Drug intelligence / Profile preview

iparomlimab + tuvonralimab (Akeso, Inc.)

Development stage
Unknown
Lead developer
Qilu Pharmaceutical
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Iparomlimab + Tuvonralimab is an immunotherapy combination regimen currently being evaluated for the treatment of advanced biliary tract cancer. The regimen consists of iparomlimab (AK105, penpulimab), a humanized IgG1 monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor, and tuvonralimab (AK104, cadonilimab), a first-in-class bispecific antibody that simultaneously targets both PD-1 and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). By blocking these two distinct immune checkpoints, the combination aims to synergistically enhance anti-tumor T-cell activation and overcome immune evasion mechanisms within the tumor microenvironment. This regimen is being investigated in the SAIB (Sequential Anti-angiogenic Therapy in Biliary Tract Cancer) trial, a randomized Phase 2 study sponsored by the First Affiliated Hospital of Zhejiang University, where it is administered as a first-line therapy in combination with gemcitabine and cisplatin chemotherapy.

Brand names
AnnikoKaitaini
Other names
penpulimabcadonilimabPD-1/CTLA-4 Dual Functional Antibody
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)

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