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 produced 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 versus controls, along with a reduction in metastatic burden in the liver and peritoneum.

The data also indicated remodeling of the tumor microenvironment, including decreased cancer-associated fibroblast activity and reduced fibrosis. PRP appeared to enhance sensitivity of chemo-resistant PDAC cells to gemcitabine/nab-paclitaxel, the standard-of-care regimen, at lower chemotherapy 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.

"These new data reinforce PRP's differentiated mechanism — targeting cancer stem cells, disrupting the fibrotic microenvironment, and potentially overcoming resistance — and give us strong conviction as we move into the clinic," said James Nathanielsz, Propanc's chief executive officer.

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 primary focus. The submission is expected in the coming months. The company has a memorandum of understanding with Avance Clinical to support the trial and is targeting GMP manufacturing completion in late 2026.