Current Report Filing (8-k)

Date: November 14, 2014

IMMUNOCELLULAR THERAPEUTICS, LTD.

/s/ David Fractor

David Fractor

Principal Accounting Officer

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): November 14, 2014

IMMUNOCELLULAR THERAPEUTICS, LTD.

(Exact name of registrant as specified in its charter)

Delaware

001-35560

93-1301885

(State or other jurisdiction of

incorporation or organization)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

23622 Calabasas Road

Suite 300

Calabasas, California 91302

(Address of Principal Executive Offices) (Zip Code)

Registrant’s telephone number, including area code: (818) 264-2300

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01

Regulation FD Disclosure

On November 14, 2014, ImmunoCellular Therapeutics, Ltd. posted slides presented by Patrick Y. Wen, David Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William Curry, Jay-Jiguang Zhu, Michael Glantz, David Peereboom, James Markert, Renato Larocca, Donald O’Rourke, Karen Fink, Lyndon Kim, Michael Gruber, Glenn Lesser, Ed Pan, Santosh Kesari and John Yu in a presentation made at the Society for Neuro-Oncology 19^th Annual Scientific Meeting held on November 14, 2014 titled, “A randomized double-blind placebo-controlled phase 2 trial of dendritic cell (DC) vaccine ICT-107 following standard treatment in newly diagnosed patients with GBM,” a copy of which is attached as Exhibit 99.1 and is incorporated herein by reference.

The information included in this Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” under the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under this Securities Act of 1933, as amended, except as may expressly set forth by specific reference to this Item 7.01 in such a filing.

Item 8.01

Other Events

On November 14, 2014, ImmunoCellular Therapeutics, Ltd. issued a press release titled “ImmunoCellular Therapeutics Presents Updated ICT-107 Phase II Data at the Society for Neuro-Oncology Annual Meeting 2014,” a copy of which is attached as Exhibit 99.2 and is incorporated herein by reference.

Item 9.01.

Financial Statements and Exhibits

99.1 Slides presented by Patrick Y. Wen, David Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William Curry, Jay-Jiguang Zhu, Michael Glantz, David Peereboom, James Markert, Renato Larocca, Donald O’Rourke, Karen Fink, Lyndon Kim, Michael Gruber, Glenn Lesser, Ed Pan, Santosh Kesari and John Yu in a presentation made at the Society for Neuro-Oncology 19^th Annual Scientific Meeting held on November 14, 2014 titled, “A randomized double-blind placebo-controlled phase 2 trial of dendritic cell (DC) vaccine ICT-107 following standard treatment in newly diagnosed patients with GBM.”

99.2 Press Release, dated November 14, 2014, titled “ImmunoCellular Therapeutics Presents Updated ICT-107 Phase II Data at the Society for Neuro-Oncology Annual Meeting 2014.”

The information included in this Exhibit 99.1 hereto shall not be deemed “filed” under the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under this Securities Act of 1933, as amended, except as may expressly set forth by specific reference to this Item 9.01 in such a filing.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

EXHIBIT INDEX


Exhibit		Description

99.1		Slides presented by Patrick Y. Wen, David Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William Curry, Jay-Jiguang Zhu, Michael Glantz, David Peereboom, James Markert, Renato Larocca, Donald O’Rourke, Karen Fink, Lyndon Kim, Michael Gruber, Glenn Lesser, Ed Pan, Santosh Kesari and John Yu in a presentation made at the Society for Neuro-Oncology 19^th Annual Scientific Meeting held on November 14, 2014 titled, “A randomized double blind placebo-controlled phase 2 trial of dendritic cell (DC) vaccine ICT-107 following standard treatment in newly diagnosed patients with GBM.”

99.2		Press Release, dated November 14, 2014, titled “ImmunoCellular Therapeutics Presents Updated ICT-107 Phase II Data at the Society for Neuro-Oncology Annual Meeting 2014.”

