Prestige Biopharma: US FDA approves Phase 1/2a clinical trial for pancreatic cancer treatment

KUALA LUMPUR, June 27 (Bernama) -- Singapore-based biopharmaceutical company, Prestige Biopharma Limited announced the U.S. Food and Drug Administration (FDA) has approved the Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510 (INN: Ulenistamab), for the treatment of pancreatic cancer.

The clinical trial will be conducted on patients with advanced/metastatic pancreatic cancer in the Massachusetts General Hospital and the Ronald Reagan UCLA Medical Center by Principal Investigators (PI) comprising leading authorities at Harvard Medical School and UCLA School of Medicine.

According to a statement, the study aims to identify an optimal dose of PBP1510 in combination with gemcitabine through Phase 1 study and continue on Phase 2a to investigate clinical efficacy.

CEO of Prestige BioPharma, Lisa S. Park said: “We are very pleased to initiate the Phase 1/2a clinical trial of PBP1510 in the world-class medical institutions in the US.

“The company will accelerate the Phase 1/2a 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.”

Limited efficacy of treatment modalities and rapid progression of pancreatic cancer can be partly explained by Pancreatic Adenocarcinoma Up-regulated Factor (PAUF) found in majority of pancreatic cancer patients.

PAUF plays an important role in disease progression, but no targeted molecular therapy against PAUF currently exists. Prestige BioPharma’s anti-PAUF antibody PBP1510 is envisioned to provide significant benefit to all patients affected by PAUF-positive pancreatic cancer.

PBP1510 is also expected to be eligible for FDA’s accelerated approval programme if certain conditions are met. This programme allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint.

The company believes that PBP1510 will be able to apply for the accelerated approval programme with the validated surrogate endpoint from its Phase 2 study.

More details at www.prestigebiopharma.com.

-- BERNAMA