ImmunoCellular Therapeutics. Industry-leading, next-generation, cancer immunotherapy. November 2012. Disclaimer.
This presentation contains certain “forward-looking statements” (statements as to matters other than historical facts) as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual events or results to differ materially from the events and include statements about our plans, objectives, expectations and intentions with respect to the potential for success of our scientific approach to cancer immunotherapy, clinical development efforts, operations, financial condition and other statements that are not historical in nature, particularly those that use terms such as “will,” “potential”, “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “projects,” “estimates” or similar language.
Important factors known to us that could cause actual results to differ materially from those expressed in such forward-looking statements include those set forth in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q and other reports filed with the SEC.
You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec.gov. The information in this presentation speaks only as of the date hereof, and except as required by law, we disclaim any obligation to update or revise any forward-looking statement.
Cancer Stem Cell Targeting
= Effective Cancer Eradication
Minimal residual disease
Immune competent patients at diagnosis
Dendritic cells with persistent T-cell immune response
Without killing CSCs, it is like spraying for weeds without killing the roots. The weeds (tumors) come back.
Antibodies only target CSC antigens on the surface of cancer cells
Cytotoxic T-cells target CSC antigens cancer presented by MHCs
GMP Manufacturing Facility
Culture with cytokines
Peripheral blood mononuclear cells
Activated dendritic cells
Pulse w/ tumor-associated antigens
Shipback to physician
Aliquot & freeze
ICT-107 targets six tumor antigens (nine amino acid epitopes that elicit an immune response in HLA-A1/A2 patients)
All GBM patients express three or more antigens
75% expressed all six
Patients from ICT-107 Phase I clinical trial
Nonrandomized, single-center study at Cedars-Sinai
Six patients without recurrence for over 4 years (3 of them over 5 years)
No Grade 3 or 4 toxicities.
Adverse events (Grade 1 or 2) include diarrhea, fatigue, flushing, pruritis, rash, vomiting
Stupp et al. N Engl J Med. 2005 Mar 10;352(10):987-96 & Stupp et al.LancetOncol. 2009 May;10(5):459-66.
Progression Free Survival (PFS)
Overall Survival (OS)
Historical standard of care
Historical standard of care
*Surgery followed by radiation and temozolomide (TMZ). Stupp et al. N Engl J Med. 2005 Mar 10;352(10):987-96.
Phuphanich et al. Cancer Immunol Immunother. 2012 Jul 31.
Newly Diagnosed GBM Patients (n=123)
Unloaded DCs + TMZ
Source: Quarterly earnings transcripts and public filings.
Ovarian cancer is similar to GBM
Dendritic cell vaccine targeting CSCs
CD133 expression correlates inversely with grade II to IV glioma patient survival time. The survival time calculated from the day of operation was plotted against the percentage of CD133+ cells in the CD45-cell fraction from the specimens of each patient. UD: undetectable CD133 expression. Bold black bars indicate the median survival time for patients in groups with CD133+ cells either lower or higher than 30% of total CD45-cells.
Source: Rebetz et al. PLoS ONE. 2008.
28+ patents and patent applications
Vaccine patents and applications include
Issued patents on monoclonal antibodies cover composition of matter, therapeutic treatments and diagnostics
Experience in developing over 20 products in cell & gene therapy and vaccines
John Yu, MD, Chairman & CSO, Interim CEO
Elma Hawkins, PhD, Head of Clinical Development
Jim Bender, PhD, MPH, VP of Manufacturing & Product Development
David Fractor, CPA, CFO
Peter Ho, PhD, Director of Business Development
Phase II trial
Phase I/II trial
Phase I trial
NYSE MKT listing
ICT-107 Ph 2 final
ICT-121 Ph 1
ICT-140 Ph 1/2
ICT-107 Ph 2 interim
ICT-107 Ph 2 enrollment