Anupama Kundoo Cost Effective detailed ppt with plans and elevations with det...
03 avth
1. AV
THERAPEUTICS
Investor
presenta6on
Confiden'al
-‐
not
for
distribu'on
Except
for
historical
information,
the
statements
made
in
this
presentation
are
forward
looking
statements
involving
significant
risks
and
uncertainties.
“Be9er
Treatment
of
Cancer
through
Innova6on”
A
New
York
Based
Biotechnology
Company
1
2. AV
Therapeu6cs:
Developing
Safer
and
More
Effec6ve
Chemotherapeu6c
Agents
Capridine:
-‐Patented
drug
-‐Specific
ac'vity
against
prostate
cancer
plus
an
immuno-‐
therapeu'c
vaccine
Preliminary
efficacy
on
range
of
cancers
World-‐class
team
of
physicians
and
clinical
researchers
Confiden'al
-‐
not
for
distribu'on
2
3. Capridine-‐β
(C-‐1748)
Confiden'al
-‐
not
for
distribu'on
Deriva6ve
R1
R2
R3
R4
C-‐1748
H
(CH2)2OH
CH3
H
Data
on
file
AV
Therapeu6cs,
Inc.
3
4. Management
Team
Abraham
Mi9elman
,
M.D.,
Chief
Execu6ve
Officer
and
Chairman
of
the
Board
• Oncologist
and
Associate
Prof.
at
New
York
Medical
College
(NYMC)
with
over
30
years
of
experience
in
pa'ent
treatment
and
clinical
trials.
Raj
Tiwari,
Ph.D.,
Chief
Scien6fic
Officer
• Professor
of
Microbiology
&
Immunology
and
Graduate
Program
Director
at
NYMC
with
over
30
years
of
Cancer
Research,
inventor
of
AVTs
IPs
related
to
Capridine
and
Pep'de
Vaccine
Technology.
Morton
Coleman,
M.D.,
Vice
President,
Director
of
Clinical
Development
• Clinical
Professor
at
Weill
Medical
College,
Cornell
University,
Director
of
the
Center
for
Lymphoma
and
Myeloma
at
New
York
Presbyterian
Hospital
Robert
Pollock,
President
• Over
40
years
business
experience.
Founder
and
managing
partner
of
Con'nuum
Partners,
a
global
network
security
and
business
development
consul'ng
firm.
Jan
Geliebter,
Ph.D.,
Secretary,
VP
Genomic
Plaborms
• Professor
of
Microbiology
&
Immunology
at
NYMC
with
over
30
years
of
Cancer
Research
experience
Holder
of
mul'ple
patents,
including
AVTs
IP
BCG-‐based
prostate
cancer
vaccine
Debabrata
Banerjee,
Ph.D.,
VP
Preclinical
Development
• Associate
Professor
of
Medicine
and
Pharmacology,
Rutgers
University
with
Over
30
years
of
experience
in
preclinical
and
exptal
therapeu'cs
and
Inventor
of
several
patents.
