imuc_corporate_presentation_nove
Short Description
Download imuc_corporate_presentation_nove...
Description
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 forwardlooking statement.
2
Disruptive Validated Technology Cancer Stem Cell Targeting +
Potent Immunotherapy
= Effective Cancer Eradication 3
Why Cancer Vaccines Previously Failed? Problem
Solution
• Late-stage disease
• Minimal residual disease
• Immune compromised patients
• Immune competent patients at diagnosis • Dendritic cells with persistent Tcell immune response
• Weak immune response
• Tumor mutation/escape • Flawed trial endpoints • Targeted tumor bulk
• Target multiple antigens • Overall survival endpoint • Target cancer stem cells
4
Without killing CSCs, it is like spraying for weeds without killing the roots. The weeds (tumors) come back.
Immunotherapy Has Advantages in Targeting Cancer Stem Cells Immunotherapy can elicit T-cell mediated rejection of tumors • T cells are the way the body kills cancer cells • Improves specificity • Targets intracellular & surface antigens • Better safety profile • Differentiates between CSCs and normal stem cells Antibodies only target CSC antigens on the surface of cancer cells
Cytotoxic T-cells target CSC antigens cancer presented by MHCs MHC
Antibody Antigen
Antigen Cancer cell
Cytotoxic T-cell Cancer cell 6
Product Pipeline Overview Multiple therapies in different cancer indications Active immunotherapies ICT-107 ̶ Dendritic cell vaccine targeting glioblastoma antigens and CSCs ̶ Phase I trial showed compelling clinical outcomes ̶ Phase II study results anticipated late 2013 ICT-140 ̶ Dendritic cell vaccine targeting ovarian cancer antigens and CSCs ̶ IND filing Q4/2012 ICT-121 ̶ Dendritic cell vaccine targeting CD133 (CSC marker) ̶ IND approved; plan enrollment Q4/2012
Antibody immunotherapies Licensed to Caerus Molecular Discovery, funded by BioWa
7
ICT-107 Preparation & Manufacturing Multiple doses from only one apheresis procedure GMP Manufacturing Facility Ship overnight
Apheresis
Apheresis product
Patient
Culture with cytokines
Peripheral blood mononuclear cells
Activated dendritic cells Pulse w/ tumorassociated antigens
Intradermal injection
Ship back to physician ICT-107
Aliquot & freeze ~30 doses
8
ICT-107
ICT-107 targets both tumor cells and CSCs
9
AIM2
TRP-2
CDX-110 (Celldex)
Tumor Lys
HER2/neu
HSP Ags
IL-13Rα2
EGFRvIII
MAGE-1
ICT-107 (IMUC)
gp100
ICT-107 Targets Antigens Overexpressed on Glioblastoma Cancer Stem Cells
DC Vax (Northwest Bio)
Prophage (Agenus)
ICT-107 targets six tumor antigens (nine amino acid epitopes that elicit an immune response in HLA-A1/A2 patients) 10
Pt # Pt ID 1630 1636 1639 1640 1597 1587 1544 1576 1577 1551 1552 1562 1564 1540 1542 1519 1522 1523 1525 1412 1466 2 1526 5 1351 6 1431 7 1508 8 1468 9 1498 11 1539 12 1561 13 1550 14 1547 15 1594 16 1560 17 1578 18 1585 19 1614
AIM ++ +++ ++ +++ ++++ ++ ++ + ++ +++ ++ ++++ ++ ++ +++ ++++ +++++ ++++ +++ +++ ++ ++++ +++ ++++ +++++ ++++ + +++ ++ ++ ++++ ++ +++ +++ ++ +
gp100 ++ + + ++ ++ wk ++ wk + + wk + wk + ++ wk + + wk + + + + + neg ++ ++ + wk ++ neg + neg wk ++ +
MAGE wk wk wk wk + wk wk neg wk + wk + wk +++ wk ++ + + wk + wk + wk + + neg wk wk wk neg + wk wk wk wk wk
TRP-2 +++ +++ +++ +++ +++ ++ ++ ++ ++ +++ ++ +++ ++ +++ ++ ++ ++++ +++ ++ ++++ +++ ++ +++ +++ ++ ++++ ++ ++ +++ +++ ++ ++ neg ++ +++ ++
Her-2 ++++ +++ +++ ++++ ++++ ++ +++ +++ ++ +++ +++ +++ +++ +++ +++ +++ ++++ +++ ++++ ++++ ++++ +++ +++ ++++ ++++ neg ++++ +++ +++ ++++ +++ +++ +++ ++ ++++ +++
IL-13R ++++ ++++ ++++ neg +++++ ++++ ++ ++ ++ ++ ++ ++ +++ ++++ ++++ + ++++ ++++ ++++ +++++ +++ ++ ++++ +++++ ++++ +++++ ++++ + +++ ++++ ++++ +++ neg ++ ++++ ++++
wk + ++ +++ ++++ +++++
1E5 >1E4 >1E3 >1E2 >1E1
Expression of Tumor Antigens in GBM by RT-PCR All GBM patients express three or more antigens 75% expressed all six
