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Chimeric Antigen Receptor •Tumor Killing Via Ctls (CAR) T Cells • T-Cell Recruiting Bispecific Antibodies • Preventative Vaccines

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Chimeric Antigen Receptor •Tumor Killing Via Ctls (CAR) T Cells • T-Cell Recruiting Bispecific Antibodies • Preventative Vaccines CANCER IMMUNOTHERAPY OVERVIEW OF CURRENT LANDSCAPE 2018 AMWA Annual Meeting 1 November 2018 Petra Volna, Senior Regulatory Documentation Scientist Genentech Inc. When Was Cancer Immunotherapy First Used? Hint: The answer may surprise you FOR EDUCATIONAL PURPOSES ONLY 2 2 William B. Coley, MD: The Father of Immunotherapy FOR EDUCATIONAL PURPOSES ONLY 3 3 The Nobel Prize in Physiology or Medicine 1908 Awarded jointly to Ilya Mechnikov and Paul Ehrlich "in recognition of their work on immunity." FOR EDUCATIONAL PURPOSES ONLY 4 The Nobel Prize in Physiology or Medicine 2011 One half awarded jointly to jointly to Bruce A. Beutler and Jules A. Hoffmann "for their discoveries concerning the activation of innate immunity" and the other half to Ralph M. Steinman "for his discovery of the dendritic cell and its role in adaptive immunity." Ralph M. Steinman FOR EDUCATIONAL PURPOSES ONLY 5 Dendritic cells (DCs) have the unique capacity to initiate primary and secondary immune responses Maturation in situ Early Intermediate Late Pierre P. et al. Nature. 1997;388:787-92 FOR EDUCATIONAL PURPOSES ONLY Discovery of T-cell Growth Factor (Interleukin-2) ElectronGillian MicroscopyM Griffiths, Facility Cambridge at The ImmunologyNational Cancer Network Institute atUniversity Frederick (NCIof Cambridge-Frederick) FOR EDUCATIONAL PURPOSES ONLY 7 T-cell-mediated Cytotoxicity against Autologous Malignant Melanoma Out of 13 patients recurrent or metastatic malignant melanoma, only 1 patient, a 31-year-old male, who underwent resections of extensive metastatic melanoma of axillary, supraclavicular, and cervical lymph nodes in 1976 and 1978 and remained free of detectable melanoma. This patient’s lymphocytes were found to be strongly cytotoxic for autologous cultured melanoma cells FOR EDUCATIONAL PURPOSES ONLY 8 Binding of immunogenic peptides to Ia histocompatibility molecules FOR EDUCATIONAL PURPOSES ONLY 9 Immunological Synapse Created Gillian M Griffiths, Cambridge Immunology Network University of Cambridge FOR EDUCATIONAL PURPOSES ONLY 10 Key steps for effective immune response • Effective antigen presentation • T-cell infiltration • Tumor or pathogen killing • Immunologic memory • High-affinity antibodies and memory T and B cells FOR EDUCATIONAL PURPOSES ONLY 11 11 CANCER-IMMUNE EQUILIBRIUM Elimination, Equilibrium and Escape Immunoediting: Nonsilent point mutations (which lead to antigenic neoepitopes) are more frequently lost in cancers compared with silent point mutations (not recognized by T cells) Adaptive Immune Resistance: Tumor antigen-specific T cells attempt to attack the cancer, but the cancer changes in a reactive fashion to protect itself from this immune attack Ribas A. Cancer Discov. 2015 5(9):915-9 FOR EDUCATIONAL PURPOSES ONLY 13 Cancer Immunity Cycle and Immune Phenotypes Priming and activation (APCs and T cells) T-cell trafficking T-cell infiltration (T cells and endothelial cells) Antigen presentation (dendritic cells/APCs) T-cell recognition Antigen release T-cell–mediated killing of tumor cells Chen DS, Mellman I. Immunity. 2013;39:1-10 Chen DS, Mellman I. Nature. 