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 by the FDA on November 10, 2020.2,6 It is set to enter phase 3 clinical trials.4,5
- 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 a non-COVID-19-related comorbidity who require an increased oxygen flow rate due to COVID-19.6,7
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- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- 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
Target Actions Organism ASpike glycoprotein antagonistSARS-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
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Bamlanivimab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Bamlanivimab. Aducanumab The risk or severity of adverse effects can be increased when Aducanumab is combined with Bamlanivimab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Bamlanivimab. Alirocumab The risk or severity of adverse effects can be increased when Alirocumab is combined with Bamlanivimab. Amivantamab The risk or severity of adverse effects can be increased when Bamlanivimab is combined with Amivantamab. Anifrolumab The risk or severity of adverse effects can be increased when Anifrolumab is combined with Bamlanivimab. Ansuvimab The risk or severity of adverse effects can be increased when Bamlanivimab is combined with Ansuvimab. Anthrax immune globulin human The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Bamlanivimab. Antilymphocyte immunoglobulin (horse) The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Bamlanivimab. 
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- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Bamlanivimab Injection, solution 35 mg/1mL Intravenous Eli Lilly and Company 2020-11-09 Not applicable US 
Bamlanivimab Solution 700 mg / 20 mL Intravenous Eli Lilly & Co. Ltd. 2020-12-24 Not applicable Canada 
- Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Bamlanivimab Bamlanivimab (35 mg/1mL) Injection, solution Intravenous Eli Lilly and Company 2020-11-09 Not applicable US
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
- 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]
- 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]
- Eli Lilly: Initial LY-CoV555 statement [Link]
- Eli Lilly: LY-CoV555 phase three statement [Link]
- NIH: LYCoV555 phase three statement [Link]
- FDA Emergency Use Authorization Letter: Bamlanivimab [Link]
- FDA Emergency Use Authorization Fact Sheet: Bamlanivimab [Link]
- External Links
- 2463114
- Wikipedia
- Bamlanivimab
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Active Not Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1 4 Completed Treatment Coronavirus Disease 2019 (COVID‑19) 1 4 Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) / Hospital Acquired Infections 1 3 Completed Prevention Coronavirus Disease 2019 (COVID‑19) 1 3 Recruiting Other Coronavirus Disease 2019 (COVID‑19) 1 3 Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1 2 Active Not Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1 2 Completed Treatment Coronavirus Disease 2019 (COVID‑19) 1 2 Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1 2, 3 Active Not Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, solution Intravenous 35 mg/1mL Solution Intravenous 700 mg / 20 mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Targets
- 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
- 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]
- Eli Lilly: Initial LY-CoV555 statement [Link]
- FDA Emergency Use Authorization Fact Sheet: Bamlanivimab [Link]
Drug created on August 06, 2020 17:33 / Updated on October 18, 2021 04:55