Xeophin Pty Ltd is based in Melbourne, Australia, and is a Biotech Company with a focus on Immunotherapeutic Protein based technologies, and is committed to the research, development and commercialisation of new and novel medical treatments, in a number of high growth therapeutic areas.
Our mission and vision are simple: “Take our core technologies and drive them through our six step process, with the outcome being a transaction ready and IP protected technology portfolio from which Xeophin will undertake commercialisation activities to provide value for our shareholders and key stakeholders”.
Rheumatoid arthritis is the most common type of immune mediated inflammatory disease which is triggered by a faulty immune system and mostly affects the wrist and small joints of the hand including the knuckles and the middle joints of the fingers. In this disorder, the body’s immune system, which normally protects the health of the individual, starts attacking foreign substances, like bacteria and viruses and mistakenly it attacks its own joints as well.
In cases where the inflammation goes unchecked, it can damage the cartilage and the elastic tissue that covers the end of bones in a joint as well as the bones themselves. Treatments have improved greatly and help many of those who are affected. For most people inflicted with rheumatoid arthritis, early treatment can control the joint pain and swelling, and lessen joint damage.
About 1.5 Million people in the United States have rheumatoid arthritis (RA). The occurrence of rheumatoid arthritis in women is nearly three times more prevalent than in men. In women, rheumatoid arthritis most commonly begins between 30yrs to 60yrs of age. In men, it often occurs later in life. Having a family member with rheumatoid arthritis increases the odds of you suffering from rheumatoid arthritis; however, the majority of people with rheumatoid arthritis have no family history of the disease.
Tumor Necrosis factor in
The symptoms of rheumatoid arthritis include joint pain, swollen joints, fever, limping, loss of range of motion, tender joints, loss of joint function, stiff joints, joints infirmity and many more.
It is well established that pro-inflammatory cytokines such as IL-6 and TNF-α, are involved in the pathogenesis of rheumatoid arthritis. Both TNF- α and IL-6 play dominant roles in the pathobiology of rheumatoid arthritis. TNF is a key mediator of cell migration and inflammation in rheumatoid arthritis.
Anti-TNF therapy induces a shift in the cytokine equilibrium producing less anti-inflammatory cytokines. Studies have demonstrated the improvement in the synovial inflammation in rheumatoid arthritis patients using Anti-TNF therapy.
Mechanism of Action
In the diagram below, we outline the how TNF acts at a cellular level, and how we believe Xeophin's XeRA-1 can be used to treat inflammatory conditions...
Click to expand
How our potential
There is a common misconception amongst Biotech investors that the end user of the therapeutic is the patients, or even the doctors prescribing to them. Whilst this is technically true, a more realistic perspective is that Big Pharma is the actual market. This is especially true for Boutique Biotech’s such as Xeophin. More specifically, the “market” is a handful of Business Development heads working within the Big Pharma’s.
The largest pharmaceutical companies spend almost a fifth of their revenue on Research & Development. A key component of this spend is on bringing in therapeutics and IP from smaller biotech’s via “deals”, with over 70% of their pipeline being created by companies like Xeophin.
The large pharmaceutical companies in this way, can be seen primarily as enormous marketing and distribution companies. The products are not necessarily developed in-house, but rather sourced from smaller private operations who serve to “de-risk” technologies.
Early discovery and pre-clinical work under taken by the smaller companies de-risk products to a point where success in clinical trials becomes high. Deals take place where the product and IP changes hands, and the Big Pharma can gain regulatory approval, then market and distribute the outcomes.
Market & Prevalence
The global pharmaceutical industry has experienced an unpredicted amount of challenges and changes over the past several years. Global market growth is trending down and the current pace is below the historical 5 year average. The slowing trend is noteworthy along with the stark contrast between the slowing overall growth of the developed markets of Europe and North America which are expanding at the rates below the 3% and the significantly higher growth rates of pharmaceutical markets in developing countries.
The total level of pharmaceutical revenue worldwide has reached nearly US$ 1 Trillion. North America is responsible for the largest portion and generating more than 40% of these revenues. This is mostly due to the leading role of the U.S. pharmaceutical industry. The other industries like the Chinese pharmaceutical sector shows the highest growth rates over the last years.
The leading pharmaceutical companies come from the United States and Europe. In 2013, Johnson and Johnson (J&J) was the largest pharmaceutical company based on annual revenues. J&J generated revenues of over US$70 Billion. The other top global players from the United States are Pfizer Merck & Co. and AbbVie. Novartis and Roche from Switzerland, GlaxoSmithKline and AstraZeneca from the United Kingdom, and French Sanofi are the European big five.
