Drug intelligence / Profile preview

hlx301

Development stage
Phase 2
Lead developer
Henlius
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

HLX301 is an innovative bispecific antibody that targets both PD-L1 and TIGIT immune checkpoint pathways. It is composed of an anti-PD-L1 IgG1 subtype monoclonal antibody coupled with an anti-TIGIT variable domain of a heavy-chain antibody, the latter derived from high-affinity VHH fragments selected from a synthetic humanized llama VHH library. HLX301 simultaneously blocks the PD-1/PD-L1 and TIGIT/PVR pathways, restoring T-cell receptor (TCR) signaling and inhibiting tumor growth. Preclinical studies suggest it may be superior to blocking either pathway alone or to combination therapy with separate anti-PD-L1 and anti-TIGIT agents. The drug is being developed for the treatment of various advanced cancers, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma, gastric/esophagogastric junction adenocarcinoma, urothelial carcinoma, lymphoma, and other solid tumors[2][3][4][5][6].

Other names
anti-TIGIT/anti-PD-L1 bispecific antibody HLX301
02

Targets

TIGIT (T cell immunoreceptor with Ig and ITIM domains)CD274 (Programmed cell death protein 1 ligand 1)

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