Pre-Made Topsalysin biosimilar, Fusion Protein: Recombinant therapeutic protein targeting proaerolysin fused with hexahistidine for drug discovery and mechanism of action (MOA) research

Cat:GMP-Bios-INN-1025

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SKU GMP-Bios-INN-1025 Category Tag

Product Details

Pre-Made Topsalysin biosimilar, Fusion Protein: Recombinant therapeutic protein targeting proaerolysin fused with hexahistidine is a biosimilar expressed by mammalian cell line as a benchmark reference therapeutic antibody for biological drug disovery items including cell culture, assay development, animal model development, PK/PD model development (Pharmacokinetics & Pharmacodynamic) and mechanism of action (MOA) research.

Topsalysin (PRX302), is a modified recombinant protein that has been engineered to be selectively
activated by an enzyme in the prostate, leading to localized cell death and tissue disruption without
damaging neighbouring tissue and nerves. Topsalysin binds to the glycosylphosphatidylinositol (GPI)-
anchored receptors on the cell surface of prostate cells. Once activated by the prostate-specific
antigen (PSA), topsalysin combines with other activated topsalysin molecules, forming stable
transmembrane pores that induce cell death. The prostate specific activation of topsalysin by
enzymatically active PSA thus limits exposure of non-prostate tissues to the drug¡¯s activity,
contributing to the safety of the therapy.

Topsalysin is a genetically modified form of proaerolysin in which the native furin activation site has been replaced with a sequence that is highly specific for enzymatically active prostate-specific antigen (PSA) for activation, present only in prostate tissue. After activation, Topsalysin spontaneously oligomerizes and forms a stable transmembrane heptameric pore that leads to cell death. Topsalysin? is used to treat the prostate cancer.

Products Name (INN Index)

Pre-Made Topsalysin biosimilar, Fusion Protein: Recombinant therapeutic protein targeting proaerolysin fused with hexahistidine

INN Name

topsalysin

Target

proaerolysin

Format

Fusion Protein

Derivation

Aeromonas hydrophila

Species Reactivity

Human

CH1 Isotype

Fusion – proaerolysin (engineered with a PSA cutting site) – hexahistidine

VD LC

Fusion – proaerolysin (engineered with a PSA cutting site) – hexahistidine

Highest_Clin_Trial (Jan '20)

NA

Est. Status

NA

100% SI Structure

NA

99% SI Structure

NA

95-98% SI Structure

NA

Year Proposed

NA

Companies

Sophiris?Bio,?Inc. (San Diego CA USA)

Conditions Approved

NA

Conditions Active

NA

Conditions Discontinued

NA

Development Tech

NA

Previous Name

NA

Gm Offical Target Name

proaerolysin

Package

, ,

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