Prestige Biopharma's Antibody New Drug for Pancreatic Cancer Designated as Orphan Drug in the US

[Asia Economy Reporter Kum Boryeong] Prestige BioPharma's antibody drug candidate for pancreatic cancer treatment has been designated as an orphan drug in the United States.

Prestige BioPharma announced on the 29th that its antibody drug candidate 'PBP1510' received orphan drug designation approval from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

So-yeon Park, CEO of Prestige BioPharma, said, "This FDA orphan drug designation is a very important achievement to accelerate the development and commercialization of PBP1510 for pancreatic cancer treatment, which currently has no adequate therapies," adding, "The anti-PAUF monoclonal antibody PBP1510 is expected to show significant therapeutic effects in PAUF-positive pancreatic cancer patients."

Prestige BioPharma has also submitted an application for orphan drug designation for pancreatic cancer treatment to the European Medicines Agency (EMA). They plan to initiate a Phase 1/2a clinical trial targeting PAUF-positive pancreatic cancer patients within this year.

A representative from Prestige BioPharma explained, "Pancreatic cancer is a highly aggressive malignant tumor originating from exocrine or endocrine pancreatic cells," adding, "Only 10-15% of patients are eligible for surgical treatment at diagnosis, while over 80% of patients are diagnosed at a stage where surgical treatment is not possible, and the response to chemotherapy and radiation therapy is known to be low."

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