Propanc Biopharma Advances Clinical Development Preparation for PRP Phase 1b First-In-Human Study in Up to 50 Advanced Cancer Patients
Human Research Ethics Submission Deadline Nov ‘26 with Site Initiation Activities Followed by First Patient Screening Planned for Feb ‘27
MELBOURNE, Australia, Oct. 28, 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 announced it is advancing its clinical development program for PRP (Company Code Name: PPC-001, Propanc Proenzyme Combination) its investigational proenzyme-based therapeutic candidate, as the Company preparations continue for its planned Phase 1b, First-In-Human study in up to 50 advanced cancer patients with solid tumors. Several key workstreams are underway, including clinical trial protocol development, preparation of the Investigator’s Brochure (IB), clinical site feasibility assessments, vendor selection, and regulatory and Human Research Ethics Committee (HREC) submission plans.
These activities support the Company's preparations for the next phase of clinical development, with particular emphasis on finalizing the documentation, operational infrastructure and regulatory requirements necessary to initiate the proposed study. The Company's clinical development activities are progressing across several interconnected workstreams:
- Clinical documentation: Preparation of the final clinical protocol and Investigator’s Brochure is ongoing, with final protocol documentation targeted for early November 2026.
- Investigator’s Brochure: Finalization is progressing, with additional stability information relating to clinical samples and the clinical formulation scheduled for incorporation during November.
- Clinical site preparation: Site feasibility and identification activities are progressing well with a first meeting scheduled alongside site budget negotiations and collection of essential regulatory documentation.
- Clinical operations: Vendor selection and contracting activities are progressing, together with the preparation of study plans and clinical data management systems.
-
Ethics and regulatory submissions: The current project schedule targets the first-site ethics submission process during November 2026, followed by regulatory activities in January 2027.
The Company currently targets February 2027 for its first clinical site initiation visit followed by its first patient screening, subject to completion of the necessary clinical, regulatory, ethics and operational requirements.
“The continued advancement of these activities represents an important step towards transitioning PPC-001 from preclinical development into clinical evaluation in patients with advanced cancer,” said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. “We are contacting multiple sites across Australia, and providing prospective clinical investigators a single, source-traceable account of the scientific rationale and the non-clinical and prior clinical evidence supporting PPC-001, together with the strategy for the proposed First-In-Human Study. I am pleased to confirm that we are fielding strong interest in participating in and acting as lead investigators to support the HREC for the world-first investigation into PPC-001 as a long-term therapy for the treatment and prevention of metastatic cancer. The Propanc management team are expending every effort to rapidly progress PPC-001 into the clinic, and these near-term milestones are expected to be transformative for the Company, its shareholders and ultimately, we hope for patients and their families as well.”
What is PRP and are proposing:
- Investigational product: PRP, trypsinogen and chymotrypsinogen A in a fixed 1:6 ratio (w/w), once weekly intravenous infusion; drug substances naturally derived.
- Therapeutic hypothesis: Not cytotoxic. Differentiation of the malignant phenotype, depletion of the stem-like subpopulation and modification of the tumor stroma.
- Lead indication: Pancreatic ductal adenocarcinoma; US FDA Orphan Drug Designation status achieved in pancreatic cancer.
- Proposed study: Phase 1b, multicenter, open-label, two-part dose escalation and expansion in advanced or metastatic solid tumors.
- Design logic: Backfill Bayesian optimal interval escalation; recommended dose selected on toxicity, delivered dose intensity, exposure and target engagement; expansion at up to two doses.
- Prior human experience: 46 patients given the predecessor proenzyme formulation JBp1 under a UK Specials License Scheme.
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.
Company:
Propanc Biopharma, Inc.
James Nathanielsz
+61-3-9882-0780
info@propanc.com
Investor Contact:
irteam@propanc.com
Released October 28, 2026