Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the presentation of new results from a Phase I clinical study of its anti-CLDN18.2 antibody-drug conjugate (ADC), IBI343, at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024. The study focuses on advanced gastric and gastroesophageal junction adenocarcinoma (G/GEJ AC).
The Phase I trial, conducted in China and Australia, involved participants with a high expression of CLDN18.2. At a 6 mg/Kg dose, the overall response rate (ORR) was 36.7%, and the disease control rate (DCR) was 93.3% among 30 participants. For the 8 mg/kg dose group, comprising 17 participants, the ORR was 47.1%, and the DCR was 88.2%. With a median follow-up time of 7.2 months for the 6 mg/kg dose group, the median progression-free survival (mPFS) for participants with high CLDN18.2 expression reached up to 6.8 months. The majority of treatment-emergent adverse events (TEAEs) were grade 1-2. In the 6 mg/kg dose group, 31.6% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs), while grade 3 gastrointestinal toxicities were minimal (<5%). Notably, no interstitial lung disease (ILD) was reported.
IBI343 is a novel recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate developed by Innovent Biologics. It is designed to bind to CLDN18.2-expressing tumor cells, facilitating ADC internalization and the subsequent release of the drug, which induces DNA damage and triggers tumor cell apoptosis. Additionally, the released drug can diffuse across cell membranes, potentially killing neighboring cells and creating a “bystander killing effect.”- Flcube.com
