Immune Cell Therapy| Edward Cohen, M.D., Founder.
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Transcript of Immune Cell Therapy| Edward Cohen, M.D., Founder.
Immune Cell Therapy| Edward Cohen, M.D., Founder
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.
Cautionary Statement on Forward-Looking Information
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 DNA-based 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.
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)
NDA Review
Phase 1
Phase 3
Clinical Studies
Phase 2
Synthesis & Purification
Animal Testing
Institutional Review Boards
IND
Submitt
ed
NDA Subm
itted
Review D
ecision
Review D
ecision
Breast Cancer Vaccine IND Ready to be Filed
Lung Cancer Vaccine Currently in Phase I Trial
First Patient Cancer FREE
Sandra Gendler, Ph.D.Scientific Advisor
Our Team
Edward Cohen, M.DFounder & Interim CEO
Mary L. (Nora) Disis, M.D.Scientific Advisor
Thomas Gajewski, M.D., Ph.D.Scientific Advisor
Alice Lin-Tsing Yu, M.D., Ph.D.Scientific Advisor
How It Works
Normal CellsNormal Cells from Unrelated Healthy IndividualCancer CellsDNA from the patient’s Cancer Cells is Transferred into Normal Cells from Unrelated Healthy Individual.
Normal cells from an unrelated healthy individual that take up DNA express cancer antigens.
How It Works
Foreign cells expressing cancer antigens are taken up by patient’s dendritic cells.
Dendritic cells incorporate DNA from the foreign cells expressing cancer antigens. They activate killer T cells in the patient.
How It Works
Activated T cells seek out cancer cells in the patient and destroy them.Leaving normal patient cells intact
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
EP Cohen, Immunology Letters, Volume 74, Issue 1; September 15, 2000; pp. 59-65
Increased Immune Response
Increased Efficacy
Target Stem Cell Markers
Pre-Clinical Results
Extended survival seen with ICT Vaccine compared to Dendritic Cell Vaccine (DC/SCC) in mice with aggressive Squamous Cell Carcinoma (SCC).
Anticancer Research 26; 2006; pp. 837-884
ICT Vaccine
DC/SCC
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.
The Journal of Immunology, Vol. 160, No. 6; March 15, 1998; pp. 2915-2922
ICT Vaccine
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.
P A T H O L O G YStage IIBPoorly diff. 6.5 cm adenocarcinoma with metastases
ICT Vaccine
*Taxotere/Cisplatin; **Case report in preparation.
Why Immune Cell Therapy?
ICT addresses key issues in Cancer Immunotherapy
Problem ICT Solution
Vaccines usually antigen specific e.g. Provenge
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 requiredCan be prepared from minute amounts
of tumor tissue enabling treatment at early stage of the disease
Requires large amounts of tissueCan 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
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.
Company-sponsored phase 1 clinical trial is ongoing.• Collaboration established with
University of Pittsburgh Cancer Institute to conduct the trial.
2006 to Present
Patents
UIC IP Id Title Status CountryApplication
NumberPatent
Number
CM10/NPA Immunotherapeutic Strategies for the Treatment of Cancer Issued 08/242,405 5,759,535
CP54/NPA Cancer Immunotherapy with Semi-Allogeneic Cells Issued 09/016,528 6,187,307
CP54/DIV Cancer Immunotherapy with Semi-Allogeneic Cells Issued 09/522,716 7,402,306
CP54/DIV2 Cancer Immunotherapy with Semi-Allogeneic Cells Issued 12/115,868 7,670,611
CP/54/GB Cancer Immunotherapy with Semi-Allogeneic Cells Issued 98904782.4 1012240
CP54/FR Cancer Immunotherapy with Semi-Allogeneic Cells Issued 98904782.4 1012240
CP54/DE Cancer Immunotherapy with Semi-Allogeneic Cells Issued 98904782.4 69839273.6
CX005/PCT/US Cancer Vaccines and Therapeutic Methods Pending 11/909,251 N/A
DB079/PCT/US Therapeutic Cancer Antigens Pending 12/922,581 N/A
DB079/PCT/EP Therapeutic Cancer Antigens Pending EP 9720018.2 N/A
Competition
Agenus Celldex ImmunoCellular Therapeutics
Northwest Biotherapeutics TVAX BioMed
Market
Technology Market SizePotential
CustomersCompetitors
Competitive Advantage
Personalized Lung Cancer Vaccine
Using Tumor DNA (ICT 1001)
$2.3 billion- $13 billion
per yearAll Lung Cancer
patients
No other company is utilizing ICT’s
Allogeneic Based DNA Approaches
Personalized to the patient’s tumor tissue antigenic DNA profile
Personalized Breast Cancer Vaccine
(ICT 1002)
$660 million - $4 billion
per year
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
Cancer Antigen Discovery Platform
$200 thousand - $2 million
per year
Companies that need to purchase
cancer antigens for research purposes
There are existing vendors selling cancer
antigens. Could be 5-10 companies worldwide
The method to produce cancer antigen has been used; ICT’s approach is
simple and specific
Future Growth
MILESTONES/INFLECTION POINTS BEING MET
2012 2013 2014 2015 2016
Launch
Build Company & Exit
Transform Company & Exit
$3.5MM Series A
$10M Series B
$30M Series B If Needed
EXIT WINDOW
Use of Funds
47%18%
18%
6%12%
$750,000 to Complete ICT Vaccine Phase 1b NSCLC Lung Cancer (37 Patients)
$750,000 to Complete Phase 1b Breast Cancer Study
$250,000 to Complete IND Filing for Breast Cancer Vaccine
$500,000 to complete and expand Intellectual Property
$2.0 Million for Salaries, Hiring New Staff, Facilities, R&D on Novel Antigen Discovery (Est. 2 Yrs)
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 Strategy- Acquisition or Partnership or Public Offering