Prestige Biopharma Files Patent Application for TASA™, a Blood-Based Pancreatic Cancer Diagnostic Platform

Highly sensitive detection of PAUF, a protein overexpressed in pancreatic cancer,
through a simple blood test

Expanding opportunities for timely treatment through early detection of pancreatic cancer

Prestige Biopharma announced that it filed a Korean patent application on August 4 for TASA™ (TAG-Assisted Switch Assay), a blood-based diagnostic platform designed to detect PAUF (Pancreatic Adenocarcinoma Up-regulated Factor), a pancreatic cancer-related protein found in the blood, with high sensitivity. Following the Korean filing, the company is preparing to file an international patent application under the Patent Cooperation Treaty (PCT) to secure global intellectual property rights.

Pancreatic cancer is one of the most difficult cancers to treat, with early diagnosis playing a critical role in determining a patient’s chance of survival. Because early-stage pancreatic cancer often presents no obvious symptoms, the majority of patients are diagnosed only after the disease has progressed to a stage where surgery is no longer feasible. Once the cancer has metastasized, survival rates decline sharply. Through TASA™, Prestige Biopharma aims to enable earlier detection of pancreatic cancer using a simple blood test, thereby bringing diagnosis forward to a stage when treatment remains possible and expanding patients’ opportunities to receive timely care.

At the core of TASA™ is PAUF, which Prestige Biopharma has studied extensively over many years. Discovered and continuously researched by the company, PAUF is overexpressed in more than 80% of pancreatic cancer patients and is known to play an important role in cancer progression and metastasis. High PAUF expression has also been reported to be significantly associated with lower survival rates and poor prognosis. Accordingly, PAUF is gaining attention not only as a therapeutic target but also as a potential biomarker for the diagnosis and prognosis of pancreatic cancer.

However, because PAUF is present only at trace levels in the blood, conventional analytical methods have limitations in accurately detecting and quantifying it. To address this challenge, Prestige Biopharma’s R&D hub, the Innovative Discovery Center (IDC), developed TASA™, which effectively captures, concentrates and detects trace amounts of PAUF in the blood.

TASA™ uses antibodies and magnetic particles to selectively isolate and concentrate trace amounts of PAUF in the blood before detecting it with high sensitivity. Specifically, PAUF-recognising antibodies and magnetic nanoparticles selectively capture and concentrate trace amounts of PAUF in the blood. TAG™ (Type III ADA-IgG) antibodies then bind specifically to the PAUF-antibody complex to amplify the detection signal. The concentration of PAUF in the blood is subsequently quantified by measuring the intensity of the colorimetric signal. This enables rapid and highly sensitive detection of trace amounts of PAUF that are difficult to identify using conventional analytical methods.

Prestige Biopharma evaluated the PAUF detection performance of TASA™ using serum samples from healthy controls and pancreatic cancer patients. The results showed higher PAUF concentrations in the pancreatic cancer group than in the healthy control group, with sensitivity of more than 72% and specificity of more than 82%. The company plans to further improve the platform’s diagnostic performance and reproducibility through additional clinical validation.

TASA™ has also been developed as an adaptable platform that can incorporate antibodies suitable for specific target biomarkers. If additional cancer-specific biomarkers and antibodies that recognise them are secured, the platform could potentially be expanded beyond pancreatic cancer to support blood-based diagnosis across a range of cancer types.

Prestige Biopharma is pursuing an R&D strategy that leverages PAUF as both a diagnostic biomarker and a therapeutic target. The company’s investigational pancreatic cancer antibody therapy, PBP1510 (ulenistamab), is designed to selectively target PAUF and inhibit its function and is currently preparing to enter Phase 2 clinical trials in patients with pancreatic cancer. The company is also conducting research on an immunohistochemistry (IHC)-based companion diagnostic to assess PAUF expression levels in tumour tissue and identify patients who may be suitable for treatment with PBP1510. By integrating TASA™-based blood testing, IHC-based patient selection and PBP1510 targeted therapy, Prestige Biopharma is building a comprehensive PAUF-based pancreatic cancer strategy spanning diagnosis and treatment.

Lisa S. Park, Chairperson of Prestige Biopharma, said, “Pancreatic cancer is a disease in which how quickly it is detected and connected to appropriate treatment can determine a patient’s opportunity to receive care. By expanding our extensive PAUF research from therapeutic targeting into the field of diagnostic biomarkers, we aim to increase the possibility of detecting pancreatic cancer at an earlier stage through TASA™.”

She added, “We will continue working to complete a comprehensive PAUF-based pancreatic cancer strategy that connects TASA™-based blood testing, IHC-based patient selection and PBP1510 targeted therapy, covering the entire continuum from diagnosis to treatment.”