Prestige Biopharma submits clinical trial plan in Australia

Prestige Biopharma, a Singapore-based biopharmaceutical company with operations in South Korea and the US,  has applied to the Australian clinical trial review committee for its phase 1 and 2a clinical trial plan of its new pancreatic cancer drug PBP1510 (ulenistamab).

The company specializing in antibody development will assess the safety and drug resistance of PBP1510 in combination with the existing cancer drug Gemcithabin on 30 healthy adults in phase 1 trials, followed by a phase 2a trial to evaluate the efficacy of the drug on 50 patients.

PBP1510, an antibody that neutralizes proteins present in pancreatic cancer, received orphan drug designation from the Korean Ministry of Food and Drug Safety, the US FDA, and the European Medicines Agency in 2020.

"We aim to secure meaningful results as quickly as possible by conducting phase 1/2a clinical trials in Australia, where the process can proceed smoothly," said Park So-yeon, CEO of Prestige Biopharma.

Write to Jeong Min Nam at peux@hankyung.com