Академический Документы
Профессиональный Документы
Культура Документы
April 1, 2010
Safe-Harbor
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Mission
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CBLI Summary
Funding History
• Money raised from capital market $56 million
• Federal grants and contracts >$50 million
Partnerships
• Cleveland Clinic (CCF)
• Roswell Park Cancer Institute (RPCI)
IP
• ~16 sets of patent applications filed
• First CBLB502 US & European patents granted
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CBLI Target Product Market Opportunities
• CBLB502: Protection from Acute Radiation Syndrome
(ARS)
– >$500 million + annually
Highly efficacious
- Increases survival of primates from 20% to >70%
Safe
- Completed initial human Phase I safety trial
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CBLB502: Mechanism of Action
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A New Principle of Radioprotection
• Published in Science -
April 11,2008
% of survivors
60
40
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Animal Efficacy Rule – Path to FDA licensure
Formulation
Manufacturing
Production Strain, DSP
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CBLB502 – ARS: Summary of Primate Studies
Time relative to TBI (if applicable)
TBI Dose Parameter
-45' +1h +16h +25h +48h +72h
Survival benefit +40% +45% +45% +40%-60% +45% TBD
Thrombocytopenia reduction +++ +++ +++ +++ +++ +++
Neutropenia reduction + ++ ++ ++ + +
LD10-20
dependence for the drug,
Neutropenia reduction + ++ ++ ++ + +
Cytokine release (G-CSF, IL-6, etc.) +++ +++ +++ +++ +++ ++
efficacy time window and effects
Data on dose dependence of efficacy Ongoing √ TBD TBD TBD TBD
Increased platelet levels +++
No TBI
of various radiation doses
Increased neutrophil levels ++
Cytokine release (G-CSF, IL-6, etc.) +++
Data on dose dependence of efficacy √
+++: strong effect; ++: moderate effect; +: minor effect; √: data collected
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Summary of Phase I trial of CBLB502
• 50 human volunteers in groups of 6 received
ascending doses of the drug
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CBLB502 - ARS Market Potential “Back of the Envelope”
90
80
70
60
0 5 10 15
Days
• Open IND
• Funded by $5.3 million stimulus grant
received September 2009
• Protocol submitted to IRB
• Planned to start at Roswell Park Cancer
Institute 2010
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Protectan CBLB612
Stem Cell Inducing Agent
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CBLB612: Potential Applications
25.00
20.00
10x3/ul
15.00
10.00
5.00
0.00
day -5 day7 day14 day22
CBLB612 10.33 2.66 3.09 14.73
PBS 9.65 1.98 0.43 7.21
CBLB612 or
G-CSF
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Curaxins: Overview
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INCURON – JV for Curaxin Development
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Financial Summary
• Mcap (at 3/31/10): $96M
• Shares Outstanding:
– 27M common
– 39M fully diluted
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CBLI Management Team
Chief Executive Officer & President Chief Scientific Officer
Michael Fonstein, PhD Andrei Gudkov, PhD, D.Sci
• SVP of Basic Science, Roswell
• Scientist and serial entrepreneur
Park Cancer Institute
• Founder of Dia-M and The Fellowship
• Former Chair, Dept. Molecular
for Interpretation of Genomes (FIG)
Biology at Cleveland Clinic
• Founder and Former CEO of
• 30+ issued patents
Integrated Genomics, Inc. (‘97-03)
• 150+ research publications
Chief Financial Officer Chief Medical Officer
Jack Marhofer, MBA, CMA, CFM Michael Kurman, MD
• 20 years of financial and • 25 years global oncology drug
accounting experience development experience