Confiden'al
-‐
not
for
distribu'on
4
5. The
Problem
-‐
Prostate
Cancer
High
Incidence
• Prostate
Cancer
is
the
most
common
type
of
cancer
in
men
in
the
USA
• Annual
expenditures
exceed
$15
billion
Limited
efficacy
for
metasta'c
disease
• Radia'on,
hormonal
and
chemotherapy
remain
pallia've
High
Toxicity
• Severe
bone
marrow
toxicity
and
poor
tolerance
Confiden'al
-‐
not
for
distribu'on
Effective
drug
based
therapy
and
immunotherapy
is
an
unmet
clinical
need
in
prostate
cancer
5
6. • Low amount of drug,
high efficacy
• Low blood and bone
marrow toxicity
• Over 6 million dollars
invested in development
(pre-AVT)
• Capridines and 200 of their
derivatives are patent
protected for use as
anticancer agents in US, EU,
Mexico, Canada, Israel
The
Solu6on:
Capridine-‐β
(C-‐1748)
NCI
tested
prostate
cancer
specific
drug
Limited
side
affects
High
therapeu'c
index
for
prostate
Patent-‐
protected
Confiden'al
-‐
not
for
distribu'on
6
7. Prostate cancer cells (DU-145) are ten to 100 fold more
sensitive to Capridine-β than leukemic cells (HL-6O)
1
2
Capridine-β Kills Prostate Cancer Preferentially
Confiden'al
-‐
not
for
distribu'on
DU-145 Cells Treated with Capridine-β HL-60 Cells Treated with Capridine-β
8. Capridine-‐β
is
a
Potent
An6cancer
Drug
in
Several
Cancers
0"
10"
20"
30"
40"
50"
60"
Uterus" Leuk" Breast" Colon" lymph" Sarc" Prostate"
Mul$ples(of(effec$veness(of(
(CAP((compared(to(MITX(
Cap""
MITX"
Confiden'al
-‐
not
for
distribu'on
Comparisons between the two drugs are based on IC50 values
IC50 is the drug concentration required to kill 50% cells
8
*
*Mitoxantrane
9. Treatment started week 1, once weekly for 7 – 9 weeks
1
3
2
Capridine - β Inhibits Hormone-Responsive and
Non-Responsive Xenografts in Nude Mice
9
Confiden'al
-‐
not
for
distribu'on
4
10. Loss
of
Androgen
Receptor
Early
Step
in
Prostate
Tumor
Progression
Hormone
Dependent
Confiden'al
-‐
not
for
distribu'on
10
Hormone
Independent
Loss of
Androgen
Receptor
Upregulation
of ER-β
Upregulation of
CDC25 group
11. 6 h 12 h
C 5 nM 10 nM 5 nM 10 nM
Actin
Androgen receptor
Capridine-‐β
renders
Hormone-‐Independent
DU-‐145
CaP
Cells
Hormone
sensi6ve
Confiden'al
-‐
not
for
distribu'on
11
0
0.5
1
1.5
Control
5nm
(6hr)
10nm
(6hr)
5nm
(12hr)
10nm
(12hr)
Induction of Androgen Receptor in DU-145 Cells
RelativeDensity
12. Cell
lines
IC50
Values
(nM)
Taxane
Capridine
LnCaP
>100nM
15nM
PC3
16-‐20nM
5nM
DU145
15-‐20nM
5nM
Confiden'al
-‐
not
for
distribu'on
12
Capridine
is
superior
to
taxane
and
is
effec've
on
taxane
resistant
prostate
cancer
13. Salient
Features
of
Capridine-‐β
Capridine-‐β
is
ac've
against
taxane
resistant
prostate
cancer
cells
Capridine-‐β
does
not
kill
bone
marrow
cells
or
white
blood
cells
Capridine-‐β
has
a
wide
predicted
human
therapeu'c
dose
range
Capridine-‐
β
is
ac've
on
hormone
dependent
and
independent
Prostate
cancer
(CaP)
xenografs
Confiden'al
-‐
not
for
distribu'on
13
15. Development
Plan
for
Capridine β –
Next
Steps
Drug
manufacture
and
formula'on
under
GMP
condi'ons
Stability
tes'ng
of
the
formulated
product
Limited
rodent
and
dog
toxicology
with
formulated
product
Pharmacokine'cs
and
pharmacodynamics
IND
applica'on
Phase
I/II
clinical
trials
Confiden'al
-‐
not
for
distribu'on
15
16.
Confiden'al
-‐
not
for
distribu'on
Howard
Scher
MD,
Head
of
Clinical
Consor6um
16
17. Scien6fic
Advisory
Board
•
Joseph
Ber6no,
MD,
Associate
Director
and
Chief
Scien'fic
Officer,
The
Cancer
Ins'tute
of
New
Jersey
and
past
President
of
the
American
Associa'on
for
Cancer
Research
and
The
American
Associa'on
of
Clinical
Oncologists,
organiza'ons
of
over
50,000
researchers,
worldwide.
He
is
the
founding
Editor
of
the
Journal
of
Clinical
Oncology.
•
Charles
Cantor,
PhD,
is
Director
of
the
Center
for
Advanced
Biotechnology
at
Boston
University
and
Chief
Scien'fic
Officer
at
Sequenom,
Inc.
in
La
Jolla
(a
publicly
traded
company).