Patients from ICT-107 Phase I clinical trial
11
Phase I Trial with ICT-107 Nonrandomized, single-center study at Cedars-Sinai 19 GBM patients 16 newly diagnosed, 3 recurrent ~75% fully resected
Patients received standard of care (surgery and chemo-radiation) followed by three vaccinations of ICT-107 every two weeks. 12
Pre- and Post-Operative MRI Scans of Four GBM Patients on ICT-107
13
ICT-107 Phase I Results Newly diagnosed GBM patients (efficacy and safety) RT/Chemo Historical
Vaccine
Fully-resected
Progressive disease
= Death
ICT-107
B-06 B-04 B-07 B-10 B-14 B-15 B-19 B-20
B-13 B-18
Six patients without recurrence for over 4 years (3 of them over 5 years)
B-16 B-02 B-11
No Grade 3 or 4 toxicities. Adverse events (Grade 1 or 2) include diarrhea, fatigue, flushing, pruritis, rash, vomiting
B-12 B-09 B-17 0
10
20
30
40
50
Months from Surgery
Stupp et al. N Engl J Med. 2005 Mar 10;352(10):987-96 & Stupp et al. Lancet Oncol. 2009 May;10(5):459-66.
14
60
70
ICT-107 Improves Survival in GBM Progression Free Survival (PFS)
Overall Survival (OS)
ICT-107 ICT-107 Historical standard of care
Historical standard of care
Significant increase in median PFS 16.9 months for ICT-107 6.9 months for historical SoC*
Significant increase in median OS 38.4 months for ICT-107 14.6 months for historical SoC*
*Surgery followed by radiation and temozolomide (TMZ). Stupp et al. N Engl J Med. 2005 Mar 10;352(10):987-96.
15
Correlation of PFS and OS with Antigen Expression
16
CD133 Expression (CSC Biomarker) Primary & recurrent tumor samples from the same patient Chemotherapy
ICT-107
6.6 5.3 3.5
After2 12.3
7.6
2.1
2.5 0.6
A
After
12.3
19.1
CD133 Expression
Relative Increase in CD133 Expression
Before
B
C
D
E
F
Patient
0.2
1.4 0
0
0 0
G
H
I
Patient
Phuphanich et al. Cancer Immunol Immunother. 2012 Jul 31.
17
J
ICT-107 Phase II Trial Design Randomized, placebo-controlled, double-blind trial
2:1 randomization
ICT-107 + TMZ Newly Diagnosed GBM Patients (n=123)
Surgery
Placebo Unloaded DCs + TMZ
Apheresis
• 123 patients treated at 25 centers HLA-A1/A2 50-75% of US population • 278 patients enrolled • Primary endpoint: OS • Secondary endpoints: PFS OS/PFS at various time intervals Immune response (T-cells) Safety • Interim analysis (based on 50% events) in Q1/2013 • Final results in 2H2013 • Derisked by improving DC function, timing, frequency Vaccinations
Radiation TMZ 7 weeks
6 weeks
4 weeks
18
4 weeks
4 weeks
4 weeks
4 weeks
ICT-107 Phase II Trial Enrollment 25 clinical trial sites – 278 patients enrolled 300
250
200
150
100
50
Planned 19
Actual
AUG
JUL
JUN
MAY
APR
MAR
FEB
JAN
DEC
NOV
OCT
SEP
AUG
JUL
JUN
MAY
APR
MAR
FEB
0
JAN
Johns Hopkins University New York University University of Texas at Houston Northwestern University Arizona Cancer Center New Jersey Neuroscience Institute UC San Diego Moffitt Cancer Center Penn State University of Pennsylvania University of Virginia Wake Forest Cornell Presbyterian Massachusetts General Kentuckiana Cancer Institute Cedars-Sinai Medical Center University Hospital Case Medical Center Rush University Overlook Hospital Baylor University Cleveland Clinic University of Alabama Thomas Jefferson Long Island Brain Center
FDA Approvals Newly Diagnosed GBM Gliadel Approval in 2003 Double-blind, placebo-controlled, randomized Phase III trial showing 13.8 vs. 11.6 month survival
Temozolomide Approval in 2005 Double-blind, placebo-controlled, randomized Phase III trial showing 14.6 vs. 12.1 month survival
20
Projected Costs: ICT-107 vs. Provenge Lower cost of goods, better logistics ICT-107
Provenge
60%-90%
15%-20%
Interleukin-12
Yes
No
Target antigens
Six
One
Doses/apheresis
~30
1
Liquid nitrogen
N/A
Administration
Intradermal injection
IV infusion
Cost of Goods
5%-10%
70%
% DCs/APC
Storage
Source: Quarterly earnings transcripts and public filings.
