MELBOURNE, Australia, Oct. 07, 2026 (GLOBE NEWSWIRE) -- Propanc Biopharma, Inc. (Nasdaq: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company focused on developing novel treatments for chronic diseases including recurrent and metastatic cancer, today highlighted new preclinical data for its lead candidate PRP in pancreatic ductal adenocarcinoma (PDAC) and compared that profile with a clinical standard recently established by Revolution Medicines, Inc.
“PRP is aimed at a different node. The preclinical package — deep tumor control, fewer metastases, a less fibrotic microenvironment, and chemo…”On August 26, 2026, the U.S. Food and Drug Administration approved daraxonrasib (RASONQUE), Revolution Medicines’ oral RAS(ON) multi-selective inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, or who are not candidates for multiagent systemic therapy. Approval was based on the Phase 3 RASolute 302 trial. In the RAS G12 population, daraxonrasib delivered median overall survival of 13.2 months versus 6.6 months with chemotherapy (hazard ratio 0.40), median progression-free survival of 7.3 months versus 3.5 months (hazard ratio 0.45), and a confirmed objective response rate of 33.2% versus 11.8%. Results in the intent-to-treat population were consistent: median overall survival 13.2 versus 6.7 months (hazard ratio 0.40) and median progression-free survival 7.2 versus 3.6 months (hazard ratio 0.49).
Those data validate RAS as a druggable driver in a disease in which RAS mutations are present in roughly 90% of cases. They also leave a defined residual problem: epithelial-mesenchymal transition (EMT), cancer stem cells, fibrosis, and metastatic dissemination are not the primary targets of RAS pathway blockade.
PRP is a proprietary intravenous fixed-ratio combination of the pancreatic proenzymes, trypsinogen and chymotrypsinogen (1:6). It does not inhibit RAS. In orthotopic and patient-derived xenograft models of advanced PDAC, three-times-weekly intravenous PRP produced:
- >90%, mean, tumor growth inhibition, versus vehicle (p < 0.001), building on previously reported inhibition above 85%.
- A marked reduction in metastatic burden in the liver and peritoneum.
- Remodeling of the tumor microenvironment, including lower cancer-associated fibroblast activity, less fibrosis, and suppression of EMT markers.
- Greater sensitivity of chemo-resistant PDAC cells to gemcitabine plus nab-paclitaxel, supporting the potential for lower chemotherapy doses with improved activity.
- A median overall survival extension of more than 2.5-fold versus controls.
Limited prior compassionate-use experience with related proenzyme formulations has shown signals of prolonged survival in advanced solid-tumor patients, with a favorable safety profile and no severe treatment-related adverse events reported in that experience. PRP holds FDA Orphan Drug Designation Status for the treatment of pancreatic cancer and is not restricted to the RAS genotype.
“Daraxonrasib is a genuine advancement for patients with metastatic pancreatic cancer, and the RASolute 302 survival benefit is the clinical benchmark the field now has to beat or complement,” said James Nathanielsz, Propanc’s Chief Executive Officer. “PRP is aimed at a different node. The preclinical package — deep tumor control, fewer metastases, a less fibrotic microenvironment, and chemo re-sensitization — is the biology RAS inhibition does not directly address. We see PRP as a potential combination or sequential partner, not a substitute, and we are moving it into patients.”
The Company plans to start a multicenter, open-label Phase 1b first-in-human study of PRP in the first quarter of 2027. The study is expected to enroll up to 50 patients with advanced solid tumors, including pancreatic, ovarian, and refractory prostate cancers, at sites across Australia.
Comparative Summary
AttributePRPDaraxonrasib / RASONQUEModalityIV proenzyme combination (trypsinogen + chymotrypsinogen, 1:6)Oral RAS(ON) multi-selective inhibitorPrimary biologyDifferentiation, EMT reversal, cancer stem cells, fibrosis, metastasisOncogenic RAS(ON) signalingStagePreclinical PDAC plus clinical efficacy evaluated in advanced cancer patients on compassionate grounds; Phase 1b planned Q1 2027FDA-approved August 26, 2026; Phase 3 RASolute 302PDAC activity reported>90% mean tumor-growth inhibition; >2.5-fold median survival in animal models; reduced liver and peritoneal metastasesmOS 13.2 vs 6.6–6.7 months; mPFS 7.2–7.3 vs 3.5–3.6 months; ORR ~32% vs ~12%GenotypeNot RAS-mutation restricted; FDA Orphan Drug Designation Status in pancreatic cancerFDA Approved in metastatic pancreatic adenocarcinoma after prior therapy, activity shown across RAS G12 and overall populations
About Propanc Biopharma, Inc.
Propanc Biopharma, Inc. (Nasdaq: PPCB) is developing a novel approach to preventing cancer recurrence and metastasis by targeting and eradicating cancer stem cells through proenzyme activation. The Company’s lead product candidate, PRP, is designed to address the underlying drivers of cancer proliferation and spread.
More information: www.propanc.com
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding its market position and market opportunity, expectations and plans as to its product development, manufacturing and sales, and relations with its partners and investors, made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections regarding its business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond the Company’s control. Forward-looking statements are not guarantees of future actions or performance. Actual results may differ materially from those in the forward-looking statements because of several factors, including, without limitation, risks and uncertainties related to market conditions, as well as those risks described under “Risk Factors” in the prospectus related to the proposed offering and those described in the Company’s filings with the SEC. The Company undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.
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