Transcript Document

Immune Cell Therapy| Edward Cohen, M.D., Founder
Cautionary Statement on Forward-Looking Information
Certain information contained in this presentation, including any information as to our strategy, projects, plans or future financial or
operating performance and other statements that express management's expectations or estimates of future performance, constitute
"forward-looking statements”. All statements, other than statements of historical fact, are forward-looking statements. The words
“believe”, "expect", "will", “anticipate”, “contemplate”, “target”, “plan”, “continue”, “budget”, “may”, “intend”, “estimate” and similar
expressions identify forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and
assumptions that, while considered reasonable by management, are inherently subject to significant business, economic and
competitive uncertainties and contingencies. Immune Cell Therapy, Inc. cautions the reader that such forward-looking statements
involve known and unknown risks, uncertainties and other factors that may cause the actual financial results, performance or
achievements of the company to be materially different from the company's estimated future results, performance or achievements
expressed or implied by those forward-looking statements and the forward-looking statements are not guarantees of future
performance. Such risks include but are not limited to: the ability to obtain financing immediately in current markets, the impact of
general economic conditions, general conditions in the pharmaceutical and/or nutraceuticals industry, changes in the regulatory
environment in the jurisdictions in which the Immune Cell Therapy, Inc. does business, fluctuations in costs, and changes to the
competitive environment due to consolidation, achievement of forecasted burn rate, and that actual results may vary once the final
and quality-controlled verification of data and analyses has been completed. Immune Cell Therapy, Inc. disclaims any intention or
obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
About Immune Cell Therapy, Inc. (ICT)
ICT possesses the exclusive Intellectual Patent Property for the
utilization of Allogeneic Cell Lines (ACL) in the modification and
method of use in the treatment of human cancers.
Pre-clinical data provides strong
evidence that the relative effects
of ACL processes are highly
immunogenic and efficacious
• Personalized Cellular Vaccines for
Lung Cancer
• Vaccines for Breast Cancer
Our Objective
Adjuvant to current treatment methods with proprietary DNAbased vaccine methods developed by ICT that have shown
evidence to be more effective at eliminating residual cancer cells in
patients who have completed conventional treatment.
Phase 2
Phase 3
Lung Cancer
Vaccine Currently
in Phase I Trial
Review Decision
Breast Cancer
Vaccine IND
Ready to be Filed
First Patient
Cancer FREE
Review
Review Decision
Institutional
Review Boards
Phase 1
NDA Submitted
Animal Testing
IND Submitted
Synthesis &
Purification
NDA
Clinical Studies
Pre-Clinical Research
ICT Plans to Complete Phase I/II Clinical Trial of
immunotherapy for 37 eligible patients with pathologically
documented Non-Small Cell Lung Cancer (NSCLC)
Our Team
Edward Cohen, M.D
Founder & Interim CEO
Mary L. (Nora) Disis, M.D.
Alice Lin-Tsing Yu, M.D., Ph.D.
Scientific Advisor
Scientific Advisor
Thomas Gajewski, M.D., Ph.D.
Sandra Gendler, Ph.D.
Scientific Advisor
Scientific Advisor
How It Works
DNA
from
thefrom
patient’s
Cancer Cells
is Transferred
Normal
cells
an unrelated
healthy
individual into
thatNormal
take upCells
DNA
Normal
Cells
Normal
Cells
from
Unrelated
Healthy
Cancer Individual
Cells
from
Unrelated
Healthy
Individual.
express
cancer
antigens.
How It Works
Dendritic
Foreign
cells
cells
incorporate
expressingDNA
cancer
from
antigens
the foreign
are taken
cells expressing
up by
cancer antigens. patient’s
They activate
dendritic
killercells.
T cells in the patient.
How It Works
Activated T cells seek out cancer cells in the patient
Leaving normal patient cells intact
and destroy them.
