Announcement • 5h
Propanc Biopharma, Inc. Commences Finalization Of Clinical Trial Protocol And Feasibility Assessment For Phase 1b Study Of PRP In Advanced Cancer Patients Propanc Biopharma, Inc. has commenced finalization of a clinical trial protocol and will conduct a feasibility assessment for its First-In-Human, Phase 1b clinical study of PRP in up to 40 advanced cancer patients suffering from solid tumors. Preparatory activities for the multi-trial center investigation will be led by Avance Clinical Pty Ltd. and will consist of a detailed review of the Company’s Investigator’s Brochure, preparation of a Briefing Document from the Investigator’s Brochure, as well as finalization of a Clinical Trial Protocol using the jointly prepared Clinical Trial Synopsis which summarizes the design of the 40-patient study. The documents will be provided to Investigators in Clinical Trial Centers located across Australia for the world-first study to obtain detailed and thorough feedback as part of a feasibility assessment prior to the submission of a Clinical Trial Application planned for Fourth Quarter this year. The world-first clinical study is a Phase 1b, open-label, dose escalation and dose expansion study of PRP in patients with advanced solid tumors. It will consist of a multicenter, open-label, two-part (dose escalation, Part A, and dose expansion, Part B) study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary activity of PRP in participants with advanced solid tumors. PRP will be administered as a weekly intravenous infusion (Days 1, 8, 15 and 22 of every 28-day treatment cycle). Treatment with PRP may continue until a withdrawal criterion is met. Part A will use a Bayesian Optimal Interval design with target dose limiting toxicity probability, with backfill allowed, to identify the maximum tolerated dose, if reached, and/or up to two recommended doses for optimization/expansion of PRP. Up to 5 dose levels are planned for escalation. Following determination of the recommended dose(s) in Part A, Part B will further evaluate the safety, tolerability, and preliminary antitumor activity of PRP at the selected doses into one or more tumor specific expansion cohorts. The design of the Phase 1b study has been undertaken with the Company’s research and development team, partners, and will be led by the Company’s appointed CRO, Avance Clinical. Many hours have been spent preparing the Company’s supporting documents incorporating scientific research, non-clinical and clinical evidence, formulation development and API purification, and manufacturing process development to be ready for the Phase 1b study. The Company will advance towards the submission of the Clinical Trial Application and commencement of the GMP manufacture of PRP this year. Metastatic cancer remains the single most common cause of death among sufferers from solid tumors. Announcement • Aug 13
Propanc Biopharma Provides Scientific Comparison Of Lead Candidate PRP With RAS-Targeted Approaches And Highlights PRP As Potential Long-Term Therapy Of Choice For Aggressive Cancers Propanc Biopharma provided a scientific comparison of its lead candidate PRP with the RAS-targeted approaches of Revolution Medicines, Inc. and Erasca, Inc. PRP’s unique mechanism—promoting cancer cell differentiation, reversing epithelial-mesenchymal transition (EMT), and targeting cancer stem cells via pancreatic proenzymes—positions it as a potential long-term therapy of choice, particularly for aggressive, treatment-resistant cancers such as pancreatic ductal adenocarcinoma (PDAC). PRP is a proprietary fixed-ratio combination of pancreatic proenzymes trypsinogen and chymotrypsinogen, administered once weekly by intravenous injection. Unlike cytotoxic agents or pathway inhibitors that directly kill dividing cells or block signaling, PRP activates upon administration to induce differentiation of malignant cells toward a more normal phenotype (cellular characteristics). Key effects include: Reversal of EMT, reducing invasive and stem-like properties of cancer cells. Suppression of metastasis, angiogenesis, and tumor microenvironment support (including effects on cancer-associated fibroblasts). Enhanced cell adhesion and promotion of natural cell death pathways. Favorable preclinical activity: >90%, mean tumor growth inhibition in orthotopic and patient-derived xenograft (PDX) models of advanced PDAC, marked reduction in metastatic burden (liver and peritoneum), and >2.5-fold extension of median overall survival versus controls (p < 0.001). PRP has also shown potential to resensitize chemo-resistant PDAC cells to standard agents such as gemcitabine/nab-paclitaxel at