Melbourne, Australia — October 30, 2026
Propanc Biopharma, Inc. announced progress in analytical development activities supporting its planned Phase 1b first-in-human study of PPC-001, an investigational combination of pancreatic proenzymes being developed for patients with advanced solid tumors. The planned study is expected to enroll up to 50 patients. Current development work includes immunogenicity assay feasibility assessments, pharmacokinetic bioanalytical method optimization and stability testing. The company reported that its two proenzyme components, trypsinogen and chymotrypsinogen, remained detectable in human serum and plasma samples without significant degradation over the investigated sample-handling periods. Follow-up testing involving samples from three individual human donors produced recovery results generally exceeding 85% after 60 minutes at room temperature, supporting the feasibility of the proposed clinical blood sample collection and processing procedures. Propanc also reported progress in preparing labelled reagents for anti-drug antibody (ADA) assay development, with no detectable degradation under the tested laboratory conditions. These activities are intended to establish the analytical methods needed to evaluate PPC-001 exposure, stability and potential immune responses during clinical development. The company said the work is being conducted with support from its contract research organization (CRO) partner as it prepares for the planned clinical study.
Stability Testing Supports Clinical Sample Handling
Propanc’s initial bioanalytical studies evaluated the stability of trypsinogen and chymotrypsinogen in human blood matrices, an important requirement for reliable pharmacokinetic analysis. The company reported that both components remained detectable without evidence of significant degradation during the investigated sample-handling periods. Follow-up experiments conducted by FyoniBio used serum and plasma samples from three individual donors to further assess the initial findings. In a September study, recovery results generally exceeded 85% after 60 minutes at room temperature. These results provide preliminary support for developing clinical sample collection, transportation and processing procedures. The company also reported successful use of liquid chromatography-mass spectrometry (LC-MS) methods to measure both proenzyme components in human serum and plasma. This analytical approach is expected to form the basis for further pharmacokinetic method development. However, the reported findings represent analytical feasibility and stability assessments rather than validated clinical bioanalytical methods. Additional optimization and validation will be needed before the methods can be relied upon for formal pharmacokinetic assessments in the planned clinical study.
Immunogenicity and Pharmacokinetic Assay Development
A second major development area involves establishing assays to detect potential anti-drug antibodies (ADAs) against the two PPC-001 proenzyme components. Propanc reported successful preparation of biotin-labelled and sulfoTAG-labelled trypsinogen and chymotrypsinogen reagents. SDS-PAGE analysis showed no detectable degradation following the labelling procedures under the conditions tested. The labelled reagents also showed no detectable degradation after one day of storage at 4°C, supporting continued feasibility work for the proposed immunogenicity assays. The company is evaluating existing positive-control antibodies for their suitability in developing separate ADA assays targeting trypsinogen and chymotrypsinogen. Following successful feasibility assessments, the program is expected to progress to assay establishment and subsequent validation. In parallel, the pharmacokinetic bioanalytical program is focused on improving the sensitivity and performance of methods used to measure PPC-001 components in clinical samples. Planned activities include evaluating stable isotope-labelled peptides as internal standards, minimizing biological matrix effects, optimizing sample volumes and reducing analytical turnaround time. These steps are intended to improve the reliability and efficiency of measuring the investigational product in future clinical samples
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PPC-001 Clinical Preparation and Development Outlook
The ongoing analytical program is intended to provide the supporting infrastructure for the planned Phase 1b study of PPC-001 in up to 50 patients with advanced solid tumors. Propanc describes PPC-001 as a combination therapy containing two pancreatic proenzymes from naturally derived sources. The company’s broader development strategy focuses on targeting cancer stem cells through proenzyme activation, with the aim of addressing mechanisms associated with cancer recurrence and metastasis. Propanc Research and Development Director Dr. Ralf Brandt said the feasibility assessment of immunogenicity assays, pharmacokinetic method optimization and stability testing represents an important part of the company’s clinical development preparations. Chief Executive Officer James Nathanielsz described the analytical work as a foundation for the planned study and highlighted the company’s interest in evaluating the potential of its proenzyme-based approach in advanced cancer. The announcement did not provide a confirmed clinical trial start date, detailed patient eligibility criteria, dose-escalation design or clinical efficacy findings. The reported laboratory results therefore indicate progress in analytical readiness, not evidence of therapeutic benefit in patients. Further assay development, pre-validation and validation activities remain necessary to support the planned first-in-human evaluation.
Source:Propanc Biopharma Press release