2017;541:321-330 FOR EDUCATIONAL PURPOSES ONLY 14 Types of Cancer Immunotherapy (CIT) Key to all forms of CIT: • Immune checkpoint blockade Effective antigen presentation • Dendritic cells and Therapeutic cancer vaccines •T-cell infiltration • Chimeric antigen receptor •Tumor killing via CTLs (CAR) T cells • T-cell recruiting bispecific antibodies • Preventative vaccines FOR EDUCATIONAL PURPOSES ONLY 15 IMMUNE CHECKPOINT BLOCKADE Allison Bruce The Nobel Prize in Physiology or Medicine 2018 Awarded jointly to James P. Allison and Tasuku Honjo "for their discovery of cancer therapy by inhibition of negative immune regulation." One of several scientists Discovery of PD-1 and who had made the its importance for observation that CTLA-4 cancer therapy functions as a brake on PD-1 is a protein T cells expressed on the Investigated CTLA-4 surface of T cells that blockade to disengage functions as a T-cell the T-cell brake and brake unleash the immune system to attack cancer cells James P. Allison Tasuku Honjo FOR EDUCATIONAL PURPOSES ONLY Immune Checkpoint Inhibitors 2010 2014 Improved survival with ipilimumab, Opdivo, nivolumab, a PD-1-specific CTLA-4-specific antibody, in antibody approved in Japan for patients with metastatic melanoma advanced melanoma 1994 2001 CTLA-4 identified as negative B7-H1 (PD-L1) and B7-DC (PD-L2) 2010 2014 regulator of T-cell activation identified as ligands for PD-1 PD-1-specific antibody, induces FDA approves Keytruda, 1996 2003 frequent tumor regressions in pembrolizumab, for advanced CTLA-4 blockade could CTLA-4-specific antibody patients with advanced melanoma, melanoma cause tumor rejection induces clinical renal, lung and colon cancer 2015 in mice regressions in patients 2011 FDA approves Tecentriq, 1999 with advanced melanoma PD-1 Identified as FDA approves Yervoy, ipilimumab, atezolizumab, for bladder immune checkpoint for advanced melanoma cancer 2012 Anti-PD-1 antibody shows dramatic efficacy results in Ph 1 trial 1995 2000 2005 2010 2015 FOR EDUCATIONAL PURPOSES ONLY 18 How Do Immune Checkpoint Inhibitors Work? Activation of T cells requires PD-1 is another T-cell that the T-cell receptor binds brake that inhibits T-cell to structures on other activation immune cells recognized as ”non-self”. A protein functioning as a T-cell accelerator is also required for T cell activation. CTLA-4 functions as a brake on T cells that inhibits the function of the accelerator Antibodies (green) against Antibodies against PD-1 inhibit CTLA-4 block the function of the function of the brake the brake leading to activation leading to activation of T cells of T cells and attack on cancer and highly efficient attack on cells. cancer cells. Graphic courtesy of The Nobel Foundation FOR EDUCATIONAL PURPOSES ONLY Blockade of CTLA-4 and of PD-1 and PD-L1 to induce antitumor responses Antoni Ribas, and Jedd D. Wolchok Science 2018;359:1350-1355 Published by AAAS FOR EDUCATIONAL PURPOSES ONLY 20 Timing of clinical development of anti–CTLA-4, anti–PD-1, and anti–PD-L1 antibodies from first administration to humans to FDA approval Antoni Ribas, and Jedd D. Wolchok Science 2018;359:1350-1355 Published by AAAS FOR EDUCATIONAL PURPOSES ONLY 21 Too Much of a Good Thing? Trial explosion More than 1000 clinical trials are combining other cancer treatments with immunotherapy drugs, called checkpoint inhibitors, that target the proteins PD-1 or PD-L1 (bottom bars). The number of subjects needed for those trials has skyrocketed, and some trials may not find enough patients.