Prestige Biopharma Receives FDA Approval for Phase 1/2a Trial of Pancreatic Cancer Drug PBP1510

Prestige Biopharma Receives FDA Approval for Phase 1/2a Trial of Pancreatic Cancer Drug PBP1510


Prestige Biopharma announced on the 27th that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a clinical trial of its antibody therapeutic candidate, PBP1510, for the treatment of pancreatic cancer.

PBP1510 is an antibody therapy designed to neutralize the PAUF protein, which is overexpressed in pancreatic cancer and pancreatic ductal adenocarcinoma. By targeting PAUF, the treatment aims to inhibit tumor progression and metastasis, while enhancing the sensitivity of cancer cells to the immune system and existing anticancer therapies. The candidate has been designated as an orphan drug in the United States, Europe, and Korea.

Following ongoing clinical trials in France and Spain, Prestige Biopharma is now able to expand its clinical development into the United States.

In the Phase 1 study, the safety and tolerability of PBP1510 will be evaluated both as a monotherapy and in combination with the existing chemotherapy agent gemcitabine. The Phase 2a study will assess the safety and efficacy of the recommended dose of PBP1510 in combination with gemcitabine, as determined in the Phase 1 trial.

Soyeon Park, CEO of Prestige Biopharma, stated, “This FDA approval marks the first step toward entering the U.S. market. We will accelerate development in both Europe and the United States to generate meaningful clinical results.”

Reference: The Korea Economic Daily (https://www.hankyung.com/article/202206279231i)