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 First in Class Targeted Therapy for Metastatic Breast Cancer www.sixonesolutions.com Ginny Orndorff, CEO INTRODUCTION Once breast cancer has spread to other sites in the body, today’s therapies have little efficacy and patients eventually die. SixOne Solutions LLC (SixOne) is an early-­‐stage preclinical company developing targeted, first-­‐in-­‐class, small-­‐molecule drugs for metastatic breast cancer. SixOne spun out of the University of Colorado School of Medicine in 2013 in order to pursue a streamlined, cost-­‐effective development plan for compounds that show Funding History: promise in preventing or treating metastatic breast cancer. Each year more than 1.7 • $ 2 M pre-­‐company million new cases of breast cancer are diagnosed worldwide and $10 B is spent treating formation the disease, expected to grow to $10.9 B by 2018. Currently available breast cancer • $340K non-­‐dilutive therapies can be highly effective, but in 20% of patients the cancer metastasizes, leading funds post-­‐formation to patient death. Our products address a novel target, Eya/Six1, not targeted by current cancer drugs. The central role of Eya/Six1 in breast cancer, and, importantly, in metastasis, was discovered by our scientific founder Dr. Heide Ford. Additionally, many of the hardest to treat primary tumors, those called “triple negatives”, contain the target of our products. By targeting Eya/Six1, the drugs we are developing are expected to address the following critical market needs: [email protected] (303) 638-­‐3521 4580 Augusta Dr. Broomfield, CO 80023 •
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Better treatment outcomes for metastatic breast cancer. Eya/Six1 turns on genes leading to metastasis (spread) of cancer cells from the original breast tumor. Drugs targeting Eya/Six1 are expected to block cancer metastasis. Broad effectiveness. The cancer pathway controlled by Eya/Six1 is found in a majority of breast cancer patients (incluing “triple negatives” while the major targeted therapy for breast cancer, Herceptin, targets only 25% of breast cancer patients and has no effect on “triple negative” patients. Fewer side effects. SixOne’s drugs are expected to have minimal toxicity and cause few side effects because they will be specific to Eya/Six1, which is present in cancer cells but generally not found in normal cells. Proof of Concept validated: Eya/Six1 is a complex of two “transcription factor” proteins that are generally only present and active during embryo growth and development. Dr. Ford discovered that Eya/Six1 is abnormally present in breast cancer tumors. She demonstrated that when normal breast cells in culture are manipulated to express high levels of the Eya/Six1 complex, they are transformed into tumor cells capable of invasion and metastasis in mouse models. When the levels of Eya/Six1 are knocked down, tumor growth and metastasis are dramatically decreased. We have shown in cell culture studies that the small-­‐molecule compounds we are developing block cancer hallmarks (transcription and migration) in breast cancer cell models. Eya2 and Six1 are found in many breast cancer subtypes including “triple negative”, the most aggressive breast cancer for which current therapies have little effectiveness. Longer-­‐term Opportunities: Eya/Six1 complex has been found to be abnormally present in many other cancers, including ovarian, cervical, pancreatic, markets which are forecast to cumulatively comprise over $4 Billion by 2017. LARGE MARKET WITH SIGNIFICANT NEED Breast cancer is the second most prevalent cancer in the world, with 1.7 million new cases diagnosed and 450,000 deaths yearly. It is the leading cause of cancer death for women. Treatment of localized breast cancer is fairly effective today. However, about 20% of breast cancer patients develop metastatic disease, for which current therapies are far less effective with only 25% of patients with metastatic breast cancer surviving five years. Key market drivers are: •
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Short-­‐lived responses in the 20% of patients who develop metastatic disease; metastases are the principal cause of death from breast cancer. Widely used treatments such as radiation and chemotherapy non-­‐specifically impact normal cells as well as cancer cells, resulting in severe side effects. •
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Targeted breast cancer therapies, which selectively impact cancer cells, can be very effective, but only in 10% to 30% of patients whose tumors express the proteins they target. Cancer cells accumulate mutations over time, which results in the development of resistance when single therapies are administered sequentially, but most current therapies are too toxic to combine for more effective treatment. There is a great need for targeted drugs effective in metastatic breast cancer that address a large percentage of patients and can be combined with other therapies for better treatment outcomes with minimal side effects. The compounds we are developing are expected to address these shortcomings associated with current treatments. COMPETITVE LANDSCAPE Herceptin commands the greatest revenue of all targeted breast cancer therapies with U.S. sales of $1.9 B in 2013. Herceptin targets HER2, which is overexpressed in only 25% of breast cancer patients. SixOne’s compounds target Eya2/Six1, found in a majority of breast cancer patients and 90% of metastases, thus our drugs are expected to address a larger segment of the breast cancer market. Many other compounds targeting HER2 and related targets are under development by other companies, but none target the Eya/Six1 complex. MANAGEMENT MILESTONES ACHIEVED Ginny Orndorff, CEO • 20 years biotech management experience • Founder of Evolutionary Genomics and CEO for 10 years • Raised $ 8 M equity • Exit through reverse m erger 2014 Dr. Heide Ford, Univ. CO, School of Pharmacy, Scientific Founder • BS Biology (minor Chemistry) summa cum laude SUNY, Geneseo • PhD Biochemistry Univ of Rochester, • Post-­‐docs at Dana-­‐Farber Cancer Institute and Harvard Medical School • 6 patents/applications; 40 primary research articles; 20 reviews/book chapters Dr. Rui Zhao, Univ. CO, Biochemistry/ Molecular Genetics, Scientific Founder • BS Biology University of Science and Technology of China • PhD Structural Biology/Virology Purdue University • Post-­‐doc UNC, Chapel Hill • 3 patents/applications ; 40 primary research articles •
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Discovered and thoroughly validated novel cancer target Identified compounds that specifically disrupt this target Demonstrated efficacy of compounds in gold standard breast cancer cell model assays INTELLECTUAL PROPERTY Proprietary small molecules and Patent Application 2011003879 filed in 2009 and foreign equivalents, relating to treatment methods for inhibiting Eya and Six1 proteins and compositions. Issued US Patent 7,153,700 relating to methods and compositions for diagnosing and predicting behavior of cancer. FUNDING •
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$2.0 Million in grants prior to company formation $340,000 in non-­‐dilutive funds to SixOne Current raise is $800,000 USE OF FUNDS Funds will be used to optimize potency of compounds in hand through a comprehensive medicinal chemistry program. This program has been developed by a consultant to the company who has over 20 years of experience in compound optimization leading to successful clinical commercial development. Compound efficacy will then be demonstrated in a gold standard mouse breast cancer model. EXIT STRATEGY Our strategy is to develop a lead compound through lead compound optimization and demonstration of efficacy in a standard mouse model. Successful demonstration of efficacy should position SixOne for an exit through M/A with a larger pharmaceutical company within 18 – 24 months. WHY INVEST IN SIXONE SOLUTIONS LLC •
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Experienced management team “Virtual”, low-­‐cost operation, contracting out many functions to rapidly and cost-­‐effectively develop our products Large breast cancer market with significant unmet need for targeted cancer drugs with low toxicity, low side effects and greater efficacy, all addressed by the compounds we are developing First-­‐mover advantage; our scientific founders discovered Eya/ Six1’s role in cancer and compounds to block it and are actively involved with our development program. 2 3