SHERMAN BIOTECH

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SHERMAN BIOTECH
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SHERMAN BIOTECH

• Drug Development for Anxiety in Fragile X and
  Autism
• Diagnostic Test Development for Fragile X and
  Autism

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SHERMAN BIOTECH

• Drug Development for Anxiety in Fragile X and
  Autism

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SHERMAN BIOTECH

• Drug Development for Anxiety in Fragile X and
  Autism
• Lead drug SB15

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SHERMAN BIOTECH
Fragile X (FXS)
Autism (ASD)
Behavioral disorder, varying degrees of severity
Genetic (multiple chromosomes) 1 in 200
Abnormal motor, sensory and communication
Anxiety Other autistic behaviors

• Behavioral disorder, varying degrees of
  severity
• Genetic (X chromosome)
• 1 in 2000
• Abnormal motor, sensory and communication
• Anxiety
• Autistic-like behaviors
• Most common known cause of autism

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SHERMAN BIOTECH
Anxiety in Fragile X and Autism
Significantly interferes with social development
and learning Controlling anxiety can
greatly improve therapies Current anti-anxiety
drugs are broad acting and usually ineffective
Valium, Prozac, amphetamines,
anti-psychotics etc Hit or Miss,
singly or in combination Targeted drugs are
needed SB15 - a targeted Glutamate Blocker
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Small Molecule Cell-Cell Signaler
Glutamate
hippocampus
Anxiety areas in the brain
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Small Molecule Cell-Cell Signaler
Glutamate
SB15
ANXIETY
ANXIETY DECREASED
hippocampus
Anxiety areas in the brain
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SHERMAN BIOTECH

• Summary
• Glutamate transmits signals between nerve cells
  
• Glutamate is in parts of the brain that have a
  role in anxiety
• Uncontrolled Glutamate stimulation is
  associated with anxiety
• SB15 blocks Glutamate and decreases anxiety

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SHERMAN BIOTECH

• SB15 Summary to date
• Inhibits anxiety in animals and humans
• Mechanism of action is targeted and different
• from antidepressants, amphetamines
  antipsychotics etc
• Non-sedative, non-muscle relaxant, non addictive
  and
• no interaction with alcohol
• Easily synthesized ( 0.1- 0.3 / dose)

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SHERMAN BIOTECH

• SB15 Challenges
• Short life in blood, variation in patients
• Solutions Exist
• Controlled / Prolonged release capsules
• Targeted release to brain
• Skin patch development to prolong release
• Drug stabilization

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SHERMAN BIOTECH
The Drug Development Process
TASK
STATUS
Drug Discovery
Completed
In Progress
Optimize Delivery
6 - 9 Months
Animal Studies
2 Months
Human Studies
Clinic identified Patients recruited
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SHERMAN BIOTECH
Sales Projections
Fragile X 100,000 diagnosed 50 will take
drug 20 / day 50,000 x 20 x 365 365 M /
yr.
Autism 1,200,000 diagnosed Off-label usage
? 20 / day 600,000 x 20 x 365 4,380 B/yr
Sherman Biotech will licenses the drug to a large
pharmaceutical company for a percentage of gross
sales. 10-15
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SHERMAN BIOTECH

• Experienced Resources
• Albert Einstein Medical School, Columbia
  University
• Scynexsis Contract Research Laboratory
• Fragile X Clinic, Rush Medical School
• Fragile X Foundation

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SHERMAN BIOTECH

• Drug Development for Anxiety in Fragile X and
  Autism
• Diagnostic Test Development for Fragile X and
  Autism
• Hospital Laboratory
• Point Of Care
• Over The Counter

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SHERMAN BIOTECH

• The Need for a Screening Test for Fragile X and
  Autism
• Diagnosis is based on complicated behavioral
  evaluation
• May be delayed 2-3 years after birth
• Can be confused with other disorders, e.g., ADD,
  ADDH etc
• Genetic test for fragile X is expensive,
  restricted and under-utilized
• Most families want to know
• Various studies

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SHERMAN BIOTECH
Latest Research May Provide a Test
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Glutamate Chemical Signaler
hippocampus
Anxiety areas in the brain
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Glutamate
SB15
Glutamate receptor
Signal enzymes
Diagnostic Test
FXMP
Protein
Normal
IMPROVEMNET
Fragile X
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SHERMAN BIOTECH
Diagnostic Development Process
TASK
STATUS
Test Discovery
Completed
In Progress
Laboratory Version
6 - 9 Months
POC Version
6 Months
OTC Version
Pan Probe Inc
Overlapping
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SHERMAN BIOTECH
Drug and Diagnostic Development
Expertise David Schwartz, PhD, Chief Science
Officer Drug and Diagnostic Test Development
Experience Sam Hopkins, PhD, Advisor Drug
Development Experience (FDA Pre-Clinical) Clive
Taylor, MD, PhD, Advisor Chairman, Department of
Pathology, USC Medical School SHUIJE CIU, MD,PhD
President, Pan Probe Inc
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SHERMAN BIOTECH
Clinical Trial Expertise Elizabeth
Berry-Kravis, MD, PhD Founder, Fragile X Clinic,
Rush Medical Center Sue Ellen Krause,
PhD Consultant, Fragile X Clinic, Rush Medical
Center Sam Hopkins, PhD, Advisor Drug
Development Experience (FDA Phase 1-3)