TORONTO, ON / ACCESSWIRE / January 10, 2019 / The Wealthy Biotech Trader (or ''WBT''), an investment newsletter focused on showing everyday investors new opportunities in rapidly growing, little-known biotech, pharma, medical device stocks making news and subsequent market moves, would like to update investors on several breakthroughs in cancer therapies hitting the market.
Stock investors have soured on biotech companies over the past several months, as demonstrated by the SPDR S&P Biotech ETF (XBI), off 30% since June, and the NYSE Biotechnology Index (NYSE:NBI), which has dropped from 3500 in mid-2018 to just under 3000 at year-end, and a host of their component companies and others in addition. Still, there is innovation and competitive potential brewing in the market at publicly-traded companies that are flying below the radar. One of those is Propanc Biopharma, Inc. (OTCQB:PPCB), an Australian biotech company with strong management and technology that has the potential to help millions of cancer patients worldwide.
Propanc Biopharma, Inc. Company Overview
Propanc is a biopharmaceutical company developing new cancer treatments for patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers. Propanc has developed a formulation of anti-cancer compounds designed to control or prevent tumors from recurring and spreading throughout the body. Propanc's lead product candidate, PRP, utilizes proenzymes, which are the inactive precursors of the enzymes that drive essential processes throughout the human body. Propanc achieved Orphan Drug Designation status from the FDA for the treatment of pancreatic cancer, a niche indication with a significant unmet medical need. Propanc has completed preclinical development for PRP and intends to initiate a First-In-Human study this year.
Propanc's aim is to prevent tumor recurrence and metastasis, or growth, of solid tumors. Four out of five cancers are from solid tumors, and metastasis is the main cause of patient death. Propanc's unique patented approach is designed to target and eradicate cancer stem cells not killed by radiation or chemotherapy. This addresses a massive unmet need because cancer stem cells are resistant to standard treatments, remain dormant for long periods, then migrate to other organs, triggering explosive tumor growth that causes the patient to relapse.
It's a unique approach to oncology attempting to make current therapies work better and taking new approaches to treatment similar to Clovis Oncology, Inc. (CLVS), a smaller US-based biotech company developing several anti-cancer technologies.
Propanc's management brings decades of biotech experience to its technological development and its investors. Director and CEO James Nathanielsz has led the company since 2007, leveraging his twenty-plus years of experience in R&D, manufacturing and distribution, including more than more than fifteen years in oncology. UK-based Chief Scientific Officer (CSO) Dr. Julian Kenyon also serves as Director and is a Co-Founder of the company. His clinical background is deep, having held Primary Fellowship of the Royal College of Surgeons at Edinburgh for over forty years. He is the Medical Director of the Dove Clinic for Integrated Medicine, which he founded in 2000 to treat chronic illnesses with a range of complementary therapies. Chief Medical Officer Prof. Klaus Katz brings his own deep experience to Propanc: as Professor of Medicine at the University of Bonn, one of Germany's most important institutes of higher education; as head of clinical pharmacology at two multinational pharma companies, and as a consultant in clinical pharmacology and safety specializing in oncology for more than twenty years.
Partnership and Collaboration
No innovator stands alone, so Propanc benefits from a range of partnerships and collaborative agreements with well-known academic research centers and established companies around the world. It holds joint IP ownership and commercialization agreements with the University of Bath, a leading UK university with an international reputation for teaching and research excellence. In Spain, Propanc is leveraging a trio of strong institutional partnerships, with the University of Jaen, the University of Granada, and with FIBAO, a major health research institute in the Andalusia region. The company's joint research collaborations in Spain include participation in an oncology drug discovery program, screening of new compounds for therapeutic potential, translational research partnerships, and clinical development agreements that enable the Propanc's leadership to focus on getting novel treatments from the laboratory into the real world where they meet the needs of doctors and patients. To ensure that every ingredient in its products meets the highest standards, Propanc works with research organization Amatsi Biologicals to define and improve production and quality assurance processes for producing its products, purify active drug substances, and enable the company to analyze current and future products at the most exacting level of precision.
Biotech Industry Overview
Biotechnology is notoriously volatile as an investment class, owing in part to constant dynamic of declining prices of mature technologies and the changing pace of approvals of new products that could command a price premium. Every biotech company hopes to make its mark and its fortune by using biological systems or living organisms to create novel products for specific uses in healthcare. Key drivers of the industry include drug approvals, label expansion of existing high-profile drugs that make them applicable and available to more patients, movement of new technologies through clinical approval processes, and increased prevalence of diseases that are difficult to treat and therefore require more specialized and higher-cost therapies. Propanc is positioned to take advantage of these key drivers despite broader market weakness by leveraging its core technology and corporate leadership.
