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| 8-K - FORM 8-K - INFINITY PHARMACEUTICALS, INC. | d8k.htm |
 Innovation.
Evolution.
Impact.
Exhibit 99.1 |
 Innovation. Evolution. Impact.
2
Safe Harbor Statement
•
This presentation contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. •
These statements involve risks and uncertainties that could cause actual results to be
materially different from historical results or from any future results
expressed or implied by such forward-looking statements. •
Such forward-looking statements include statements regarding the therapeutic
potential of Infinity’s Hedgehog pathway, FAAH, PI3K and Hsp90 chaperone
inhibitors; future development activity for IPI-504, IPI-493, IPI-926, IPI-940 and IPI-145; the presentation of
clinical data for IPI-504, IPI-493 and IPI-926; estimates of 2010
financial performance; the continuation of the Purdue/Mundipharma
alliance;
and
the
expectation
that
Infinity
will
have
capital
to
support
its
current
operating
plan
into
2013.
•
Such
forward-looking
statements
are
subject
to
numerous
factors,
risks
and
uncertainties
that
may
cause
actual
events
or
results
to
differ
materially
from
the
company's
current
expectations.
For
example,
there
can
be
no
guarantee
that
Infinity’s
strategic
alliance
with
Purdue/Mundipharma
will
continue
for
its
expected
term
or
that
these
entities
will
fund
Infinity’s
programs
as
agreed,
or
that
any
product
candidate
Infinity
is
developing
will
successfully
complete
necessary
preclinical
and
clinical
development
phases.
Further,
there
can
be
no
guarantee
that
any
positive
developments
in
Infinity’s
product
portfolio
will
result
in
stock
price
appreciation.
Infinity’s
expectations
could
also
be
affected
by
risks
and
uncertainties
relating
to:
results
of
clinical
trials
and
preclinical
studies,
including
subsequent
analysis
of
existing
data
and
new
data
received
from
ongoing
and
future
studies;
the
content
and
timing
of
decisions
made
by
the
U.S.
Food
and
Drug
Administration
and
other
regulatory
authorities,
investigational
review
boards
at
clinical
trial
sites,
and
publication
review
bodies;
Infinity's
ability
to
enroll
patients
in
its
clinical
trials;
unplanned
cash
requirements
and
expenditures,
including
in
connection
with
business
development
activities;
market
acceptance
of
any
products
Infinity
or
its
partners
may
successfully
develop;
Infinity’s
license
and
development
agreement
with
Intellikine
and
Infinity's
ability
to
obtain,
maintain
and
enforce
patent
and
other
intellectual
property
protection
for
any
product
candidate
it
is
developing.
•
These
and
other
risks
which
may
impact
management's
expectations
are
described
in
greater
detail
under
the
caption
"Risk
Factors"
included
in
Infinity's
quarterly
report
on
Form
10-Q
filed
with
the
U.S.
Securities
and
Exchange
Commission
on
November
9,
2010.
•
Further,
any
forward-looking
statements
contained
in
this
presentation
speak
only
as
of
the
date
hereof,
and
Infinity
expressly
disclaims
any
obligation
to
update
any
forward-looking
statements,
whether
as
a
result
of
new
information,
future
events
or
otherwise.
•
All
trademarks
used
in
this
presentation
are
the
property
of
their
respective
owners.
•
Our
Internet
website
is
http://www.infi.com.
We
regularly
use
our
website
to
post
information
regarding
our
business,
product
development
programs
and
governance.
We
encourage
investors
to
use
www.infi.com,
particularly
the
information
in
the
section
entitled
“Investors/Media,”
as
a
source
of
information
about
Infinity.
References
to
www.infi.com
in
this
presentation
are
not
intended
to,
nor
shall
they
be
deemed
to,
incorporate
information
on
www.infi.com
into
this
presentation
by
reference.
2
2 |
 Innovation. Evolution. Impact.
Infinity:
Innovation. Evolution. Impact.
3
Integrated Team
Proven drug developers
and company builders
Financial Strength
Cash runway into 2013
Ownership of Valuable Product Rights
Establishing commercial infrastructure in U.S.
Diverse Pipeline of Broadly
Applicable Targeted Therapies
Spanning Oncology and
Autoimmune/Inflammatory Diseases
Four candidates in the clinic
Fifth new IND planned for 2011 |
 Innovation. Evolution. Impact.
Financial Strength to Create Value
Substantial Capital to Invest in Pipeline and Access
External Opportunities
4
January 1, 2011: Est. $225M -
$235M in Capital |
 Innovation. Evolution. Impact.
Strategic Partnerships Enabling INFI To Become
a Fully Integrated Biopharmaceutical Company
•
100% R&D funding for partnered programs, including Hedgehog, PI3K, FAAH
and early discovery programs
–
INFI leads all discovery and development efforts through registration for
programs other than FAAH
–
Mundi expected to make a decision about 2012 program funding
commitment during the first half of December
•
Retention
of
valuable
commercial
rights
and
downstream
financial
participation
–
INFI has U.S. commercialization rights to all programs other than FAAH
–
Significant royalties on ex-U.S. sales and U.S. sales of FAAH inhibitors
•
Access to worldwide leadership in pain management and ex-US commercial
markets |
 Innovation. Evolution. Impact.
