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Immune Cell Therapy| Edward Cohen, M.D., Founder

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Presentation on theme: "Immune Cell Therapy| Edward Cohen, M.D., Founder"— Presentation transcript:

1 Immune Cell Therapy| Edward Cohen, M.D., Founder

2 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.

3 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 Fine. But will be

4 Pre-Clinical Research First Patient Cancer FREE
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 Clinical Studies NDA Review Synthesis & Purification Animal Testing Institutional Review Boards Phase 1 First Patient Cancer FREE IND Submitted Phase 2 NDA Submitted Review Decision Review Decision Phase 3 Breast Cancer Vaccine IND Ready to be Filed Lung Cancer Vaccine Currently in Phase I Trial ICT Plans to Complete Phase I/II Clinical Trial of immunotherapy for 37 eligible patients with pathologically documented Non-Small Cell Lung Cancer (NSCLC)

5 Our Team Edward Cohen, M.D Founder & Interim CEO
Mary L. (Nora) Disis, M.D. Scientific Advisor Alice Lin-Tsing Yu, M.D., Ph.D. Scientific Advisor Thomas Gajewski, M.D., Ph.D. Scientific Advisor Sandra Gendler, Ph.D. Scientific Advisor

6 Normal Cells from Unrelated Healthy Individual
How It Works DNA 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. Normal Cells Normal Cells from Unrelated Healthy Individual Cancer Cells

7 How It Works Dendritic cells incorporate DNA from the foreign cells expressing cancer antigens. They activate killer T cells in the patient. Foreign cells expressing cancer antigens are taken up by patient’s dendritic cells.

8 Leaving normal patient cells intact
How It Works Activated T cells seek out cancer cells in the patient and destroy them. Leaving normal patient cells intact

9 SB5b + LM-IL-2Kb/SB5b + CD8+ antibodies
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 INCREASED IMMUNE RESPONSE INCREASED EFFICACY TARGETING STEM CELL MARKERS EP Cohen, Immunology Letters, Volume 74, Issue 1; September 15, 2000; pp

10 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 ICT Vaccine Anticancer Research 26; 2006; pp

11 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

12 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

13 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. Pathology Stage IIB Poorly diff. 6.5 cm adenocarcinoma with metastases ICT Vaccine Patient is disease free and no toxicity. Make implication to tie in with disease free. Prehaps a subliminal on health. Cancer cell being distroyed *Taxotere/Cisplatin; **Case report in preparation.

14 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 required Can be prepared from minute amounts of tumor tissue enabling treatment at early stage of the disease Requires large amounts of tissue Other Cancer Vaccines require novel delivery methods to administer No foreign delivery technology required Immune system naturally incorporates foreign cells/processes antigens

15 Benefits Only small quantity of tumor tissue required
Vaccine is conveniently and readily prepared at relatively low cost. Leukapheresis is not required Vaccine specifies a broad array of tumor antigens and is personalized to patients tumor Non-Toxic More Efficacious and Immunogenic than other Vaccine Approaches (Preclinical Head to Head Models) 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 Added text. Modify with graphics

16 Milestones Extensive patent portfolio protects technology (4 issued patents (US/Europe Coverage) and 2 Pending In Excess of $2 Million in Grant and Venture Funding to date Company-sponsored phase 1 clinical trial is ongoing. Collaboration established with University of Pittsburgh Cancer Institute to conduct the trial. IRB (Institutional Review Board) approval obtained for phase I Lung Cancer Study FDA-approved human cells/facilities to prepare vaccine are on-hand 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. Extensive Preclinical In Vitro and In Vivo research validates technology and efficacy Put in timeline framework. 2006 to Present

17 Patents UIC IP Id Title Status Country Application Number
Patent 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 09/016,528 6,187,307  CP54/DIV 09/522,716 7,402,306  CP54/DIV2 12/115,868 7,670,611 CP/54/GB CP54/FR CP54/DE CX005/PCT/US Cancer Vaccines and Therapeutic Methods Pending 11/909,251  N/A DB079/PCT/US Therapeutic Cancer Antigens 12/922,581 DB079/PCT/EP EP

18 ImmunoCellular Therapeutics Northwest Biotherapeutics
Competition ImmunoCellular Therapeutics Northwest Biotherapeutics Agenus Celldex TVAX BioMed

19 Market Technology Market Size Potential Customers Competitors
Competitive Advantage Personalized Lung Cancer Vaccine Using Tumor DNA (ICT 1001) $2.3 billion - $13 billion per year 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 Personalized Breast Cancer Vaccine (ICT 1002) $660 million - $4 billion per year All Breast Cancer Patients 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 Modified to reflect better language Combine in table with next two slides. Rows: Lung Cancer Vaccine using tumor DNA, Breast Cancer Vaccine using 1 or more breast cancer antigens (ICT 1002), Cancer Antigen Discovery Platform Columns: Market Size, Potential Customers, Competitors, Competitive Advantage Use range when identifying Market Size, condense text in other columns

Future Growth MILESTONES/INFLECTION POINTS BEING MET 2012 2013 2014 2015 2016 Launch $3.5MM Series A EXIT WINDOW Build Company & Exit $10M Series B Transform Company & Exit $30M Series B If Needed

21 Use of Funds $500,000 to complete and expand Intellectual Property
$250,000 to Complete IND Filing for Breast Cancer Vaccine $2.0 Million for Salaries, Hiring New Staff, Facilities, R&D on Novel Antigen Discovery (Est. 2 Yrs) $750,000 to Complete Phase 1b Breast Cancer Study Make room and create a pie chart for the combined amounts. Group similar items together in the same color, differentiate with different shade: Complete ICT Vaccine Phase 1B & Complete Phase 1B Breast Cancer Study Complete IND Filing for Breast Cancer Vaccine, Complete Technology Transfer Licensing…, and Additional patent filings Salaries Show valuation $750,000 to Complete ICT Vaccine Phase 1b NSCLC Lung Cancer (37 Patients)

22 Conservative valuation of ICT at USD $17.5 Million
Liquidity Event Conservative valuation of ICT at USD $17.5 Million Contemporary Vaccine companies with single compound leads at Phase 2 with inferior DC technology and valuations in excess of $100MM Strong Patent-Portfolio of Issued Patents Phase 1b Trial that has commenced in NSCLC Positive Phase 1 Proof of Concept to increase valuation of Company and provide ROI- 1 year out 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) Post Phase 1 Strategy- Acquisition or Partnership or Public Offering Client to provide. Show valuation

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