21
Other Immunotherapy Candidates
22
ICT-140: Ovarian Cancer Vaccine Ovarian cancer is similar to GBM Minimal residual disease after surgery Immuno-responsive
Dendritic cell vaccine targeting CSCs Seven antigens over-expressed in ovarian cancer, including three antigens used in ICT-107 ̶ HER2/neu, IL-13Rα2, MAGE1, mesothelin, EphA2, & two more antigens File IND by Q4/2012
23
ICT-121: CSC-targeted Universal Vaccine • Dendritic cell vaccine loaded with two CD133 peptides • CD133 is highly expressed on CSCs • CD133 is expressed on most solid tumors, including brain, colon, non-small cell lung, melanoma, pancreatic, and breast cancer • Initial indication in recurrent GBM • PI-sponsored Phase I trial at Cedars-Sinai Medical Center 20 patients IND approved; plan enrollment Q4/2012
24
Inverse Correlation between CD133 Expression with Survival on Gliomas
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.
Strong IP Position 28+ patents and patent applications 10 patents issued or allowed 18+ patents pending
Vaccine patents and applications include
Method of use for six antigen vaccine (ICT-107) Manufacturing process for production of ICT-107 Use of dendritic cells with chemotherapy for neural cancers Immunotherapy targeting IL-13Rα2 Immunotherapy targeting CD133
Issued patents on monoclonal antibodies cover composition of matter, therapeutic treatments and diagnostics 26
Experienced Management Team John Yu, MD, Chairman & CSO, Interim CEO Neurosurgeon at Cedars-Sinai, Mass General Hospital, Harvard Medical School
Elma Hawkins, PhD, Head of Clinical Development Antigenics, Genzyme, Warner Lambert/Parke Davis
Jim Bender, PhD, MPH, VP of Manufacturing & Product Development IDM Pharma, Baxter Healthcare
David Fractor, CPA, CFO HemaCare, Andwin, Deloitte & Touche
Peter Ho, PhD, Director of Business Development Grey Healthcare Group, Prudential Equity Group, Allergan, D.E. Shaw
Experience in developing over 20 products in cell & gene therapy and vaccines
27
Product Pipeline 2011 Q1
Q2
2012
Q3
Q4
ICT-107 New GBM
Q1
Q2
2013
Q3
Q4
Q1
Q2
Q4
Q1
Preclinical
Final results Phase I/II trial
IND ICT-121 Recurrent GBM
Q2
Phase II trial Interim analysis
ICT-140 Ovarian
Q3
2014
Preclinical
Phase I trial
IND
28
Q3
Q4
Recent & Upcoming Milestones May 2012
NYSE MKT listing July 2012
ICT-121 IND October 2013
October 2012
SITC abstract
SITC abstract December 2012
Q3 2013
ICT-121 Ph 1
ICT-140 Ph 1/2
Q1 2013
2H 2013
ICT-107 Ph 2 final
June 2013
November 2013
ASCO abstract
SNO abstract
ICT-107 Ph 2 interim ICT-140 IND November 2012
SNO abstract August 2012
ICT-107 Ph 2 enrollment
29
Strong Financial Position & Capitalization Cash (as of 9/30/2012) $10 million (A) Burn rate $3 million per quarter Outstanding debt None Shares outstanding (as of 41.1 million (A) 9/30/12)
Market capitalization $98 million (as of 11/6/2012) Warrants outstanding (as 8.9 million (A) of 9/30/12) 10.4 million (average weighted Options outstanding exercise price of $1.15) (A) In October 2012, we raised $19.3 million from the issuance of 10 million shares of common stock and 4.5 million warrants. 30
ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy November 2012
View more...
Comments