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Technology for cancer diagnostics
and personalized treatment
based on tumor molecular profile
RusGenDiagnostics, LLC
Tatiana Nikolskaya, Ph.D., CEO
tnikolsk@gmail.com
+7 916 586 85 16
Product and Technology
Diagnostic system for personalized cancer treatment:
• Diagnostic panels for tumor molecular profiling (NGS, expression microarrays)
• Software for data clinical interpretation
3 commercial product versions
PlatinumGold
Silver
Decision making
algorithms for
drug efficacy
evaluation using
database
information
Drug efficacy
evaluation based
on reconstructed
key signaling
pathways
Expert
team
analysis
Database of Biomarkers and Drugs
• Sales to existing oncology centers in
Russia and several European counties
• Diagnostic services
• Service projects in consortium with
pharmaceutical companies
Results are “translated” for typical oncologist, report provides
recommendations for the best personalized treatment strategy
Based on proprietary technology (US Patent) and unique experience in systems biology
Identification of individual tumor-promoting molecular mechanisms and the most effective drug
combinations for their suppression
Technology proof of concept:
4 personalized medicine pilot projects In
collaboration with N.N. Blokhin Cancer
Research Center: identification of individual
drug combinations based on tumor
expression profile
Market and Commercialization Plan
Global market – billion dollars:
• 2.9M cancer patients in Russia, 0.5M are newly diagnosed yearly
• Estimated 17M of new cases worldwide in 2020
• Expected worldwide spending on cancer drugs ~ $90B in 2013
• The average drug only works in ~25% cases
No comparable competitive analogs
Key Product advantages compared to existing
solutions
• Analysis of multiple genomic and
transcriptomic alterations at once
• Reconstruction of the individual tumor
molecular "blueprint“ on the level of biological
pathways
• Efficacy evaluation for targeted drugs and
standard chemotherapeutics
• Treatment recommendations are “translated”
for typical oncologist
Commercialization Plan
• Contract research projects starting from 2013
• September 2013: the first analytical project in
consortium with Big Pharma – Personalized Cancer
Therapy, 10 terminal patients with triple-negative
breast cancer
• Further consortium expanding
• Product commercialization starting from 2014
• In-house diagnostic services
• Sales of diagnostic system to oncology centers
(federal – from 2014, regional – from 2015)
• Sales to oncology centers in Germany and Nordic
countries starting from 2014
• We expect that product will be approved by
Russian government between 2017 and 2020 and
will be partially covered for patients
• So we will be able to sale the product to 60 out of
120 oncology centers in Russia till 2020
• Break-even with enough funding: by the end of 2014
Project Team
Tatiana Nikolskaya
• Project leader, CEO
• 2000-2010: Founder, President & CSO, GeneGo, Inc, St.
Joseph, MI
• 2006-2010: Head of Laboratory for Systems
Biology, IOGEN, Moscow, Russia
• 2010-2011: Chief Scientific Officer, Thomson
Reuters, Encinitas, CA
• Supervised and led the research and development of
• unique system pathway reconstruction
technology
• the most comprehensive and accurate
knowledgebase of protein-protein and small
molecule-protein database, MetaBase
• leading Systems Biology software platform and
products:
MetaCore, MetaDrug, MapEditor, ToxHunter, Me
taMiner, Eureka (Currently a part of Thomson
Reuters product offerings)
• Broad experience in both academia and commercial
biotechnology sector in genetics, genomics, systems
biology, translational research and personalized
medicine
• Over 65 peer-reviewed publications (including
Science, Nature Biotech., Cancer Cell, PNAS) and 12
awarded SBIR grants (> $10M)
• Citation index: 6710, h-index: 28
Sergei Tjulandin
• Chief, Clinical Research
• 2002 - to date: Deputy Director (Clinical Research), Institute
of Clinical Oncology, Cancer Research Center, Moscow
• 2005 - to date: Head, Department of Clinical Pharmacology
and Chemotherapy, Cancer Research Center, Moscow
• Biopsy acquisition, data interpretation, clinical research
• Broad expertise in cancer diagnostics and treatment,
clinical studies including targeted therapy
• Over 200 peer-reviewed publications including New
England Journal of Medicine, Lancet, J. of Clinical Oncology
Alexander Khvat
• Chief, Medicinal chemistry
• Senior Director of Research & Development, ChemDiv Inc.
