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Wednesday, August 19, 2009
7:30am Morning Coffee (Breakfast Sponsored Presentation Opportunity Available)
CASE STUDIES AND LESSONS LEARNED FROM PRECLINICAL AND CLINICAL DEVELOPMENT PROGRAMS
8:25 Chairperson’s Remarks
Mark W. Frohlich, M.D., Chief Medical Officer and Senior Vice President, Clinical Affairs, Dendreon Corporation
8:30 Of Mice & Men (and Dogs!): Xenogeneic DNA Vaccines for Cancer
Philip J. Bergman, D.V.M., M.S., Ph.D., Diplomate ACVIM, Chief Medical Officer, BrightHeart Veterinary Centers
Melanoma is the most common oral malignancy in the dog. Oral and/or mucosal melanoma is generally considered an extremely malignant tumor with a high degree of local invasiveness and metastatic propensity. Numerous immunotherapeutic strategies have been employed to date with variable clinical efficacy; however, the use of xenogeneic DNA vaccines as outlined in the lecture may represent a leap forward in clinical efficacy. Oral melanoma is a spontaneous syngeneic cancer occurring in outbred, immunocompetent dogs and appears to be a more clinically faithful therapeutic model for human melanoma; further use of spontaneous cancers in pets as therapeutic models for human malignancies is strongly encouraged.
9:00 Vaccination in Combination with Multiple Immunomodulators
Thomas Davis, M.D., Chief Medical Officer, Clinical Development, Celldex Therapeutics
It is widely believed that in order to increase the potency of vaccination it will be necessary to use combinations with specific immunopotentiating interventions (TLR agonists, cytokines, T-reg depletion). Celldex is advancing a clinical platform using DC targeted antigens and combination adjuvants (TLR 3 and TLR 7/8 agonist along with GM-CSF) in the hope of breaking tolerance to tumor antigens.
9:30 The Development of BiovaxID: An Autologous Anti-idiotype Vaccine for the Treatment of Follicular non-Hodgkin’s Lymphoma
Carlos F. Santos, Ph.D., Chief Scientific Officer, Accentia Biopharmaceuticals
This year, Biovest announced the success of its heretohybridoma-based autologous anti-idiotype vaccine, BiovaxID. In a pivotal multi-center placebo-controlled Phase III clinical study, BiovaxID significantly prolonged disease-free survival in follicular lymphoma in first remission and demonstrated durable and potent anti-tumor immune responses in a large majority of treated patients. We present an overview of the clinical study results, including a review of the Phase III trial outcomes and discuss the development and regulatory path for BiovaxID. We also discuss the key manufacturing challenges faced in the development of this first autologous vaccine for cancer.
10:00 Networking Coffee Break
10:30 Sipuleucel-T for the Treatment of Advanced Prostate Cancer: Recent Progress and Lessons Learned
Mark W. Frohlich, M.D., Chief Medical Officer and Senior Vice President, Clinical Affairs, Dendreon Corp.
Provenge® (sipuleucel-T) is an investigational active cellular immunotherapy for prostate cancer. It is composed of autologous peripheral blood antigen presenting cells (APC) pulsed with PA2024, a recombinant Prostatic Acid Phosphatase (PAP)-cytokine fusion protein and is designed to stimulate an immune response to the patient’s tumor. Results from a multicenter, double blind, placebo-controlled phase 3 trial (D9901) showed that men with asymptomatic, metastatic, androgen-independent prostate cancer who received sipuleucel-T had a 41% reduction in the risk of death (HR=1.71, p=0.010). A third randomized Phase 3 trial (D9902B, IMPACT) has completed enrollment of 512 patients. Interim results in October 2008 revealed a 20% reduction in the risk of death. Results from the primary analysis anticipated by April 2009 will be discussed. The development history, clinical trial results, and regulatory milestones will be discussed.
11:00 Behavioral and Social Science Considerations for Clinical Research
Chuen-Yen Lau, M.D., Senior Physician, Henry Jackson Foundation, US Military HIV Research Program
Behavioral and social science (BSS), which study behavioral processes at the individual and societal level, influence nearly every aspect of clinical research. For example, study design must consider cultural context, potential social confounders and methods of data collection. During trial conduct, barriers and facilitators to recruitment and retention, as well as potential social impacts, must be addressed. Data analysis and interpretation may be confounded by lack of a priori consideration of behavioral issues. Community engagement at all stages, from concept development to results dissemination, impacts research success. In HIV vaccine clinical research, the STEP trial experience highlights the importance of behavioral and social science considerations.
11:30 Recent Progress for the GeoVax Clade B DNA/MVA HIV/AIDS Vaccine
Harriet L. Robinson, Ph.D., Senior Vice President, Research and Development, GeoVax Labs, Inc.
The GeoVax clade B DNA/MVA expresses HIV-1 clade B virus-like particles from single multiprotein-expressing recombinant DNA and MVA vectors. The DNA was developed at the Emory Vaccine Center, and the MVA in the laboratory of Bernard Moss at the US NIH. Both have been licensed for commercial development by Geovax. Two applications are being pursued: preventative and therapeutic. For the preventative use, the vaccine would be used in uninfected people to prevent the development of disease and transmission should they become infected. For the therapeutic use, recently infected individuals on successful drug treatment would be vaccinated and then taken off of drugs to determine if the vaccine could supplant the need for drugs. Clinical trials for use of the vaccine as a preventative vaccine have been sponsored by the NIH-supported HIV Vaccine Trials Network (HVTN).
