Propanc Biopharma, Inc. (Nasdaq: PPCB) announced preclinical 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, three-times-weekly intravenous PRP produced greater than 90% mean tumor growth inhibition versus vehicle controls (p < 0.001), a median overall survival extension of more than 2.5-fold in treated animals compared with controls, and a reduction in metastatic burden in the liver and peritoneum.

The data also showed remodeling of the tumor microenvironment, including decreased cancer-associated fibroblast activity and reduced fibrosis, as well as enhanced sensitivity of chemo-resistant PDAC cells to gemcitabine/nab-paclitaxel chemotherapy.

PRP is a fixed-ratio combination of two pancreatic proenzymes, trypsinogen and chymotrypsinogen. The company states the candidate operates through a differentiation-based mechanism distinct from RAS-targeted therapies. PRP holds FDA Orphan Drug Designation for pancreatic cancer.

The press release references Revolution Medicines' RAS(ON) inhibitor daraxonrasib, which delivered Phase 3 results in previously treated metastatic PDAC showing median overall survival of 13.2 months versus 6.6–6.7 months with chemotherapy. Propanc presented this clinical data as context, noting PRP uses a different mechanism not limited to RAS mutations.

"We are accelerating our Phase 1b First-in-Human study in advanced solid tumors, with pancreatic cancer as a key focus indication," said James Nathanielsz, Chief Executive Officer of Propanc.

The company said it is advancing GMP manufacturing, pharmacokinetics assay validation, and clinical partnerships in support of a planned Phase 1b study in approximately 40 to 45 patients with advanced solid tumors. A clinical trial application is expected in the coming months.