Policy & Regulation
Transcenta Holding's TST001 receives US FDA Orphan Drug Designation
29 July 2021 -

Transcenta Holding Limited, a China-based clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announced on Wednesday that it has received Orphan Drug Designation from the United States Food and Drug Administration (FDA) for its TST001, an anti-Claudin18.2 monoclonal antibody currently in Phase I clinical trial, to treat patients with gastric cancer or gastroesophageal junction.

According to preclinical and clinical data, the product indicated potent anti-tumour activities in tumour model of gastric cancer or patient of gastric cancer expressing Claudin18.2.

The product is the second Claudin18.2 aimed at antibody therapeutic candidate being developed globally after Zolbetuximab (IMAB362). It is a high-affinity recombinant humanised monoclonal antibody aimed at Claudin18.2 generated by Transcenta's Immune Tolerance Breaking Technology platform.

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