FDA Grants Orphan Drug Designation to Prestige BioPharma’s Anti-Cancer mAb

July 1, 2020

While there currently is no molecular therapy targeted against the PAUFgene, Prestige believes its monoclonal antibody has the potential to benefit patients affected by PAUF-positive pancreatic cancer.

Prestige BioPharma, a Singapore-based biopharmaceutical company, announced on June 30, 2020 that FDA has given orphan drug designation (ODD) to its first-in-class anti-pancreatic adenocarcinoma up-regulated factor (PAUF) monoclonal antibody (mAb), PBP1510, for the treatment of pancreatic cancer.

According to a company press release, the rapid expression of pancreatic cancer can be partially pinpointed to the PAUF gene. While there isn’t currently a molecular therapy targeted against PAUF, Prestige believes its mAb has the potential to benefit patients affected by PAUF-positive pancreatic cancer.

“The [o]rphan [d]rug [d]esignation we received from [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,” said Dr. Lisa S. Park, CEO of Prestige BioPharma, in the press release.

Source: Prestige