On July 30th, Remegen announced that it has received an ethical approval from the Australian Human Research Ethics Committee for the phase I clinical trial of antibody-drug conjugate (ADC) RC118. Phase I clinical trials of locally advanced unresectable or metastatic malignant solid tumors in patients positive for Claudin18.2 will be conducted in Australia. This is the first clinical trial approval of Remegen product in Australia.
Before this, Remegen has submitted RC118 clinical trial application to NMPA on July 19th, and currently awaiting formal approval. RC118 is the third Claudin 18.2 ADC that filed IND application in China, and the fourth ADC product developed by Remegen after RC48 (Disitamab Vedotin), RC88 and RC108.
The antibody of RC118 is a collaboration between Remegen and Biocytogen. The clinical approval of RC118 in Australia is supported by Accelagen, a CRO (contract research and development) company. Accelagen has extensive experience in biomedical and medical devices as well as clinical trial design, clinical trial planning, and clinical regulation.