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

July 1, 2020
Pharmaceutical Technology Editors

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