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7:30 am Registration and Morning Coffee(Breakfast Workshop Sponsorship Available)
8:30 - 8:35 Chairperson’s Remarks
David Avigan, M.D., Director, Hematological Malignancies/Bone Marrow Transplantation, Beth Israel Deaconess Medical Center, Harvard Medical School
8:35 KEYNOTE PRESENTATIONDendritic Cell Tumor Fusions from the Bench to the BedsideDavid Avigan, M.D., Director, Hematological Malignancies/Bone Marrow Transplantation, Beth Israel Deaconess Medical Center, Harvard Medical School
Pre-clinical development and clinical translation of patient specific tumor vaccines using dendritic cells chemically fused with patient derived tumor cells.
9:05 GRNVAC1, hTERT-LAMP Transfected Autologous Dendritic Cell Vaccine for CancerLaurence Elias, M.D., Executive Director, Oncology Clinical Development, Geron CorporationGRNVAC1 is an autologous patient-specific DC product. Cells from a leukapheresis harvest are enriched for PBMC by density gradient centrifugation, followed by adherence of PBMC to a plastic surface to enrich monocytes. Adherent cells are cultured with a cytokine mix to induce differentiation to immature DCs, and the resulting immature DC are transfected by electroporation with mRNA encoding the sequences for the human telomerase catalytic subunit (hTERT) linked to a lysosomal targeting sequence (LAMP). hTERT-LAMP is expressed within the transfected cells as protein prior to processing to peptides which can be presented in the context of each patient’s specific HLA. The transfected cells are then matured in medium containing a cytokine mix, and cryopreserved aliquots of the final mature DC preparations are ultimately supplied to the clinic for intradermal injections on a protocol defined schedule. GRNVAC1 has been studied in Phase I trials at Duke University, and currently is in a multi-center Phase II study of AML patients in remission.
9:35 HAAH as a Cancer Specific Antigen for ex vivo Maturation of Dendritic CellsHossein A. Ghanbari, Ph.D., Chairman, CEO and CSO, Panacea Pharmaceuticals, Inc.HAAH is specifically expressed on the surface of all malignant cells and phenotypes of cancer cells. Neutralizing or inhibiting the cell-surface HAAH reverses cancer cells to normal phenotype. HAAH as an aggregate, is an excellent immunogen and should be effective in ex-vivo dentritic cell markers. Finally, serum HAAH levels can be used to enroll patients; qRT-PCR for HAAH mRNA as well as HAAH serum levels can be used for monitoring the efficacy of HAAH-based vaccine therapy. HAAH is a true cancer marker with specificity and sensitivity of more than 90% and passive immunotherapy has been effective in cell and animal models.
10:05 Coffee Break in the Exhibit Hall
10:45 The Adenylate Cyclase from B.pertussis: a Protein Antigen Delivery System for Tumor ImmunotherapyMyriam Bouillette, Ph.D., Head, Preclinical & Early Clinical Development, BT PharmaThe bacterial protein vector, adenylate cyclase (CyaA) of Bordetella pertussis is able to target antigen presenting cells through specific interaction with the CD11b/CD18 integrin. CyaA can be used to deliver CD4+ and CD8+ T-cell epitopes to the MHC-class II and class I presentation pathways to trigger specific, protective and curative Th and CTL responses in vivo. From this technology, BT PHARMA develops candidate cancer immunotherapeutics from design to proof of concept. Outstanding pre-clinical results in a tumor model for HPV16 induced cancers has led BT PHARMA to start clinical development of a bivalent immunotherapeutic for the treatment of HPV16 and HPV18-associated cervical neoplasia. An overview of pre-clinical results with CyaA antigen delivery system will be presented.
11:15 An Automated Approach for Manufacturing Personalized Dendritic Cell ImmunotherapiesFred Miesowicz, Ph.D., Chief Operating Officer, Argos TherapeuticsDendritic cell (DC) active immunotherapy is potentially efficacious in a broad array of malignant disease settings. However, challenges remain in optimizing DC-based therapy for maximal clinical efficacy within manufacturing processes that permit quality control and commercial production of consistent products. To address these challenges, Argos Therapeutics has collaborated with Invetech PLC to develop working prototypes of equipment capable of automating cellular and RNA processing to make autologous immunotherapy production a higher throughput process with a lower cost of goods.
11:45 Overcoming Challenges in Manufacturing and Commercializing an HSP-based Autologous Cancer ImmunotherapeuticStephen Monks, Ph.D., Vice President of Manufacturing, Process & Analytical Technologies, Antigenics
Oncophage (vitespen) is a novel, patient-specific, autologous immunotherapeutic that has been evaluated clinically in a number of cancer indications. It is a peptide-heat shock protein complex that when administered intradermally, delivers tumor-specific antigens to antigen-presenting cells, leading to the stimulation of powerful T cell–mediated antitumor immune responses. Following surgery, frozen tumor is shipped to Antigenics, where Oncophage is prepared individually for each patient by a rapid small-scale purification process. Product quality is ensured by application of release assays focusing on key biochemical and biological attributes of the molecule. These assays allow the resulting non-renewable vaccine to be released in a timeframe suitable for patients to begin immunotherapy. The challenges inherent in the manufacture, logistics and release of an autologous product, along with the various developmental & regulatory hurdles facing this unique therapy, will be presented.