Exhibit 99.1

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Exhibit 99.1

A randomized double blind placebo-controlled phase 2 trial of dendritic cell (DC) vaccine ICT-107 following standard treatment in newly diagnosed patients with GBM

Patrick Y. Wen, David Reardon, Surasak Phuphanich, Robert Aiken, Joseph Landolfi, William Curry, Jay-Jiguang Zhu, Michael Glantz, David Peereboom, James Markert, Renato Larocca, Donald O’Rourke, Karen Fink, Lyndon Kim, Michael Gruber, Glenn Lesser, Ed Pan, Santosh Kesari, John Yu

Society for Neuro-Oncology 19th Annual Scientific Meeting

November 14, 2014

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Rationale for Immunotherapy in GBM

Immunoprivilege of the CNS is circumvented in diseased brain tissue such as in brain tumors and MS

Patients with GBM demonstrate impaired immune function in numbers and function of cytotoxic and helper T cells, with decreased antigen presentation function of dendritic cells

DC vaccination removes DCs from immunosuppressive milieu, increasing the yield and potency of these antigen presenting cells

T cells generated from DCs can target intracranial glioblastoma

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ICT-107 is an Autologous Six-antigen DC Vaccine

Matured, Activated,

Peptide-loaded DC

MHC

Class I

Six 9-10 amino acid antigen epitopes

MAGE-1 (HLA—A1)

AIM-2 (A1) gp100 (HLA—A2)

IL-13R 2 (A2)

HER2/neu (A2)

TRP-2 (A2)

Rationale for antigen choice

Targeting multiple antigens minimizes tumor escape

High expression levels for all antigens on GBM samples

Bias toward TAA associated with cancer stem cells

Control used in Ph II

Matured, activated DC without peptide loading

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ICT-107 Ph II Trial Design

Consent Randomize

Phase Patient-Specific

Screen SOC Eligibility Vaccination

Surgery and Chemo- ICT-107 or Control

Confirmation Induction

Enroll radiation 1/wk for 4 wks

Vaccine

Week – 3

Phase Week – 1 Week – 2 Clinical Assessments Week – 4

+ maintenance vaccine

SOC Maintenance TMZ Rest Week (ICT-107 or Control) Rest Week

Maintenance + tumor assessments

Maintenance includes vaccination on a 1, 3, 6, 6… monthly schedule as long as the patient does not recur

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Eligibility Criteria and Objectives

Key INCLUSION Criteria

– Complete surgical resection or minimum residual tumor <1 cm3 GBM

– Human leukocyte antigen (HLA) A1, HLA-A2, or HLA-A1/A2

– Karnofsky Performance Status (KPS) score of 70% Key EXCLUSION Criteria

– Recurrent disease assessed after surgery / before chemoradiation

– Radiosurgery and placement of Gliadel Primary Objective

– OS

Secondary Objectives

– PFS

– Safety and tolerability of ICT-107

– Describe the immune response to ICT-107

– Determine predictors of response Outcome Stratification

– MGMT methylation status: single largest factor for predicting survival

– Age category: 50 and >50

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Patient Demographics

Population Characteristic ICT-107 Control Total P-Value

(N=81) (N=43) (N=124) Fishers Exact

Gender [n(%)] 0.082

Male 44 (54.3%) 31 (72.1%) 75 (60.5%)

Female 37 (45.7%) 12 (27.9%) 49 (39.5%)

Age Category [n(%)] 0.830

<50 years 20 (24.7%) 12 (27.9%) 32 (25.8%)

>50 years 61 (75.3%) 31 (72.1%) 92 (74.2%)

MGMT status [n (%)] 0.476

Methylated 28 (34.6%) 18 (41.9%) 46 (37.1%)

Unmethylated 47 (58.0%) 24 (55.8%) 71 (57.3%)

KPS Category [n (%)] 0.241

100 24 (29.6%) 8 (18.6%) 32 (25.8%)

90 36 (44.4%) 18 (41.9%) 54 (43.5%)

<90 20 (24.7%) 17 (39.5%) 37 (29.8%)

HLA Type [n (%)] 0.289

A1=Positive, A2=Negative 33 (40.7%) 14 (32.6%) 47 (37.9%)

