ZielBio, Inc., a US-based clinical-stage biotechnology company, announced on Tuesday that it has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for its lead program, ZB131, intended to treat cholangiocarcinoma.

The product is a monoclonal antibody with a high affinity and specificity for cancer-specific plectin (CSP).

The company said that during preclinical studies, the product showcased high specific binding to CSP and strong anti-cancer activity. The company is conducting a Phase 1/2 trial to study the safety, tolerability, and efficacy of the product in patients with solid tumours, including cholangiocarcinoma, pancreatic, and ovarian cancers.