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Cambridge Healthtech Institute’s Ninth Annual
Novel Vaccines
Part Two: Emerging Vaccine Technologies
August 12-13, 2014


Overview/Description: Speaker Biographies 

An ever-expanding array of technologies and approaches are being employed to create more efficacious vaccines and advance the field, including developing predictive models and Synthetic Biology.  Next- Generation Sequencing (NGS) is also being used to elucidate viral evolution in an effort to more deeply understand infection.

The Ninth annual “Novel Vaccines” meeting tackles these emerging technologies in an effort to crystallize where the field is headed, along with novel modes and routes of delivery, such as patches, VLPs and microparticles.  Ways to test vaccines in order to ensure quality will also be explored, including rapid microbiological methods (RMM), potency tests, and large-scale arrays.  Vaccine stability and targeting specific populations will also be discussed as part of the push to achieve more effective vaccines and support vaccine development.


Recommended Dinner Short Course*

Vaccine Production & Manufacturing 


*Separate registration is required.


TUESDAY, AUGUST 12

12:30  Conference Registration

 


SYNTHETIC BIOLOGY AND IN SILICO TOOLS

1:55pm  Chairperson’s Opening Remarks
J. Robert Coleman, Ph.D., MBA, Chief Operating Officer, Co-founder, Codagenix, Inc. 
 
 

2:00 Keynote Presentation:

Synthetic Genomics to Address Emerging Threats and Global Supply Challenges

Bolyn HubbyBolyn Hubby, Ph.D., Senior Director, Head, Vaccine and Phage R&D, Synthetic Genomics Vaccines, Inc.

The potential of synthetic biology is being realized in the vaccine space. This presentation will describe the application of synthetic genomics tools, coupled with automation, to produce synthetic vaccine candidates across a variety of targets. SGVI and partners have applied this technology to improve response to emerging threats and the lead influenza program has advanced through initial clinical testing. Converting digital sequence information into DNA, RNA, and protein in an automated fashion enables distributed manufacturing to address vaccine supply challenges.


2:45 Databases and in silico Tools for Vaccine Design

OliverHeYongqun (Oliver) He, D.V.M., Ph.D., Associate Professor, Microbiology and Immunology, Affiliated Member, Center for Computational Medicine and Biology (CCMB), Member, Comprehensive Cancer Center, University of Michigan

Many databases and tools are available to support rational vaccine design. The Protegen protective antigen database, VirmugenDB “virmugen” database, and Vaxign vaccine design tool are parts of the integrative VIOLIN vaccine database and analysis system (http://www.violinet.org). The analyses of Protegen and Virmugen data allow prediction of genes for subunit and live attenuated vaccine development. Vaxign is the first Web-based vaccine design program based on reverse vaccinology. New vaccine design methods are being developed based on the community-based Vaccine Ontology (VO).

3:15 Sponsored Presentation (Opportunity Available)

3:30 Refreshment Break in the Exhibit Hall with Poster Viewing


NEXT-GENERATION VACCINE TECHNOLOGIES

4:15 Engineering Cancer Immunotherapy One (DNA) Sequence at a Time

MarkBagarazziMark Bagarazzi, M.D., CMO, Inovio Pharmaceuticals

Inovio is developing cancer immunotherapeutics by targeting both viral oncogenes (HPV E6, E7) as well as self proteins associated with cancer progression and metastases (PSA, PSMA, hTERT). Our common approach involves enhancing the delivery of optimized DNA sequences with the use of our proprietary in vivo electroporation system. We will share both preclinical and clinical data regarding several cancer indications.

4:45 Deep Profiling of HIV-Specific T Cell Responses by Mass Cytometry

DamienSoghoianDamien Soghoian, Ph.D., Researcher, Virology, Harvard University

HIV-specific T cell responses play an important role in the antiviral immune response and will likely be critical for an HIV vaccine. However, the functional and phenotypic features of these cells that are most beneficial remain unclear. Mass cytometry, or cytometry by time of flight (CyTOF), affords the ability to obtain an unprecedented level of information on single cells. This presentation will describe the highly multiparametic profiling of HIV-specific T cells by CyTOF and how insights gained from this analysis may inform HIV vaccine development.

