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

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

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

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

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

Page 2: 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

Page 3: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 4: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 5: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 6: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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.

Page 7: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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.

Page 8: Immune Cell Therapy| Edward Cohen, M.D., Founder.

How It Works

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

Page 9: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 10: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 11: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 12: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 13: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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.

Page 14: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 15: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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)

Page 16: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 17: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 18: Immune Cell Therapy| Edward Cohen, M.D., Founder.

Competition

Agenus Celldex ImmunoCellular Therapeutics

Northwest Biotherapeutics TVAX BioMed

Page 19: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 20: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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

Page 21: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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)

Page 22: Immune Cell Therapy| Edward Cohen, M.D., Founder.

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