FDA Grants Orphan Drug Designation to Novel Monoclonal Antibody in Pancreatic Cancer

The FDA has granted Orphan Drug Designation to PBP1510, a first-in-class anti-PAUF monoclonal anti-body, for the treatment of patients with pancreatic cancer.

“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 treatment, said Lisa S. Park, PhD, chief executive officer, Prestige BioPharma.

Currently, the development of the drug is still in preclinical stages with no data to report. The developer of PBP1510, Prestige BioPharma, noted that there is limited efficacy overall with treatment options for pancreatic cancer. The survival rate for pancreatic cancer is just 9%. However, knowledge that PAUF overexpression contributes to disease progression, which may present a new treatment strategy to the landscape of pancreatic cancer.

In addition to the Orphan Drug Designation granted by the FDA, Prestige BioPharma has also filed an application with the European Medicines Agency (EMA) to obtain an Orphan Drug Designation in Europe.

Further research in pancreatic cancer from the company is underway with the trastuzumab (Herceptin) biosimilar HD204, which is being evaluated in a phase 3 clinical. Applications to the FDA and EMA for review of the agents have been accepted by both regulatory bodies.

_Reference:

_{US FDA grants Orphan Drug Designation (ODD) for Prestige BioPharma’s PBP1510 anti-pauf monoclonal antibody for the treatment of pancreatic cancer. News release. Prestige BioPharma. June 30, 2020. Accessed June 30, 2020.}