The total sales generated by anti-TNF drugs was 18% of the total therapeutic market revenue in 2015. Humira, generated over US$ 16 Billion of revenue worldwide. Oncologic continue to be the leading therapeutic class based on revenue. In 2015 the cancer drugs market surpassed US$ 100 Billion of revenue globally. Other major therapy classes were pain drugs, antihypertensives and antidiabetics.
Among all the diseases which are treated by the anti-TNF drugs, the rheumatoid arthritis disease market is the largest. Rheumatoid arthritis is a chronic, debilitating disease which affects around 2-3% of the world’s population.
The market for disease modifying rheumatoid arthritis therapeutics is expected to increase from US$ 56.6 Billion in 2013 to US$ 80.7 Billion in 2020, at a Compound Annual Growth Rate (CAGR) of 5.2%. First line Disease Modifying Anti Rheumatic Drugs (DMARDs) are expected to remain stagnant, as the late stage pipeline mainly constitutes the second line therapies. The high number of clinically and commercially strong products in the current market represents a barrier for the market infiltration of such emerging therapies.
The prevalence is expected to grow to just over 8.5 Million individuals by 2023. The anti-TNFs have been effective in treating the signs and symptoms of rheumatoid arthritis and inhibit progression to erosive bone diseases. Anti-TNFs are extremely effective therapies for rheumatoid arthritis and the market is extremely competitive for new entrants.
Market of Anti-TNF Blockbuster Drugs
Cytokine modulators, such as Rituxan and Xeljanz are growing in popularity as promising substitutes to TNF-α inhibitors. It is becoming far more difficult to find a place in this market for emerging companies and their candidate drugs. The three TNF specific monoclonal antibodies, Humira, Remicade and Enbrel, ranked among the ten best selling drugs in the world in 2015 and ranking in revenues amounting to US$ 14.01 Billion, US$ 8.3 Billion and US$ 9.47 Billion respectively. Appendix 1 outlines the global revenues for Enbrel, Humira and Remicade in 2015, 2016 and expected global revenues for these therapies in 2020. It also illustrates potential royalty revenues based on different royalty assumptions for these drugs.
Global - Top Anti-Rheumatic Drug Sales (US$ Million), 2015 & 2022
Each of the leading three anti-TNF therapies generated at least US$8.3B in global revenues in 2015.
Due to the different safety profiles of the anti-TNF compounds, some patients are forced to change their therapeutics strategy. Because of the differences in the site of action and molecular structures of each anti-TNF agent, individual patients have different responses. Patients may experience treatment failure with one anti-TNF agent due to the either inefficacy or toxicity.
Tumor Necrosis Factor as an Anti-Cancer Agent
Tumor necrosis factor has cytotoxic, cytostatic and immune-modulatory effects on malignant tumors. TNF acts as a chemotherapeutic drug which has been hampered by its deleterious side effects, including systemic shock and widespread inflammatory responses.
There are a number of mechanism by which the tumor necrosis factor induces the anticancer effect. TNF's antitumor role may involve immune responses that inhibit the tumor formation, for example by promoting the tumor stroma destruction by cytotoxic T lymphocytes (CTL) or tumor infiltrating macrophages and activating the tumor infiltrating dendritic cells (DCs), thereby activating a potent adaptive immune response leading to tumor rejection.
Due to the complicated role of TNF in carcinogenesis, more studies are needed to determine the mechanism behind the development of different cancers before TNF moderating approaches can be used for cancer prevention.
A UNIQUE OPPORTUNITY
There are 4 registered therapies targeting the TNF signalling pathway and they are all anti-bodies that act to suppress TNF cytokines and can affect the immune pathway. These therapies have various success rates with inflammatory diseases and over time most become ineffective as your body builds neutralising antibodies to these therapies.
Along with the reduced efficacy over time, there are also considerable safety issues that come with the use of these therapies, ranging from injection site reactions to disabling of the immune system significantly enough to allow serious infections to occur.
Xeophin’s XeRA-1 has the potential to be able to address the five main areas that healthcare regulatory bodies look at when comparing the effectiveness of drugs, which are:
- Efficacy – XeRA-1 is from a protein family that has shown in animal studies to be more than 10 times more potent than the current anti-TNF’s in suppressing TNF. This may translate into a more efficacious drug when treating inflammatory diseases. As XeRA-1 works differently to the current registered anti-TNF therapies we can target patients who are both responders and non-responders to the current antibody therapies;
- Safety – XeRA-1 is not an antibody therapy and it only suppresses the TNF pathway, leaving the other immune pathways open to allow your body to fight potential infections. This is different from how the other anti-TNF’s work as they suppress other immune pathways, allowing your body to be susceptible to serious infections. Given the potency that XeRA-1’s protein family has shown in animal studies we believe XeRA-1 may be able to be delivered in much smaller quantities than the current antibody therapies and this may provide a safer, more tolerable treatment for these patient groups;
- Cost of treatment – As XeRA-1 is not an antibody it has a much lower cost of manufacture, compared to the antibody technologies which can translate into a significantly cheaper therapeutic option;
- Route of administration – because of XeRA-1’s protein family’s superior potency it may be the first anti-TNF that can be delivered orally. This would be a significant marketing benefit given the competitor drugs are delivered either with injections administered by the patient or intravenously at a medical centre;
- Health-economic benefits – due to the increasing cost of the pharmaceutical reimbursement system in Western Countries Governments are increasing looking at ways to reduce the cost of healthcare. If XeRA-1 can be effectively and efficaciously delivered orally this would decrease significantly the cost to the health system as there would be no need for patients to attend medical centres to receive treatment. With a significant advantage of cost of manufacture this would allow pricing for XeRA-1 be very competitive in the market and w this would be seen as another benefit in reducing the cost of healthcare. Should XeRA-1 be more efficacious and/or safer than the existing anti-TNF therapies the improvement to the standard of care for patients would be seen as a significant benefit by the Healthcare authorities.
