Propanc Biopharma Executes Service Agreement with FyoniBio to Establish & Validate Pharmacokinetics Assay for Phase 1b First-In-Human Study
MWN-AI** Summary
Propanc Biopharma, Inc. (Nasdaq: PPCB), a biopharmaceutical company dedicated to developing innovative treatments for chronic diseases, particularly recurrent and metastatic cancer, has announced a strategic partnership with FyoniBio GmbH, a German Contract Development Organization. The service agreement, executed on March 10, 2026, aims to establish and validate a liquid chromatography-mass spectrometry (LC-MS) based pharmacokinetics (PK) assay. This will play a crucial role in Propanc’s upcoming Phase 1b, First-In-Human (FIH) study, which evaluates the safety and efficacy of their lead asset, PRP.
PRP consists of two proenzymes—trypsinogen and chymotrypsinogen—as well as their active forms, trypsin and chymotrypsin. The study will quantify the concentration of PRP and its components in the serum of patients with advanced solid tumors, aiding in the assessment of anti-tumor activity while monitoring patient safety and tolerability. The LC-MS PK assay is expected to achieve a maximum sensitivity of 0.1 µg/mL, allowing for effective tracking of PRP levels throughout the trial.
Dr. Ralf Brandt, Propanc’s Research and Development Director, highlighted that this PK assay is one of the three key activities leading to the initiation of the FIH study, alongside the Good Manufacturing Practice (GMP) production of PRP and the clinical trial application. He expressed confidence in FyoniBio’s expertise to assist in advancing Propanc’s biologics from early development to clinical settings.
Propanc’s innovative approach focuses on disrupting cancer recurrence by targeting cancer stem cells through proenzyme activation, aiming to mitigate cancer proliferation and metastasis. For further updates, investors and interested parties can visit the company’s website at www.propanc.com.
MWN-AI** Analysis
Propanc Biopharma (Nasdaq: PPCB) has recently executed a pivotal service agreement with FyoniBio GmbH to establish and validate a pharmacokinetics (PK) assay for its lead asset, PRP, in preparation for a Phase 1b First-In-Human (FIH) study targeting advanced cancer patients. This development is a crucial step in understanding the systemic effects and potential efficacy of PRP, which aims to combat cancer recurrence by targeting cancer stem cells.
Investors should note that the robust nature of the LC-MS PK assay, with a sensitivity of at least 0.1µg/mL, positions Propanc favorably for data collection during the FIH study. This validation enhances investor confidence, demonstrating that the company is actively working toward critical regulatory milestones, which include good manufacturing practices (GMP) for PRP and the clinical trial application.
Key performance indicators for Propanc will hinge on the outcomes of this study and the safety profiles established through the PK assays. Should the data support the efficacy of PRP, it could pave the way for further investment and potential strategic partnerships, essential for a biopharmaceutical firm's growth trajectory.
However, caution is warranted. The biopharmaceutical landscape remains unpredictable, affected by regulatory hurdles and market competition in the oncology space. Hence, while the forward-looking statements made by Propanc reflect optimism, they come with inherent risks typical of biotech firms.
In summary, while Propanc presents a compelling opportunity in the biopharmaceutical sector, potential investors should approach with due diligence, keeping abreast of developments surrounding the FIH study and how they translate into market performance. A balanced assessment of both the potential upside and the risks involved is essential for making informed investment decisions.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
MELBOURNE, 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 processes for the upcoming study which we plan to commence in the fourth calendar quarter of this year.”
About Propanc Biopharma, Inc.
Propanc Biopharma, Inc. (Nasdaq: PPCB) is developing a novel approach to preventing cancer recurrence and metastasis by targeting and eradicating cancer stem cells through proenzyme activation. The Company’s lead product candidate, PRP, is designed to address the underlying drivers of cancer proliferation and spread.
More information: www.propanc.com
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding its market position and market opportunity, expectations and plans as to its product development, manufacturing and sales, and relations with its partners and investors, made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections regarding its business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond the Company’s control. Forward-looking statements are not guarantees of future actions or performance. Actual results may differ materially from those in the forward-looking statements because of several factors, including, without limitation, risks and uncertainties related to market conditions, as well as those risks described under “Risk Factors” in the prospectus related to the proposed offering and those described in the Company’s filings with the SEC. The Company undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.
Company:
Propanc Biopharma, Inc.
James Nathanielsz
+61-3-9882-0780
info@propanc.com
Investor Contact:
irteam@propanc.com
FAQ**
How does the partnership with FyoniBio GmbH enhance the development capabilities of Propanc Biopharma Inc PPCB in validating its pharmacokinetics assay for the upcoming First-In-Human study?
What are the expected impacts of measuring the serum concentrations of PRP and its analytes on the treatment outcomes for patients in the First-In-Human study by Propanc Biopharma Inc PPCB?
Can you elaborate on the significance of the GMP manufacture of PRP and its timelines in conjunction with the clinical trial application for Propanc Biopharma Inc PPCB's Phase 1b study?
What key milestones should investors monitor in the near term regarding Propanc Biopharma Inc PPCB's development process as it approaches the Fourth Quarter launch of its First-In-Human study?
**MWN-AI FAQ is based on asking OpenAI questions about Propanc Biopharma Inc (OTC: PPCB).
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