Phase I/IIa pancreatic cancer trial.
Singapore-based Prestige Biopharma has received approval from the US Food and Drug Administration (FDA) for the Phase I/IIa clinical trial of PBP1510 to treat pancreatic cancer, an aggressive malignancy.
The clinical trial of the company’s first-in-class anti-PAUF monoclonal antibody will be carried out on advanced/metastatic pancreatic cancer patients in the Massachusetts General Hospital and the Ronald Reagan UCLA Medical Center.
An optimal dose of PBP1510 will be identified along with gemcitabine through Phase I trial and continue Phase IIa to study clinical efficacy.
Prestige BioPharma CEO Lisa Park said: “We are very pleased to initiate the Phase I/IIa clinical trial of PBP1510 in the world-class medical institutions in the US.
“The company will accelerate the Phase I/IIa study of PBP1510 to demonstrate the solid evidence to provide better treatment for pancreatic cancer, an extremely difficult to treat indication with a poor response to the currently available treatments.”
In 2020, PBP1510 received Orphan Drug Designation (ODD) from the FDA, the European Medicines Agency (EMA) and Korean MFDS.
Additionally, the antibody is expected to be eligible for the accelerated approval program of the FDA meeting certain conditions.
The program allows for earlier approval of drugs that are intended to treat serious ailments and cater to an unmet medical need based on a surrogate endpoint.
Prestige Biopharma believes that PBP1510 will be able to apply for this program with the validated surrogate endpoint from its Phase II study.
With an overall survival rate of around 11% in the US at five years, pancreatic cancer contributes to high morbidity and mortality.