A1=Negative, A2=Positive 42 (51.9%) 22 (51.2%) 64 (51.6%)

A1=Positive, A2=Positive 6 (7.4%) 7 (16.3%) 13 (10.5%)

Resection Status 0.834

Complete resection 58 (71.6%) 32 (74.4%) 90 (72.6%)

Subtotal resection 23 (28.4%) 11 (25.6%) 34 (27.4%)

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Safety – Common Adverse Events

Adverse Events by Body System with an Incidence >5%

AE Category ICT-107 (N=80) Control DC (N=43)

Grade 2 Grade 3 Grade 4 Grade 2 Grade 3 Grade 4

Nervous system 25(31.3%) 14(17.%) 21(48.8%) 7(16.3%)

General 16(20.0%) 6(7.5%) 12(27.9%) 5(11.6%)

Fatigue 9(11.3%) 3(3.8%) 8(18.6%) 3(7.0%)

Gastrointestinal 11(13.8%) 6(14.0%)

Musculoskeletal 10(12.5%) 1(1.3%) 8(18.6%)

Weakness 2(2.5%) 3(7.0%) 3(7.0%)

Investigations 5(6.3%) 4(5.0%) 4(9.3%) 2(4.7%)

WBC Decreased 4(5.0%) 0(0.0%)

Skin/subcut 7(8.8%) 7(16.3%)

Blood/lymphatic 9(11.3%) 6(7.5%) 6(14.0%) 4(9.3%)

Infections 13(16.3%) 11(25.6%)

Psychiatric 9(11.3%) 6(14.0%)

Metabolism 5(6.3%) 3(3.8%) 7(16.3%) 4(9.3%)

Procedural 9(11.3%) 4(9.3%)

complications

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Safety – SAEs Above Grade 3

Active Patients and Control Patients

Relationship

Pt # SAE CTCAE Resolution

Grade to Drug

Intracranial hemorrhage 4 Resolved with sequelae NR

Increase intracranial pressure 5 Fatal NR

Cardiac arrest 4 Resolved NR

Retroperitoneal hemorrhage 5 Fatal NR

Thrombocytopenia 4 Resolved NR

Neutropenia 4 Resolved NR

Thrombocytopenia 4 Resolved NR

Septic shock 4 Resolved NR

Pulmonary embolism 4 Resolved NR

Pulmonary emboli-bilateral 4 Resolved with sequelae NR

DVT right lower extremity 4 Resolved with sequelae NR

Thrombocytopenia 4 Resolved NR

Seizure 4 Resolved NR

Altered mental state 4 Unknown NR

Thromboembolic event 4 Resolved NR

9 Acute renal failure 5 Fatal NR

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Summary of Main Results

Group Statistic Dec—2013 ASCO—2014 SNO – 2014

ITT OS – p-value 0.568 0.676 0.488

OS – HR 0.861 0.904 0.854

PFS – p-value 0.014 0.010 0.033

PFS – HR 0.565 0.571 0.640

PP HLA-A2* MGMT UnMeth OS – p-value 0.284 0.207 0.233

OS – HR 0.648 0.634 0.652

PFS – p-value 0.227 0.442 0.364

PFS – HR 0.614 0.758 0.720

PP HLA-A2* MGMT Methylated OS – P-value 0.428 0.523 0.404

OS – HR 0.591 0.692 0.631

PFS – p-value 0.020 0.005 0.004

PFS – HR 0.329 0.259 0.257

Includes HLA-A1/A2 dual positive patients

Note: p-values and HRs are stratified for age and MGMT where appropriate; December 2013 and ASCO – 2014

results have changed slightly due to a minor correction in patient data

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Progression Free Survival (PFS) for ITT Population

October 2014 results

100%

ICT-107

90% Control

80%

ITT Population (N=124)

70%

ICT-107

N = 81 (63 events)

60%

SURVIVING Median = 11.4 months

50% Age stratified HR = 0.640 (0.423 – 0.968)

Age stratified P = 0.033

40%

Control

PERCENT N = 43 (41 events)

