Propanc Biopharma, Inc. (NASDAQ: PPCB) announced preclinical and translational data for its lead drug candidate PRP in pancreatic ductal adenocarcinoma (PDAC), according to a company press release.

In orthotopic and patient-derived xenograft models of advanced PDAC, intravenous PRP administered three times weekly showed greater than 90% mean tumor growth inhibition compared with vehicle controls (p < 0.001). Treated animals showed a median overall survival extension of more than 2.5-fold compared with controls.

Additional findings included a reduction in metastatic burden in the liver and peritoneum, remodeling of the tumor microenvironment, and enhanced sensitivity of chemo-resistant PDAC cells to gemcitabine/nab-paclitaxel at lower doses.

PRP is a fixed-ratio combination of the pancreatic proenzymes trypsinogen and chymotrypsinogen, delivered by intravenous injection. The U.S. Food and Drug Administration previously granted Orphan Drug Designation to PRP for pancreatic cancer treatment.

The company said it plans to submit a clinical trial application in Australia for a Phase 1b first-in-human study in approximately 30 to 40 patients with advanced solid tumors, with pancreatic cancer as a key focus. Chief Executive Officer James Nathanielsz said the company expects to submit the application "in the coming months."

Propanc said it has entered a memorandum of understanding with Avance Clinical to support execution of the Phase 1b study and is targeting GMP manufacturing completion for late 2026.