Propanc Biopharma, Inc. Partners With FyoniBio GmbH To Develop LC-MS PK Assay For Lead PRP Therapy In First-In-Human Cancer Study

Propanc Biopharma, Inc., a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, announced that management has executed a service agreement with FyoniBio GmbH, a German Contract Development Organization (CDO) based in Berlin and formerly known as Glycotope, to establish and validate a liquid chromatography–mass spectrometry (LC-MS) based pharmacokinetics (PK) assay. 

This assay is designed to quantify the company’s lead asset, PRP, which consists of the proenzymes trypsinogen and chymotrypsinogen, as well as their activated forms, trypsin and chymotrypsin, in human serum during the Phase 1b, First-In-Human study in patients with advanced solid tumors.

The PK assay will play a critical role in the study by measuring the concentration of PRP and its analytes over time following administration to patients. This will allow Propanc to evaluate systemic concentrations of PRP that are expected to achieve anti-tumor activity, while simultaneously monitoring safety and tolerability. 

Secondary efficacy endpoints will also be assessed to guide the duration of treatment for patients who respond to therapy. The LC-MS PK assay is intended to provide a highly sensitive and robust method, capable of quantifying all four analytes in serum with a sensitivity of at least 0.1 µg/mL, ensuring accurate monitoring of PRP levels throughout the study.

Dr. Ralf Brandt, Research and Development Director at Propanc, noted that establishing and validating the PK method is one of three key activities leading up to this important milestone. The other two include the GMP manufacture of PRP and the submission of the clinical trial application, both of which are actively underway. 

He highlighted FyoniBio’s expertise in supporting biotech companies as they advance biologics from early development into clinical studies, expressing confidence that the method development work will translate into a fully validated PK assay to support informed decision-making during the upcoming First-In-Human study, which is planned to commence in the fourth quarter of this year.