Drug intelligence / Profile preview

SYSA1801

Development stage
Phase 1
Lead developer
CSPC Megalith Biopharmaceutical
Modality
Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

SYSA1801 is a fully human monoclonal antibody-drug conjugate (ADC) that targets claudin 18.2 (CLDN18.2), a tight junction protein highly expressed in gastric, pancreatic, and other solid tumors but with limited expression in normal tissues outside the gastric mucosa[1][2][5][7]. The drug consists of an anti-claudin 18.2 antibody linked to the cytotoxic payload monomethyl auristatin E (MMAE). Upon binding to CLDN18.2-expressing tumor cells, SYSA1801 is internalized and releases MMAE inside the cell, leading to cell death[7]. Preclinical studies have demonstrated significant anti-tumor activity both in vitro and in vivo against CLDN18.2-positive cancers[5][7]. Clinical development has focused on patients with resistant or refractory solid tumors expressing CLDN18.2 who have progressed on or are intolerant to standard therapies[4][5].

Other names
anti-Claudin 18.2 antibody-drug conjugateanti-Claudin18.2 antibody-drug conjugateanti-Claudin-18.2 antibody-drug conjugate
02

Targets

TUBB (Tubulin (alpha and beta subunits))Claudin 18.2

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