Drug intelligence / Profile preview

HCB101 + pembrolizumab

Development stage
Phase 2
Lead developer
HanchorBio
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

HCCB101 + pembrolizumab** is an investigational combination therapy comprising HCB101, a novel Fc-based anti-SIRPα-CD47 fusion protein, and pembrolizumab, a programmed death-1 (PD-1) immune checkpoint inhibitor monoclonal antibody. HCB101 blocks the CD47-SIRPα pathway to promote phagocytosis and innate immune activation, potentially overcoming tumor immune evasion. Pembrolizumab inhibits the PD-1 receptor on T cells, thus restoring and enhancing anti-tumor immune responses. Together, the combination aims to synergistically enhance antitumor immune activity. This combination is under clinical evaluation primarily for advanced solid tumors—including platinum-refractory, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)—with additional interest in broader advanced solid tumor populations. HCB101 has demonstrated promising tolerability, high CD47 receptor occupancy, and early efficacy signals in heavily pretreated cancer patients. Multiple phase I/II trials are underway to evaluate safety, tolerability, pharmacokinetics, and antitumor activity in combination with pembrolizumab[1][2][3][4][5].

Other names
HCB101 + pembrolizumab
02

Targets

CD47 (Cluster of Differentiation 47)PDCD1 (Programmed cell death protein 1 receptor)SIRPA (Signal-regulatory protein alpha)

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