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Oncology Deck
- 1. Peter Ellman, CEO Privileged & Confidential Do not distribute without permission Copyright © Certis Oncology Solutions, 2018 CERTIS ONCOLOGY SOLUTIONS Oncologist-Directed Solutions for Cancer Therapy & Drug Discovery
- 2. Copyright © Certis Oncology Solutions, 2018 2 Treatment is currently an odds game. • Treatment algorithms are based on statistics, not objective knowledge • Standard of Care varies from tumor type to tumor type • Many tumor types don’t have a good standard of care – and some aggressive tumors don’t have one at all • If clinical trials showed, hypothetically, a 30% survival rate versus the existing standard of care at 20%, the 30% drug would eventually become the new standard of care • Even if clinical trials were to demonstrate a standard of care with 30% survival rate, that means 70% will not benefit The Paradigm Needs to Be Changed TheChallenge A solution is required that improves the odds of longer life and better quality of life by offering scientifically proven alternatives to the current Standard of Care.
- 3. Copyright © Certis Oncology Solutions, 2018 3 There are significant obstacles to precision medicine becoming part of the Standard of Care in oncology. Drug discovery in particular is facing the following roadblocks: • The median duration of oncology clinical trials is 13.1 years • The median cost of developing a single oncology drug is $648M, based on a study of 10 drugs over a 9-year period from 2006 to 2015 • Newly approved cancer drugs cost an average of $10,000 per month, with some therapies topping $30,000 per month TheChallenge A New Approach to Discovery Is Required Sources: The Lancet (2017), Biostatistics (2018), JAMA Oncology Journal (2017), ASCO (2015) The probability of success (FDA approval) for oncology clinical trials is 3.4% – lowest of all types, which slows introduction of improved therapies into the Standard of Care.
- 4. Copyright © Certis Oncology Solutions, 2018 4 TheSolution We fill the need for certainty with a precision modeling technique that provides more timely and accurate selection of treatment therapies. • Patients today must endure treatment for three months or more before undergoing scans and other tests to determine if the therapy is working • If it's not, they are moved onto the next treatment protocol with fingers crossed and precious time wasted • Certis Oncology Solutions offers an individualized precision medical solution based on in vivo (mouse) tumor modeling • Certis determines the proper therapy in the setting of the original/primary tumor, whenever possible • We provide data for oncologists and their patients to ensure the most successful therapy is used “This is about the patients. The goal is to improve andsignificantly impact patient’s lives. AndI think the ultimate individualized medicine is tohave your tumor modeled.” Frederick “Fritz” C. Eilber, MD UCLASurgery Division of Oncology Certis Oncology: Precision Drug Discovery
- 5. Copyright © Certis Oncology Solutions, 2018 5 Patient-Derived Orthotopic Xenografts • We have perfected a microsurgical technique where we implant a tiny slice of the patient's tumor into the corresponding organ in immuno deficient mice • In numerous peer-reviewed studies we have demonstrated the abilities of our tumors to not only grow at a high rate, but to also replicate tumor growth and metastasis in humans • This allows us to test multiple drug therapies simultaneously in mice, providing valuable precise treatment data to oncologists Investigative New Drug (IND) precedent: • The data created in PDOX models has been used to obtain a drug that is not in the standard treatment algorithm. • The drug was highly effective for the patient TheSolution Certis PDOX: The Most Clinically Relevant Numerous studies demonstrate that PDOX mouse models most accurately replicate tumor growth and metastasis.
- 6. Copyright © Certis Oncology Solutions, 2018 6 1 2 3 Tumor samples are collected from the patient. Various drug therapies are tested simultaneously in Multiple mice, providing valuable treatment data to the oncologist in order to individualize the patient’s therapy. Microscopic specimens are then surgically implanted in orthotopic locations where they grow and metastasize. All tumors are banked and cryogenically preserved for future therapy testing. Once passaged, tumors are genetically analyzed. TheSolution The 3-Step Certis PDOX Process Certis PDOX provides a concurrent solution for first-line therapies and has the potential to change how first-line therapies are selected, particularly for cancers with poor – or no – Standard of Care.
