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AccuDava, Inc. Personalized Molecular Cancer Diagnostics Saving lives, Reducing costs

AccuDava, Inc. Personalized Molecular Cancer Diagnostics Saving lives, Reducing costs. What problems do we solve? According to WHO, 14 million cancer patients are treated annually with conventional chemotherapy.

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AccuDava, Inc. Personalized Molecular Cancer Diagnostics Saving lives, Reducing costs

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  1. AccuDava, Inc. Personalized Molecular Cancer Diagnostics Saving lives, Reducing costs

  2. What problems do we solve?According to WHO, 14 million cancer patients are treated annually with conventional chemotherapy. ProblemNearly 50% of these chemotherapy patients do not get much benefit from the treatments. They experience all the anguishes of chemotherapy but their tumors progress and their condition persists. Physicians then have to switch to a different regimen of chemotherapy, if it is not too late!

  3. AccuDava solution We have developed an unprecedented molecular process to improve efficacy of personalizingcancer chemotherapy. Our test enables physicians to avoid ineffective drugs and select suitable treatments, based on a patient’s tumor molecular characteristics – before treatment begins. All this from a 60-minute test on a tumor sample.

  4. AccuDava’s technology is based on the identification of two “Cell-Surface Glycan Biomarkers” • Specificity of AccuDava Biomarkers • It is on the cell-surface not within the cell. • It is a carbohydrate motif, not genomic or protein. • - Glycans are dynamic molecules involved in cell-signaling, and on the front line of cell communication and defense.

  5. Presentation of the cell-surface glycan biomarker over-expression on cancer cells Glycan biomarker Nucleus Nucleus Chemo-Resistant cancer cell Chemo-sensitive cancer cell (10X more biomarker on chemo-susceptible than chemo-resistant)

  6. Detecting Method of the glycan biomarker • Biopsy or Tissue section on slide • Surgery • Two steps staining tumor

  7. Histochemical staining of retrospective human ovarian cancer tumor sections

  8. Why AccuDava Technology? • Our products will be offered as “Prognostic Kits” for personalized cancer chemotherapy • Directly test the cancer specimen • Perform on-site in regular clinical lab setting • Kit components are readily available

  9. Product/Service Concept: • Two “Companion Diagnostic Kits” will be introduced under the trade name SETAXTMandSEPEXTMfor predicting platinum-drugs response in ovarian cancer chemotherapy. • SETAXTMandSEPEXTMprovide exclusive molecular information for chemotherapy management, by identifying patients who gain benefit from standard therapy with platinum drugs. • These tests can also be offered as a laboratory service, during the FDA clearance process for marketing SETAXTMandSEPEXTM.

  10. Science team Nahid Razi, Ph.D., Founder andPrinciple Investigator Afshin Bahador, M.D., Director of Clinical Research OBGYN and Surgical oncologist South Coast Gynecologic Oncology, Inc. Nissi Varki, M.D., Professor of Pathology at UCSD, Director of the UCSD histology and pathology laboratory Nathalie Scholler, M.D., Ph.D., Professor of OBGYN and Oncology at University of Pennsylvania, Specialist in ovarian cancer biomarkers- MesoMarkTM

  11. Management Team Nahid Razi - President Hedi Jafari, MBA - CFO Financial manager at UCSD Afshin Bahador, MD - Managing partner David Larson - Business advisor CFO/COO True Diagnostics Scientific Advisor Professor Ulf Lindahl- Senior member of the Swedish Royal Academy of Science, member of the Nobel Prize committee

  12. Achievements • 10 years of investigations identified two “glycan biomarkers” for drug response • Developed assays for detecting those biomarkers • Verified the assays' reliability, reproducibility and specificity on human cancer specimens • Validated the clinical correlation of the biomarkers with drug efficacy, on retrospective ovarian cancer tumor sections • Applied for 2 patents, received 1, the other in process

  13. Intellectual Property Two Patents filed by Knobbe-Martens • One issued patent (2009) • One pending (recently filed) • Filed under the name of Nahid Razi, Ph.D.

  14. 2 milestones to Market • Milestone #1 - Preclinical Verification • 100-200 ovarian cancer patients (sites identified) • 12-18 months • Create protocols for Clinical trial • Milestone #2 - Clinical Studies + PMA (FDA Clearance) • FDA required number of ovarian cancer patients • 18-24 months (est.) • Produce data to support PMA for FDA approval

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