pp-125 Concentrate for solution for infusion
Dossier type
CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
MHRA
Comments
Indication: Locally advanced or metastatic urothelial carcinoma (Nectin-4-expressing), 2L+ after platinum and checkpoint inhibitor
Clinical stage: Phase 2/3
Modality: Biologic (Bicycle-toxin conjugate; bicyclic peptide conjugated to MMAE)
Mechanism / Target: Targets Nectin-4 on tumour cell surface via bicyclic peptide; delivers MMAE cytotoxin causing tubulin disruption and apoptosis
Route / form: Intravenous infusion
Differentiation: Smaller molecular size than ADCs enables better tumour penetration; no Fc-mediated off-target effects; faster renal clearance potentially reduces systemic toxicity
Manufacturer #39162
Clinical-stage biotech pioneering a novel class of bicyclic peptide-toxin conjugates for oncology. Focuses on targeted cancer therapy with differentiated pharmacological properties vs antibody-drug conjugates. Wholly owned pipeline pursuing global development.
Country: United Kingdom LinkedIn: https://www.linkedin.com/company/bicycle-therapeutics
GMP: Not disclosed
None