Propanc Biopharma Engages FyoniBio for LC-MS PK Assay Ahead of Phase 1b Study
Propanc Biopharma signed a service agreement with FyoniBio to validate an LC-MS pharmacokinetics assay quantifying PRP proenzymes and activated enzymes in serum with ≥0.1 µg/mL sensitivity. The assay will enable PK profiling in the Phase 1b first-in-human study in advanced solid tumor patients.
1. Service Agreement with FyoniBio
Propanc Biopharma has executed a service agreement with FyoniBio GmbH to establish and validate a liquid chromatography-mass spectrometry (LC-MS) pharmacokinetics assay. This partnership leverages FyoniBio’s expertise in biologics development to prepare for First-In-Human trials.
2. LC-MS PK Assay Details
The validated assay will quantify PRP’s trypsinogen and chymotrypsinogen proenzymes along with activated trypsin and chymotrypsin in patient serum. It targets a minimum sensitivity of 0.1 µg/mL to accurately track systemic concentrations over time.
3. Impact on Phase 1b Study Preparation
By enabling precise PK profiling, the assay will support evaluation of PRP’s systemic exposure, safety, and preliminary efficacy in advanced solid tumor patients. These data will inform dose selection and treatment duration for responders.
4. Timeline and Next Steps
Alongside assay validation, Propanc is advancing GMP manufacture of PRP and preparing its clinical trial application. The company plans to initiate the Phase 1b first-in-human study in the fourth quarter of this year.