• Broad expertise in medicinal chemistry, drug development
• Over 40 peer-reviewed publications including Journal of Organic
Chemistry, Journal of Medicinal Chemistry, European Journal of
Medicinal Chemistry
• Over 20 patents associated with drug development
Mikhail Fedyanin
• Oncologist, Department of Clinical Pharmacology and
Chemotherapy, Federal State Budgetary Institution: Blokhin
Russian Oncology Research Center under the Russian Academy
of Medical Sciences, Moscow
• Broad expertise in cancer diagnostics and treatment, clinical
studies including targeted therapy
• Over 50 peer-reviewed publication
Project Needs
• Work space: for specialized cancer diagnostic center to which tissue samples
will be delivered from oncology centers, IV, 2014 - I, 2015
• IP registration: need help in filing patent applications
• Looking for employees
• Looking for partners
• Financing
• Company was founded in 2011, self-financed $300K
• May 2013 – MPT grant $1.2M
• We are looking for investors interested in product distribution in Russia,
with experience of working with Russian Ministry of Healthcare
• Seeking investment: $1M
• Software development – to start commercialization in 2014 in
Russia
• European market penetration (Germany, Nordic countries)
• Conditions: tbd

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RusGenDiagnostics Skolkovo Startup Village Pitch Session

  • 1. Technology for cancer diagnostics and personalized treatment based on tumor molecular profile RusGenDiagnostics, LLC Tatiana Nikolskaya, Ph.D., CEO tnikolsk@gmail.com +7 916 586 85 16
  • 2. Product and Technology Diagnostic system for personalized cancer treatment: • Diagnostic panels for tumor molecular profiling (NGS, expression microarrays) • Software for data clinical interpretation 3 commercial product versions PlatinumGold Silver Decision making algorithms for drug efficacy evaluation using database information Drug efficacy evaluation based on reconstructed key signaling pathways Expert team analysis Database of Biomarkers and Drugs • Sales to existing oncology centers in Russia and several European counties • Diagnostic services • Service projects in consortium with pharmaceutical companies Results are “translated” for typical oncologist, report provides recommendations for the best personalized treatment strategy Based on proprietary technology (US Patent) and unique experience in systems biology Identification of individual tumor-promoting molecular mechanisms and the most effective drug combinations for their suppression Technology proof of concept: 4 personalized medicine pilot projects In collaboration with N.N. Blokhin Cancer Research Center: identification of individual drug combinations based on tumor expression profile
  • 3. Market and Commercialization Plan Global market – billion dollars: • 2.9M cancer patients in Russia, 0.5M are newly diagnosed yearly • Estimated 17M of new cases worldwide in 2020 • Expected worldwide spending on cancer drugs ~ $90B in 2013 • The average drug only works in ~25% cases No comparable competitive analogs Key Product advantages compared to existing solutions • Analysis of multiple genomic and transcriptomic alterations at once • Reconstruction of the individual tumor molecular "blueprint“ on the level of biological pathways • Efficacy evaluation for targeted drugs and standard chemotherapeutics • Treatment recommendations are “translated” for typical oncologist Commercialization Plan • Contract research projects starting from 2013 • September 2013: the first analytical project in consortium with Big Pharma – Personalized Cancer Therapy, 10 terminal patients with triple-negative breast cancer • Further consortium expanding • Product commercialization starting from 2014 • In-house diagnostic services • Sales of diagnostic system to oncology centers (federal – from 2014, regional – from 2015) • Sales to oncology centers in Germany and Nordic countries starting from 2014 • We expect that product will be approved by Russian government between 2017 and 2020 and will be partially covered for patients • So we will be able to sale the product to 60 out of 120 oncology centers in Russia till 2020 • Break-even with enough funding: by the end of 2014
  • 4. Project Team Tatiana Nikolskaya • Project leader, CEO • 2000-2010: Founder, President & CSO, GeneGo, Inc, St. Joseph, MI • 2006-2010: Head of Laboratory for Systems Biology, IOGEN, Moscow, Russia • 2010-2011: Chief Scientific Officer, Thomson Reuters, Encinitas, CA • Supervised and led the research and development of • unique system pathway reconstruction technology • the most comprehensive and accurate knowledgebase of protein-protein and small molecule-protein database, MetaBase • leading Systems Biology software platform and products: MetaCore, MetaDrug, MapEditor, ToxHunter, Me taMiner, Eureka (Currently a part of Thomson Reuters product offerings) • Broad experience in both academia and commercial biotechnology sector in genetics, genomics, systems biology, translational research and personalized medicine • Over 65 peer-reviewed publications (including Science, Nature Biotech., Cancer Cell, PNAS) and 12 awarded SBIR grants (> $10M) • Citation index: 6710, h-index: 28 Sergei Tjulandin • Chief, Clinical Research • 2002 - to date: Deputy Director (Clinical Research), Institute of Clinical Oncology, Cancer Research Center, Moscow • 2005 - to date: Head, Department of Clinical Pharmacology and Chemotherapy, Cancer Research Center, Moscow • Biopsy acquisition, data interpretation, clinical research • Broad expertise in cancer diagnostics and treatment, clinical studies including targeted therapy • Over 200 peer-reviewed publications including New England Journal of Medicine, Lancet, J. of Clinical Oncology Alexander Khvat • Chief, Medicinal chemistry • Senior Director of Research & Development, ChemDiv Inc. • Broad expertise in medicinal chemistry, drug development • Over 40 peer-reviewed publications including Journal of Organic Chemistry, Journal of Medicinal Chemistry, European Journal of Medicinal Chemistry • Over 20 patents associated with drug development Mikhail Fedyanin • Oncologist, Department of Clinical Pharmacology and Chemotherapy, Federal State Budgetary Institution: Blokhin Russian Oncology Research Center under the Russian Academy of Medical Sciences, Moscow • Broad expertise in cancer diagnostics and treatment, clinical studies including targeted therapy • Over 50 peer-reviewed publication
  • 5. Project Needs • Work space: for specialized cancer diagnostic center to which tissue samples will be delivered from oncology centers, IV, 2014 - I, 2015 • IP registration: need help in filing patent applications • Looking for employees • Looking for partners • Financing • Company was founded in 2011, self-financed $300K • May 2013 – MPT grant $1.2M • We are looking for investors interested in product distribution in Russia, with experience of working with Russian Ministry of Healthcare • Seeking investment: $1M • Software development – to start commercialization in 2014 in Russia • European market penetration (Germany, Nordic countries) • Conditions: tbd