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Immune-based Therapies for Cancer
1.
©2014 MFMER |
slide-1 Immune-based Therapies for Cancer Keith L. Knutson Professor of Immunology Director, Cancer Research, Mayo Clinic Florida
2.
©2014 MFMER |
slide-2 Conflict of Interest • TapImmune, Inc. • Cancer Vaccines – Jacksonville, FL • Scientific Advisory Board (unpaid) • Several Patent Licensing Agreements (Mayo) • Kiromic, Inc. • Cancer Vaccines – Lubbock, TX • Scientific Advisory Board (Stock) • Intelligent Immunity, Inc. • Cancer Vaccines – Jacksonville, FL • Scientific Advisory Board (Unpaid) • Founder (Stockholder) • Antigen Express, Inc. • Cancer Vaccines – Cambridge, MA • Scientific Advisory Board (Paid)
3.
©2014 MFMER |
slide-3 The Burdens of Breast and Ovarian Cancers Ovarian cancer in the USA 2016: 22K new cases, 14K deaths Breast cancer in the USA 2016: 247K new cases, 40K deaths
4.
©2014 MFMER |
slide-4 Natural Host Immune Defenses Against TNBC are Associated with Reduced Recurrence Kreike et al. Breast Cancer Research 2007 9:R65 With infiltrating lymphocytes No infiltrating lymphocytes Probabilityofdisease-freesurvival
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slide-5 textbookofbacteriology.com Cells of the Immune System
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slide-6 CD4 “helper” T cells •Inflammation (macrophages and neutrophils) •Antibodies •Induce/Enhance cytotoxic T cells •Immune-surveillance •Epitope-spreading CD8 “cytolytic” T cells •Tumor lysis B cells •Antibodies •Signaling •ADCC •Complement The adaptive immune response
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slide-7 Differentiation of the adaptive immune response
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slide-8 Immuno-oncology • Cancers evade immunity by activating a variety of immune suppression mechanisms – PD-1/PD-L1 – CTLA-4 – Tregs • Approaches to boosting immune responses – Vaccines – Monoclonal antibodies – Adoptive T cell therapies – Immune checkpoint blockade
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slide-9 Why do we vaccinate?
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slide-10 Target neoantigen choices for a cancer vaccine • Microbial neoantigens • Amino acid mutation neoantigens. • Frameshift / fusion neoantigens • Splicing variant neoantigens • Nonmutated ‘self’ antigens (subdominant neoantigens)
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slide-11 MS Lawrence et al. Nature 000, 1-5 (2013) doi:10.1038/nature12213 Somatic mutation frequencies observed in exomes from 3,083 tumor–normal pairs
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slide-12 Overexpressed self proteins as a source of tumor neoantigens Normal Cell Tumor Cell MHC Dominant Epitope Subdominant Epitope
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slide-13 – Four helper T cell epitopes w/GM-CSF – One arm: • 2+(FISH+) and 3+ – Three mos. following last dose of trastuzumab • Disease-free. – Objectives • Immunogenicity (i.e. proof of principle) • Safety • Feasibility CD4T cell CD8T cell Tumor/DC Bcell e.g.Folate receptor alphaHER-2/neu Phase I Trial Design DRB1*0101, DRB1*0301 DRB1*0401, DRB1*0404 DRB1*0405, DRB1*0701 DRB1*0802, DRB1*0901 DRB1*1101, DRB1*1201 DRB1*1302, DRB1*1501 DRB3*0101, DRB4*0101 DRB5*0101