- 7. Placement of the tumor in the orthotopic location provides the most clinically relevant model because it reliably metastasizes. Copyright © Certis Oncology Solutions, 2018 9 PDOX PDX Surgical Orthotopic Implantation (SOI) Subcutaneous, non-surgical orthotopic Technology proven, innovation continues Commercializing patient treatment using technology unchanged in decades Reliably metastasizes Rarely metastasizes High tumor establishment success rate Lower success rate of tumor growth 3-4 months median interval to establishment and treatment recommendation; more accurate data 6-9 months to treatment recommendation PDOX | PDX TheSolution PDOX vs. PDX
- 8. The PDOX identified an IGF-R inhibitor as active and the patient responded well to an IGF-R inhibitor drug administered with a compassion-use IND obtained from the FDA based on the PDOX results. Murakami et al, Oncotarget 2016. 10 PDOX extended the patient’s life and provided a higher quality of life. Failure of the Standard of Care guided the therapy for a 2nd treatment, which was obtained by IND. PDOX Concordance Translational Application 50 µm 50 µm PDOX retains histological features of the primary patient tumor. Primary Tumor PDOX Tumor Copyright © Certis Oncology Solutions, 2018
- 9. Our concordance testing verified that the response of the mouse tumor closely matches that of the patient’s tumor. • Certis Oncology has implanted hundreds of patient tumor samples into thousands of mice • Disease progression and subsequent metastasis mimics the clinical progression in humans • Increases the accuracy of therapy and reduces the time to treat aggressive tumors • Certis PDOX’s time and accuracy provide a significant, sustainable competitive advantage over existing mouse models • Closely simulates tumor response to each cancer treatment option Copyright © Certis Oncology Solutions, 2018 9 With Certis PDOX tumor sensitivity, what happens in mice happens in patients. TheSolution Concordance Validation
- 10. Copyright © Certis Oncology Solutions, 2018 10 Concordance Correlation data exceeded our expectations 1. CLIA certified for High Complexity Testing 2. Will be a key marketing tool to develop revenue stream 3. Data collection is complete and is being readied for publication Core Needle Biopsy study Game changer because we will be collecting data in earlier stages of the cancer • Study in progress • Does not disrupt therapy / standard procedure • Will allow us to get patient tumors well in advance of surgical biopsy • Will allow us to begin establishment from the time of diagnosis [instead of waiting] TheSolution Outcome Studies
- 11. Copyright © Certis Oncology Solutions, 2018 11 • Allows the ability to test drugs against metastasis, which frequently have a different drug response pattern than the primary tumor • Avoids the possible false positives and false negatives due to the tumor growing ectopically (the wrong place) • Helps identify the ideal patient population for different drugs • Despite the complexity of SOI, pricing is more reasonable than competitors • (We will charge if we have success establishing xenografts, enabling us to proceed to testing) Today, in vivo studies are recognized by leading oncologists as key pillars in finding the right therapies for each patient: • Surgery • Radiation • Targeted Molecular Therapy • Chemotherapy • Immunotherapy Certis provides a new method for physicians to prioritize therapies. The oncologist makes the choice. Certis PDOX: The Value of the Certis PDOX Model TheSolution
- 12. Copyright © Certis Oncology Solutions, 2018 12 1. Once we obtain the patient’s tumor, we surgically implant them in our immuno deficient mice 2. Once they grow, we passage them multiple times to ensure future growth [per our validated model] 3. Then we cryo preserve these tumors. At any time, they can be taken out of cryo, regrown in mice and used for future testing should the Standard of Care therapy fail 4. This offer includes free establishment (immortalization) and cryo preservation 5. Drug testing is separate and is a paid service. Requirements • Patient consent and applicable forms • Compliance with HIPPA privacy and confidentiality regulations Benefit to Oncologists + Patients • We are testing the patient tumors in animal models to determine the best course of therapy • The Certis PDOX model is more clinically relevant than other PDXs • The time from implantation to results is quicker than other PDX models The Certis Offer for Oncologists Offer
- 13. Copyright © Certis Oncology Solutions, 2018 13 PDOX tumor banking steps: 1. Specimens of a patient tumor are implanted in mice as a PDOX model 2. Once established, they are transferred (by passage) to other mice 3. After several passages, tumors are immortalized and the model is validated 4. Immortalized tumors can be used indefinitely for future drug discovery studies and patient testing 5. Cryopreserved tumors are stored indefinitely at -180°C in liquid nitrogen (N2) Offer Cryopreservation of Immortalized Tumors
- 14. Copyright © Certis Oncology Solutions, 2018 22 Oncology Drug Development PDOX Cancer Types Currently Available • Cervical cancer • Colon cancer • Esophageal cancer • Extraskeletal myxoid chondrosarcoma • Liver metastasis • Melanoma • Ovarian cancer • Pancreatic cancer • Sarcoma Novel Drugs Evaluated in PDOX • Cobmetinib • Dactolisib • Entinostat • Lapatinib • Linsitinib • Nab-paclitaxel • Palbociclib • Pazopanib • Trametinib • Trastuzumab • Vemurafenib • Yondelis RevenueM odel Tumor Models
- 15. Copyright © Certis Oncology Solutions, 2018 15 James H. Berglund Chairman Enterprise Partners Venture Capital Frederick (Fritz) C. Eilber, MD Director UCLA Surgery Division of Oncology Arun S. Singh, MD Director UCLA Hematology- Oncology Gail Bryan Director Latitude Link Mark Grosvenor Director Grosvenor Industries Peter Ellman CEO Nextec, Stratagene, ParagonDx, Thermoscan Certis Oncology Board Our Team Stephen Bonner Former CEO & Director Cancer Treatment Centers of America
- 16. Copyright © Certis Oncology Solutions, 2018 16 • Dr. Nicholas M. Bernthal, UCLA Pediatric Orthopedic Surgery Complex General Surgical Oncology • Dr. William Tap, Memorial Sloan Kettering Chief, Sarcoma Medical Oncology Service Specializes in soft tissue and bone sarcoma • Dr. James Tomlinson, UCLA Surgery Complex General Surgical Oncology Scientific Advisory Board Our Team