Prestige Biopharma Receives US FDA Approval for Phase 1/2a Clinical Trial Plan of Pancreatic Cancer Antibody New Drug

[Asia Economy Reporter Lee Gwan-joo] Prestige BioPharma announced on the 27th that it has received approval from the U.S. Food and Drug Administration (FDA) for the clinical trial plan of its pancreatic cancer antibody drug 'PBP1510' for Phase 1 and 2a trials in the United States.

In Phase 1, the safety and tolerability of the drug will be evaluated through PBP1510 monotherapy and combination therapy with the existing anticancer drug gemcitabine. In Phase 2a, the safety and efficacy of the recommended dose of PBP1510 in combination with gemcitabine, determined through Phase 1, will be assessed.

PBP1510 is a novel antibody drug that neutralizes the pancreatic cancer treatment target PAUF (Pancreatic Adenocarcinoma Upregulated Factor) protein. It blocks various cancer progression and metastasis caused by PAUF and makes cancer cells more sensitive to the body's immune system and existing anticancer drugs.

PBP1510 is designated as an orphan drug by the FDA, granting seven years of market exclusivity upon entry into the U.S. market. So-yeon Park, CEO of Prestige BioPharma, stated, “The FDA clinical trial approval for PBP1510, one of our most important pipelines, will be the first step toward entering the U.S. market,” adding, “We will focus all our efforts on simultaneously accelerating development at prestigious medical institutions in Europe and the U.S. to produce meaningful clinical results that will enable new drug approval applications.”