30%

Median = 10.1 months

20%

10%

0 100 200 300 400 500 600 700 800 900 1000

DAYS

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Overall Survival (OS) for ITT Population

October 2014 results

100%

90% ICT-107

80% Control

70%

SURVIVING 60% ITT Population (N=124)

50% ICT-107

N = 81 (56 events)

40% Median = 18.3 months

PERCENT Age stratified HR = 0.854 (0.547 – 1.334)

30% Age stratified P = 0.488

20% Control

N = 43 (32 events)

10% Median = 16.7 months

0 200 400 600 800 1000 1200

DAYS

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Antigen Presentation in Primary Tumors

Percentage of Patients Expressing TAA via qPCR

99% 99% 100% 100% 100% 100%

100% 94%

91%

90%

79%

80%

70%

60%

48% A2 A2 A2 A2 A2 A2 A2 A2

50%

40%

A1 A1

30%

20%

10% 6% 5%

0% A1 A1

ICT-107 (n = 77) Control (n=42)

AIM-2 MAGE-1 gp100 Her2/neu IL-13Ra2 TRP-2

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PFS for HLA-A2* Methylated MGMT

PP Population – October 2014 results

100%

ICT-107

90%

Control

80% Censored

70%

SURVIVING 60%

50% PP Population (N=31)

15.6 month median PFS

ICT-107

40% N = 17 (9 events) benefit for ICT-107

PERCENT Median = 24.1 months

30% Age stratified HR = 0.257 (0.095 – 0.697)

Age stratified P = 0.004

20%

Control

10% N = 14 (13 events)

Median = 8.5 months

0 100 200 300 400 500 600 700 800 900 1000

DAYS

Includes dual HLA-A1/A2

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OS for HLA-A2* Methylated MGMT

PP Population – October 2014 results

100%

90% ICT-107

Control

80% Censored

70%

SURVIVING 60%

50% PP Population (N=31)

40% ICT-107 65% of ICT-107 patients alive

N = 17 (6 events)

PERCENT Median = not yet defined 50% of Control alive

30% Age stratified HR = 0.631 (0.212 – 1.880)

Age stratified P = 0.404

20%

Control

10% N = 14 (7 events)

Median = 23.9 months

0 200 400 600 800 1000 1200

DAYS

Includes dual HLA-A1/A2

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PFS for HLA-A2* Unmethylated MGMT

PP Population – October 2014 results

100% Early progressors in

both groups could ICT-107

90% have been excluded

Control

80% Censored

70%

PP Population (N=38)

60%

SURVIVING 4.5 month median PFS ICT-107

50% benefit for ICT-107 N = 24 (21 events)

Median = 10.5 months

40% Age stratified HR = 0.720 (0.351 – 1.474)

PERCENT Age stratified P = 0.364

30% Control

N = 14 (14 events)

20% Median = 6.0 months

10%

0 100 200 300 400 500 600 700 800 900 1000

DAYS

Includes dual HLA-A1/A2

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OS for HLA-A2* Unmethylated MGMT

PP Population – October 2014 results

100%

ICT-107

90%

Control

80% Censored

70%

60%

SURVIVING 4 month median OS

50% PP Population (N=38) benefit for ICT-107

40% ICT-107

N = 24 (21 events)

PERCENT Median = 15.8 months

30% Age stratified HR = 0.652 (0.320 – 1.325)

Age stratified P = 0.233

20%

Control

10% N = 14 (13 events)

Median = 11.8 months

0 200 400 600 800 1000

DAYS

Includes dual HLA-A1/A2

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Early Unmethylated MGMT Progressors can be Excluded in the Phase III Design

Phase II Design

Surgery and Recovery ChemoRadiation Randomization

weeks 6 weeks and Vaccination

Inclusion/exclusion criteria checked Progression assessed via MRI

Some patients known to progress in this period

Most progressors are unmethylated MGMT patients who are unresponsive to chemotherapy

Some inclusion/exclusion criteria re-checked at randomization

Progression NOT reassessed Last assessment of progression was post-surgery

Phase III trial design will re-assess progressive disease at randomization and exclude patients who have progressed This practice is built into GBM trial designs for other experimental treatments