12:15pm Networking Luncheon (Riverfront Room)
PLENARY SESSION – FOCUS ON ADJUVANTS
1:40 Chairperson’s RemarksWilliam Egan, Ph.D., Executive Director, PharmaNet Consulting
1:50 Plenary Keynote PresentationA CBER Perspective on the Use of Novel Adjuvants in Vaccines: Challenges and OpportunitiesNorman W. Baylor, Ph.D., Director, Office of Vaccines, CBER, FDA
2:30 KEYNOTE PRESENTATION
Unique Vaccine Adjuvant Efficacy of Toll-like Receptor 8 (TLR8) Agonists that Activate Human Antigen-Presenting CellsOfer Levy, M.D., Ph.D., Staff Physician, Infectious Diseases and Principal Investigator, Harvard Medical School/Children’s Hospital BostonActivation of antigen-presenting cells is a key feature of effective vaccine adjuvants. Our group has discovered that uniquely among the many TLR agonists, a novel family of compounds called imidazoquinolines that activate cells via TLR8 can effectively activate antigen-presenting cells from human newborn cord blood, inducing production of Th1-polarizing cytokines (TNF, IL-12) and upregulation of co-stimulatory molecules (CD40). These obeservations suggest that these agents may have unique vaccine adjuvant activity in infants and newborns.
3:00 FEATURED PRESENTATION
CpG TLR9 Agonists as Adjuvants for Prophylactic and Therapeutic VaccinesHeather Davis, Ph.D., Senior Vice President, Vaccines Research Site Head, Ottawa Research Laboratories, Coley Pharmaceutical Group, a Pfizer company
Oligodeoxynucleotides containing CpG motifs are activate innate immunity through Toll-like Receptor 9 (TLR9), and when combined with antigens act as potent adjuvants to augment both humoral and cell-mediated responses. This talk will review animal and human clinical data testing CpG ODN with a variety of antigens.
3:30Artificial Cells Derived from Biodegradable Materials that Boost the Immune ResponseTarek Fahmy, Ph.D., Assistant Professor, Biomedical Engineering, Yale University
While dendritic cells (DCs) are the most potent professional antigen-presenting cells, their widespread utility in therapeutic approaches involving ex vivo stimulation of T lymphocytes is hindered by several practical factors such as generation of autologous DCs, labor and isolation and preparation for clinical applications. Thus, artificial antigen-presenting cells (aAPC) have been proposed and tested in the expansion of a number of specific T cells for the treatment of a variety of disease states. Here we have developed a novel physiologically compatible system of “cell-like” particles for ex vivo and in vivo T cell stimulation using biodegradable polymers. Our approach fabricates FDA approved polymers into particles presenting T cell antigens, thus providing the multivalent interactions necessary for efficient stimulation of T cells. A key feature of this technology is the ability to co-encapsulate cytokines and program their release during and after activation and in a sustained fashion, facilitating long-term bioavailability and efficient stimulation of lymphocytes.
4:00 Refreshment Break in the Exhibit Hall (Last chance for viewing)
4:45 From “Alchemy” to Agonists of the Innate Immune System - Features and Applications of the Next Generation Vaccine AdjutantsBenjamin Wizel, Ph.D., Head, Preclinical R&D, Intercell AGSeveral decades ago, adjuvants have entered the vaccine arena in order to facilitate the built-up of protective immunity by vaccines. Up till now only a few adjuvants have been formulated into registered vaccine products; mostly the salts of aluminum. The mode of action of the existing adjuvants is not well understood. Aside of their protection of the antigens against degradation and depot formation at the injection site, it’s very little known, how they kick off the immune cascade. The discovery of the Toll-like receptors on the surface of dendritic cells that are able to binding to so-called Pathogen Associated Molecular Signals, PAMS, has opened a new target to design specific adjuvants that not only induce antibodies, but also cellular immunity, thereby broadening the specificity and the quantity of immune responses towards vaccine antigens. At Intercell, we have developed a novel adjuvant, IC31, comprising an antibacterial peptide and a Toll-like 9 agonist that is mixed together with the vaccine antigens. I will discuss in my presentation profile and mode of action of IC31 and the promising results obtained when the adjuvant was tested in a variety preclinical and clinical settings.
5:15 The Use of SCV-07, a Novel Immune-Stimulating Dipeptide, as an Enhancer for VaccinesCynthia Tuthill, Ph.D., Senior Vice President and Chief Scientific Officer, SciClone Pharmaceuticals
SCV-07, or γ-D-glutamyl-L-tryptophan, is being evaluated for therapeutic use in a number of immune-compromised conditions, including hepatitis C, mucositis, and certain cancers. The immune-stimulating effects of SCV-07 treatment, including polarization of the immune response towards the Th1 profile, suggest that SCV-07 could also be useful for enhancement of responses to certain vaccines. This talk will focus on recent data from animal models which have demonstrated improved responses to various vaccines, including those for influenza, tuberculosis, and breast cancer.
5:45 Nanoemulsion-Based Vaccines are Safe Adjuvants that Deliver Antigens to Mucosal SurfacesJoyce Sutcliffe, Ph.D., Vice President, Research, NanoBio Corporation
Nanoemulsion-based vaccines employ oil-in-water emulsions composed of nanodroplets with an average diameter of 400 nm. The nanodroplets can inactivate whole viruses or bacteria, incorporating native-like antigenic components into their structure. Alternatively, purified antigens can be mixed with the nanoemulsion adjuvant for delivery to mucosal surfaces. The composition and particle size of the nanodroplets are designed for preferential uptake by dendritic cells. Antigen processing triggers maturation of the dendritic cells and trafficking to secondary lymphoid tissues. A robust response to nanoemulsion-based vaccines has been shown for multiple antigens and intranasal administration of these vaccines in several animal models has occurred without signs of toxicity to the mucosal structure or local irritation.
6:00 Networking Refreshment & Appetizer Break
615 Interactive Panel Discussion with Plenary Speakers (Grand Ballroom B)
Please join in the extended discussion of Adjuvants
Moderated by William Egan, Ph.D., Executive Director, PharmaNet Consulting
7:15 End of Day Two – Novel Vaccines, Close of Advances in Cancer Vaccines
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