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slide-14 Generation of HER2-Specific T Cells with Resected HER2 Breast Cancer C D 1 p5 9 p8 8 p4 2 2 p8 8 5 E C D IC D TT 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 6 0 0 8 0 0 1 0 0 0 1 2 0 0 1 4 0 0 1 6 0 0 A n tig e n Antigen-specificTcells (permillionPBMC) P re -Im m u n iz a tio n P o s t-Im m u n iz a tio n C ontrol A g
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slide-15 Phase 1B DCIS – Degenerate Subdominant Epitope Vaccines -1 0 6 8 6 12 18 24 Registration Consent Week SAFETY AND IMMUNOGENICITY Surgery • Dose finding (n=9 arm) • 500 mg/peptide • 1000 mg/peptide • 1500 mg/peptide • Expansion (n=25) • Immunogenicity • Safety 2 4 VACCINATIONS HER2 Expression 1+, 2+, or 3+ DOD BCRP BC151104
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slide-16 FRa in Breast Cancer is Associated with Cancer Recurrence Hartmann et al. Int J Cancer 2007; 121:938-42 100 80 60 40 20 0 Weak FR expression Strong FR expression 0 1 2 3 4 Years Average Staining Intensity — 0-1.0 — 1.1-3 ProportionFreeofRecurrence(%)
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slide-17 C y c D 1 F R 3 0 F R 5 6 F R 7 6 F R 1 1 3 F R 2 3 8 F R P ro te in T T 0 2 5 0 5 0 0 7 5 0 1 0 0 0 1 2 5 0 1 5 0 0 A n tig e n Antigen-specificTcells (permillionPBMC) P re -Im m u n iz a tio n P o s t-Im m u n iz a tio n N S p = 0 .0 0 4 p = 0 .0 0 8 p = 0 .0 0 0 0 4 p = 0 .0 0 0 0 9 p = 0 .0 0 1 p = 0 .0 0 5 p = 0 .0 1 C o n tro l A g Generation of FRa-specific T cells
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slide-18 BC141410: FRa Vaccination to Prevent Progression of Triple Negative Breast Cancer Stages IIb/III TNBC Placebo N=93 Vaccine N=187 Conventional Therapy • Multicenter Phase II Trial to Test Whether Vaccine Prevents Recurrence in Patients Diagnosed and Treated for TNBC FRa is preferentially overexpressed in TNBC
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slide-19 IgG immunity to tumor antigens increasesfTreatment with herceptin and chemotherapy Taylor, et al., 2007, Clin Cancer Research Knutson, et al., 2015, ASCO Annual meeting Knutson, et al., 2015, Cancer Research, In Press P re P o s t 0 1 2 3 4 P re P o s t 0 .0 0 .5 1 .0 1 .5 Antibodies(g/ml) P re P o s t 0 .0 0 .5 1 .0 Antibodies(g/ml) P re P o s t 0 1 2 3 4p = 0.01 p = 0.01 p < 0 .0 0 1 p = 0 .0 0 7 A B C D Antibodies(g/ml) Antibodies(g/ml) P re P o s t 0 .0 0 .1 0 .2 0 .3 0 .4 0 .5 P re P o s t 0 2 4 6 8 C E A T T FE Antibodies(g/ml) Antibodies(g/ml) N SN S H E R 2 -IC D H E R 2 -E C D F ra g IG F B P 2 p 5 3
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slide-20 Increases in HER2 antibody following treatment is associated with improved survival Knutson, et al., 2014, ASCO Annual meeting Generation of antibody responses to HER2 is associated with improved progression free and overall survival Marker or Collection Time Cox Univariate Hazard Ratio (95% CI) Score p-value PROGRESSION-FREE SURVIVAL HER2-ICD 0.0042 No --- Yes 0.506 (0.253-1.014) HER2-ECD Frag 0.0007 No --- Yes 0.383 (0.193-0.758) OVERALL SURVIVAL HER2-ICD 0.038 No --- Yes 0.733 (0.367-1.465) HER2-ECD Frag 0.026 No --- Yes 0.643 (0.346-1.196)Knutson, et al., 2015, ASCO Annual meeting Knutson, et al., 2015, Cancer Research, in press NCI R01 CA152045
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slide-21 Anticancer Research 2009 T cells are isolated from surgical specimens. Presumably, the T cells are enriched in tumor killers. Adoptive T cell therapy with tumor infiltrating lymphocytes
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slide-22 What do CD8 T cells do?
