Propanc Biopharma Advances Bioanalytical & Immunogenicity Assay Development for Phase 1b First-In-Human Study in up to 50 Advanced Cancer Patients

Laboratory findings support continued assay optimization and pre-validation work ahead of the planned clinical study.

Rhea-AI Summary

Propanc Biopharma (Nasdaq: PPCB) is advancing analytical development for its planned Phase 1b first-in-human PPC-001 study in up to 50 patients. The planned study targets advanced cancer patients with solid tumors.

Testing detected both proenzyme components, trypsinogen and chymotrypsinogen, without evidence of significant degradation during investigated handling periods. Follow-up testing covered three human donors; September testing showed recovery generally exceeding 85% after 60 minutes at room temperature. Mass spectrometry measured both components in serum and plasma. Labelled reagents showed no detectable degradation under tested labelling conditions or after one day at 4°C.

Feasibility work continues on two anti-drug antibody assays, which measure immune responses to treatment. Assay establishment and validation depend on successful feasibility assessment. Propanc plans further optimization of methods measuring drug components in clinical samples.

Positive

• Minor pointAnalytical development is advancing for a planned Phase 1b PPC-001 study in up to 50 advanced cancer patients.
• Minor pointBlood-sample testing found no significant component degradation; follow-up covered three donors, with September recovery generally exceeding 85% after 60 minutes.
• Minor pointMass spectrometry successfully measured both proenzyme components in human serum and plasma.
• Minor pointLabelled assay reagents showed no detectable degradation under tested labelling conditions or after one day at 4°C.
• Minor point. Forward-looking: it has not happened yet and may not happen.Propanc plans bioanalytical method optimization to improve sensitivity and reduce sample analysis time.

Negative

• Minor pointDevelopment of two anti-drug antibody assays remains at feasibility assessment; establishment and validation depend on successful assessment.

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Details

Market move: PPCB -5.21% vs previous close. Phase 1b assay development

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$1.96 – $2.15 Day Range

$2.07M Mkt Cap at Last Price

On Oct 30, the day this news came out, the latest delayed price for PPCB is 5.21% below the previous close. Argus tracked a trough of -1.5% from its starting point during tracking. Our momentum scanner has recorded 3 alerts for this stock so far that day. The latest delayed price is $2.00. Relative volume is above average at 1.6x the average.

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Key Figures

Planned study enrollment: Up to 50 patients Human donors: 3 donors Sample recovery: Generally >85% +1 more

Planned study enrollment

Up to 50 patients

Phase 1b First-In-Human study in advanced cancer patients with solid tumors

Human donors

3 donors

Serum and plasma stability follow-up experiments

Sample recovery

Generally >85%

After 60 minutes at room temperature in the September study

Reagent stability interval

1 day at 4°C

Labelled assay reagents showed no detectable degradation under tested conditions

Previous Clinical trial Reports

2 past events · Latest: Oct 28

Same Type 2 events

1. Oct 28

   Clinical trial preparation

   24h Move

   -13.2%

   Outlined Phase 1b protocol, site-preparation timelines, and targeted first-patient screening in February 2027.

2. Sep 09

   Clinical trial preparation

   24h Move

   -3.9%

   Set out planned Phase 1b trial and underway PK validation and anti-drug antibody assay preparations.

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

Key Terms

immunogenicity assay, pharmacokinetic, lc-ms, sds-page, +1 more

5 terms

immunogenicity assay medical

"including immunogenicity assay feasibility"

A laboratory test that measures whether and how a patient’s immune system responds to a therapeutic biological product by detecting immune markers such as anti‑drug antibodies or cellular responses. Immunogenicity assays typically report whether antibodies that bind the drug are present (binding assays) and, in some cases, whether those antibodies block the drug’s function (neutralizing assays); they use controls and thresholds to classify results but can vary in sensitivity and may not fully predict clinical effects. Regulators require these assays during development and post‑marketing to monitor immune responses that could affect safety or efficacy.

pharmacokinetic medical

"pharmacokinetic method optimization and stability testing"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

lc-ms technical

"LC-MS-based analytical methods were used to measure both proenzyme components"

LC-MS is a laboratory method that first separates a mixture into its individual chemical components using liquid flow, then measures each component’s weight to identify and quantify it. For investors, LC-MS acts like a high-precision barcode scanner for molecules: it provides hard evidence about a product’s composition, purity and contaminants, which affects regulatory approvals, product quality, manufacturing risk and potential liability.

sds-page technical

"with no degradation observed by SDS-PAGE under the tested labelling conditions"

SDS-PAGE is a laboratory method for separating proteins by size using an electric field to pull protein molecules through a porous polyacrylamide gel; proteins are first treated with sodium dodecyl sulfate (SDS) which denatures them and gives them a uniform negative charge so migration distance mainly reflects molecular weight. After electrophoresis, protein bands can be visualized with stains or transferred to membranes for further analysis; the technique estimates relative size but does not prove a protein's biological activity or precise identity without additional assays.

anti-drug antibody medical

"supporting continued development of anti-drug antibody (ADA) assays"

Antibodies produced by a patient’s immune system that recognize and bind a therapeutic biological drug (such as a recombinant protein, monoclonal antibody, or enzyme). These immune proteins can block the drug’s intended activity, speed its removal from the body, or cause side effects, so they affect how well a treatment works, its safety profile, dosing needs, and regulatory or commercial prospects—like neutralizers that reduce a medicine’s intended effect.

