Transcript AccuDava, Inc.

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.
Problem
Nearly 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!
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
AccuDava solution
We have developed an unprecedented molecular
process to improve efficacy of personalizing cancer
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.
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
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.
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
Presentation of the cell-surface glycan biomarker overexpression on cancer cells
Glycan biomarker
Nucleus
Chemo-sensitive
cancer cell
(10X more biomarker on
chemo-susceptible than
chemo-resistant)
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
Nucleus
Chemo-Resistant
cancer cell
Detecting Method of the glycan biomarker
Biopsy or
Surgery
Tissue section on slide
tumor
Two steps staining
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
Histochemical staining of retrospective human ovarian
cancer tumor sections
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
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
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
Product/Service Concept:
 Two “Companion Diagnostic Kits” will be introduced under the
trade name SETAXTM and SEPEXTM for predicting platinum-drugs
response in ovarian cancer chemotherapy.
 SETAXTM and SEPEXTM provide 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 SETAXTM and SEPEXTM.
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
Science team
Nahid Razi, Ph.D., Founder and Principle 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
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
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
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
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
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
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.
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics
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
AccuDava, Inc.
Personalized Molecular Cancer Diagnostics