Denintuzumab mafodotin

Denintuzumab mafodotin (INN; development codes SGN-19A or SGN-CD19A) is a humanized monoclonal antibody-drug conjugate designed for the treatment of CD19-positive acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.[1][2][3][4] It consists of an anti-CD19 mAb linked to monomethyl auristatin F (MMAF), a cytotoxic agent.[5] This drug was developed by Seattle Genetics.

Denintuzumab mafodotin
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD19
Clinical data
Other namesSGN-19A
ATC code
  • none
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG

Denintuzumab refers to the anti-CD19 antibody, and mafodotin refers to MMAF and the chemical linkage.[6]

Clinical trials

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The drug is in phase I clinical trials.[7] Preliminary phase I results for B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL) and B-lineage acute lymphocytic leukemia (B-ALL) were presented at the ASH medical conference Dec 2015.[4]

Phase 2

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A separate randomized phase 2 trial started in 2015 to evaluate SGN-CD19A in combination with R-ICE chemotherapy for second-line DLBCL.[4] A phase 2 clinical trial in front-line DLBCL is started in 2016.[4] Both trials were terminated by the sponsor based on portfolio prioritization.[8][9]

References

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  1. ^ "About Denintuzumab Mafodotin (SGN-CD19A; 19A)". Seattle Genetics. Archived from the original on 2017-05-17. Retrieved 2019-05-01.
  2. ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Denintuzumab Mafodotin, American Medical Association.
  3. ^ World Health Organization (2014). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 111" (PDF). WHO Drug Information. 28 (2).
  4. ^ a b c d "Seattle Genetics Highlights Data from Denintuzumab Mafodotin (SGN-CD19A) Antibody-Drug Conjugate Program at ASH 2015". www.businesswire.com. December 6, 2015.
  5. ^ "Seattle Genetics Presents Data from Novel Antibody-Drug Conjugate (ADC) SGN-CD19A at ASH 2013". Seattle Genetics. Archived from the original on 2013-12-21. Retrieved 2019-05-01.
  6. ^ "Statement on a nonproprietary name adopted by the USAN Council: Mafodotin" (PDF).
  7. ^ "Search of: SGN-CD19A - List Results - ClinicalTrials.gov". clinicaltrials.gov.
  8. ^ Clinical trial number NCT02592876 for "Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma" at ClinicalTrials.gov
  9. ^ Clinical trial number NCT02855359 for "Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma" at ClinicalTrials.gov