Welcome Letter | Day 1 | Day 2
7:30am Morning Coffee (Breakfast Sponsored Presentation Opportunity Available)
8:25 Chairperson’s Remarks
Michael G. Hanna, Jr., Ph.D., Founder, Chairman & CEO, Vaccinogen
8:30 Bridging Format ELISA to Facilitate Bioanalytical Testing Across Species
Travis Harrison, Ph.D., Associate Director, SRI International
We utilize a bridging format ELISA to measure immunogenicity of therapeutic human mAbs. One of the advantages of this approach is that the assay is species-independent and allows us to use a single reference standard for multiple species. We will present development and validation data from a bridging format ELISA designed to measure immunogenicity in both rat and monkey.
9:00 Treating Human Brain Cancer With Personalized Immunotherapy Using Autologous Tumor-Derived Heat Shock Protein-Peptide Complexes
Andrew T. Parsa, M.D., Ph.D., Associate Professor in Residence of Neurological Surgery, Principal Investigator, Brain Tumor Research Center, University of California, San Francisco
Autologous heat shock protein vaccine HSPPC-96 (Oncophage®) is derived from a patient's tumor and contains glycoprotein-96 polypeptide associated with cancer-specific peptides. In ongoing investigations we evaluated the efficacy and immunogenicity of HSPPC-96 in patients with recurrent GBM (multi-center) and newly diagnosed GBM (single-center). HSPPC-96 vaccine therapy is well-tolerated with no serious adverse events attributable to vaccine. An interim review of patients with recurrent GBM (Phase 1/2 trial; n=32), demonstrated a median survival of 44 weeks post-resection. Further, all patients tested exhibited innate and adaptive immune response. In newly diagnosed GBM (n=8; trial-initiated 2009), there have been no toxicities associated with concurrent treatment of HSPPC-96 and temozolomide. Clinical and immunologic evaluation is ongoing.
9:30 Cancer Vaccine Forum Immunotherapies & Adjuvants
What are some of the challenges for testing immunotherapies, specifically for cancer, in the presence of adjuvants? Panelists will identify and address these challenges, in addition to answering audience questions and comments.
Moderator:
- Bruce L. Levine, Ph.D., Director Director, Clinical Cell & Vaccine Production Facility, Research Associate Professor, Pathology and Laboratory Medicine, University of Pennsylvania
Panelists:
- Michael Kalos, Ph.D., Director, Translational and Correlative Studies Laboratory, University of Pennsylvania School of Medicine
- James Gulley, M.D., Ph.D., Director, Clinical Trials Group, Laboratory of Tumor Immunology and Biology, The Center for Cancer Research (CCR), National Cancer Institute, NIH
- Andrew T. Parsa, M.D., Ph.D., Associate Professor in Residence of Neurological Surgery, Principal Investigator, Brain Tumor Research Center, University of California, San Francisco
- Robert Hawkins, Ph.D., Professor, Medical Oncology, University of Manchester, Coordinator, ATTACK Project
10:00 Networking Coffee Break
10:25 Chairperson’s Remarks
Bruce L. Levine, Ph.D., Director, Clinical Cell & Vaccine Production Facility, University of Pennsylvania
10:30 Strategies for the Non-Clinical Safety Assessment of Vaccines
Jayanthi Wolf, Ph.D., Associate Director, Safety Assessment, Merck & Co., Inc.
This presentation will provide considerations for developing non-clinical safety assessment programs for vaccines. Regulatory guidelines from the EMEA, WHO, and U.S. FDA will be outlined, which address the non-clinical safety assessment of vaccines. The choice of a relevant animal model, types of toxicology studies, design of the treatment schedule, and the ante-mortem and post-mortem parameters investigated will be described.