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slide-23 Discovery Medicine Adoptive T cell therapy with CAR T cells
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slide-24 The Checkpoint Blockade Revolution Lymphomation.org
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slide-25 Immune checkpoint targets
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slide-26
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slide-27 PD-1 / PD-L1 Blockade in Melanoma OncoLog, February 2014, Vol. 59, No. 2 A patient with ipilimumab-refractory melanoma is shown before (left), after one cycle, and after three cycles of treatment with the anti–PD-1 antibody MK-3475 (10 mg/kg every 3 weeks).
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slide-28 PD-1 / PD-L1 Blockade in Triple Negative Breast Cancer
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slide-29 Combination therapy results in complete regression and sustained progression free survival ~75% Complete Regression Rate Karyampudi, et al. Cancer Res. 2014 TX
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slide-30 PD-1 blockade leads to an enhanced production of IL- 10 by murine ovarian TIDCs. Ig G a -P D -1 a -P D -L 1 0 4 0 0 8 0 0 1 2 0 0 IL-10(pg/mL) * * * * * * n .s . S e ru m A s c ite s 0 4 0 0 8 0 0 5 0 0 0 6 0 0 0 IL-10(pg/mL) N T a -P D -1 p < 0 .0 0 1 p < 0 .0 0 1 Lamichhane P. 2015, unpublished
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slide-31 Conclusions • The immune system is a complex system designed to deal with many different diseases and infections. • Cancers utilize sophisticated suppressive mechanisms to evade immunity. • Immune-based therapies are designed to boost adaptive immunity to the extent of overcoming suppressive mechanisms. • Vaccines • Monoclonal Antibody Therapy (Trastuzumab) • Adoptive T Cell Therapy • Immune Checkpoint Blockade
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slide-32 Acknowledgements Financial support VGTI FL K01 100764 R01 113861 R01 152045 Mayo Ovarian Cancer SPORE Mayo Breast Cancer SPORE Mayo Comp Cancer Center Komen Foundation Mayo CTSA MOCA VaxOnco TapImmune Andersen Foundation Cancurables National Breast Cancer Coalition Department of Defense BCRP Department of Defense OCRP Cathy Andorfer, Ph.D. Michael Asiedu, Ph.D. Karla Ballman, Ph.D. Marshall Behrens, B.Sc. Matt Block, M.D., Ph.D. Amy Degnim, M.D. Haidong Dong, Ph.D. Courtney Erskine, B.Sc. Karin Goodman, R.N. Lynn Hartmann, M.D. Karen Hedin, Ph.D. Timothy Hobday, M.D. Jim Ingle, Ph.D. Kimberly Kalli, Ph.D. Scott Kaufmann, M.D., Ph.D Michael Kline, Ph.D. James Krempski, B.Sc. Puru Lamichhane, Ph.D. Matt Maurer Toni Kay Mangskau Sharon Mercill, Ph.D. Manu Nair Aziza Nassar, M.D. Douglas Padley Edith Perez, M.D. Claudia Preston, M.D. Danell Puglisi-Knutson, B.A. Barath Shreeder Vera Suman, Ph.D. Jennifer Reiman, Ph.D. Marta Santisteban, M.D., Ph.D. Jean Stahl, R.N. Dan Visscher, M.D. Raphael Clynes, M.D. Ph.D. Columbia University Martin Cannon, Ph.D. University of Arkansas Nora Disis, M.D. UW Mac Cheever, M.D. UW Doug McNeel, M.D. Ph.D. Uwisc Glynn Wilson, Ph.D. Tapimmune Eric von Hofe, Ph.D. Antigen Express Mayo VGTI FL Lavakumar Karyampudi, Ph.D. Patrick Yeramian, M.D. Ph.D. Richard Jove, Ph.D. Kathleen Kemp Shaun White, M.A. Outside
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