Prestige Biopharma Initiates Development of PAUF-Based Diagnostic Kit for Pancreatic Cancer

Prestige Biopharma Initiates Development of PAUF-Based Diagnostic Kit for Pancreatic Cancer

“Patent Filed for Blood-Based PAUF Detection Method… Full Application Planned Within One Year”

Prestige Biopharma, a biopharmaceutical company specializing in antibody therapeutics, announced on the 9th that it has filed a provisional patent application for a pancreatic cancer diagnostic kit and has officially initiated development, including early-stage discussions on commercialization with leading diagnostic companies in Korea and abroad.

The provisional filing was made to secure priority rights for the patented technology in a timely manner while accelerating the patent process ahead of commercialization. Through this initiative, Prestige Biopharma aims to advance pancreatic cancer treatment by combining the development of its antibody therapeutic PBP1510, currently in Phase 1/2a clinical trials in the United States and Europe, with the commercialization of a precision diagnostic kit for early detection.

At the core of Prestige Biopharma’s pancreatic cancer research is its proprietary therapeutic target, the PAUF protein, which is known to be overexpressed in more than 80% of pancreatic cancer patients and plays a critical role in tumor progression and metastasis. The company is currently developing PBP1510, an antibody therapeutic designed to neutralize PAUF.

According to the company, the diagnostic kit under development at its Innovative Discovery Centre (IDC) is capable of detecting PAUF in blood with high sensitivity and specificity. In comparative analyses, pancreatic cancer patients showed approximately 1.9 times higher PAUF levels than healthy individuals. The kit also demonstrated a high sensitivity of 86.3% in ROC (receiver operating characteristic) analysis, indicating its potential for early diagnosis of pancreatic cancer.

The development of the diagnostic kit is being carried out as a collaborative project across the Prestige Biopharma Group, aligned with its broader pipeline strategy. The development of the high-sensitivity PAUF detection method is being led by the Busan IDC, while the Singapore headquarters, responsible for clinical trials and regulatory approvals of PBP1510, is preparing for global market entry based on its biosimilar development expertise. In addition, its affiliate CDMO company, Prestige Biologics, has expanded its business scope to include the manufacturing of antibody diagnostic devices, preparing for clinical production and commercialization.

Soyeon Park, CEO of Prestige Biopharma, stated, “Early diagnosis of pancreatic cancer is as important and urgent as developing effective treatments. Given the proven correlation between PAUF overexpression and pancreatic cancer, we have accelerated the development of a PAUF-based diagnostic kit.” She added, “Combining early diagnosis with therapeutic development could represent a life-saving innovation that significantly improves survival rates for pancreatic cancer patients.”

Meanwhile, PBP1510 (INN: Ulenistamab), an antibody therapeutic that neutralizes PAUF, was designated as an orphan drug by the U.S. FDA, the European Medicines Agency (EMA), and Korea’s Ministry of Food and Drug Safety in 2020. It is currently undergoing Phase 1/2a clinical trials in the United States and Europe, and the company has recently applied for Fast Track designation from the FDA to accelerate development.

Reference: PharmNews (https://www.pharmnews.com/news/articleView.html?idxno=219724)