5:15 Robust Induction of Cytotoxic T Lymphocyte (CTL) Response through Low-Frequency Sonophoresis Assisted Transcutaneous Immunization

DiviyaSinhaDiviya Sinha, Ph.D. Candidate, Chemical Engineering, Blankschtein & Langer Research Groups, Massachusetts Institute of Technology (MIT)

Traditional vaccinations have had limitations at inducing a potent CTL response; essential for protection against intra-cellular infections and effective cancer vaccine development. Here, we demonstrate that a needle-less skin vaccination strategy based on low-frequency sonophoresis (LFS) is able to induce long-lived antigen specific CTLs in the absence of any external adjuvants. Innate adjuvancy associated with LFS skin pretreatment is hypothesized to result in the observed induction of CTLs, which respond rapidly against a viral LCMV challenge months following a single immunization.

5:45 End of Day


WEDNESDAY, AUGUST 13

7:45am   Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


PREDICTING & ENHANCING HUMAN RESPONSE

8:25  Chairperson’s Opening Remarks
Mark Bagarazzi, M.D., CMO, Inovio Pharmaceuticals 

8:30  Genomic Analysis of Vaccine Response in Humans

NicholasHainingW. Nicholas Haining, B.M., B.Ch., Assistant Professor of Pediatrics, Harvard Medical School, and Scientific Co-Leader, HSCT Program, Pediatric Oncology, Dana-Farber Cancer Institute Children’s Hospital, and Associate Member, Broad Institute of Harvard and MIT

Vaccination is one of the most effective methods of preventing human disease. However, many vaccines are not universally protective and even widely used vaccines fail to achieve protective immunity. This presentation will discuss advances in genomic approaches to identify the biological features of the early vaccine response that predict the subsequent development of vaccine immunity.

9:00  Identification of Novel Vaccine Candidates Using a Robust Immunogen Optimization System

SeanDuSean Du, Ph.D., COO, Altravax, Inc.

Altravax has developed a robust Immunogen Optimization System™ (IOS) that can be applied to a variety of vaccine candidates for the improvement of overall immunogenicity, antibody cross-reactivity, potent T-cell responses, manufacturing efficiency, and product stability. Using IOS, we have developed a preclinical vaccine pipeline including a novel preventive dengue vaccine, based on a single-component VLP that can induce tetravalent immunity capable of neutralizing all four dengue serotypes, and a first-in-class therapeutic vaccine for chronic hepatitis B infection.

9:30  Innovative Preclinical Models for Developing Staphylococcus aureus Vaccines

FabioBagnoliFabio Bagnoli, Ph.D., Project Leader, Novartis Vaccines and Diagnostics

Staphylococcus aureus is a major human pathogen and current antibiotics are not efficacious against emerging multidrug resistant strains. Unfortunately, S. aureus vaccine development is hindered by the lack of known correlates of protection. Three-dimensional organotypic human tissue models may represent a valid alternative to animal infection models. This talk will present data on a novel S. aureus vaccine formulation as well as research to develop innovative preclinical models for predicting vaccine efficacy in humans.

10:00 Sponsored Presentation (Opportunity Available)

10:15  Coffee Break in the Exhibit Hall with Poster Viewing

11:00  Genomics of TB and HIV Disease Progression in African Children

GraemeMardonGraeme Mardon, Ph.D., Professor, Developmental Biology & Pathology, Baylor College of Medicine

The Collaborative African Genomics Network (CAfGEN) seeks to integrate genetic and genomics technologies to identify host factors that are important to the progression of HIV and HIV-TB infection in sub-Saharan African children. This will include recruitment of cohorts of HIV and HIV-TB infected children, whole-exome and RNA sequencing, and SNP genotyping of patients at the extremes of HIV and TB disease progression. These projects will provide important mechanistic insights to pediatric HIV and HIV-TB disease progression.

