Policy & Regulation
Prestige Biopharma Develops PAUF-Detecting Diagnostic Kit
14 March 2023 - - Singapore-based biopharmaceutical company Prestige Biopharma Ltd has developed a first-in-class diagnostic kit for pancreatic cancer, the company said.

Pancreatic cancer is a characteristically aggressive tumor, with an extremely poor prognosis, as shown by a 1-year survival rate of 10 to 23%, and an estimated 5-year survival rate of less than 9%.

The low survival rates associated with pancreatic cancer are attributed to late diagnosis coupled with non-specific symptoms, early metastasis, rapid progression, and the lack of effective treatment modalities.

Thus, early detection and diagnosis are crucial for improving patient outcomes and increasing survival rates.

Prestige Biopharma is developing a diagnostic kit for the detection of Pancreatic Adenocarcinoma Upregulated Factor.

PAUF is a distinctive tumor-specific biomarker overexpressed in approximately 80% of pancreatic cancer cases, correlated with early progression and metastasis.

The novel diagnostic method exhibits high sensitivity and specificity in detecting PAUF. According to Prestige Biopharma IDC (Innovative Discovery Centre), preliminary investigations indicated that the expression level of PAUF in the blood plasma of pancreatic cancer patients is approximately 1.9 times higher than healthy individuals.

Additionally, in Receiver Operating Characteristic analysis, which is used to evaluate a biomarker's effectiveness, PAUF demonstrated a noteworthy sensitivity of 86.3% in detecting pancreatic cancer.

The company has submitted a provisional patent application for the diagnostic method in South Korea and started partnership discussions with major diagnostic companies to co-develop and market the diagnostic kit to target the global market.

In addition, Prestige Biologics, the CDMO (Contract Development and Manufacturing Organization) affiliate of the company, is in preparation to manufacture antibody diagnostic kits for clinical and commercial use.

Meanwhile, Prestige Biopharma has also been developing PBP1510, a first-in-class anti-PAUF monoclonal antibody, for the treatment of pancreatic cancer.

PBP1510 binds to and neutralizes PAUF to inhibit the proliferation, migration, invasion, and growth of pancreatic cancer cells. In 2020, PBP1510 was granted Orphan Drug designation by the United States Food and Drug Administration (US FDA), European Medicines Agency, and Ministry of Food and Drug Safety.

Currently preparing for Phase 1/2a clinical trial in Europe and the US, the company recently requested for Fast Track Designation from the US FDA to accelerate development of the drug.