Odronextamab
Identification
- Summary
Odronextamab is a CD20xCD3 bispecific antibody used to treat relapsed/refractory B-Cell non-Hodgkin lymphoma.
- Generic Name
- Odronextamab
- DrugBank Accession Number
- DB16684
- Background
Odronextamab is a hinge-stabilized, fully human immunoglobulin G4 (IgG4)-based CD20×CD3 bispecific antibody currently evaluated for the treatment of relapsed/refractory (R/R) B-Cell non-Hodgkin lymphoma (NHL).1,4 Preliminary studies have shown that in patients with R/R NHL, the use of odronextamab does not lead to the development of neurologic toxicity; however, it can lead to the development of cytokine release syndrome (CRS), a serious condition associated with the use of immunotherapy.1 In December 2020, the FDA placed a partial clinical hold and requested the drug developer, Regeneron Pharmaceuticals, to amend clinical protocols to reduce the incidence of CRS. The partial clinical hold was later lifted in May 2021.5,6
A phase I clinical study (NCT02290951) showed that in heavily pre-treated patients with B-cell non-Hodgkin lymphoma, odronextamab elicited a durable response with a manageable safety profile.2
- Type
- Biotech
- Groups
- Investigational
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- Anti-CD20/CD3 monoclonal antibody REGN1979
- External IDs
- REGN 1979
- REGN-1979
- REGN1979
Pharmacology
- Indication
Not Available
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- Pharmacodynamics
Not Available
- Mechanism of action
Odronextamab is a CD20×CD3 bispecific antibody that binds to the CD20 antigen present on the surface of lymphoid cells and the CD3 antigen on CD3-positive effector T-cells. By engaging both targets, odronextamab induces targeted B-cell lysis and cell death.1,3
Target Actions Organism AB-lymphocyte antigen CD20 binderHumans AT-cell surface glycoprotein CD3 binderHumans - Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- 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. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.
- Toxicity
Not Available
- 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.Not Available
- Food Interactions
- Not Available
Categories
- Drug Categories
- Not Available
- 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
- Not Available
Chemical Identifiers
- UNII
- 8R5CM46UIO
- CAS number
- 1801338-64-6
References
- General References
- Tun AM, Ansell SM: Immunotherapy in Hodgkin and non-Hodgkin lymphoma: Innate, adaptive and targeted immunological strategies. Cancer Treat Rev. 2020 Aug;88:102042. doi: 10.1016/j.ctrv.2020.102042. Epub 2020 May 30. [Article]
- Bannerji R, Arnason JE, Advani RH, Brown JR, Allan JN, Ansell SM, Barnes JA, O'Brien SM, Chavez JC, Duell J, Rosenwald A, Crombie JL, Ufkin M, Li J, Zhu M, Ambati SR, Chaudhry A, Lowy I, Topp MS: Odronextamab, a human CD20xCD3 bispecific antibody in patients with CD20-positive B-cell malignancies (ELM-1): results from the relapsed or refractory non-Hodgkin lymphoma cohort in a single-arm, multicentre, phase 1 trial. Lancet Haematol. 2022 May;9(5):e327-e339. doi: 10.1016/S2352-3026(22)00072-2. Epub 2022 Apr 1. [Article]
- Salvaris R, Ong J, Gregory GP: Bispecific Antibodies: A Review of Development, Clinical Efficacy and Toxicity in B-Cell Lymphomas. J Pers Med. 2021 Apr 29;11(5). pii: jpm11050355. doi: 10.3390/jpm11050355. [Article]
- Smith EJ, Olson K, Haber LJ, Varghese B, Duramad P, Tustian AD, Oyejide A, Kirshner JR, Canova L, Menon J, Principio J, MacDonald D, Kantrowitz J, Papadopoulos N, Stahl N, Yancopoulos GD, Thurston G, Davis S: A novel, native-format bispecific antibody triggering T-cell killing of B-cells is robustly active in mouse tumor models and cynomolgus monkeys. Sci Rep. 2015 Dec 11;5:17943. doi: 10.1038/srep17943. [Article]
- OncLive: FDA Lifts Partial Clinical Hold on Odronextamab Studies in Follicular Lymphoma and DLBCL [Link]
- Regeneron: Regeneron Provides Update on Odronextamab Clinical Trials in B-cell NonHodgkin Lymphomas [Link]
- External Links
- Not Available
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 3 Recruiting Treatment B-Cell Non-Hodgkin Lymphoma (NHL) 1 3 Recruiting Treatment Diffuse Large B-Cell Lymphoma (DLBCL) 1 3 Recruiting Treatment Follicular Lymphoma ( FL) 2 3 Recruiting Treatment Marginal Zone Lymphoma (MZL) / Relapsed or Refractory Follicular Lymphoma 1 2 Recruiting Treatment B-Cell Non-Hodgkin Lymphoma (NHL) 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
- Not Available
- Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Binder
- General Function
- Mhc class ii protein complex binding
- Specific Function
- This protein may be involved in the regulation of B-cell activation and proliferation.
- Gene Name
- MS4A1
- Uniprot ID
- P11836
- Uniprot Name
- B-lymphocyte antigen CD20
- Molecular Weight
- 33076.99 Da
References
- Tun AM, Ansell SM: Immunotherapy in Hodgkin and non-Hodgkin lymphoma: Innate, adaptive and targeted immunological strategies. Cancer Treat Rev. 2020 Aug;88:102042. doi: 10.1016/j.ctrv.2020.102042. Epub 2020 May 30. [Article]
- Smith EJ, Olson K, Haber LJ, Varghese B, Duramad P, Tustian AD, Oyejide A, Kirshner JR, Canova L, Menon J, Principio J, MacDonald D, Kantrowitz J, Papadopoulos N, Stahl N, Yancopoulos GD, Thurston G, Davis S: A novel, native-format bispecific antibody triggering T-cell killing of B-cells is robustly active in mouse tumor models and cynomolgus monkeys. Sci Rep. 2015 Dec 11;5:17943. doi: 10.1038/srep17943. [Article]
- Kind
- Protein group
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Binder
- General Function
- Transmembrane signaling receptor activity
- Specific Function
- The CD3 complex mediates signal transduction.
Components:
References
- Tun AM, Ansell SM: Immunotherapy in Hodgkin and non-Hodgkin lymphoma: Innate, adaptive and targeted immunological strategies. Cancer Treat Rev. 2020 Aug;88:102042. doi: 10.1016/j.ctrv.2020.102042. Epub 2020 May 30. [Article]
- Smith EJ, Olson K, Haber LJ, Varghese B, Duramad P, Tustian AD, Oyejide A, Kirshner JR, Canova L, Menon J, Principio J, MacDonald D, Kantrowitz J, Papadopoulos N, Stahl N, Yancopoulos GD, Thurston G, Davis S: A novel, native-format bispecific antibody triggering T-cell killing of B-cells is robustly active in mouse tumor models and cynomolgus monkeys. Sci Rep. 2015 Dec 11;5:17943. doi: 10.1038/srep17943. [Article]
Drug created at April 01, 2021 22:01 / Updated at July 18, 2023 22:58