Presentation on theme: "Immune Cell Therapy| Edward Cohen, M.D., Founder."— Presentation transcript:
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 Submitted NDA Submitted Review Decision 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.D Founder & 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 Cells Normal Cells from Unrelated Healthy IndividualCancer Cells DNA from the patients 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 patients 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-2K b /SB5b). SB5b + LM-IL-2K b /SB5bSB5b + LM-IL-2K b SB5b + Media SB5b + LM-IL-2K b /SB5b + CD8 + antibodies EP Cohen, Immunology Letters, Volume 74, Issue 1; September 15, 2000; pp 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 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 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 ICTs 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 *Taxotere/Cisplatin; **Case report in preparation.
Why Immune Cell Therapy? ICT addresses key issues in Cancer Immunotherapy
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 patients 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 to Present
Future Growth MILESTONES/INFLECTION POINTS BEING MET Launch Build Company & Exit Transform Company & Exit $3.5MM Series A $10M Series B $30M Series B If Needed EXIT WINDOW
Use of Funds $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