* Jocelyn Kaiser Science 2018;359:1346-1347 FOR EDUCATIONAL PURPOSES ONLY DENDRITIC CELLS AND THERAPEUTIC CANCER VACCINES Magnification 16,000x. (Rita Serda/FEI Image) Dendritic cells and Therapeutic cancer vaccines 1998 2003 2005 2010 A landmark study showed First data indicating that Type, density, and location of immune cells FDA approves the use of that accumulation of CD8+ T presence of tumor-infiltrating within tumor samples found to be a better sipuleucel-T (Provenge®) for the cells within the tumor (TILs) lymphocytes in the primary predictor of patient survival than previous treatment of prostate cancer predicted improved patient tumor strongly correlated with pathological criteria for tumor staging survival patient survival 2011 Artificial antigen presenting cells 2003 2005 (aAPC) could successfully NKT cells enhance CD4+ and Rapid and strong human CD8+ T cell enhance adoptive therapy of tumor CD8+ T cell responses to soluble responses to vaccination with peptide, IFA, antigen-specific CD8+ T cells antigen in vivo through direct and CpG oligodeoxynucleotide interaction with dendritic cells 2011 2009 Peptide vaccine + IL-2 improves 2004 Mycobacterial cell wall-DNA melanoma responses 1992 The first tumor antigenic complex showed antineoplastic First characterization of peptides produced by activity in patients with bladder peptides from MHC class I peptide splicing reported cancer 2000 2005 2010 FOR EDUCATIONAL PURPOSES ONLY 24 Personalized Vaccines for Cancer Immunotherapy Customizing a patient-specific cancer vaccine Ugur Sahin, and Özlem Türeci Science 2018;359:1355-1360 Published by AAAS FOR EDUCATIONAL PURPOSES ONLY 25 Neoepitope Vaccines Promote a Functional Cancer Immunity Cycle Ugur Sahin, and Özlem Türeci Science 2018;359:1355-1360 FOR EDUCATIONAL PURPOSES ONLY 26 Personalized Cancer Medicine Ugur Sahin, and Özlem Türeci Science 2018;359:1355-1360 FOR EDUCATIONAL PURPOSES ONLY 27 The Interconnected Dimensions of Cancer Heterogeneity Ugur Sahin, and Özlem Türeci Science 2018;359:1355-1360 FOR EDUCATIONAL PURPOSES ONLY 28 Source: Sahin, U. et al. Nature 547, 222–226 (2017) CHIMERIC ANTIGEN RECEPTOR (CAR) T CELLS Meletios Verras / Getty Images Magnification 16,000x. (Rita Serda/FEI Image) Chimeric antigen receptor (CAR) T cells 1992 2002 2007 2011 Primary T-cell engineering In vitro-expanded T cells can cause First IND for CD19 CAR Adoptive immunotherapy with CD8+ tumor regressions in advanced therapy (BB-IND#11411) T cells genetically engineering to 1993 melanoma recognize the NY-ESO-1 induce First generation of CARs 2006 remissions in sarcoma and 2002 (CD3ζ-based) Bulk T cells transduced with T cell melanoma 2017 Second generation of CARs receptor genes are used to treat FDA approves CD19 CAR (CD28-based) T therapy for pediatric ALL patients with melanoma 2011 and NHL 2003 New CAR T cell treatment Demonstration of CD19 cures patients with CLL as a valid target for CARs 2008 CAR T cells induce 2013 CAR T cell therapy 2004 clinical responses in patients with attains complete Third generation of CARs responses in ALL (4-1BB-based) B cell lymphomas 1995 2005 2010 2015 FOR EDUCATIONAL PURPOSES ONLY 32 CAR T cell immunotherapy for human cancer Engineered T cells: design of TCR versus CAR T cells Carl H. June et al. Science 2018;359:1361-1365 Published by AAAS FOR EDUCATIONAL PURPOSES ONLY 33 CAR-T Cell Therapy Is Associated with Cytokine Release Syndrome and Neurotoxicity Carl H. June et al. Science 2018;359:1361-1365 Published by AAAS FOR EDUCATIONAL PURPOSES ONLY 34 Conditionally Expressed CAR using Notch as a Signal Induction and Response Pathway System Carl H.
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