On November 29th, first patient was enrolled in phaseⅠclinical trial in Australia by RemeGen for RC118, an ADC drug targeting Claudin18.2, to treat locally advanced unresectable or metastatic malignant solid tumors. After first enrollment for Telitacicept in IgA nephropathy PhaseⅡclinical trial in the U.S., this becomes another milestone of RemeGen in promoting globalization of product pipelines.
Claudin is a tight junction molecule that maintains cell polarity and regulates the permeability of the upper cortex. As one of the Claudin proteins, Claudin18.2 is a highly tissue-specific protein mainly expressed in gastric epithelial cells and highly expressed in primary malignant tumors such as gastric cancer, breast cancer, colon cancer and liver cancer.
Due to this specific characteristic of Claudin18.2, it has become a hot target of many pharmaceutical companies, but no biologics targeting Claudin18.2 have received approval around the world.
RC118, which achieved its first patient enrollment in Australia this time, is the fourth ADC biologics developed by RemeGen and targeting Claudin18.2, it has shown good efficacy and safety results in pre-clinical researches. On September 22th, RC118 received IND approval from the National Medical Products Administration for clinical trials in the indication of "locally advanced unresectable or metastatic malignant solid tumors with positive expression of Claudin 18.2."