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Propanc Biopharma Executes Service Agreement with FyoniBio to Establish & Validate Pharmacokinetics Assay for Phase 1b First-In-Human Study
A German CDO Supporting Biotech Companies Bringing Biologics from Early Development to Clinic MELBOURNE, Australia, March 10, 2026 (GLOBE NEWSWIRE) -- Propanc
About this update from Propanc Biopharma, Inc.
[{"type":"text","content":"A German CDO Supporting Biotech Companies Bringing Biologics from Early Development to Clinic\nMELBOURNE, Australia, March 10, 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 management has executed a service agreement with FyoniBio GmbH (formerly Glycotope, est. 2010), a German Contract Development Organization (CDO) based in Berlin for establishing and validating a liquid chromatography-mass spectrometry (LC-MS) based pharmacokinetics (PK) assay. The objective is to quantify the Company’s lead asset, PRP, consisting of two proenzymes trypsinogen and chymotrypsinogen, as well as their activated enzyme forms trypsin and chymotrypsin from human serum during the Phase 1b, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors. The purpose and design of the study will be used as an important tool to measure the concentration of PRP and its analytes over time upon administration to advanced cancer patients suffering from solid tumors. Results from the PK assay will evaluate the systemic concentration of PRP sufficient to expect anti-tumor activity in patients whilst carefully evaluating their response according to safety and tolerability parameters. Secondary efficacy endpoints will also be observed to support duration of treatment for responders. The LC-MS PK assay should offer a robust method to quantify all four analytes in patients’ serum with a maximum sensitivity of at least 0.1µg/mL, sufficient to monitor the concentration of PRP in patients during the FIH study. “Establishing and validating our PK method for the First-In-Human study is one of three key activities in preparation for this pivotal milestone. The other two are the GMP manufacture of PRP and clinical trial application for the study which we are actively undertaking,” said Dr Ralf Brandt, Propanc’s Research and Development Director. “FyoniBio provides expertise in assisting biotech companies bringing biologics from early development to the clinic. My clinical research team and I are confident that the method development work initiated will successfully translate into a fully validated method that will support our team’s decision-making proce...