Propanc Biopharma, Inc., a biopharmaceutical company focused on developing innovative treatments for patients suffering from recurrent and metastatic cancers, is excited to announce a shareholders update. In preparation of the upcoming filing of the Form 10-K Annual report, the company has revealed some of their plans for 2023/24.
This includes their ambitious undertaking of the Phase Ib, First-In-Human (FIH) study inspired by their lead product candidate ‘PRP’, which will be used to trial it on patients with advanced solid tumors. It is clear even at this early stage, that the company is entering a transformational phase.
Propanc’s Chief Executive Officer, James Nathanielsz, has expressed growing optimism heading into the new financial year. The company is set to enter clinical development with PRP, an innovative therapy for the treatment and prevention of metastatic cancer, without the severe side effects such as hair loss, nausea, and immune suppression which come with standard therapies.
With a strong IP portfolio featuring 76 patents filed in major global jurisdictions, and a share capital restructure allowing for more financing options, Propanc is ready to further develop their R&D activities and start leveraging strategic partnerships to commercialize PRP. The company is eager to collaborate with both investors and shareholders in order to maximize the therapeutic benefits of PRP for those suffering from this incurable disease.
PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (US FDA) for treatment of pancreatic cancer.
POPIOM is developing a revolutionary solution for the treatment and prevention of metastatic cancer – PRP. This novel therapeutic approach targets and eradicates cancer stem cells, making it less toxic than standard treatments, such as chemotherapy and radiotherapy.
Moreover, the Company is partnering with the Universities of Granada and Jaén to develop a fully synthetic alternative to PRP known as POP1, as well as investigate future applications of PRP as a chemosensitizer to combat chemoresistant solid tumors.
The Company’s IP portfolio has seen major strides in both North America and Europe. A foundation patent, granting composition claims for PRP, has been successfully validated in the Canadian Intellectual Property Office. On top of that, the dosing patent relating to PRP has been validated in 12 European countries.
Furthermore, the method to treat cancer stem cells (CSCs) using PRP has been granted a patent by the United States Patent and Trademark Office and a notice of allowance from the European Patent Office. Drawing from these accomplishments, the Company has launched discussions with potential partners, including Australia’s largest cancer research institute, a merged group of hospitals located in the Andalusian region of Spain, and a multi-billion-dollar, global, biomedical company with over 50,000 employees.
These collaborations will provide the resources to catapult PRP into clinical development and pave the way for its future commercialization. Laboratory studies at the University of Jaén, Granada, Spain have also confirmed downregulation of chemoresistant genes in PRP-treated pancreatic tumor cells, a testament to the therapeutic potential of this promising treatment.
Propanc recently achieved the milestone of a 1:1000 reverse stock split, with the newly adjusted shares trading on Tuesday, May 23, 2023. This was followed by a successful warrant exercise from a lead investor whom the company has recently raised an additional $2.25 million from. Management is actively looking for further operating capital and is planning to negotiate with the lead investor accordingly. Moreover, Propanc is also finalizing negotiations with another investor for a $5 million equity line of credit which will be provided through a resale S-1 registration statement.
PRP Drug Development Program:
Propanc seeks to compile the Investigational Medicinal Product Dossier, study proposal, and Investigator’s Brochure in 2023 with the goal of constructing a clinical trial application for submission. With sufficient capital, Propanc will launch a Phase Ib, FIH study to evaluate the safety, pharmacokinetics, and anti-tumor efficacy of their cancer-targeting PRP system. The trial is intended to involve people with advanced solid tumors and is scheduled to commence in early 2024.
POP1 Joint Research & Drug Discovery Program:
After an extensive assessment of naturally derived proenzymes trypsinogen and chymotrypsinogen from animal sources, researchers have devised a way to create a fully synthetic recombinant version of PRP. This version is currently undergoing preclinical studies to compare its safety and efficacy profiles to that of the natural compound, with results projected to be available in the 2023 and 2024 calendar years. In the event of successful trials, this alternative, recombinant version of PRP can be used as an additional clinical compound.
Propanc has made impressive progress, having raised over $23 million and propelling its lead asset to clinical development and a preclinical second compound. With a burgeoning IP portfolio, the Company is now eyeing strategic collaborations to further its mission and realise significant commercial value arising from future R&D milestones. This pursuit of progress is backed by an estimated combined market size of $18.1 billion for the Company’s target therapies PRP, pancreatic and ovarian cancers, by 2029, according to global research entities.
About Propanc Biopharma, Inc.
Propanc Biopharma, Inc. (the “Company”) is developing a novel approach to prevent recurrence and metastasis of solid tumors by using pancreatic proenzymes that target and eradicate cancer stem cells in patients suffering from pancreatic, ovarian, and colorectal cancers.
The Company’s novel proenzyme therapy is based on the science that enzymes stimulate biological reactions in the body, especially enzymes secreted by the pancreas. These pancreatic enzymes could represent the body’s primary defense against cancer.
Today, we are thrilled to announce a strategic partnership, financing activity, and planned study that will help propel TandemX Technology into the future! However, there are certain risks and uncertainties involved that could potentially impact our ability to successfully execute our business strategy.
Some of these include competing with other companies, securing financing, and obtaining any necessary regulatory clearances for our technology applications. Nonetheless, we are confident in our ability to turn our grand plans for the company into a reality and are confident that our technology will stay one-of-a-kind through the patent process.