FDA Grants Prestige Biopharma Fast Track Status for Revolutionary Pancreatic Cancer Treatment!

Prestige Biopharma has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for PBP1510 (International Non-proprietary name: Ulenistamab), a revolutionary potential treatment for unresectable or metastatic pancreatic adenocarcinoma (PDAC) that has relapsed following and/or is refractory to at least one line of prior therapy. This incredible breakthrough targets Pancreatic Adenocarcinoma Upregulated Factor (PAUF), a tumour-specific protein found to be overexpressed in the majority of pancreatic cancer cases.

PAUF overexpression is known to promote key cellular functions such as proliferation, migration, invasion, and growth of pancreatic cancer cells, and contributes to the development of acquired resistance to current treatment options. PBP1510 has been designed to target these key biological mechanisms and could potentially be the game-changer in the fight against pancreatic cancer.

PBP1510 has the potential to revolutionize pancreatic cancer treatment. This innovative therapy has been demonstrated to effectively inhibit the tumorigenic effects of PAUF overexpression in preclinical models, offering a promising solution for the currently unmet medical needs of pancreatic cancer patients. Now, a global Phase 1/2a clinical trial is underway in the United States, Europe, and Asia, bringing PBP1510 closer to becoming a reality.

The Phase 1/2a study of PBP1510 in advanced/metastatic pancreatic cancer is an unparalleled opportunity to investigate the potential of a novel therapeutic. This open-label, multi-center study will assess the safety and efficacy of PBP1510 in two separate dose-escalation cohorts, either as monotherapy or in combination with gemcitabine.

The Phase 1 data will be used to determine the Recommended Phase 2a Dose (RP2D) – which will then be evaluated in a dose-expansion phase to assess safety and efficacy. With this new therapeutic, we have a chance to make a real difference in the fight against pancreatic cancer.

The Phase 1/2a study of PBP1510 is an important opportunity to explore the safety and efficacy of combining the compound with gemcitabine. The study offers the potential to build upon preclinical evidence of synergistic antitumour activity without increased toxicity, thanks to the distinct mechanisms of action of both treatments. The results could help to revolutionise the treatment of cancer with a more effective and safe combination therapy.

Prestige Biopharma is thrilled to announce that their investigational drug PBP1510 has earned Fast Track designation from the FDA, a major breakthrough in the pursuit of effective treatments for pancreatic cancer. This groundbreaking designation from the FDA will enable Prestige Biopharma to provide faster access to the life-saving treatment for those suffering from the disease.

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