Endpoints to Evaluate Cancer Vaccines

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1 22 nd Annual Cancer Progress Conference Novel Strategies for Drug Development in Oncology Endpoints to Evaluate Cancer Vaccines H. Kim Lyerly, M.D. Duke Comprehensive Cancer Center

2 Autologous antigen presenting cells for cancer immunotherapy activation Production of Sipuleucel-T by Dendreon

3 IMPACT OVERALL SURVIVAL ENDPOINT American Urological Association 104th Annual Scientific Meeting: Late Breaking Abstract 9: Presented April 28, 2009.

4 Randomized phase II study of Prostvac RELAPSE FREE SURVIVAL OVERALLSURVIVAL From Kantoff et al. JCO 2010

5 Immunization in minimal residual disease PANVAC PHASE II STUDY SCHEMA Patients with Stage IV colon cancer after resection of metastasis, and post operative chemotherapy Randomized Prime boost immunization with CEA vaccinia and CEA TRICOM x 3 NO DENDRITIC CELLS DENDRITIC CELLS Prime boost immunization with autologous DC loaded with CEA vaccinia and CEA TRICOM x endpoint- TTR 2 0 endpoint- CEA specific ELISPOT 1 0 endpoint- TTR 2 0 endpoint- CEA specific ELISPOT Sites: Duke University Medical Center, Medical University of South Carolina, Georgetown, Wake Forest/Bowman Gray, MD Anderson, Moffitt, and Portland Medical Center.

6 Biomarkers of antigen specific T cells in the evaluation of cancer vaccines: Tetramer Cytokine flow cytometry ELISpot Analysis of 16 HLA A*0201 volunteer donors detect specific cellular immunity to CMV Adapted from Hobeika et al, Cytotherapy 2008 Number Tetramer Positive Cells per 100K PBMC Number IFN? Positive Cells per 100k PBMC Mean Number IFN? Producing Cells per 100K PBMC Donor CMV status ELISPOT of CMV cells/10 5 PBMC * * * A. Peptide- MHC Tetramer B. Intracellular Cytokine C. ELISpot

7 ELISPOT- PBMC stimulated 96 hours rather than 48 hours ELISPOT of CMV cells/10 5 PBMC From Kenter et al. NEJM 2010

8 Overall 5 Year Survival of Patients in Phase I trial of HER2 protein pulsed DC Serum from long term survivors post HER2 vaccination has anti-tumor effects Michael A Morse, Amy Hobeika, Takuya Osada, Donna Niedzwiecki, Paul K Marcom, Kimberly L Blackwell, Carey Anders, Gayathri R Devi, H K Lyerly and Timothy M Clay. Long Term Disease-Free Survival and T Cell and Antibody Responses in Women with High-Risk HER2+ Breast Cancer Following Vaccination Against HER2+. Journal of Translational Medicine. J Transl Med Sep 6;5:42. Michael A Morse, Amy Hobeika, Takuya Osada, Donna Niedzwiecki, Paul K Marcom, Kimberly L Blackwell, Carey Anders, Gayathri R Devi, H K Lyerly and Timothy M Clay. Long Term Disease-Free Survival and T Cell and Antibody Responses in Women with High-Risk HER2+ Breast Cancer Following Vaccination Against HER2+. J Transl Med Sep 6;5:42.

9 Complete blockage with mab and TKI have benefit Fig 3. Kaplan-Meier estimates of overall survival (OS) in the intent-to-treat population Randomized Study of Lapatinib Alone or in Combination With Trastuzumab in Women With ErbB2-Positive, Trastuzumab- Refractory Metastatic Breast Cancer Kimberly L. Blackwell, Harold J. Burstein, Anna Maria Storniolo, Hope Rugo, George Sledge, Maria Koehler, Catherine Ellis, Michelle Casey, Svetislava Vukelja, Joachim Bischoff, Jose Baselga, Joyce O'Shaughnessy Journal of Clinical Oncology, Vol 28, No 7 (March 1), 2010: pp

10 We generated a novel Ad-HER2 vaccine Hartman Z, Osada T, Hobeika AC, Morse MA, Amalfitano A, Lyerly HK, Clay TM. An adenoviral vaccine encoding full-length inactivated human HER2 exhibits potent immunogenicity and enhanced therapeutic efficacy without oncogenicity. Clin Cancer Res Mar 1;16(5): Epub 2010 Feb 23.

11 We demonstrated HER2 internalization from HER2 antibodies Morse MA, Wei J, Hartman Z, Xia W, Ren XR, Lei G, Barry WT, Osada T, Hobeika AC, Peplinski S, Jiang H, Devi GR, Chen W, Spector N, Amalfitano A, Lyerly HK, Clay TM. Synergism from combined immunologic and pharmacologic inhibition of HER2 in vivo. Int J Cancer Jun 15;126(12):

12 We demonstrated anti-signaling effects alone and with TKI Morse MA, Wei J, Hartman Z, Xia W, Ren XR, Lei G, Barry WT, Osada T, Hobeika AC, Peplinski S, Jiang H, Devi GR, Chen W, Spector N, Amalfitano A, Lyerly HK, Clay TM. Synergism from combined immunologic and pharmacologic inhibition of HER2 in vivo. Int J Cancer Jun 15;126(12):

13 Indicators of biologic activity 2011 Immune function/adaptive immune response Effects on tumor-? RR,?RFS Patient outcome- OS? Signaling effects of anti-tumor antigen response (especially targeting signaling molecules)

14 Duke University Medical Center Program in Molecular Therapeutics H. Kim Lyerly, MD Gayathri Devi, PhD Barbara Horne, RN Timothy M. Clay, PhD Amy Hobeika, PhD Liz Anderson, RN Michael A. Morse, MD Takuya Osada, MD, PhD Emily Privette Wei Chen, PhD Junping Wei, PhD Teresa Doldo-Brehm Zachary Hartman, PhD Sharon Peplinski Xiao Yi Yang, MD Katherine Aird Xiaoying Liu, PhD Oliver Glass Gangjun Lei, PhD Manar Ghanayem Delila Serra Karrie Comatas Amanda Bradshaw Spector Lab

15 May 18-20, A Postgraduate Workshop for Accelerating Clinical and Translational Cancer 2011 Investigations Focused on Anticancer Agent Strategic Planning to Develop and North Development and Validate New Anticancer and Bethesda, Prevention Agents and Validation Workshop Cancer Pathways MD Acceleratingworkshop.org

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