Propanc Biopharma, Inc. (Nasdaq: PPCB) entered into a service agreement with German contract development organization FyoniBio GmbH on March 10 2026 to develop and validate a liquid chromatography‑mass spectrometry (LC‑MS) pharmacokinetics (PK) assay for its lead candidate PRP.
The LC‑MS method will quantify PRP’s two proenzymes—trypsinogen and chymotrypsinogen—and their activated forms in human serum, with a sensitivity of at least 0.1 µg/mL. The assay will be used during the planned Phase 1b first‑in‑human study in advanced solid‑tumor patients, enabling measurement of systemic exposure and assessment of safety and tolerability.
"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.
PRP is a proenzyme therapy designed to target cancer stem cells and prevent recurrence and metastasis. The candidate consists of trypsinogen and chymotrypsinogen in both proenzyme and activated forms, and it has received FDA Orphan Drug Designation for pancreatic cancer in 2017. The therapy is being developed for pancreatic, ovarian, and colorectal cancers.
Propanc’s financial profile includes a market capitalization of approximately $2.1–$2.7 million as of early March 2026, a $4 million raise following its Nasdaq up‑listing, and a private placement facility of up to $100 million. These resources support ongoing development activities, including the current PK assay project.
By securing a validated PK assay, Propanc removes a key technical barrier to clinical testing and positions itself to initiate the Phase 1b study in the fourth quarter of 2026. The milestone signals to investors that the company is actively advancing its pipeline despite broader financial challenges, and it provides a concrete step toward generating the first human safety data for PRP.
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