On June 27, 2022 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company with operations in USA and South Korea, reported that the U.S. Food and Drug Administration (FDA) has approved the Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510 (INN: Ulenistamab), for the treatment of pancreatic cancer (Press release, Prestige BioPharma, JUN 27, 2022, View Source [SID1234616295]).
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The clinical trial will be conducted on patients with advanced/metastatic pancreatic cancer in the Massachusetts General Hospital and the Ronald Reagan UCLA Medical Center by Principal Investigators (PI) comprised of leading authorities at Harvard Medical School and UCLA School of Medicine. The study aims to identify an optimal dose of PBP1510 in combination with gemcitabine through Phase 1 study and continue on Phase 2a to investigate clinical efficacy.
Pancreatic cancer is a highly aggressive malignancy which contributes to high morbidity and mortality with an overall survival rate in the U.S. of around 11%1) at five years. Currently, the only curative options are surgical resection in combination with adjuvant chemotherapy. However, only 10 to 15%2) of patients are candidates as the diagnosis occurs in advanced or metastatic stages that are surgically inoperable. Limited efficacy of treatment modalities and rapid progression of pancreatic cancer can be partly explained by Pancreatic Adenocarcinoma Up-regulated Factor (PAUF) found in majority of pancreatic cancer patients. PAUF plays an important role in disease progression, but no targeted molecular therapy against PAUF currently exists. Prestige BioPharma’s anti-PAUF antibody PBP1510 is envisioned to provide significant benefit to all patients affected by PAUF-positive pancreatic cancer.
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Korean MFDS granted Orphan Drug Designation (ODD) to PBP1510 in 2020. ODD is granted to investigational drugs intended for the safe and effective treatment of rare diseases with an unmet medical need that affect few individuals but cause great suffering. This designation provides certain benefits and incentives including clinical protocol assistance, differentiated evaluation procedures for health technology assessments in certain countries, and if approved, marketing exclusivity in the EU for 10 years, in the U.S. for 7 years.
PBP1510 is also expected to be eligible for FDA’s accelerated approval program if certain conditions are met. This program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint. The company believes that PBP1510 will be able to apply for the accelerated approval program with the validated surrogate endpoint from its Phase 2 study.
Lisa S. Park, CEO of Prestige BioPharma, commented: "We are very pleased to initiate the Phase 1/2a clinical trial of PBP1510 in the world-class medical institutions in the US," and "the company will accelerate the Phase 1/2a study of PBP1510 to demonstrate the solid evidence to provide better treatment for pancreatic cancer, an extremely difficult to treat indication with a poor response to the currently available treatments".