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Change in Treatment Effect when Early Progressors are Removed

PP Patients Who Progressed in 90 Days were Removed – 8 Total; 6 Active, 2 Control

Group / Endpoint Medians P-value† HR†

HLA-A2* Stayed the same at Changed from 0.364 Changed from 0.720

unmethylated PFS 4.5 months in favor to 0.149 to 0.556

of ICT-107

HLA-A2* Increased from 4.0 Changed from 0.233 Changed from 0.652

unmethylated OS months to 5.9 to 0.183 to 0.580

months in favor of

ICT-107

This analysis informs phase III design and statistics

Includes dual HLA-A1/A2

† Age stratified

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Antigen-Specific Vaccine Response

Percent of Patients Responding to Antigen Challenge in Elispot*

Study Arm Tested Samples Responders (rate)*

ICT-107 69 25 (36.2%)

Control 40 7 (17.5%)

Fisher’s exact

p-value = 0.03

Response was assessed based on a score using a modified distribution free resampling (mDFR) analysis

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Conclusions for the ICT-107 Phase II Trial

No significant difference in adverse events between ICT-107 and control The vaccine is biologically active in terms of producing an immune response PFS was statistically improved for the entire treated population

– No other immunotherapy has shown statistical benefit for a clinical outcome in newly diagnosed GBM in a controlled trial

ICT-107 activity is strongest in the predefined HLA-A2 subgroup

– Tumor antigen expression proportions were high for A2 antigens

– The MGMT methylated subgroup showed the largest treatment effect with statistically significant PFS and OS expected to trend toward significance as more events occur

– The MGMT unmethylated subgroup showed trends toward PFS and OS treatment benefit that were more pronounced when early progressors were removed

Results support advancement to phase III testing

– OS hazard ratios in both per-protocol HLA-A2 MGMT subgroups are better than 0.70

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Acknowledgements

The Authors and ImmunoCellular Therapeutics Wish to Thank

Additional Investigators:

Andrew Sloan, Susan C. Pannullo, James Chandler, Jeffrey Raizer, David Schiff, Tina Mayer, Jay Grewel

Terri Armstrong for Analysis of the QOL Data

Trial Sites:

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

Patients and Families

Exhibit 99.2

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Contact:

ImmunoCellular Therapeutics, Ltd.

Investor Relations

Jane Green

415.348.0010 direct

415.652.4819 mobile

jane@jmgcomm.com

ImmunoCellular Therapeutics Presents Updated ICT-107 Phase II Data

at the Society for Neuro-Oncology Annual Meeting 2014

Continued Positive Trends in Overall Survival and Progression-Free Survival;

Phase 3 Registration Program Anticipated to Start 1H15;

Company to Host Conference Call on Tuesday, November 18th

Los Angeles, CA – November 14, 2014 – ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT:IMUC) announces the presentation today of updated efficacy data from the phase II trial of dendritic cell-based immunotherapeutic vaccine ICT-107 at the 19^th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology, being held in Miami, FL. Patrick Y. Wen, MD, Director of the Center for Neuro-Oncology at Dana Farber Cancer Institute and Professor of Neurology at Harvard Medical School, and principal investigator on the trial, will present the maturing data set in patients with newly diagnosed glioblastoma multiforme (GBM) in an oral presentation.

Consistent with prior data presentations in December 2013 and June 2014, the results demonstrate a statistically significant progression-free survival (PFS) benefit, and a numeric overall survival (OS) benefit in ICT-107 treated patients compared to the control group. The ICT-107 treatment effect continues to be strongest in the pre-defined HLA-A2 subgroup of patients in which the MGMT methylated patients showed the largest treatment effect, with a significant PFS advantage over the control group, and continued potential for the OS advantage to move toward significance as more events occur. There were no differences in adverse events between the ICT-107 treated group and the control group.

“ICT-107 continues to hold promise for patients with newly diagnosed glioblastoma, as no other immunotherapy has shown statistical benefit for a clinical outcome in a controlled trial in this patient population,” said Dr. Wen. “I think that the data from the phase II trial strongly support advancing to a registrational program.”