12:00pm Sponsored Presentation (Opportunity Available)
12:15 Lunch on Your Own (Lunch Workshops Sponsorship Available)
1:40 Chairperson’s Remarks
Sue Clarke, Ph.D., Head, Project Management & Development, ImmunoBiology Ltd.
1:45 An Adjuvanted / Targeted Nanoparticle-Based Platform for Genetic Vaccination
Pirouz Daftarian, Ph.D., Director, Biological Modifiers Lab, Wallace H. Coulter Translational Center for Research, Miller School of Medicine, University of Miami
Current approaches to vaccine design have shown that vaccines which mimic natural antigens to be produced in their native conformations are most effective in generation of functionally relevant immune response. Since use of live virus as vaccine is not practical for many applications, recent approaches to vaccine design have focused on the use of DNA vaccines. These vaccines present a broader repertoire of epitopes in a more physiologically relevant form which more closely resemble that seen in active infection, and are expected to induce stronger and more lasting humoral and cellular immunity, and presumably afford a greater degree of protection to subsequent infection. Unfortunately, in vivo delivery of DNA by current methods has poor in vivo transfection frequency, targets all cells including non-professional antigen presenting cells, and does not induce robust immune responses, therefore limiting the usefulness of genetic immunization. Here, we describe a novel (proprietary) “targeted/adjuvanted nanoparticle-DNA delivery platform” which specifically target and transfect Antigen Presenting Cells (APC) and induce innate immune responses via activation of T helper cells whereby inducing strong immune responses. The platform showed ~ 80% APC targeted DNA delivery/expression, was able to activate primary CD4 Helper T cells, and induced robust immune responses in mice. This platform is an ideal candidate as a therapeutic (cancer) vaccine.
2:15 Expert Panel Discussion: Commonalities and Lessons Learned from Infectious Disease and Cancer Immunotherapy and Vaccine/Immunotherapy Development Programs
Ronald C. Kennedy, Ph.D., Professor and Chair, Department of Microbiology and Immunology, Texas Tech University Health Sciences Center
3:15 Networking Refreshment Break
PROACTIVE RISK MANAGEMENT IN VACCINE DEVELOPMENT PROGRAMS
3:30 A Therapeutic Vaccine for Cancers with Mutated ras; Integration of a Technology Platform, Target Selection and Clinical Development
David Apelian, M.D., Ph.D., M.B.A., Chief Medical Officer and Senior Vice President, Research and Development, GlobeImmune, Inc.
GlobeImmune is developing a therapeutic vaccine platform called Tarmogen® that utilizes the potent immunostimulatory characteristics of whole, recombinant, heat-killed yeast. Tarmogens are administered sub-cutaneously and deliver target antigens to dendritic cells and other antigen presenting cells (APCs) at the site of injection. Potent APC stimulation promotes Tarmogen uptake and processing, resulting in the downstream activation of antigen specific CD4+ and CD8+ T cells. By targeting essential antigens that are highly conserved, Tarmogens are being developed to treat cancer, chronic viral disease, and fungal infections. Tarmogens have been well tolerated to date, with > 200 patients treated and treatment exposures of up to 3 years of monthly dosing.
Our lead cancer program (GI-4000) targets mutated versions of K-ras for the treatment of mutant ras positive cancers. Preclinical models and Phase I clinical data have demonstrated ras specific T cell responses. Our ongoing Phase II program in newly diagnosed, mutant ras +, resected pancreas cancer uses prospective screening of the ras genotype to qualify patients for treatment with GI-4000. This Phase II study has been designed with a Bayesian statistical plan which will allow for potential sample size expansion based on recurrence-free survival and overall survival trends. Additional cancer targets are being developed with the Tarmogen technology with the goal of building a panel of oncology vaccines that may be used separately or in combination based on the prospective profiling of tumor genotypes.
4:00 Risk Management in Vaccine Development Programs
Adrian Dana, M.D., Senior Director, Clinical Risk Management and Safety Surveillance, Merck Research Labs
The acquisition of knowledge about the risks and safety of a drug product should continue throughout its life cycle Proactive risk management by manufacturers has major benefits for patients, health care professionals, regulators and the manufacturers themselves. Regulatory agencies are requiring a proactive approach to risk management for all products, especially vaccine products intended for use in healthy populations. Risk management should start early in product development and continue throughout the life cycle. The risk management planning for recently approved vaccine products will used to illustrate how risk management planning can be built into the various stages of development.
4:30 Proactive Risk Management During Development: Ways to Improve the Probability of Success
Paul Coplan, Sc.D., M.B.A., M.Sc., Senior Director, Global Safety Surveillance & Epidemiology, Wyeth Pharmaceuticals; and Adjunct Assistant Professor, Department of Clinical Biostatistics & Epidemiology, University of Pennsylvania School of Medicine
5:00 End of Pre-Clinical/Clinical Development of Immunotherapies & Vaccines meeting
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