Pre-Clinical Results
Mice vaccinated had fully regressed tumor 35 days post-immunization with ICT
Vaccine (LM-IL-2Kb/SB5b).
SB5b + LM-IL-2Kb/SB5b
SB5b + LM-IL-2Kb
SB5b + Media
SB5b + LM-IL-2Kb/SB5b + CD8+
antibodies
Increased Immune Response
Increased Efficacy
Target Stem Cell Markers
EP Cohen, Immunology Letters, Volume 74, Issue 1; September 15, 2000; pp. 59-65
Pre-Clinical Results
Extended survival seen with ICT Vaccine compared to Dendritic Cell Vaccine
(DC/SCC) in mice with aggressive Squamous Cell Carcinoma (SCC).
DC/SCC
Anticancer Research 26; 2006; pp. 837-884
ICT
Vaccine
Pre-Clinical Results
Mice with melanoma treated solely by immunization with the ICT Vaccine
developed strong, long-term resistance to the growth of the tumor. In some
instances, the mice survived indefinitely.
ICT
Vaccine
The Journal of Immunology, Vol. 160, No. 6; March 15, 1998; pp. 2915-2922
Pre-Clinical Results
Mice with breast cancer treated by immunization with ICT Vaccine survived more
than 55 days without evident disease. They rejected the breast cancer cells.
ICT
Vaccine
Early Phase 1 Progress
First lung cancer patient who
received conventional
therapy* followed by
immunization with ICT’s
DNA-based vaccine has
remained disease free with
no toxicity for more than two
years.
*Taxotere/Cisplatin; **Case report in preparation.
PAT H O L O G Y
Stage IIB
Poorly diff. 6.5 cm
adenocarcinoma with
metastases
ICT Vaccine
Why Immune Cell Therapy?
ICT addresses key issues in Cancer Immunotherapy
Problem
Vaccines usually antigen specific
e.g. Provenge
ICT Solution
Is patient-specific-Immune response is
directed toward the unique characteristics
of each patient’s cancer (all antigens)
Dendritic cell based vaccines
costly/difficult to prepare
Can be readily prepared and administered
at low cost to patients
Leukapheresis required
Can be prepared from minute amounts
of tumor tissue enabling treatment at
early stage of the disease
Requires large amounts of tissue
Can be prepared from minute amounts
of tumor tissue enabling treatment at
early stage of the disease
Other Cancer Vaccines require
novel delivery methods to administer
No foreign delivery technology required
Immune system naturally incorporates
foreign cells/processes antigens
Benefits
• Only small quantity of tumor tissue
required
• Vaccine specifies a broad array of
tumor antigens and is personalized
to patients tumor
• Recipient cell line can be modified in
advance to augment its inherent
immunogenic properties (e.g.,
cytokine-secretion)
• Number of vaccine cells can be
expanded as required for multiple
immunizations
• Vaccine is conveniently and readily
prepared at relatively low cost.
Leukapheresis is not required
• Non-Toxic
• More Efficacious and Immunogenic
than other Vaccine Approaches
(Preclinical Head to Head Models)
Milestones
Extensive patent portfolio
protects technology (4 issued
patents (US/Europe Coverage) and
2 Pending
FDA-approved human
cells/facilities to prepare
vaccine are on-hand
Extensive
Preclinical In Vitro
and In Vivo
research validates
technology and
efficacy
In Excess of $2 Million in
Grant and Venture Funding
to date
IRB (Institutional Review
Board) approval obtained
for phase I Lung Cancer
Study
Company-sponsored phase 1
clinical trial is ongoing.
• Collaboration established with
University of Pittsburgh Cancer
Institute to conduct the trial.
IND (Investigational New Drug) issued for Lung Cancer
Vaccine
• Phase I/II toxicity/efficacy study.
• Permission granted to treat up to 37 lung cancer patients.
• Only Lung Cancer Vaccine in clinical trials that targets multiple
epitopes unique to the patient’s tumor (Lucanix in Phase 3
development in lung cancer targets only TGF-Beta.
