NEW YORK – Biotherapeutics company Transcenta said on Monday that the US Food and Drug Administration has accepted its investigational new drug application for the Claudin 18.2 monoclonal antibody TST001, allowing for the start of clinical trials.
The drug has also received permission from China's National Medical Products Administration to initiate trials for TST001 in patients with Claudin 18.2-expressing metastatic solid tumors.