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A randomized, double‑blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients Presented By Patrick Wen at 2014 ASCO Annual Meeting

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Page 1: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

A randomized, double‑blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 2: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Rationale for Immunotherapy in GBM

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 3: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

ICT-107 is an Autologous Six-antigen DC Vaccine

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 4: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

ICT-107 Phase I Highlights from ASCO 2013

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 5: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

ICT-107 Ph II Trial Design

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 6: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Eligibility Criteria and Objectives

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 7: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Patient Disposition<br />October 2013 and April 2014 Data Analysis

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 8: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Patient Demographics

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 9: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Safety – Common Adverse Events

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 10: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Safety – SAEs Above Grade 3<br />Active Patients and Control Patients

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 11: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

OS (From Randomization) for ITT and PP Populations<br />Updated in April 2014

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 12: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

PFS for the ITT and PP Populations <br />(Central Radiology Review)<br />Updated in April 2014

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 13: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

MGMT Status Creates Two Different Patient Populations From the Survival Perspective<br />Per-Protocol Population with April 2014 Survival Data

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 14: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

OS in the Unmethylated MGMT and HLA-A2† Subgroup<br />Per-Protocol Population with April 2014 Survival Data

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 15: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

PFS in the Unmethylated MGMT and HLA-A2 Subgroup (Central Radiology Review)<br />Per-Protocol Population with April 2014 PFS Data

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 16: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

OS in the Methylated MGMT and HLA-A2 Subgroup<br />Per-Protocol Population with April 2014 Survival Data

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 17: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

PFS in the Methylated MGMT and HLA-A2 Subgroup<br />(Central Radiology Review)<br />Per-Protocol Population with April 2014 PFS Data

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 18: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Quality of Life Assessed via FACT-BR and Performance Status

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 19: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Proportion of Steroid Usage During Trial

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 20: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Relationship between Indicators of Vaccine Potency and Survival<br />Cox Proportional Hazards Model – Assessments of DC Maturity and Activation in Vaccine Prior to Administration

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 21: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Antigen-Specific Vaccine Response

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 22: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Antigen Presentation in Primary Tumors<br />Percent of Patients Expressing Antigens via qPCR<br />

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 23: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Conclusions for ICT-107 Ph II

Presented By Patrick Wen at 2014 ASCO Annual Meeting

Page 24: A randomized, double ‑ blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients

Acknowledgements

Presented By Patrick Wen at 2014 ASCO Annual Meeting