Drug intelligence / Profile preview

bulumtatug fuvedotin + toripalimab

Development stage
Phase 3
Lead developer
Junshi Biosciences
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Bulumtatug fuvedotin plus toripalimab is an investigational combination therapy consisting of bulumtatug fuvedotin (BFv; 9MW2821), a Nectin-4-directed antibody-drug conjugate (ADC), and toripalimab, a recombinant humanized anti-PD-1 monoclonal antibody. Bulumtatug fuvedotin is developed by Mabwell and utilizes a site-specific interchain-disulfide conjugation technology to link a humanized anti-Nectin-4 antibody to the microtubule inhibitor monomethyl auristatin E (MMAE) via a cleavable valine-citrulline linker. Toripalimab, developed by Junshi Biosciences, is an immune checkpoint inhibitor that blocks the interaction between PD-1 and its ligands. The combination is being evaluated in Phase Ib/II and Phase III clinical trials for the treatment of locally advanced or metastatic urothelial carcinoma, recurrent or metastatic cervical cancer, and perioperative muscle-invasive bladder cancer (MIBC). Early clinical data have demonstrated encouraging antitumor activity and a manageable safety profile.

Other names
9MW2821 + JS0019MW2821 + toripalimabBFv + toripalimabbulumtatug fuvedotin + JS001bulumtatug fuvedotin and toripalimabtoripalimab + 9MW2821toripalimab + bulumtatug fuvedotin
02

Targets

PVRL4 (Nectin cell adhesion molecule 4)PDCD1 (Programmed cell death protein 1 receptor)CD274 (Programmed cell death protein 1 ligand 1)PDCD1LG2 (Programmed cell death 1 ligand 2)

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