China-based biotechnology company Transcenta Holdings Ltd (HKG: 6628) has announced that its drug TST001 (osemitamab), a humanized ADCC-enhanced anti-Claudin 18.2 monoclonal antibody (mAb), has received orphan drug designation (ODD) status from the US FDA for the treatment of pancreatic cancer. This follows a previous ODD granted in 2021 for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJC) in the United States.
TST001: A Promising Treatment for Pancreatic Cancer
TST001 is a high-affinity humanized anti-Claudin18.2 mAb that demonstrates enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities, along with potent anti-tumor effects in tumor xenograft models. Developed using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform, TST001 is recognized as the second most advanced Claudin18.2 targeting antibody in global development. Clinical trials for TST001 (osemitamab) are actively ongoing in both the US and China, with trial identifiers NCT04396821, NCT04495296/CTR20201281.
Clinical Data and Preclinical Studies
Clinical data released in 2022 indicated that patients with pancreatic cancer and low Claudin 18.2 expression treated with osemitamab alone experienced sustained partial remission. Preclinical studies have further shown that osemitamab exhibits excellent anti-tumor activity in pancreatic cancer tumor models expressing Claudin 18.2, irrespective of KRAS mutation status. These findings suggest that osemitamab has the potential to be a significant treatment option for patients with pancreatic cancer.-Fineline Info & Tech