“With this second update of the original trial results, we remain confident that there is a meaningful treatment benefit in HLA-A2 patients. In the per-protocol population, OS hazard ratios are in the 0.6-0.7 range for all HLA-A2 patients as a group as well as for each of the MGMT subgroups. If our upcoming phase III program generates statistically significant results in this range, ICT-107 could represent a clinically meaningful advance for GBM patients,” said Andrew Gengos, ImmunoCellular’s Chief Executive Officer. “The US FDA and three national European regulators have indicated support for phase III testing. We anticipate hearing shortly from the EMA, and then expect to be in position to finalize our phase III design and move into trial execution in 2015.”

Updated ICT-107 Phase II OS and PFS Results

•

As of October 2014, a total of 88 events (patient deaths) had been recorded from the 124 randomized patients, representing 9 additional events since these data from the phase II trial were last updated in June 2014. There were 25 active and 11 control patients alive for a total of 36 patients available for additional follow-up.

•

Median PFS for the HLA-A2 methylated MGMT per-protocol (PP) population was 24.1 months for the ICT-107 treated group and 8.5 months for control, representing a statistically significant 15.6-month PFS benefit for the ICT-107 treated group (age stratified HR = 0.257 [0.095-0.697], p = 0.004).

•

Median OS for the HLA-A2 methylated MGMT PP population was 23.9 months for the control group, and the median has not yet been reached for the ICT-107 treated group. At the time of the analysis, 65% of ICT-107 patients and 50% of the control patients were alive (age stratified HR = 0.631 [0.212-1.880], p = 0.404), suggesting the potential for long-term survival with ICT-107 treatment.

•

Median PFS for the HLA-A2 unmethylated MGMT PP population was 10.5 months for the ICT-107 treated group and 6.0 months for the control group, representing a 4.5-month median PFS benefit for the ICT-107 treated group (age stratified HR = 0.720 [0.351-1.474], p = 0.364).

•

Median OS for the HLA-A2 unmethylated MGMT PP population, was 15.8 months for ICT-107 patients, and 11.8 months for the control group, representing a 4-month median OS benefit for the ICT-107 treated group (age stratified HR = 0.652 [0.320-1.325], p = 0.233).

•

Median PFS in the intent-to-treat (ITT) population (all phase II patients) was 11.4 months for the ICT-107 treated group and 10.1 months for the control group, representing a statistically significant benefit in the ICT-107 treated group (age stratified HR = 0.640 [0.423-0.968], p = 0.033).

•

Median OS in the ITT population was 18.3 months for the ICT-107 treated group and 16.7 for the control group, representing a numeric, but not statistically significant, advantage for the treatment group (age stratified HR = 0.854 [0.547-1.334], p = 0.487).

The Company is utilizing all available information from the controlled phase II trial to design phase III testing in order to increase its probability of success, including the timing of randomization within the standard-of-care treatment these patients receive, in an attempt to limit the number of patients who are “early progressors” and unlikely to respond to therapy.

About the ICT-107 Phase II Trial

The ICT-107 phase II trial is a randomized, double-blind, placebo-controlled phase II study of the safety and efficacy of ICT-107 in patients with newly diagnosed glioblastoma multiforme following resection and chemoradiation. ICT-107 is an intradermally administered autologous vaccine consisting of the patient’s own dendritic cells pulsed with six synthetic tumor-associated antigens: AIM-2, MAGE-1, TRP-2, gp100, HER-2, IL-13Ra2. The placebo control consists of the patient’s unpulsed dendritic cells.

A total of 124 patients were randomized at 25 clinical trial sites in the US. One third of the patients or 43 patients were treated with placebo, and the treatment arm included two thirds or 81 patients. All patients in the trial received standard-of-care temozolomide. The regimen is four induction doses of ICT-107 after chemoradiation, and then maintenance doses until the patient progresses. The primary endpoint of the trial is OS, defined as the time from randomization until date of death or the last date the patient is known to be alive. Secondary endpoints include PFS, defined as the time from randomization until the date of documented progressive disease or death, whichever occurs first, or the last date the patient is known to be alive and progression-free if progression or death is not observed. Other secondary endpoints include the rates of OS and PFS at six months after surgery, then assessed every three months until the end of the study. Safety and immune response are additional secondary endpoints.

