ADJUVANTS & DELIVERY SYSTEMS
August 15-16, 2012
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THURSDAY, AUGUST 16
8:00am Morning Coffee
8:25 Chairperson’s Remarks
David E. Anderson, Ph.D., Vice President, Research, VBI Vaccines
8:30 Engineering Vaccine Adjuvants with a Focus on Safety and Tolerability
Nicholas M. Valiante, Ph.D., Head, Immunology, Novartis Vaccines & Diagnostics, Inc. - Biography
Although vaccine efficacy is greatly enhanced by adjuvants, very few have been licensed for human use. A key impediment to adjuvant advancement is poor tolerability caused by activation of inflammatory responses, a necessary event in the generation of immunological memory. The seminar will highlight the power of rational drug design to identify and then optimize novel small molecule immune potentiators targeting toll-like receptor 7 (TLR7). Moreover, the data will show how advanced medicinal and formulation chemistry can be exploited further to develop stable, scalable and reproducible formulations with remarkable potential for prophylactic vaccines and beyond.
9:00 Paying the Toll: Getting Modern Adjuvants to Make T Cell Responses
Ross Kedl, Ph.D., Associate Professor, Associate Graduate Program Director, Department of Immunology, University of Colorado Denver - Biography
The majority of modern vaccine adjuvants target innate activating pathways such as the Toll Like Receptors. Despite inducing ample degrees of inflammation, few of these adjuvants demonstrate the capacity to elicit potent, durable and protective cellular immunity. We will explore the molecular mechanisms underlying this deficit and the various means by which we have attempted to circumvent it.
9:30 Agonists of TLRs 3, 7, 8, and 9 as Vaccine Adjuvants
Nicola La Monica, Ph.D., Vice President, Biology, Idera Pharmaceuticals
Adjuvants are a key component of vaccines. Toll-like receptors 3, 7, 8, and 9 are endosomal receptors and are expressed on different immune cells. Agonists targeted to these TLRs induce Th-1 type immune responses. Studies on the use of agonists of TLRs as vaccine adjuvants have shown promising results, thereby providing a novel class of adjuvants.
10:00 Coffee Break
10:30 Novel Approaches to Pre-Clinical Development of Pediatric Vaccines
Ofer Levy, M.D., Ph.D., Principal Investigator, Medicine/Infectious Diseases, Children’s Hospital Boston - Biography
The immune system of newborns and infants is distinct from that of older individuals, rendering them particularly susceptible to infections and simultaneously impairing responses to many vaccines. To date, the development of vaccines for pediatric populations has been largely ad hoc and empiric; herein, we will explore novel approaches for in vitro modeling of immune responses and for adjuvantation of vaccines targeting key pediatric pathogens.
11:00 IM Injection Pain Association from the Perspective of Osmolality for Vaccine Drugs
Murali Bilikallahalli, Ph.D., Vaccines & Adjuvant Systems, MedImmune LLC - Biography
Pain upon injection is a limitation in the administration of parenteral drugs, predominantly through intramuscular, intravenous and sub-cutaneous routes. It is important to understand the physiology underlying the pain process as well as the drug product formulation ingredients and devices associated with injection site pain and irritation. Osmolality of the formulation is one of the key components along with buffer species and pH that drives injection site pain. Various methods used to measure osmolality, solution conditions & molecular interactions that drive osmolality will be discussed in this presentation with particular emphasis on the intramuscular delivery of adjuvanted and non-adjuvanted vaccine drugs.
11:30 Liposomes as a Versatile Co-Delivery System: Novel Adjuvanticity
Andrew Bacon, Principal Scientist and Head, Liposome-Based Vaccines Group, R&D Laboratories, Xenetic Biosciences plc - Biography
Liposomes are a licensed product proven adjuvant system, application of liposomes to co-deliver various vaccine components by Xenetic has yielded novel vaccine candidates with enhanced efficacy, reduced dosage and fewer injections. Co-delivery of a protein antigen along with the encoding plasmid DNA, presumably promoting both MHC class I and II presentation within the same antigen presenting cell, demonstrates enhanced immune responses and protective immunity against both influenza and hepatitis E (NHP) preclinical studies. Similarly co-delivery of polysaccharide antigens together with a protein creates vaccines like conventional glycoconjugate (hapten-protein carrier) methods, as shown by examples of Haemophilus and multivalent Streptococcus vaccine product candidates. The potential of Xenetics liposome vaccine formulations are under investigation by IAVI and Gates Foundation Grand Challenges Explorations.