2006 to Present
Patents
UIC IP Id
CM10/NPA
CP54/NPA
CP54/DIV
CP54/DIV2
CP/54/GB
CP54/FR
CP54/DE
CX005/PCT/US
Title
Immunotherapeutic Strategies for the
Treatment of Cancer
Cancer Immunotherapy with SemiAllogeneic Cells
Cancer Immunotherapy with SemiAllogeneic Cells
Cancer Immunotherapy with SemiAllogeneic Cells
Cancer Immunotherapy with SemiAllogeneic Cells
Cancer Immunotherapy with SemiAllogeneic Cells
Cancer Immunotherapy with SemiAllogeneic Cells
Cancer Vaccines and Therapeutic
Methods
Application
Number
Patent
Number
Issued
08/242,405
5,759,535
Issued
09/016,528
6,187,307
Issued
09/522,716
7,402,306
Issued
12/115,868
7,670,611
Issued
98904782.4
1012240
Issued
98904782.4
1012240
Issued
98904782.4
69839273.6
Pending
11/909,251
N/A
12/922,581
N/A
9720018.2
N/A
Status
DB079/PCT/US
Therapeutic Cancer Antigens
Pending
DB079/PCT/EP
Therapeutic Cancer Antigens
Pending
Country
EP
Competition
Agenus
Celldex
ImmunoCellular
Therapeutics
Northwest
Biotherapeutics
TVAX BioMed
Market
Technology
Market Size
Personalized Lung
Cancer Vaccine
Using Tumor DNA
(ICT 1001)
$2.3 billion
- $13 billion
per year
Personalized Breast
Cancer Vaccine
(ICT 1002)
$660 million
- $4 billion
per year
Cancer Antigen
Discovery Platform
Potential
Customers
Competitors
Competitive
Advantage
All Lung Cancer
patients
No other company is
utilizing ICT’s
Allogeneic Based
DNA Approaches
Personalized to the
patient’s tumor tissue
antigenic DNA profile
All Breast Cancer
Patients
No other company is
utilizing ICT’s
Allogeneic Based
DNA Approaches
Personalized to the
patient’s tumor tissue
antigenic DNA profile
Companies that
There are existing
The method to produce
$200 thousand
need to purchase vendors selling cancer cancer antigen has been
- $2 million
cancer antigens for antigens. Could be 5-10 used; ICT’s approach is
per year
research purposes companies worldwide
simple and specific
Future Growth
MILESTONES/INFLECTION POINTS BEING MET
2012
Launch
2013
2014
2015
2016
$3.5MM Series A
EXIT WINDOW
Build Company & Exit
Transform Company & Exit
$10M Series B
$30M Series B If Needed
Use of Funds
$500,000 to complete and
expand Intellectual Property
$250,000 to Complete IND
Filing for Breast Cancer Vaccine
$750,000 to Complete Phase
1b Breast Cancer Study
12%
6%
$2.0 Million for Salaries, Hiring New Staff,
Facilities, R&D on Novel Antigen Discovery
(Est. 2 Yrs)
18%
47%
17%
$750,000 to Complete ICT Vaccine Phase
1b NSCLC Lung Cancer (37 Patients)
Liquidity Event
Conservative valuation of ICT at USD $17.5 Million
• Strong Patent-Portfolio of Issued
Patents
• Phase 1b Trial that has
commenced in NSCLC
• IND Trial that is ready to be filed
in Breast Cancer
• Antigen Discovery Proprietary
Technology (that has identified
20 New Cancer Immunotherapy
Antigens to Date)
• Contemporary Vaccine
companies with single
compound leads at Phase 2 with
inferior DC technology and
valuations in excess of $100MM
• Positive Phase 1 Proof of
Concept to increase valuation of
Company and provide ROI- 1
year out
• Post Phase 1 StrategyAcquisition or Partnership or
Public Offering