Both the OS and PFS median results in the ICT-107 phase II trial were measured from the time of randomization (at the start of vaccination after standard-of-care surgery and chemoradiation). In historical studies of newly diagnosed GBM patients (e.g., Stupp, et al.), OS and PFS measurements were likely assessed from the time of surgery. In the ICT-107 phase II trial, there was an average of about 83 days from surgery to randomization.

The subgroups analyzed in the phase II trial were based on age, gender, HLA type, MGMT status, performance status and resection status.

HLA (human leukocyte antigens) are cell-surface antigen-presenting proteins. These molecules are on dendritic cells and present the tumor-associated antigens to T-cells to induce the immune response to the ICT-107 vaccine. HLA-A2 was one of two HLA types that were treated in the phase II trial. Of the two types, HLA-A2 is twice as common in the population as HLA-A1, and is the most common HLA type in North America and the EU.

HLA-A2 patients comprised about 62% of all patients randomized in the trial, meaning that these numeric and statistical outcome benefits were conveyed to a majority of treated patients.

MGMT status has been demonstrated to be predictive of response to radiation or chemotherapy. The O(6)-methylguanine-DNA methyltransferase, or MGMT, gene is responsible for a DNA repair mechanism in cells. Methylation of MGMT impedes the DNA repair mechanism in cancer cells, making them susceptible to radiation or chemotherapy, such as temozolomide. The DNA repair mechanism in cancer cells with unmethylated MGMT is intact, enabling them to survive and proliferate. GBM is the most common and aggressive primary cancer of the brain. Patients with this disease have few therapeutic options; temozolomide is currently the only FDA-approved systemic chemotherapy for newly diagnosed GBM.

For patient-related information about the ICT-107 clinical program in glioblastoma, please visit the ImmunoCellular website at www.imuc.com and access the ICT-107 “Frequently Asked Questions.” The email address to contact the company directly is clintrials@imuc.com.

ImmunoCellular to Host Conference Call on Tuesday, November 18^th

ImmunoCellular plans to host a conference call and webcast to discuss the ICT-107 updated data presented at SNO and other corporate matters on Tuesday, November 18, 2014, at 5:00 pm EST. The call will be hosted by Andrew Gengos, President and CEO.


LIVE CALL:		(877) 853-5636 (toll-free); international dial-in: (631) 291-4544; conference code 35132957

WEBCAST:		Interested parties who wish to listen to the webcast should visit the Investor Relations section of ImmunoCellular’s website at www.imuc.com, under the Events and Presentations tab. A replay of the webcast will be available one hour after the conclusion of the event.

The conference call will contain forward-looking statements. The information provided on the teleconference is accurate only at the time of the conference call, and ImmunoCellular will take no responsibility for providing updated information except as required by law.

About ImmunoCellular Therapeutics, Ltd.

ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers.

ImmunoCellular is conducting a phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor-associated antigens for glioblastoma. ImmunoCellular’s pipeline also includes ICT-121, a dendritic cell vaccine targeting CD133, and ICT-140, a dendritic cell vaccine targeting ovarian cancer antigens and cancer stem cells. To learn more about ImmunoCellular, please visit www.imuc.com.

Forward-Looking Statements for ImmunoCellular Therapeutics

This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including the risk that ICT-107 can be further successfully developed or commercialized, the timing and outcome of the post-phase II meeting with the FDA and EU regulatory authorities, the status of the current data and whether further analyses or later studies may confirm the successful PFS results to date, the potential for initiation and design of phase III trials and possibility of successful results from such studies. Additional risks and uncertainties are described in IMUC’s most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. Except as permitted by law, IMUC undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In this press release, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential,” “future,” “intend,” “certain,” and similar expressions intended to identify forward-looking statements.

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