Developing a Pipeline of Broadly Applicable,
Targeted Therapies
6
IPI-926
Hedgehog
Pain
Oncology
Inflammation
IPI-145
PI3K
/
IPI-940
FAAH
IPI-504; IPI-493
Hsp90 |
 Broadly Applicable, Targeted Therapies
in Oncology |
 Innovation. Evolution. Impact.
8
IPI-926:
Significant Anti-Cancer Opportunity by Inhibiting
Malignant Activation of the Hedgehog Pathway
Targeting the Microenvironment
Targeting the Tumor Cell
Targeting Residual Disease |
 Innovation. Evolution. Impact.
Mean (±SD) Plasma IPI-926 Concentrations Following a Single 130 mg Dose
and Following Repeated Once-Daily Administration of 130 mg
IPI-926 .
IPI-926 Phase 1 Study in Advanced or
Metastatic Solid Tumors
PK Profile Supports Once Daily Dosing
9
Rudin et al. ESMO 2010 |
 Innovation. Evolution. Impact.
10
Rudin
et al. ESMO 2010
IPI-926 Phase 1 Study
Evidence of Clinical Activity in BCC Patients
Patients with BCC Who Have Not Had Prior Treatment with a Hh-Inhibitor
|
  Innovation. Evolution. Impact.
11
Patient A
Evidence of Clinical Activity in Patients with BCC
Rudin
et al. ESMO 2010
Baseline
6 Mos. |
 Innovation. Evolution. Impact.
12
Evidence of Clinical Activity in Patients with BCC
Rudin
et al. ESMO 2010 |
 Innovation. Evolution. Impact.
•
The majority of related AEs
were Grade 1 or 2
•
No Grade 4 or 5 related AEs
have been observed
•
Primary related AEs
were Grade 1 and 2 fatigue and
nausea
13
Rudin
et al. ESMO 2010
IPI-926 Phase 1 Study
Favorable Tolerability Profile |
 Innovation. Evolution. Impact.
IPI-926: Strong Preclinical Rationale for
Targeting Minimal Residual Disease
14
IPI-926 in SCLC model
1
1
Travaglione et al., 2008 AACR
3
Mandley
et al., 2010 AACR
2
Proctor et al., 2010 AACR
IPI-926 in castration resistant
prostate cancer model
2
IPI-926 in NSCLC model
3
Phase 2 study in minimal residual disease setting
expected to begin in 2011 |
 Innovation. Evolution. Impact.
Pancreatic Cancer: A Difficult-to-Treat,
Devastating Disease
•
4
th
leading cause of cancer death in the U.S.
–
Estimated 40,000 new cases expected in 2010
•
Highest mortality rate of all major cancers
–
Average survival is <6 months
–
5-year survival < 5%
•
Highly resistant to treatment with many drugs
•
Historically considered an “undruggable”
tumor
15
IPI-926 represents a fundamentally new approach to
treating pancreatic cancer |
 Innovation. Evolution. Impact.
IPI-926: Strong Preclinical Rationale for
Targeting the Tumor Microenvironment
16
1
Olive et al., 21 May 2009 Science
2
Travaglione et al., 2010 AACR
IPI-926
+
Gemzar
®
doubles
median
survival
in
pancreatic
cancer
model1
IPI-926
+
Abraxane
®
significantly
decreased
tumor
growth
(77%)
and
increased
tumor
perfusion
in
pancreatic
cancer
model
2 |
 Innovation. Evolution. Impact.
IPI-926: Phase 1b/2 Study in Pancreatic Cancer
•
Phase 1b: Determine safety profile and MTD
•
Phase 2: Evaluate safety and efficacy
–
Primary
endpoint
is
overall
survival;
secondary
endpoints
include
progression
free
survival,
time
to
progression,
overall
response
rate
–
Rigorous
design
to
mitigate
Phase
3
risk
17
Dose
Escalation
MTD
Randomization
IPI-926 + Gemcitabine
Placebo + Gemcitabine
Phase 1b
Phase 2 |
 Innovation. Evolution. Impact.
IPI-926: Significant
Potential Across a Broad
Range of Difficult-to-Treat Cancers
18
•
Preclinical models support development in all three modes of action
•
Promising Phase 1 data in BCC recently reported
•
Phase 2 study in residual disease setting anticipated in 2011
•
Rigorous Phase 1b/2 study in pancreatic cancer study ongoing
Targeting the Microenvironment
Targeting the Tumor Cell
Targeting Residual Disease |
 Innovation. Evolution. Impact.
19
Hsp90 chaperone stabilizes
oncoproteins
Hsp90 inhibitors combinable with
best available therapies
Inhibiting Hsp90 degrades
oncoproteins, stopping tumor growth
IPI-504 and IPI-493:
Broadly Attacking Oncoproteins through
Hsp90 Chaperone Inhibition |
 Innovation. Evolution. Impact.
