Prestige BioPharma today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreatic cancer.

Pancreatic cancer is a highly aggressive malignancy originating in the exocrine or endocrine pancreatic cells suspected to be caused by poor diet, smoking, and genetic factors. It contributes to high morbidity and mortality with a survival rate of 9% at five years in the United States. Currently, the only curative options are limited to surgical resection in combination with adjuvant chemotherapy.

However, only 10 to 15% of patients are candidates as the diagnosis occurs in advanced or metastatic stages that are surgically inoperable. Limited efficacy of treatment modalities and rapid progression of pancreatic cancer can be partly explained by the overexpression of a gene called Pancreatic Adenocarcinoma Up-regulated Factor (PAUF) found in the majority of pancreatic cancers. PAUF plays an important role in disease progression, but no targeted molecular therapy against PAUF currently exists. Prestige BioPharma’s anti-PAUF antibody PBP1510 is envisioned to provide significant benefit in all patients affected by PAUF-positive pancreatic cancer.

Dr. Lisa S. Park, CEO of Prestige BioPharma noted, “The Orphan Drug Designation we received from the US FDA is of significant importance in accelerating the development of PBP1510 to provide better treatment for pancreatic cancer, an extremely difficult to treat indication with a poor response to the currently available treatments.”

The FDA grants ODD status to medicines intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Prestige Biopharma has also filed to the European Medicines Agency to obtain orphan designation status in the European Union as well.

Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics. Its lead program, HD201 trastuzumab biosimilar, has been filed and accepted for review with the EMA in 2019 and will also be filed with the US FDA in 2020. Prestige BioPharma´s next products in the line include a Bevacizumab biosimilar (HD204) in Phase III, an Adalimumab biosimilar (PBP1502) in Phase I and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in Phase I stages. Manufacturing facilities for global commercial supply are located in Osong, South Korea.