Travis Molloy BSc.
Travis’ background lies in over 15 years of Biotech and Pharmaceutical experience, ranging from research and pharmaceutical production in companies such as CSL, to executive and board positions in a range of Biotech’s. In parallel, Travis has consulted and worked on leadership, change management and executive development in companies such as BP, Standard & Poor, the Australian Defense Force and a range of other Australian top 500s.
Chief Executive Officer & Managing Director
Troy is an experienced and passionate Biotechnology Entrepreneur with a track record of successful start-ups and consultancy in Australia and abroad, in companies such as Tenix, Energex, Parsons Brinckerhoff and Worley Parsons. Transferring his skill set into Biotech in 2008, he has since influenced and created success as CEO, Director and Chairman, in a series of Biotechnology endeavours. Troy brings an excellent commercial and technical understanding from his many years in the Biotechnology and Pharmaceutical space to his role as Managing Director.
Chief financial Officer, Senior Vice President of Business Development & Collaborations
Jason has over twenty-five years experience in various Management, Executive and Board roles in diverse industries including extensive experience in both Board and Executive Management roles in listed Australian biotech companies. Jason has been responsible for the operational oversight of many large clinical trial programs, negotiating research and development collaborations with major pharma companies, and raising in excess of over $120M through capital raising initiatives for both listed and private companies. Jason brings expertise in managing all aspects of listed biotechnology companies, and has built strong connections at the Board and Executive level with some of the largest global Pharma companies.
Chairman, Clinical Advisory Committee
Dr Ando has held the position of Chairman of Novo Nordisk A/S since 2013, and has been on the board since 2005, being re-elected several times throughout his tenure. Dr Ando is a specialist in general medicine and a founding fellow of the American College of Rheumatology in the US. Dr Ando serves as chairman of the board of Symphogen A/S, Denmark and as a board member of Novo Holdings A/S, Denmark, Molecular Partners AG, Switzerland, EUSA Pharma Ltd., UK, and ICMEC, US. Dr Ando also serves as a Senior Advisor to Essex Woodlands Healthcare Partners, UK.
Head of intellectual property
Dr Patrick McManamny is a Partner with FB Rice, with extensive experience in relation to filing and management of international patent portfolios, freedom-to-operate issues, patentability and due diligence. Patrick’s technical expertise arise from his PhD primarily focused molecular biology and physiology. He has substantial experience in protecting and conducting due diligence in relation to biological therapeutics such as antibodies, proteins, peptides and stem cells and processes for their manufacture. Patrick also has experience in diagnostics and drug screening methods. Patrick is a registered patent attorney in Australia and New Zealand.
Head of CMC & GMP
Susan Dexter has over thirty years of experience in biotechnology science and business development, and is a Managing Director at Latham BioPharm. Susan was Chief Business Officer at Xcellerex, Inc. responsible for all aspects of business development for contract manufacturing services (CMO), and the sale of disposable technologies and integrated modular manufacturing facilities (FlexFactory®). Prior to Xcellerex, Ms. Dexter was the VP of Business Development at The Dow Chemical Company, and prior to this, Susan was Chief Business Officer at Xcellerex, Inc. responsible for all aspects of business development for contract manufacturing services (CMO), CMC and the sale of disposable technologies and integrated modular manufacturing facilities (FlexFactory®). Prior to Xcellerex, Ms. Dexter was the VP of Business Development at The Dow Chemical Company.
With over 15 years in corporate leadership, change management, and outsourcing, Caroline has worked with companies including Diners Club International, CitiPower, Origin Energy and other large energy organizations both in Australia and abroad. Caroline’s strengths center around project management, strategic global outsourcing, contract management and relationship management. Her proven track record of bringing together multi-disciplined specialists, to create high performing teams, over geographical distances, will be key in the development of Xeophin’s core technologies and relationships.
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