8:00 - 8:30 Registration and Morning Coffee
(Breakfast Workshop Sponsorship Available)

8:30 - 8:35 Chairperson's Remarks 

9:20 - 9:50 Blocking Negative Immunoregulation to Enhance Tumor Immunity
Masaki Terabe, Ph.D., Staff Scientist, Molecular Immunogenetics and Vaccine Research Section, Vaccine Branch, National Cancer Institute, USA
We have identified a new immunoregulatory pathway that inhibits tumor immunosurveillance. The pathway involves NKT cells, IL-13, myeloid cells, and TGF-beta. Blockade of the pathway enhances natural immunosurveillance as well as cancer vaccine efficacy in mouse tumor models.

9:50 - 10:05 Poster Snap-Shots
Several poster presenters will be given the opportunity for a brief oral presentation of their work in the area of Targeted Cancer Therapies. The presentations will be selected from all abstracts submitted prior to the deadline on July 21.

10:05 - 10:45 Coffee Break in the Exhibit Hall 

10:45 - 11:15 Development of Plasmid-Based Immunotherapeutics for the Treatment of Metastatic Solid Tumors
Alain Rolland, Pharm.D., Ph.D., Senior Vice President, Product Development, Vical Inc., USA
This presentation describes the preclinical and clinical development of two different plasmid-based immunotherapeutic product candidates administered intralesionally to affect both local and metastatic solid tumors: Allovectin-7® (a bicistronic plasmid that encodes HLA-B7 and b-2 microglobulin, formulated with a cationic lipid system) and Interleukin-2 (IL-2) plasmid administered with electroporation. For Allovectin-7®, the results of a Phase 2 and the design of a Phase 3 clinical trial will be presented. For IL-2 plasmid delivered by intratumoral injection followed by electroporation, the antitumor efficacy and mechanism of action were evaluated in a mouse model of melanoma. The applicability of such type of therapy to distant metastases was also evaluated in an animal tumor model that supports an ongoing Phase 1 trial with intratumoral injection of IL-2 plasmid followed by electroporation in late-stage malignant melanoma patients.

11:15 - 11:45 A Scalable Approach to the Production of Personalized Immunotherapies: A Vaccine for B-cell Lymphomas 
Carl M. Cohen, Ph.D., Chief Operating Officer, Biovest International 

11:45 - 12:15 Imaging and Therapeutic Targeting of HER2-positive Tumors using Picomolar Affinity Affibody® Molecules
Fredrik Nilsson, Ph.D., Project Manager Biopharmaceuticals, Affibody AB, Sweden
Affibody molecules are a class of small and very stable protein domains, capable of binding to a wide range of protein targets. Their small size of 58 amino acids holds promise for good penetration properties for diagnostic and therapeutic in vivo delivery and they can be functionally produced by conventional peptide synthesis. To assess the feasibility of using tumor-targeting Affibody molecules in medical imaging and therapy, (111)In-and (177)Lu-labeled HER-2 specific Affibody® molecules were administered to Balb C nu/nu mice carrying HER2-positive SKOV-3 xenografts. Already one hour pi, a tumor uptake of 23 ± 3 % IA/g, and tumor-to-blood ratio of 7.6 was obtained for the monomeric Affibody®. For therapy, complete curative tumor eradication could be observed with a modified dimeric albumine-associated Affibody® molecule, indicating that this molecule may have a potential for treatment of micrometastases of HER2-overexpressing tumors.

12:15 - 1:40 Lunch on Your Own or Luncheon Technology Workshop (Sponsorship Available)

1:40 - 1:45 Chairperson's Remarks

 

KEYNOTE PRESENTATIONS:

1:45 - 2:30  New Vaccine Technologies: A Regulatory Perspective Jon R. Daugherty, Ph.D., U.S. Public Health Service, Senior Regulatory Review Officer, Office of Vaccines Research and Review, CBER / FDA  The Office of Vaccines Research and Review (OVRR) is responsible for regulatory review of Investigational New Drug (IND) Applications and Biologics License Applications (BLAs) for preventive vaccines and related products. Through this review process, OVRR ensures that these products are safe, pure, potent and effective. This presentation will focus initially on regulatory considerations for the development of preventive vaccine candidates in general, including adventitious agents, preservatives, adjuvants, and toxicology studies. The second part of the discussion will cover regulatory issues specific to development of newer, non-traditional, preventive vaccine technologies. Examples of these include novel adjuvants, DNA vaccines, live attenuated strains, intracellular bacterial vaccine vectors, non-replicating antigen delivery systems and needle-free delivery systems.

Immunomodulators / Adjuvants

 

FEATURED PRESENTATION

2:30 - 3:15 Adjuvanting DNA Based Therapeutics and Vaccines Kenneth E. Ugen, Ph.D., Professor, Center for Molecular Delivery and Department of Molecular Medicine, University of South Florida College of Medicine  Naked DNA based therapeutics and vaccines are promising technologies for delivering therapies and inducing specific immune responses in humans. Although to date the safety profile in humans obtained with these technologies has been excellent, there is a need to enhance the immune potency of these reagents including the inclusion of immunomodulatory cytokines as adjuvants (i.e. molecular adjuvants) to drive specific immune responses. Several additional techniques have been utilized to enhance multiple aspects of the plasmid technology. These include the modification of the molecular adjuvants and vaccine antigens themselves, the use of unique formulations and delivery platforms, including in vivo electroporation. In this presentation we will discuss the use of “adjuvanting” DNA-based therapeutics and vaccines against infectious agents and cancers and their implications for future clinical use.

3:15 - 4:00 Refreshment Break in the Exhibit Hall

4:00 - 4:30 Advances in Delivery Systems and Immunopotentiators for Vaccines
Manmohan Singh, Ph.D., Associate Director, Vaccine Delivery Group, Chiron Vaccines 
New generation vaccines have a strong need for an optimal delivery system to carry the antigens to the target cell population. In some cases, inclusion of a secondary immunopotentiator along with the selected delivery system enables the generation of a potent B and T cell response with these antigens. The presentation will cover recent advances in vaccine delivery systems and review current immunopotentiators in clinical trials.

Autologous Cell Technologies

4:30 - 5:00 Active Immunotherapy of Prostate Cancer with Provenge (sipuleucel-T)
David L. Urdal, Ph.D., Chief Scientific Officer, Dendreon Corporation
Sipuleucel-T is an autologous active cellular immunotherapy being developed by Dendreon Corporation for men with advanced prostate cancer. Phase III trials have been completed and show that treatment with sipuleucel-T resulted in a significant overall survival advantage compared with placebo. The history of development of this product candidate will be discussed.

5:00 - 5:30 Heat Shock Protein Peptide Complexes as the Basis for Immunotherapy of Human Cancer
Roman M. Chicz, Ph.D., Senior Vice President, Research & Preclinical Development, Antigenics Inc.
The role of heat shock proteins in the activation of targeted cellular immune responses will be presented. Preclinical data in support of cancer vaccine development and the recent clinical responses to an autologous vaccine approach will be discussed. 

5:30 - 6:30 Happy Hour in the Exhibit Hall 

6:30 End of Day 2 and Close of Targeted Cancer Therapies Conference