Drug intelligence / Profile preview

oportuzumab monatox

Development stage
Phase 3
Lead developer
Carisma Therapeutics Inc
Modality
scFv Fragments → Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Bacterial Toxin Conjugates → Immunotoxins → Antibody Conjugates → Antibody-Based Therapeutics, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravesical
01

Overview

Oportuzumab monatox is an investigational fusion protein immunotoxin designed for the treatment of non-muscle invasive bladder cancer (NMIBC), particularly in patients unresponsive to Bacillus Calmette-Guérin (BCG) therapy. The drug consists of a humanized single-chain variable fragment (scFv) monoclonal antibody targeting the epithelial cell adhesion molecule (EpCAM), which is highly expressed on carcinoma cells of epithelial origin. This antibody fragment is conjugated to a truncated form of Pseudomonas exotoxin A. Upon binding to EpCAM-positive tumor cells, the fusion protein is internalized and releases the toxin moiety into the cytosol, where it inactivates elongation factor 2 through ADP ribosylation—resulting in inhibition of protein synthesis and induction of apoptosis in target cells. Oportuzumab monatox has been developed for locoregional delivery via intravesical administration to maximize local concentration and minimize systemic exposure[1][5][6][8]. The drug was originally developed by Viventia Bio and later by Sesen Bio following acquisition[3].

Brand names
VicineumViciniumVysyneum
Other names
oportuzumab monatox-qqrs
02

Targets

EPCAM (Epithelial cell adhesion molecule)EEF2 (Eukaryotic elongation factor 2)

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