Propanc Biopharma Advances Clinical Development Preparation for PRP Phase 1b First-In-Human Study in Up to 50 Advanced Cancer Patients

The proposed trial would evaluate dose escalation and expansion, with expansion at up to two doses.

Rhea-AI Summary

Propanc Biopharma (Nasdaq: PPCB) is advancing preparations for a planned Phase 1b first-in-human study of PRP in up to 50 advanced cancer patients.

The proposed multicenter, open-label study would use dose escalation and expansion in advanced or metastatic solid tumors. Final protocol documentation is targeted for early November 2026, with additional stability information scheduled for the Investigator’s Brochure during November. Propanc targets first-site ethics submission in November, regulatory activities in January 2027, and first-site initiation followed by first patient screening in February 2027. That timing depends on completing clinical, regulatory, ethics and operational requirements.

Site assessments, vendor contracting and study systems preparation remain underway. PRP has US FDA Orphan Drug Designation in pancreatic cancer; pancreatic ductal adenocarcinoma is its lead indication.

5 points · 0 major

PositiveiHow this balance works

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0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.Phase 1b preparations advance toward a proposed study in up to 50 advanced cancer patients with solid tumors.
• Minor point. Forward-looking: it has not happened yet and may not happen.Final protocol documentation is targeted for early November 2026; brochure stability information is scheduled for November.
• Minor point. Forward-looking: it has not happened yet and may not happen.First-site ethics submission is targeted for November 2026, followed by regulatory activities in January 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Site initiation followed by first patient screening is targeted for February 2027.
• Minor pointUS FDA Orphan Drug Designation has been achieved in pancreatic cancer.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.February 2027 timing remains subject to completion of clinical, regulatory, ethics and operational requirements.

News Explained

The planned Phase 1b is PRP’s first-in-human study, while Propanc reports that 46 patients previously received its predecessor formulation, JBp1, under a UK Specials License Scheme.

Key Figures

Planned enrollment: Up to 50 patients First-site ethics submission: November 2026 Regulatory activities: January 2027 +4 more

Planned enrollment

Up to 50 patients

Phase 1b study in advanced cancer patients with solid tumors

First-site ethics submission

November 2026

Targeted submission milestone

Regulatory activities

January 2027

Planned activities following ethics submission

Site initiation and first screening

February 2027

Company target, subject to completion of required preparations

Prior human experience

46 patients

Received predecessor formulation JBp1 under the UK Specials License Scheme

Formulation ratio

1:6 (w/w)

Trypsinogen and chymotrypsinogen A in PRP

Administration schedule

Once weekly

Intravenous infusion

Previous Clinical trial Reports

2 past events · Latest: Sep 09

Same Type 2 events

1. Sep 09

   Phase 1b study planning

   24h Move

   -3.9%

   Outlined the Australia study plan, up-to-50-patient enrollment and ethics submission preparation.

2. Aug 18

   Phase 1b study preparation

   24h Move

   +0.9%

   Reported protocol finalization and feasibility work for an earlier up-to-40-patient study plan.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigator’s brochure, open-label, dose escalation, bayesian optimal interval, +2 more

6 terms

investigator’s brochure medical

"Preparation of the Investigator’s Brochure (IB)"

A document prepared by a drug or device sponsor that compiles all relevant preclinical and clinical information about an investigational product for investigators, ethics committees, and regulators. It summarizes what is known about the product’s safety, pharmacology, dosing, and potential risks and benefits, is distinct from the trial protocol, and is updated whenever new important safety or efficacy data emerge so those running or reviewing trials have the current evidence about the investigational therapy.

open-label medical

"Phase 1b, multicenter, open-label, two-part dose escalation"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

dose escalation medical

"two-part dose escalation and expansion in advanced or metastatic solid tumors"

Dose escalation is the process of gradually increasing the amount of a treatment or substance over time. In finance, it can refer to slowly raising investments or commitments to manage risk and assess performance. For investors, understanding dose escalation helps gauge how companies or strategies adjust their approaches, which can impact future growth or stability.

bayesian optimal interval technical

"Backfill Bayesian optimal interval escalation"

A Bayesian optimal interval is a statistical method used in early-stage clinical trials to decide whether a tested drug dose is too toxic, too weak, or acceptable by comparing observed patient outcomes to pre-set probability ranges. It uses Bayesian probability to update beliefs as data arrive and sets simple decision rules for dose escalation or de-escalation. Investors care because these rules affect how quickly and reliably a development program finds a safe, effective dose, which influences trial timelines, costs, and the chance a drug advances—think of it as a recipe that adjusts ingredients as you taste, to reach the right balance faster.

orphan drug designation regulatory

"US FDA Orphan Drug Designation status achieved in pancreatic cancer"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

intravenous infusion medical

"once weekly intravenous infusion"

Intravenous infusion is the delivery of fluids, medications or nutrients directly into a vein over a controlled period using tubing and often a pump—like giving a plant a slow, steady watering instead of one big splash. It matters to investors because many hospital treatments and advanced drugs must be made, tested and billed for this form of use; that affects production complexity, clinical trial design, regulatory approval and potential revenue.

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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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What study is Propanc Biopharma planning for PRP?

Propanc is preparing a Phase 1b first-in-human study in up to 50 advanced cancer patients with solid tumors. The proposed multicenter, open-label study has two parts: dose escalation and expansion, with expansion at up to two doses.

When does Propanc Biopharma plan to begin PRP patient screening?

Propanc targets February 2027 for its first clinical site initiation visit followed by first patient screening. This schedule is subject to completion of the necessary clinical, regulatory, ethics and operational requirements.

What prior human experience does Propanc report for PRP’s predecessor formulation?

46 patients received the predecessor proenzyme formulation JBp1 under a UK Specials License Scheme. That experience concerns JBp1, rather than enrollment in the proposed PRP first-in-human study.