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MELBOURNE, Australia, Oct. 30, 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 that key analytical development activities are underway, including immunogenicity assay feasibility, pharmacokinetic method optimization and stability testing, supporting preparations for the planned Phase 1b, First-In-Human study of the Company’s lead clinical candidate, PPC-001, in up to 50 advanced cancer patients with solid tumors.

“Propanc continues to advance its analytical development activities in parallel with preparations for its Phase 1b First-In-Human study,” said Dr. Ralf Brandt, Propanc’s Research & Development Director. “The ongoing feasibility assessment of immunogenicity assays, together with the planned optimization of pharmacokinetic bioanalytical methods and stability testing, represents an important component of the Company's clinical development strategy.”

Key achievements include:

• Encouraging stability results for PPC-001 in human blood matrices: Bioanalytical studies demonstrated that the two proenzyme components of PPC-001, trypsinogen and chymotrypsinogen, remained detectable without evidence of significant degradation over the investigated sample-handling periods.
• Stability demonstrated across three human donors: Follow-up experiments conducted by FyoniBio evaluated serum and plasma samples from three individual donors, strengthening the initial feasibility findings.
• Stability over 60 minutes at room temperature: The September study demonstrated recovery results generally exceeding 85% after 60 minutes, supporting the feasibility of clinical blood sample collection and processing procedures.
• Successful application of mass spectrometry: LC-MS-based analytical methods were used to measure both proenzyme components in human serum and plasma, providing a foundation for further development of pharmacokinetic assays.
• Progress in immunogenicity assay development: Laboratory experiments demonstrated successful preparation of biotin- and sulfoTAG-labelled trypsinogen and chymotrypsinogen reagents, with no degradation observed by SDS-PAGE under the tested labelling conditions.
• Additional evidence of short-term reagent stability: Labelled assay reagents showed no detectable degradation by SDS-PAGE following storage for one day at 4°C under the tested conditions, supporting continued development of anti-drug antibody (ADA) assays.
  
  

Advancement toward clinical bioanalytical readiness – together, these findings support continued assay optimization and pre-validation activities required for the planned clinical development of PPC-001 and are structured in the three key areas based on the unique properties of treatment. These activities are expected to provide the analytical foundation required to support the evaluation of PPC-001 during its clinical development program.

1. Anti-Drug Antibody Assay Development: The feasibility assessment for the development of two ADA assays, targeting the individual proenzyme components trypsinogen and chymotrypsinogen, is currently underway. The feasibility program is evaluating the suitability of existing positive control antibodies to support the development of reliable immunogenicity assays. Following successful feasibility assessment, the program is scheduled to progress to assay establishment and subsequent validation.
2. Pharmacokinetic Bioanalytical Method Development: The Company has established a structured analytical development program aimed at optimizing the sensitivity and performance of bioanalytical methods for measuring PPC-001 components in clinical samples. The program includes the evaluation of stable isotope-labelled peptides as internal standards, strategies to minimize biological matrix effects, and optimization of sample volumes to improve analytical sensitivity. Additional activities will focus on reducing sample analysis time and establishing a suitable analytical method for subsequent clinical application.
3. Stability Assessment and Analytical Support: Stability testing activities covering the drug product and its analytical characteristics are included in the development program. The analytical program is intended to generate the data necessary to support appropriate sample handling, analytical reliability and clinical bioanalytical assessments.
   
   

“The work undertaken led by Dr Ralf Brandt, our R&D Director, his team, and our partner CRO is of a high standard and provides an excellent framework for our world-first study for PPC-001 in advanced cancer patients,” said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. “PPC-001, a combination therapy consisting of two pancreatic proenzymes from naturally derived sources is a unique approach to cancer treatment which has the capacity to reverse the effects of cancer cell dissemination and recurrence. By undertaking these important bioanalytical activities, we are going to obtain great insight into the effects of PPC-001.”

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 is Propanc Biopharma preparing for its PPC-001 Phase 1b study?

Propanc is advancing analytical development for a planned first-in-human study in up to 50 advanced cancer patients with solid tumors. Work includes anti-drug antibody assay feasibility, optimization of methods measuring drug components in clinical samples, and stability testing.

What did Propanc's PPC-001 blood-sample stability testing show?

September testing showed recovery generally exceeding 85% after 60 minutes at room temperature. Both proenzyme components remained detectable without evidence of significant degradation over investigated handling periods. Follow-up experiments evaluated serum and plasma from three individual donors.

How does Propanc plan to improve PPC-001 drug measurement methods?

Propanc plans to evaluate labelled peptide reference standards, reduce interference from biological samples, and optimize sample volumes to improve analytical sensitivity. Additional work will focus on reducing sample analysis time and establishing a method suitable for clinical use.