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.