Propanc Biopharma Engages European CDMO for GMP Production of PRP for Phase 1b, FIH Study in 30 – 40 Advanced Cancer Patients
Rhea-AI Summary
Propanc Biopharma (Nasdaq:PPCB) engaged a European CDMO to provide GMP production of PRP for a planned Phase 1b, first-in-human study in 30–40 advanced solid tumor patients. The CDMO offers end-to-end biologics services, including cell line generation, process and analytical development, and drug substance/product manufacturing. PRP will be given once-weekly by IV. Compassionate use data with a related suppository formulation indicated life extension in 19 of 46 terminal patients without severe or serious side effects. PRP holds US FDA Orphan Drug Designation for pancreatic cancer.
Positive
- European CDMO engaged for GMP manufacture of PRP
- Planned Phase 1b FIH trial in 30–40 advanced cancer patients
- CDMO provides end-to-end biologics development and manufacturing services
- Compassionate use data showed life extension in 19 of 46 patients
- No severe or serious side effects reported in compassionate use study
- PRP has US FDA Orphan Drug Designation for pancreatic cancer
Negative
- None.
News Market Reaction – PPCB
In the May 19 session, PPCB declined 2.20%, reflecting a moderate negative market reaction. Argus tracked a peak move of +10.1% during that session. Argus tracked a trough of -7.2% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 15 | Earnings & update | Positive | -7.0% | Q3 results plus financing and PRP development update; shares fell despite progress. |
| May 13 | Reverse stock split | Negative | -21.4% | 1-for-25 reverse split to support Nasdaq compliance; stock declined afterward. |
| Mar 24 | Research collaboration | Positive | -5.9% | New multi-year Spanish university collaboration on anti-aging and cancer research. |
| Mar 12 | Preclinical data PRP | Positive | -13.6% | Reported >85% tumor inhibition in pancreatic models and plans for Phase 1b FIH. |
| Mar 10 | Assay development deal | Positive | -20.5% | FyoniBio engaged to develop LC‑MS PK assay supporting planned Phase 1b FIH study. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent history shows PPCB often trading lower on generally constructive corporate and clinical updates, with the reverse split news aligning with a negative price reaction.
Over the last few months, Propanc has repeatedly highlighted progress toward a Phase 1b FIH trial of PRP. On Mar 10, it signed FyoniBio to build a PK assay, and on Mar 24 it expanded a multi‑year anti‑aging and cancer research collaboration in Spain. Preclinical data on Mar 12 showed >85% tumor inhibition, and a corporate/earnings update on May 15 detailed financing and balance sheet metrics. A 1‑for‑25 reverse split effective May 18 weighed on shares. Today’s CDMO engagement fits this steady march toward first‑in‑human testing.
Key Terms
cdmo technical
gmp regulatory
phase 1b medical
first-in-human (fih) medical
solid tumors medical
intravenous (iv) medical
compassionate use regulatory
orphan drug designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Provides End-To-End Services for Preclinical & Clinical Projects with Extensive Experience in Decoding Biologics Production
MELBOURNE, Australia, May 19, 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 a Contract and Development Manufacturing Organization (CDMO) has been engaged for the GMP manufacture of the Company’s lead asset, PRP, for the upcoming Phase 1b, First-In-Human (FIH) study in 30 – 40 advanced cancer patients suffering from solid tumors. Based in Europe, the CDMO provides end-to-end services for preclinical and clinical projects, with extensive experience in decoding biologics production (plasmid DNA and recombinant proteins) providing services of cell line generation, banking and characterization, analytical development, process development and batches production of both drug substances and drug products (decoding biologics production refers to the specialized process of understanding, optimizing, and controlling the manufacturing of complex medicines derived from living cells, such as proteins, vaccines, and monoclonal antibodies).
“After a thorough process, management are pleased to undertake this pivotal step for GMP production of PRP for the upcoming Phase 1 FIH clinical study which we plan to file the clinical trial application for later this year. Further, I am confident we have selected the right partner to execute our plan to enter early-stage clinical development, at the earliest opportunity,” said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. “PRP is a world first clinical study of proenzyme therapy by once weekly intravenous (IV) administration for the treatment of advanced cancer patients suffering from solid tumors. Management believes PRP is a first in class therapy which has the potential to enhance survival prospects for late-stage patients like recent clinical advancements observed with other candidates in the sector, such as KRAS inhibitors. Results from this upcoming trial can potentially be transformative for the Company, and its shareholders.”
Unlike most treatment approaches which kills cancer cells directly, PRP induces differentiation so that cells return towards a normal state and die off naturally. Compassionate use data from a study published in Scientific Reports, an online Nature journal, demonstrates a significant life extension of 19 from 46 terminal patients suffering from a range of solid tumors via a fixed combination of trypsinogen and chymotrypsinogen in a suppository formulation, administered once daily, without severe, or even serious side effects observed from treatment. The planned Phase 1b study for PRP administered once weekly intravenously will be at significantly higher doses based on non-clinical safety and tolerability studies, which translates to a safe starting dose in humans. PRP achieved Orphan Drug Designation status from the US Food and Drug Administration (USFDA) for the treatment of pancreatic cancer in 2017.
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
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