The US Food and Drug Administration has granted fast track designation to Prestige Biopharma’s PBP1510 (Ulenistamab) to treat unresectable or metastatic pancreatic adenocarcinoma (PDAC).
PBP1510 will mainly act on a tumour-specific protein called pancreatic adenocarcinoma upregulated factor (PAUF), which is overexpressed in most pancreatic cancer patients.
PAUF overexpression is said to advance major cellular functions such as proliferation, migration, invasion, and growth of pancreatic cancer cells. It will also lead to the development of acquired resistance to chemotherapeutic agents.
PBP1510 is expected to target these crucial biological mechanisms.
Prestige is currently carrying out a global Phase I/IIa clinical study with PBP1510 in the US, Europe, and Asia.
According to the company, the first-in-human Phase 1/2a study is an open-label, multicentre and two-part study in advanced/metastatic pancreatic cancer patients.
Phase I is a dose-escalation phase, under which PBP1510 will be administered either as monotherapy or along with gemcitabine in two separate dose-escalation cohorts.
Following this part of the study, a recommended Phase IIa dose (RP2D) will be determined based on pharmacokinetics, safety, and efficacy data analysis, noted the company.
In the Phase II dose-expansion phase, PBP1510 at the RP2D along with gemcitabine will be administered for assessing the efficacy and safety of PBP1510.
Furthermore, the Phase I/IIa study intends to gather significant safety data on the application of PBP1510 as a single agent or in combination with gemcitabine besides evaluating the efficacy of a combined PBP1510 and gemcitabine regimen.
The study is also expected to justify the preclinical data of PBP1510’s synergistic antitumour activity in combination therapy with gemcitabine without increased toxicity.