He
has
published
more
than
400
ar'cles,
and
has
been
awarded
more
than
sixty
(60)
patents.
He
is
most
known
for
his
authoring
of
the
book,
Genomics:
The
Science
and
Technology
Behind
the
Human
Genome
Project.
•
Roy
G.
Smith,
PhD,
is
the
Director
of
then
Huffington
Center
on
Aging,
Professor
in
the
Department
of
Molecular
and
Cellular
Biology,
and
Professor
in
the
Department
of
Medicine
at
Baylor
College
of
Medicine.
He
was
previously
Vice
President
of
Basic
Research
at
Merck
and
was
responsible
for
iden'fying
new
drug
targets
for
metabolic
diseases
•
Pramod
Srivastava,
PhD,
is
a
Professor
of
immunology
at
the
University
of
Connec'cut,
where
he
holds
an
Endowed
Chair
in
Cancer
Immunology
and
is
the
Director
of
the
Cancer
Center
and
the
Scien'fic
Founder
of
An'genics.
He
is
among
the
founding
members
of
the
Academy
of
Cancer
Immunology.
Confiden'al
-‐
not
for
distribu'on
17
18. Use
of
proceeds
for
development
of
Capridine
Confiden6al
-‐
not
for
distribu6on
Clinical
product
synthesis
and
testing
IND
application
&
FDA
approval
for
Phase
I
Initiation
and
completion
of
Phase
I
Overall
development
Cost
($000)
Activities
•
GMP
synthesis
• Stability
• Toxicology
• Formulation
• Contractual
services
for
IND
• Data
analysis
and
compilation
• Chem
manufacture
write
up
• Comp
lab
mechanism
studies
•
Multicenter
Phase
I
•
Consortium
lead
• 60
patients
•
Clinical
development
of
Capridine
Output
•
Capridine
IND
•
Approval
for
Phase
I
•
Phase
I/
II
trial
• Licensing
of
Capridine
to
strategic
partner
• Continue
development
1,000
500
1,500
$3
million
months
0-‐6
Months
6-‐12
months
12-‐18
Strategy
Output
Output
Output
Activities
Activities
18
19. Summary
• Preclinical
studies
complete
for
Capridine.
Unique
proper'es
include
no
blood
toxicity
and
wide
therapeu6c
dose
range
with
specificity
towards
prostate
cancer
-‐
ready
to
commence
phase
I
and
II
human
trials
• A
world-‐class,
interna'onally
recognized,
well
published
scien'sts
and
clinicians
(PhD’s
and
MDs)
from
A+
ins'tu'ons
• World
class
medical
research
collaborators
and
Scien'fic
Advisory
Board
• All
IP
is
patent
protected
Confiden'al
-‐
not
for
distribu'on
19
20. Pros-‐Vax
Pep6de
Therapeu6c
Vaccine
• Synthe'c
pep'de
vaccine
(Pros-‐Vax)
that
mimics
cancer
proteins,
induces
the
host’s
immune
response
directed
against
mul'ple
cancer-‐specific
proteins
• Easily
manufactured,
small
molecule
drug
• Preclinical
studies
complete
• Expected
to
eliminate
micrometasa'c
and
residual
disease
and
hence
prevent
recurrence
Confiden'al
-‐
not
for
distribu'on
20
21. Immunization
with
peptide
vaccines
prevents
metastatic
prostate
cancer
growth
Unimmunized
rat
Immunized
rats
BTE6-‐LX-‐8b
ProVac
1
BTE6-‐X-‐15-‐7
ProVac
2
Confiden'al
-‐
not
for
distribu'on
21
22. Current
Capital
Structure
• Authorized
Common
shares
:
200,000,000
• Outstanding
AVT
principals
and
prior
investors:
58,000,000
• Barry
Honig
and
PubCo
Group
investors
:
17,000,000
• Proposed
$3.5
million
raise
by
PPM
@
$0.20/share
and
a
warrant
to
purchase
one
half
of
a
share
of
the
Company’s
common
stock
Confiden'al
-‐
not
for
distribu'on
22