Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Wednesday that Nature Medicine has published the results of the Phase 1 clinical study of IBI343, an innovative anti-CLDN18.2 ADC, for the treatment of advanced gastric/gastroesophageal junction (G/GEJ) adenocarcinoma.

Based on the study findings, a multi-regional Phase 3 clinical trial (G-HOPE-001) was launched in 2024 to further evaluate IBI343 as a safe and effective treatment option for patients with advanced G/GEJ adenocarcinoma.

CLDN 18.2 is a tight junction protein expressed in differentiated epithelial cells on the gastric mucosa under normal physiological conditions. Previous studies have revealed that Claudin18.2 is highly expressed in multiple types of cancer, including gastric cancer (60-80%), pancreatic cancer (50%), oesophageal carcinoma (30-50%), and lung cancer (40-60%). Targeting CLDN18.2 with monoclonal antibodies (mAbs) and ADCs represents a promising new approach for treating gastric cancer.

The global, multicentre Phase 1 clinical trial was designed to evaluate the safety, tolerability and preliminary efficacy of IBI343 in patients with advanced solid tumours. Between October 2022 and June 2024, a total of 116 subjects with advanced G/GEJ adenocarcinoma were enrolled to receive IBI343 monotherapy (8 in escalation and 108 in expansion).

The relevant indication has been granted Breakthrough Therapy Designation (BTD) by China's NMPA.

The multi-regional Phase 1 clinical trial of IBI343 for advanced pancreatic ductal adenocarcinoma is also enrolling patients. This indication has received Fast Track Designation (FTD) from the US FDA and been granted BTD by China's NMPA.