Race Oncology is a specialty pharmaceutical company, whose business model is to pursue later stage drug assets, principally in the cancer field. Our first important asset is a chemotherapy drug, called Bisantrene, which was the subject of more than 40 phase II clinical studies, before it was lost in a series of pharmaceutical mergers during the 1990s. Race Oncology is rediscovering Bisantrene. We own recent patent filings on Bisantrene and have secured Orphan Drug Designation in the US. Now our goal is to complete final development of Bisantrene and bring this valuable cancer drug to market.
Bisantrene is a cancer drug that is related to the anthracyclines, the most widely used class of chemotherapy drugs.
Bisantrene is a cancer chemotherapy drug related to the anthracyclines, a class of drugs used as the first line of treatment for AML and many other cancers. However, one of the disadvantages of anthracyclines is their risk of cardiac toxicity and consequent heart failure. This means that once patients have received an amount of anthracyclines that approaches the maximum recommended dose to avoid cardio-toxicity, the oncologist may have to stop treatment, even when the drug is working. In addition, anthracyclines are associated with high levels of cancer drug resistance after initial treatment. Essentially, this means that the after an initial remission, the cancer relapses and progresses.
Bisantrene has been shown to have greatly reduced cardiac toxicity compared to anthracyclines and to be effective against some cancers that have relapsed after the patients have already received high levels of anthracyclines. This makes Bisantrene potentially well-suited as a second- or third-line treatment for patients who have reached their cardio-toxic limit of anthracyclines or whose cancer has become resistant to anthracycline treatment. The initial clinical opportunity for Bisantrene is as a salvage treatment for elderly patients with Acute Myeloid Leukaemia (AML).
Bisantrene was discovered by the US pharmaceutical company Lederle (a division of American Cyanamid) in the 1970s. Through the 1980s and into the early 1990's, Bisantrene was tested in more than 40 published phase II clinical trials, including 33 clinical trials at the National Cancer Institute (NCI) in the US, to assess its efficacy and safety in a wide range of cancers. In these studies, in total covering more than 2,000 treated patients, Bisantrene was shown to possess low cardiotoxicity potential and useful therapeutic efficacy in several cancers, notably AML (Acute Myeloid Leukaemia).
In 1990, and despite its phase II clinical status, Bisantrene was actually approved for marketing in France for the treatment of AML.
Since then, and despite all the improvements in treatment for breast and other cancers, the treatment of AML has not changed appreciably. Today, it remains a disease of the elderly with a high unmet medical need and where a clear opportunity exists for Bisantrene, once anthracycline and other chemotherapy treatments fail.
In addition to its direct cytotoxic actions (like other chemotherapy drugs), Bisantrene has also been shown to have immunologic and genomic effects. In allogeneic transplant (animal) models, Bisantrene has been found to activate macrophages (one type of immune cell) to attack and destroy tumour cells. Further, it binds to DNA at a site that displaces telomerase binding proteins, enabling tumour cells to regain their mortality and die of old age (apoptosis), rather than continue to proliferate.
Because of these additional immune-stimulating and apoptotic mechanisms of action, Race Oncology believes that Bisantrene may have an important role in certain cancers in combination with some of the new immunotherapeutic agents.
Race Oncology plans to generate early sales revenues under a Named Patient Program.
Race Oncology intends to re-open the Bisantrene IND in the US and complete its clinical development, allowing it to be brought to market in the US, Europe and other markets as a useful chemotherapeutic agent, initially for salvage therapy in AML, and then in certain other cancers, where it could be used in combination with modern immunotherapeutic agents. Apart from AML, Bisantrene also has potential in breast cancer, lymphoma and ovarian cancer.
In addition, once the IND is re-opened in the US, the company will apply to offer the drug for sale in France and several other countries on a Named Patient Program basis, which is expected to generate valuable early sales revenues for Race Oncology and provide funding for the US development and FDA registration program. The NPP will be aimed initially at AML and Race believes there are at least four countries in Europe where it will be possible to make early sales under the NPP arrangement, before the drug is registered in the US.
Peter Molloy graduated from the University of Melbourne as a microbiologist and biochemist and then worked for 18 years in the pharmaceutical industry. At the Australian pharmaceutical company, Faulding, he managed several Faulding subsidiaries, before joining Pharmacia (now Pfizer) as Managing Director of its Australia and NZ operations, where he managed four pharmaceutical marketing divisions including the oncology business. Promoted to Vice President of Strategic Marketing, he was then responsible for Pharmacia’s marketing strategy and portfolio across 22 countries throughout Asia-Pacific and Latin America.
Dr John Rothman was a clinical scientist at the pharmaceutical companies, Schering Plough and Roche, where he was also a Clinical Director for a number of different therapeutic areas and Senior Director for all of Roche’s data acquisition, statistical analysis and report writing for all experimental and approved drugs in the Roche portfolio. His work on interferon-α in AIDS-related Kaposi’s Sarcoma (a type of cancer) resulted in the approval of first recombinant drug and AIDS treatment in the 1980s, called Roferon-A. Subsequently as an R&D Director at Roche, Dr Rothman was associated with a number of development programs that resulted in marketed drugs, including Rocephin, Coactin, Midazolam, Rimadyl, Larotid, Dalmane, Rimantidine, Versed and others, as well as providing post-marketing support for numerous drugs.
Mr Beck has an impressive commercial background in the pharmaceutical industry. He worked for 13 years in senior roles at Roche and Bristol-Myers Squibb. At Roche, he was Global Business Team leader for oncology, infectious diseases, cardiovascular disease, and CNS drugs. Subsequently, at BMS, he was Director, Cardiovascular Marketing and Business Development, providing leadership for the commercialization of the blockbuster cardiovascular drug, Plavix®. Subsequently, he consulted in strategic planning, medical communications and business development with leading companies including Amgen, Genentech, Novartis, Seattle Genetics, BMS, Gilead and Takeda.
William Garner MD, is a US physician and entrepreneur. Dr Garner is one of the inventors on the Bisantrene patents, originally filed by Update Pharma, Inc. and now owned by Race Oncology. Previously, he founded EGB Advisors LLC, a life sciences advisory firm whose clients have included the M.D. Anderson Cancer Center, the Kauffman Foundation, ChemGenex (ASX:CXS) and CoTherix. He also founded Inverseon, Inc., which was merged with the ASX-listed company cBio to create Invion Ltd, serving as CEO until May of 2013. He also founded Urigen Pharmaceuticals, Inc. and co-founded DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI). Previously, he was at Hoffmann La Roche in oncology medical affairs and worked as a merchant banker in New York City.
Dr de Kauwe completed a Bachelor of Science and Bachelor of Dental Surgery at the University of Western Australia. He also holds a Post Graduate Diploma in Applied Finance, majoring in Corporate Finance, and is an ASIC compliant (RG146) Securities Advisor. Dr de Kauwe is a Director of Otsana Capital, a corporate advisory firm, and has extensive experience in corporate restructuring and recapitalisations, mergers and acquisitions, IPO/RTO and capital markets. Dr de Kauwe’s corporate experience, coupled with his extensive technology, science and bio-medical background gives him an integral understanding in the evaluation and execution of projects and assets over a diverse range of sectors.
Mr Chris Ntoumenopoulos is Managing Director at Twenty 1 Corporate, a boutique corporate advisory firm. He has worked in financial markets for the past 12 years, focusing on Capital Raisings, Portfolio Management and Corporate Advisory. Mr Ntoumenopoulos has advised and funded numerous ASX companies from early stage venture capital, through to IPO. He is also a director of various private and public companies which span across finance, technology and medical sectors.