11:00 Evaluation of the Safety and Efficacy of a Novel RSV F Particle Vaccine in the Cotton Rat
Ramadevi Raghunandan, Ph.D., Senior Scientist, Immunology, Novavax
Novavax evaluated a novel RSV F particle vaccine in cotton rat pre-clinical studies and found it to be immunogenic and efficacious without any evidence of disease enhancement following RSV challenge. Immunization of cotton rats with the RSV F particle vaccine plus aluminum phosphate adjuvant resulted in high titers of neutralizing antibody against RSV with no enhanced disease pathology at any doses as measured by lung histopathology and absence of plaque forming virus in lung homogenates of cotton rats exposed to RSV. In contrast, the formalin inactivated RSV vaccinated group did not produce neutralizing antibody, had very high lung histopathology scores and significant plaque formation in the lungs. Cotton rats serve as excellent model for RSV induced pulmonary disease since they are susceptible to RSV infection and in this study, highlighted the contrast between the enhanced disease associated with formalin inactivated RSV and the safety and efficacy profile demonstrated by the RSV F particle vaccine.
11:30 Engineering T-cells for Cancer Therapy
Robert Hawkins, Ph.D., Professor, Medical Oncology, University of Manchester, Coordinator, ATTACK Project
Presentation covers aspects of pre-clinical and clinical development of engineered T-cell therapy. The issues of adequacy of pre-clinical models to assess toxicity will be discussed. Also included are the challenges of producing patient specific therapy.
12:00pm Sponsored Presentation (Opportunity Available)
12:15 Luncheon Presentation (Opportunity Available) or Lunch on Your Own
1:50 Developing a Potency Assay for the Variable Component of the Autologous, Protein Based Therapeutic Cancer Vaccine, Oncophage
Daniel L. Levey, Ph.D.,Senior Director Scientific Affairs, Antigenics Inc.
It is an inconvenient truth that potency of fully autologous cancer vaccines derives from the individually tumor specific antigens present in each patient’s tumor. For a cancer vaccine like Oncophage, assessing such antigens’ contribution to potency on a lot by lot basis is outside the realm of technical possibilities without likely depleting the entire supply of each patient’s product. Antigenics’ approach to this challenge will be discussed.
2:20 Perspectives on the Changing Regulatory Paradigm
Elaine Esber, M.D., Strategic Advisor, International Vaccines, formerly Merck Vaccines, formerly FDA/CBER
2:50 Regulation of Cellular Immunotherapy Products - Common Obstacles and Strategies for Success
Scott R. Burger, M.D., Principal, Advanced Cell & Gene Therapy
US FDA takes a risk-based approach to regulation of cellular immunotherapy products. Products thought to pose greater risk or that are less well understood require more rigorous control, safeguards, and regulatory oversight. Regulatory obstacles often relate to characterization of the product and its biological function, materials and manufacturing, and preclinical testing, but can be overcome with a targeted development strategy.
3:20 Networking Refreshment Break
3:35 Synthetic Peptide Vaccine for Pandemic Influenza
Douglas Powell, Ph.D., Directory, Immunobiology, Antigen Express
Recent experiences with the potentially pandemic H5N1 avian influenza and now the H1N1 swine flu make it clear that the vaccine industry is in need of a better vaccine development platform than is currently available. A synthetic vaccine platform may likely be the only type of technology with the flexibility, capacity and cost-effectiveness to address a potentially lethal pandemic virus.
4:05 Navigating the Regulatory Minefield with a Novel Cell Substrate
Daniel Adams, President & CEO, Protein Sciences
Protein Sciences’ expresSF+® cell line derived from insect ovary cells was developed in the early 1990s and has been used to make products that have been in more than 20 clinical trials involving both human and veterinary therapeutic and prophylactic vaccines. One veterinary vaccine is marketed worldwide and several human vaccines are in clinical trials including two that are late stage (FluBlok®, our recombinant subunit influenza vaccine that we expect to receive marketing approval for this year) and Diamyd®, a customer’s Type I diabetes vaccine that is in Phase III in the U.S. and E.U. The presentation will discuss the trials and tribulations of securing FDA sign off on a novel insect cell line.
4:35 End of ImVacS Conference
Day 1 | Day 2