Defining Technology: PRP
Propanc is focused on making use of natural elements in the body to help fight cancer, specifically Pancreatic Enzyme Therapy. Pancreatic enzyme therapy is a century-old story, dating back to Professor John Beard who proposed that pancreatic enzymes represent the body's primary defence against cancer. Since then, scientific experts have endorsed Beard´s hypothesis with encouraging data from patient treatment. Propanc specifically concentrates on the development of PRP, a mixture of two proenzymes, trypsinogen (T) & chymotrypsinogen (C) from bovine pancreas. Combining T and C inhibits growth of most tumor cells, with success in ovarian and colorectal cancers as well as in pancreatic, kidney, breast, brain, prostate, lung, liver, uterine and skin cancers. It is clear that PRP is a biotechnology with wide-ranging potential across a range of patient types. The company already has strong indicators that PRP is an anti-CSC therapy. A significant percentage of pancreatic CSCs did not survive post PRP treatment in animal research. This is highly significant because suppressing CSCs reduces risk of tumor recurrence, thus prolonging life.
Many therapies proven in animals, as Propanc did with PRP, do not show efficacy in humans. What is most ingesting about Propanc's lead drug, PRP, is that it was used in a 46-person human compassionate use program in Europe with profound, positive results under less than optimal conditions, providing potential evidence of human efficacy. Now Propanc is taking the optimal ratio and dosing and moving it through the proper approval process to potentially become a drug based on this thesis validation.
PRP Suppresses Cancer Stem Cells (CSCs)
PRP has the dual effect of stopping tumor progression by genetically blocking malignant features of cancer stem cells and repressing the overall CSC population. PRP is a patented approach that Propanc is working to prove as an inhibitor of tumor metastasis and relapse both alone and in complementary use with conventional anti-cancer therapies: this gives PRP added value to the market. Propanc has demonstrated in vitro and in vivo that PRP dramatically reverses the epithelial-mesenchymal transition process, or EMT. EMT is a normal biological event during embryogenesis & organ development and is associated with wound healing & tissue repair. When EMT is turned on in CSCs, however, cancer cells lose contact with neighbouring cells and may potentially invade and metastasize, leading to life-threatening, out-of-control growth. When activated, the EMT program expresses specific genes whilst others are suppressed. PRP increases the production of certain genes in order to reverse the EMT program. By stopping EMT and turning it around, PRP halts tumor progression, and represses the population of CSC. Propanc is also testing its overall safety to patients and to healthy cells to make sure that only problematic cells are affected.
Anti-Cancer Stem Cell Therapy
CSCs are unique in that they do not replicate, and they are not killed by conventional therapies. In a normal cell, tumor suppressor genes act like guardians detecting mutations and preventing malignancies. In CSCs, these tumor suppressor genes are silenced, and in those cells the EMT program is switched on, promoting metastasis, which is the main cause of patient death from cancer.
The RAC1 gene is involved in controlling several cellular activities that let CSCs grow, and its hyperactivity has been detected in breast and pancreatic cancers. Increased PRP acts to balance RAC1 and induces cell differentiation, which may convert cancerous cells into normal cells. Evidence shows that colorectal & pancreatic cancer cells exhibit normal cell behavior, after treatment with PRP. In short, PRP catalyzes the return of tumor cells to normal pathways of a differentiated, non-cancerous cell.
Competitive Advantage and Strategy
Propanc has observed no adverse effects in applications of PRP, which does not target replicating cells and so should not affect healthy cells, thus suppressing undesirable effects from cancer treatment. Demonstrated non-toxicity is not something biotech investors can take for granted: December brought bad news for Surface Oncology, Inc. (SURF), with its lead drug hitting toxicity roadblocks in early-stage human studies. The stock took a hit but was still added to the NASDAQ Biotechnology Index later in the month. PRP achieves this by regulating the expression of genes that triggers dominant pathways that are turned on in CSCs but not turned on in healthy cells. Propanc believes that this guided approach actually forces CSCs to become benign. According to CSO Dr. Julian Kenyon, Propanc's years of studies show impressive evidence that adding PRP to CSCs makes many of them disappear. Dr. Kenyon is advancing several scientific publications as co-author, including ones on the antitumor efficacy of C and T, in vitro treatment of carcinoma cell lines with PRP to suppress EMT and promote cell differentiation, and on the pilot study of PRP in pancreatic and ovarian cancer.
Propanc holds intellectual property in four patent families covering several important discoveries regarding proenzymes and their anti-cancer effects: the pharmaceutical composition, broad proenzyme composition, cancer treatment using proenzymes, and composition of proenzymes for cancer treatment. A further two patent applications are in preparation covering composition of matter and method of use, specifically the use and combination of trypsinogen and/or chymotrypsinogen (T and C) as mentioned above and an active agent.
Propanc has completed scientific advice meetings with UK regulators and has received orphan drug designation from the FDA for treatment of pancreatic cancer. The company has completed major toxicity studies and is actively planning first-in-human studies in advanced cancer patients with solid tumors, as well as scale-up manufacturing in 2019. The company plans partnership discussions with large pharma companies during first-in-human studies, with clinical trial preparation and first-patient/first-visit kickoff of the trial period slated for Q4 2019.
A Great example of the benefits to a smaller biotech collaborating with a major is Mirati Therapeutics, Inc. (MRTX) and Bristol-Myers Squibb (NYSE:BMY). The pair are taking a look at the combination of Mirati's sitravatinib and Opdivo in certain lung cancer cases, launching a Phase 3 clinical trial in the first half of 2019.
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