Announcement • Jun 11
Propanc Biopharma, Inc. (NasdaqCM:PPCB) announces an Equity Buyback for $5 million worth of its shares. Propanc Biopharma, Inc. (NasdaqCM:PPCB) announces a share repurchase program. Under the program, the company will repurchase up to $5 million worth of its shares. Announcement • May 22
Propanc Biopharma, Inc. Plans Clinical Trial Application for PRP in Advanced Cancer Patients Propanc Biopharma, Inc. announced that the Company’s CEO, Mr. James Nathanielsz, forecasts new medical breakthroughs in the fight against pancreatic cancer over the next decade. Recent developments in treatment reflect a level of progress that has been difficult to achieve in this field. Clinical stage companies like Revolution Medicines Inc. and Erasca Inc. have demonstrated significant advancements in this field. New clinical data from a late-stage trial targeting KRAS mutations, which are present in many pancreatic cancer cases, showed a meaningful improvement in overall survival. Patients receiving the targeted therapy lived approximately 13 months compared to about 7 months with standard treatment. For a disease where outcomes have remained largely unchanged for decades, this represents an important step forward. At the same time, additional data from combination therapy approaches are reinforcing a broader trend. In one study, a treatment designed to improve tumor penetration and support immune response increased one year survival rates to roughly 42%, compared to 22% with chemotherapy alone. These types of results are beginning to show that progress is more likely when multiple biological mechanisms are addressed together rather than in isolation. What stands out across these developments is not only the improvement in outcomes, but also what they reveal about the nature of pancreatic cancer. This is a disease driven by complex signaling pathways and supported by a highly resistant tumor environment. Targeting a single pathway, even one as important as KRAS, may not be sufficient on its own. Propanc’s lead asset, PRP, achieved Orphan Drug Designation status from the US Food and Drug Administration (USFDA) for the treatment of pancreatic cancer in 2017. Compassionate use data published in Scientific Reports, an online Nature journal, administering a once daily suppository of trypsinogen and chymotrypsinogen in a fixed combination of 8.92mg ea., resulted in 3 out of 4 patients significantly exceeding life expectancy from terminal pancreatic cancer with no severe or even serious side effects observed from treatment (2017). The Company plans to file a Clinical Trial Application (CTA) in Australia for a Phase 1b, First-In-Human, Maximum Tolerated Dose study in 30 – 40 advanced cancer patients suffering from solid tumors using PRP in an I.V. formulation administered once weekly later this year. It will be at significantly higher doses than the compassionate use study based on non-clinical safety and tolerability data translating to a safe starting dose in humans. After Phase 1 completion, the Company plans to then undertake two, Phase 2, 60 patient studies in pancreatic and ovarian cancers to establish proof of concept for each therapeutic indication. Announcement • May 21
Propanc Biopharma Engages European CDMO for GMP Production of PRP for Phase 1B, FIH Study in Advanced Cancer Patients Propanc Biopharma, Inc. 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). 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. 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. 
