ZG16B

SINGAPORE--(BUSINESS WIRE)-- Prestige Biopharma has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for PBP1510 (International Non-proprietary name: Ulenistamab), in the treatment of unresectable or metastatic pancreatic adenocarcinoma (PDAC) that has relapsed following and/or is refractory to at least one line of prior therapy. PBP1510 targets Pancreatic Adenocarcinoma Upregulated Factor (PAUF), a tumour-specific protein, found to be overexpressed in majority of pancreatic cancer cases. PAUF overexpression promotes key cellular functions, including proliferation, migration, invasion, and growth of pancreatic cancer cells, and contributes to the development of acquired resistance to chemotherapeutic agents. PBP1510 is designed to target these key biological mechanisms that results in limited effectiveness of current treatment options and rapid progression of pancreatic cancer. By effectively inhibiting the tumorigenic effects of PAUF overexpression in preclinical models, PBP1510 represents a promising therapeutic strategy for addressing the unmet medical needs of pancreatic cancer patients. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic. The first-in-human Phase 1/2a study is an open-label, multicentre, two-part study in patients with advanced/metastatic pancreatic cancer. Phase 1 is a dose-escalation phase, wherein PBP1510 will be administered, either as monotherapy or in combination with gemcitabine, in two separate dose-escalation cohorts. From Phase 1 part of the study a recommended Phase 2a dose (RP2D) will be determined based on the analysis of pharmacokinetics, safety, and efficacy data. Phase 2 is a dose-expansion phase, wherein PBP1510 at the RP2D in combination with gemcitabine will be administered to evaluate efficacy and safety of PBP1510. Overall, the Phase 1/2a study aims to collect important safety data on the use of PBP1510 as a monotherapy or in combination with gemcitabine and explore the efficacy of a combined PBP1510 and gemcitabine regimen. The study will substantiate the preclinical findings of PBP1510’s synergistic antitumour activity in combination therapy with gemcitabine without increased toxicity, as anticipated from their distinct mechanisms of action. With Fast Track designation from the FDA, PBP1510 represents a promising advancement in the treatment of pancreatic cancer. Prestige Biopharma intends to take full advantage of the benefits offered by the designation to provide faster access for patients in need. View source version on businesswire.com: Contacts info@prestigebio.com Source: Prestige Biopharma Limited View this news release online at:

The company’s new diagnostic kit is designed to measure the levels of Pancreatic Adenocarcinoma Upregulated Factor (PAUF), a tumour-specific biomarker that is overexpressed in around 80% of pancreatic cancer cases Prestige Biopharma develops pancreatic cancer early diagnostic kit. (Credit: CDC on Unsplash) Singapore-based biopharmaceutical company Prestige Biopharma has developed an advanced diagnostic test kit for detecting pancreatic cancer. The company’s new diagnostic kit is designed to measure the levels of Pancreatic Adenocarcinoma Upregulated Factor (PAUF). PAUF is a tumour-specific biomarker that is overexpressed in around 80% of pancreatic cancer cases, correlated with early progression and metastasis. The novel diagnostic method exhibits high sensitivity and specificity in detecting PAUF. In the preliminary investigations by the company’s Innovative Discovery Centre (IDC), pancreatic cancer patients had a higher level of PAUF expression than healthy individuals. The Receiver Operating Characteristic (ROC) analysis is used to evaluate a biomarker’s effectiveness, showing 86.3% sensitivity in detecting pancreatic cancer. Prestige Biopharma CEO Lisa S Park said: “The early detection of pancreatic cancer is just as crucial as an effective treatment, given its reputation as a silent killer. “As part of our efforts to combat this devastating disease, we are expanding into diagnostics using our innovative PAUF-based technology. “Through the successful development of the diagnostic kit on top of a novel antibody, we believe our efforts will significantly benefit patients with pancreatic cancer and contribute to improving human health, which is exactly what our mission ‘Innovation for Life’ stands for.” Pancreatic cancer is an aggressive tumour associated with extremely poor prognosis and low survival rates, due to late diagnosis, non-specific symptoms, early metastasis, rapid progression, and the lack of effective treatment modalities. The company has submitted a provisional patent application for the diagnostic method in South Korea and started partnership discussions with major diagnostic companies. In addition, the company’s Contract Development and Manufacturing Organization (CDMO), Prestige Biologics, is preparing to manufacture antibody diagnostic kits. Prestige Biopharma has been developing PBP1510, an advanced anti-PAUF monoclonal antibody to treat pancreatic cancer. PBP1510 secured the US Food and Drug Administration (FDA) Orphan Drug designation, the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) in 2020.

SINGAPORE--(BUSINESS WIRE)-- Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, has developed a first-in-class diagnostic kit for pancreatic cancer. 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%1. 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). 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 (ROC) 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. Dr. Lisa S. Park, CEO of Prestige Biopharma, stated “The early detection of pancreatic cancer is just as crucial as effective treatment, given its reputation as a silent killer. As part of our efforts to combat this devastating disease, we are expanding into diagnostics using our innovative PAUF-based technology. Through the successful development of the diagnostic kit on top of a novel antibody, we believe our efforts will significantly benefit patients with pancreatic cancer and contribute to improving human health, which is exactly what our mission ‘Innovation for Life’ stands for”. 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 (EMA), and Ministry of Food and Drug Safety (MFDS). 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. 1 The majority of patients are diagnosed with either locally advanced or metastatic disease at the time of diagnosis, and for patients with metastatic disease, the median overall survival from diagnosis ranges from 2.8 to 5.8 months. View source version on businesswire.com: Contacts info@prestigebio.com Source: Prestige Biopharma Limited View this news release online at: