NAV

Odronextamab

This drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon.

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
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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

TargetActionsOrganism
AB-lymphocyte antigen CD20
binder
Humans
AT-cell surface glycoprotein CD3
binder
Humans
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
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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
  1. 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]
  2. 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]
  3. 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]
  4. 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]
  5. OncLive: FDA Lifts Partial Clinical Hold on Odronextamab Studies in Follicular Lymphoma and DLBCL [Link]
  6. Regeneron: Regeneron Provides Update on Odronextamab Clinical Trials in B-cell NonHodgkin Lymphomas [Link]
Not Available

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3RecruitingTreatmentB-Cell Non-Hodgkin Lymphoma (NHL)1
3RecruitingTreatmentDiffuse Large B-Cell Lymphoma (DLBCL)1
3RecruitingTreatmentFollicular Lymphoma ( FL)2
3RecruitingTreatmentMarginal Zone Lymphoma (MZL) / Relapsed or Refractory Follicular Lymphoma1
2RecruitingTreatmentB-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

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Details1. B-lymphocyte antigen CD20
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
  1. 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]
  2. 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]
Details2. T-cell surface glycoprotein CD3 (Protein Group)
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:
NameUniProt ID
T-cell surface glycoprotein CD3 delta chainP04234
T-cell surface glycoprotein CD3 epsilon chainP07766
T-cell surface glycoprotein CD3 gamma chainP09693
T-cell surface glycoprotein CD3 zeta chainP20963
References
  1. 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]
  2. 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