For the treatment of pancreatic cancer, the US FDA has given Prestige Biopharma’s PBP1510 fast track designation.

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The US Food and Drug Administration (FDA) has granted PBP1510 (international non-proprietary name: ulenistamab), a biopharmaceutical product manufactured by Singapore-based Prestige Biopharma, Fast Track designation for the treatment of metastatic or unresectable pancreatic adenocarcinoma (PDAC) that has relapsed after and/or is resistant to at least one line of prior therapy.

A protein known as Pancreatic Adenocarcinoma Upregulated Factor (PAUF), which has been discovered to be overexpressed in the majority of pancreatic cancer cases, is the target of PBP1510. The proliferation, migration, invasion, and growth of pancreatic cancer cells are all made easier by PAUF overexpression, which also aids in the emergence of acquired resistance to chemotherapeutic drugs. PBP1510 is made to target these important biological processes that contribute to the pancreatic cancer’s rapid progression and the limited efficacy of conventional therapies. PBP1510 is a viable therapeutic approach for addressing the unmet medical requirements of pancreatic cancer patients by successfully reducing the tumorigenic effects of PAUF overexpression in preclinical models. With the goal of delivering this novel medicine to the clinic, a global Phase 1/2a clinical trial is now ongoing in the United States, Europe, and Asia.

An open-label, multicenter, two-part research on patients with advanced or metastatic pancreatic cancer is the first-in-human phase 1/2a study. PBP1510 will be given in two different dose-escalation cohorts during the dose-escalation phase of Phase 1, either as monotherapy or in conjunction with gemcitabine. On the basis of the analysis of pharmacokinetics, safety, and efficacy data, a recommended phase 2a dose (RP2D) from the phase 1 segment of the study will be established. PBP1510 at the RP2D in combination with gemcitabine will be delivered during phase 2’s dose-expansion phase in order to assess the drug’s effectiveness and safety.

The phase 1/2a study’s overall goals are to gather crucial safety information about the use of PBP1510 as a monotherapy or in combination with gemcitabine and to examine the efficacy of a regimen that includes both PBP1510 and gemcitabine. According to their different modes of action, PBP1510 and gemcitabine have synergistic anti-tumor effectiveness in combination therapy without increasing toxicity, which the study will support.

PBP1510, which has been given Fast Track status by the FDA, is a hopeful development in the fight against pancreatic cancer. In order to give patients who are in need of access sooner, Prestige Biopharma plans to fully capitalise on the advantages provided by the designation. A biopharmaceutical firm with its headquarters in Singapore called Prestige Biopharma is dedicated to the creation of vaccines for infectious diseases, biosimilars, and first-in-class antibody medicines.

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