12:00pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:25 Chairperson’s Remarks
Ross Kedl, Ph.D., Associate Professor, Associate Graduate Program Director, Department of Immunology, University of Colorado Denver
1:30 Featured Presentation:
Engineering Materials for Antigen and Molecular Adjuvant Delivery
Darrell J. Irvine, Ph.D., Associate Professor, Materials Science & Engineering, Biological Engineering, Massachusetts Institute of Technology
2:00 Potent Neutralizing CMV Antibodies against Both Fibroblast and Epithelial Cell Infection Induced Using a Multivalent VLP Vaccine Candidate
David E. Anderson, Ph.D., Vice President, Research, VBI Vaccines - Biography
A prophylactic vaccine against Cytomegalovirus (CMV) is the highest public health vaccine priority for which a vaccine is currently lacking. One shortcoming of current vaccines that target only the gB glycoprotein is the failure to induce potent neutralizing antibody responses that can prevent infection of epithelial cells. Using a novel VLP platform, we have developed a multivalent vaccine that targets the gB protein as well as additional proteins that induce neutralizing antibodies against epithelial cell infection and induce strong cellular immunity. The VLPs can be produced in a variety of mammalian cell types, with current production being evaluated in both 293 and CHO cell lines suitable for GMP manufacturing. Confirmatory testing in rabbits demonstrates that unadjuvanted VLP immunization induces strong neutralizing antibody responses using a novel, more quantitative flow cytometry-based neutralization assay.
2:30 Role of Adjuvants in Improving Immune Responses to Pandemic Avian Flu
Ramadevi Raghunandan, Ph.D., Manager, Pre-Clinical Immunology, Novavax - Biography
Avian flu continues to be a major threat to public health. Unlike the seasonal strains of viruses, pandemic strains replicate rapidly in the host making it essential for the candidate vaccines to elicit copious amounts of immune response to control the infection. To develop vaccines that can be produced rapidly, Novavax has utilized the insect cell-baculovirus expression system. This recombinant VLP vaccine technology could provide a rapid response to emerging influenza infections with pandemic potential. The role of adjuvants in improving humoral and cell mediated immune responses to pandemic influenza will be discussed.
3:00 Refreshment Break
3:15 Rational Design of Self-Assembling, Synthetic Nanoparticle-Based Vaccines
Takashi Kishimoto, Ph.D., CSO, Selecta Biosciences - Biography
Selecta Biosciences is a clinical stage company developing an entirely new class of Synthetic Vaccine Nanoparticles (SVP™) applicable to a wide range of antigens for both prophylactic and therapeutic vaccines. In pre-clinical experiments with rodents and non-human primates, Selecta’s nanoparticles consistently induced more than 10 fold higher immune responses than conventional vaccines approaches and robust cellular immunity. Selecta’s technology optimizes immune reactions by arraying or encapsulating antigens and using various proprietary adjuvant–immunomodulator combinations in a single nanoparticle. Toxicology studies and GMP production for Selecta’s lead nicotine vaccine in Phase 1 clinical trials confirmed the safety and scalability of the SVP™ platform.
3:45 Use of NanoStat Mucosal Adjuvant Technology to Achieve a Balanced Th1/Th2 Immune Response
Tarek Hamouda, M.D., Ph.D., MBA, Director, Vaccine Research, NanoBio Corporation
NanoStat™platform technology employs high-energy oil-in-water nanoemulsions (NE) to deliver antigen and stimulate toll-like receptors (TLR) 2 and 4. Vaccines formulated with nanoemulsions exhibit improved thermostability and immunogenicity, demonstrated with numerous antigens including recombinant proteins, viral subunits, and whole virus vaccines. We propose that intranasal delivery of vaccines may prove to be favorable in cases where mucosal and cell mediated immunity is an essential feature in protection. Further, IN delivery may avoid systemic interference that occurs as a result of preexisting immunity and transplacental transfer of maternal IgG.
4:15 End of IMVACS
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