lower doses. PRP holds FDA Orphan Drug Designation for pancreatic cancer. Limited prior compassionate-use experience with related proenzyme formulations showed signals of prolonged survival in advanced solid-tumor patients without severe treatment-related adverse events. The Company is advancing toward a Phase 1b first-in-human study in up to 40 – 45 patients with advanced solid tumors (focus on PDAC and other high-unmet-need indications), with GMP manufacturing and clinical partnerships progressing in 2026. PRP operates at a different biological layer. By promoting differentiation and reversing EMT, it aims to reduce the reservoir of cancer stem cells responsible for resistance, dormancy, and dissemination. Preclinical data showing high tumor growth inhibition, metastatic burden reduction, survival extension, and potential chemo-sensitization support the hypothesis that PRP could serve as a backbone or sequential therapy—potentially enhancing durability when combined with RAS pathway inhibitors or used in maintenance settings where chronic, low-toxicity treatment is desirable. For patients with advanced or high-risk solid tumors – particularly those with limited options after progression on chemotherapy or targeted agents – PRP’s profile offers several potential advantages: Non-cytotoxic, a differentiation-based approach that may spare normal tissues while addressing the root drivers of metastasis and recurrence. Broad applicability across solid tumors (80–90% of cancers) without requiring specific RAS mutations. Favorable tolerability supporting long-term or intermittent use, critical for preventing relapse. Synergy potential with existing standards of care and emerging RAS inhibitors (chemo-sensitization data already observed). Orphan designation and focused development in PDAC, an indication with profound unmet need where both RVMD and Erasca are also active. Announcement • Aug 07
Propanc Biopharma Announces Positive Preclinical and Early Translational Data for Prp in Pancreatic Ductal Adenocarcinoma Models Propanc Biopharma, Inc. announced compelling new preclinical and translational data for its lead candidate PRP in pancreatic ductal adenocarcinoma (PDAC), one of the most aggressive and treatment-resistant solid tumors. In orthotopic and patient-derived xenograft (PDX) models of advanced PDAC, 3 times weekly intravenous PRP achieved: Greater than 90% mean tumor growth inhibition versus vehicle controls (p < 0.001). Marked reduction in metastatic burden in liver and peritoneum. Significant remodeling of the tumor microenvironment, including decreased cancer-associated fibroblast activity, reduced fibrosis, and suppression of epithelial-mesenchymal transition (EMT) markers. Enhanced sensitivity of chemo-resistant PDAC cells to standard-of-care gemcitabine/nab-paclitaxel, allowing lower chemotherapy doses while improving efficacy. Median overall survival extension of more than 2.5-fold in treated animals compared with controls. These results are built on previously reported >85% tumor growth inhibition data and peer-reviewed findings on PRP’s impact on PDAC fibroblasts. Translational analyses from limited prior compassionate-use experience with related proenzyme formulations further support a favorable safety profile and signals of prolonged survival in advanced solid-tumor patients. PRP is a proprietary fixed-ratio combination of the pancreatic proenzymes, trypsinogen and chymotrypsinogen, administered by once – weekly intravenous injection. The U.S. Food and Drug Administration previously granted Orphan Drug Designation to PRP for the treatment of pancreatic cancer. The Company has advanced manufacturing (GMP production targeted for late 2026), pharmacokinetics assay validation, and clinical partnerships, including a memorandum of understanding with Avance Clinical, to support efficient execution of the planned Phase 1b study in approximately 30 – 40 patients with advanced solid tumors. The global pancreatic cancer treatment market is projected to grow substantially in the coming years amid rising incidence and demand for therapies that address metastasis and resistance. Propanc believes PRP’s unique mechanism positions it as a potential complementary or alternative approach that could improve outcomes while offering a more favorable tolerability profile than many existing regimens. Further details of the new studies are expected to be presented at an upcoming scientific meeting. The Company remains focused on initiating the Phase 1b trial as rapidly as possible and generating the clinical data needed to advance PRP into proof-of-concept studies in PDAC and other high-unmet-need solid tumors. 