IPI-504 i.v.: Current Status
•
Well-tolerated in multiple studies at
biologically active doses
–
Phase 2 mBC
with Herceptin
®
–
Phase 2 study NSCLC
–
Phase 1b solid tumor with Taxotere
®
•
Two NSCLC studies ongoing
–
Validation in NSCLC patients with
ALK rearrangements (IST)
–
Phase 1b study with Taxotere
®
•
No additional trials planned at this
time
–
Any future studies will be based on
data and market insights
20
1
Sequist et al., 2010 ASCO |
 Innovation. Evolution. Impact.
IPI-493 Oral: Distinct Pharmaceutical Properties
•
Phase 1 program underway
–
Two ongoing Phase 1 studies –
one in hematologic malignancies
and one in solid tumors
–
Studies designed to assess efficacy and dosing regimen
–
Demonstration of client protein degradation by IPI-493 a key
milestone for further investment
•
Data and articulation of future plans for Hsp90 program
anticipated in 2011
21 |
 Broadly Applicable, Targeted Therapies
in Pain and Inflammation |
 Innovation. Evolution. Impact.
23
IPI-940:
Combating the Magnitude of Neuropathic Pain by
Inhibiting Fatty Acid Amide Hydrolase
(FAAH) |
 Innovation. Evolution. Impact.
IPI-940: Novel Agent Enabling the Body’s Natural
Analgesia
•
Novel, oral agent designed to potentiate the magnitude and
duration of body’s natural analgesia
•
Encouraging preliminary data from single-dose study of IPI-940
in normal healthy adult volunteers
–
Marked FAAH inhibition and increased anandamide levels observed
–
No observed dose-limiting toxicities or clinically significant changes
in clinical laboratory values
•
Additional Phase 1 development of IPI-940 is ongoing
•
Purdue and Mundipharma exercised rights for worldwide
development and commercialization
24 |
 Innovation. Evolution. Impact.
IPI-940: Targeting Broad Areas of Unmet Need
Purdue Plans to Begin Phase 2 Studies in Pain in 2011
•
Neuropathic pain
–
Postherpetic
neuralgia
–
HIV pain
–
Peripheral diabetic neuropathy
–
Chemotherapy-induced neuropathy
–
Trigeminal neuralgia
–
Fibromyalgia
•
Anxiety and depression
•
Inflammatory conditions
25 |
 Innovation. Evolution. Impact.
26
IPI-145: PI3K
Inhibitor
Leveraging Oncology Expertise to Address Significant
Untapped Opportunity in Inflammatory Conditions and
Oncology |
 Innovation. Evolution. Impact.
PI3K
Distinct and Overlapping Roles in
Immunity, with Significant Therapeutic Potential
•
PI3K plays key regulatory role in cell proliferation and survival, cell
differentiation, cell trafficking and immunity
•
Delta and gamma isoforms
are restricted to immune system cells
–
Strongly implicated in broad range of inflammatory conditions and hematologic
cancers 27 |
 Innovation. Evolution. Impact.
IPI-145: Differentiated Product Candidate
Rapidly Advancing to the Clinic
•
IPI-145 is a novel, orally available, small molecule dual-specific
inhibitor of PI3K
and PI3K
–
Demonstrated activity in preclinical models of rheumatoid arthritis,
allergy, and inflammation
–
Phase 1 development expected to begin in 2011
•
Research collaboration with Intellikine to identify additional
differentiated PI3K
and/or PI3K
inhibitors for development
28 |
 Innovation. Evolution. Impact.
Key 2010 Development Objectives
IPI-926 (Hedgehog Pathway Inhibitor)
Phase 1 data presentation
Phase 2 initiation in pancreatic cancer
IPI-504 (Hsp90 Chaperone Inhibitor)
Phase 2 data presentation in NSCLC
Phase 2 data read-out in HER2+ breast cancer
IPI-493 (Hsp90 Chaperone Inhibitor)
Phase 1 initiation in hematological malignancies
IPI-940 (FAAH Inhibitor)
Phase 1 completion
IPI-145 (PI3K
Inhibitor)
Advance IND-enabling studies
29 |
 Innovation. Evolution. Impact.
Our Vision for Creating Value for Patients and
Shareholders
•
World-class organization and pipeline
–
Global discovery and development
–
U.S. commercialization
•
Strategic partnering of products, on attractive financial terms,
for market
access
–
Ex-U.S. (e.g., Mundipharma)
–
Products best served by a GP sales force (e.g., FAAH program)
•
Operational capabilities and financial strength to access additional
external opportunities
30 |
 Innovation. Evolution. Impact.
Infinity:
Innovation. Evolution. Impact.
31
Integrated Team
Proven drug developers
and company builders
Financial Strength
Cash runway into 2013
Ownership of Valuable Product Rights
Establishing commercial infrastructure in US
Diverse Pipeline of Broadly
Applicable Targeted Therapies
Spanning Oncology and
Autoimmune/Inflammatory Diseases
Four candidates in the clinic
Fifth new IND planned for 2011 |
 Innovation.
Evolution.
Impact. |