Propanc Advances Historic Enzyme Therapy to Pivotal Human Cancer Trial

MELBOURNE, Australia – January 13, 2026 – Propanc Biopharma (Nasdaq: PPCB) is set to advance a cancer therapy concept with roots stretching back more than a century into a modern clinical setting. The company announced plans to initiate a Phase 1b First-In-Human (FIH) clinical study for its lead product, PRP, a treatment designed for patients with advanced solid tumors who have exhausted other options.

This pivotal trial, slated to begin in 2026, will be conducted at the prestigious Peter MacCallum Cancer Centre in Melbourne, Australia’s largest cancer hospital. The study aims to enroll 30 to 40 patients, marking a critical step in translating years of preclinical research into potential human application. The move follows a significant period of groundwork in 2025, which, according to CEO and Cofounder Mr. James Nathanielsz, has positioned the company for meaningful growth.

“Our management and R&D teams enter this next phase of development with a high level of confidence,” Mr. Nathanielsz stated in a recent shareholder update. “Our responsibility is to advance PRP through a carefully designed, efficient, and robust clinical program that prioritizes patient safety and maximizes the likelihood of success.”

A Century-Old Concept Reimagined

At the heart of Propanc’s strategy is PRP, a fixed-dose combination of two pancreatic proenzymes: trypsinogen and chymotrypsinogen. While the formulation is modern, the idea is not. The therapeutic use of pancreatic enzymes to treat cancer was first proposed over 100 years ago by Professor John Beard of the University of Edinburgh. In the early 20th century, Beard theorized that these enzymes were the body's primary defense against cancer, and early reports published in respected journals documented remarkable outcomes from trypsin injections. However, the therapy fell out of favor due to inconsistent results and a lack of scientific refinement.

Propanc has invested over $30 million to resurrect and rigorously validate this historical concept. The company's extensive research suggests that PRP acts as an 'EMT (epithelial to mesenchymal transition) modulator,' selectively targeting cancer stem cells—the stubborn, therapy-resistant cells believed to drive cancer recurrence and metastasis. Unlike conventional chemotherapy that directly kills cells, PRP is thought to induce differentiation, essentially normalizing malignant cells and causing them to die off naturally. This mechanism, according to the company, has resulted in no severe or serious treatment-related side effects in preclinical studies to date.

Supporting this scientific rationale is a growing body of peer-reviewed research. Propanc recently had its fifth scientific paper accepted for publication in Scientific Reports, an online journal from the Nature portfolio. The study, titled "Impact of pancreatic proenzymes on pancreatic ductal adenocarcinoma associated fibroblasts," demonstrated PRP's potential to disrupt the tumor microenvironment, a complex ecosystem that supports tumor growth and spread. This adds to previous publications that showed PRP's ability to suppress pancreatic cancer stem cell populations in laboratory and animal models.

The Path From Lab to Clinic

The journey to the clinic is paved with critical logistical and regulatory milestones. Following its uplisting to the Nasdaq, Propanc raised $4 million, which is now being deployed to fund essential trial preparations. These activities include the complex manufacturing of the clinical-grade PRP drug product, the validation of a bioanalytical method to measure the drug's levels in patients' blood, and the preparation of the formal clinical trial application for ethics committee submission at the Peter MacCallum Cancer Centre. The company anticipates completing these preparatory steps by the third quarter of 2026.

While the scientific promise is compelling, the company's financial position presents a more complex picture. Trading near its 52-week low with a market capitalization under $6 million, Propanc has faced shareholder inquiries about its stock performance. The company has not generated revenue and financial analysis indicates a state of financial distress. However, Propanc has secured a significant financing agreement with Hexstone Capital LLC for up to $100 million in convertible preferred stock, with an initial $1 million tranche already received. This, along with a recent strategic decision to acquire companies holding digital assets like Bitcoin and Ethereum, suggests a proactive and diversified approach to shoring up its long-term financial foundation.

Mr. Nathanielsz addressed the market dynamics directly, emphasizing a focus on execution over short-term volatility. “Short-term market and trading dynamics can influence share price movements; however, our focus remains firmly on executing our long-term strategy and delivering meaningful clinical and scientific progress,” he affirmed.

Beyond Cancer: A Diversified Future

Propanc’s ambitions extend beyond its initial focus on oncology. The company is actively expanding its research into other areas with high unmet medical needs, most notably fibrosis. This strategic diversification targets a multi-billion-dollar global market and leverages the potential anti-fibrotic properties of its proenzyme technology. This expansion is backed by new provisional patent applications aimed at treating both resistant cancer and fibrosis, stemming from its long-standing research collaborations with the Universities of Jaén and Granada in Spain.

Further strengthening its pipeline is the development of Rec-PRP, a world-first, fully synthetic recombinant version of its lead product. This next-generation therapy is being designed for enhanced efficacy and improved room-temperature stability. Such an advancement could overcome cold-chain logistical challenges, improving global access, and potentially lowering costs through more scalable manufacturing. Both PRP and Rec-PRP are envisioned as periodic injections that would not require hospital admission, positioning them as potentially convenient and cost-effective options for chronic disease management.

This forward-looking pipeline is protected by a robust intellectual property portfolio of over 90 issued patents. Recent patent grants in major jurisdictions, including the United States, Europe, and Canada, provide strong composition of matter claims for PRP, which are considered the highest level of protection as the company moves toward commercialization. As Propanc stands on the cusp of human trials, its multi-pronged strategy—advancing its lead candidate, expanding its therapeutic targets, and developing a next-generation product—signals a determined effort to transform a century-old scientific curiosity into a modern medical reality.