug created at August 06, 2020 17:33 / Updated at June 03, 2022 07:24