11:30  T Cell Crossreactivity, Heterologous Immunity, and Viruses

LiisaSelinLiisa K. Selin, M.D., Ph.D., Professor, Pathology, University of Massachusetts Medical School

Heterologous immunity occurring as a consequence of T cell crossreactivity between unrelated pathogens has been shown by us with animal models to contribute to reduced (beneficial) or enhanced viral loads, and remarkably altered immunopathology (detrimental). Our objective is to determine how crossreactive T cells impact T cell selection and function, and influence disease outcome as the host is exposed to subsequent acute or persistent infections. Insights on these issues are necessary for the intelligent design of effective modern vaccines without unwanted side effects.

12:00pm Development of a Robust, Defined Animal-Free Virus Production Medium Optimized for Microcarrier Culture

Szczypka_MarkMark Szczypka, Ph.D., Senior Director, Applications and New Product Development, Pall Life Sciences
A hydrolysate-free and APF, Vero cell production medium that is ideal for use in stirred-tank vessels with APF Pall SoloHill® microcarriers was developed. Dengue virus production in this medium is equal to or greater than DMEM containing FBS and two different commerically-available serum-free media. The peak of wild type dengue 2 virus production advances up to 3 days earlier in microcarrier culture when compared to static conditions, and cumulative titer is increased.

 

 12:30  Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own


INNOVATIONS FOR CONQUERING DISEASE & INFECTIONS

1:55  Chairperson’s Remarks
Sean Du, Ph.D., COO, Altravax, Inc. 

2:00  Nanosponge Toxoid for Safe and Effective Vaccination

LingfangZhangLiangfang Zhang, Ph.D., Associate Professor, Nanoengineering and Moores Cancer Center, University of California, San Diego

Toxoid vaccines are routinely used to promote antitoxin immunity for the treatment and prevention of bacterial infections. A novel toxin-detainment strategy is disclosed that employs a unique toxin nanosponge to arrest and deliver non-disrupted pore-forming toxins for immune processing. Mice vaccinated with the resulting nanosponge toxoid show superior toxin-specific humoral response and protective immunity against both systemic and subcutaneous toxin challenges. These results indicate that the immunogenicity and efficacy of toxoid vaccines can be enhanced by the non-disruptive detoxification approach.

2:30 DCVax®-Direct: A Novel Personalized Immune Therapy for Inoperable and Metastatic Solid Tumors

Powers_LindaLinda F. Powers, CEO, Chairman of the Board, Northwest Biotherapeutics, Inc. 

Inoperable and metastatic solid tumors carry a bleak prognosis today in a wide range of cancers, with few treatment options. The prevailing view has been that immune therapies are mostly only suitable for early stage or minimal disease. However, NW Bio has developed DCVax-Direct, a novel personalized dendritic cell therapy, for direct injection into all types of late stage, inoperable and metastatic tumors.  Ms. Powers will describe the DCVax-Direct technology, the open label 60-patient Phase I/II trial currently under way, and the data to date.

3:00  An Ultra-Low Dose Live-Attenuated Influenza Vaccine – An Opportunity to Overcome Current Manufacturing Bottlenecks

JrobertColemanJ. Robert Coleman,  Ph.D., MBA, Chief Operating Officer, Co-founder, Codagenix, Inc.

Using our SAVE vaccine platform, we have developed a clinically relevant H1N1 live-attenuated Influenza vaccine strain against the 2009 pandemic virus that is highly immunogenic in ferrets. The vaccine has efficacy at ultra-low doses, doses 1,000-FOLD lower than current vaccines. Due to its low dose requirement, our vaccine technology could overcome critical bottlenecks in the influenza vaccine manufacturing process as well as provide a seasonal vaccine that is antigenically identical in all segments to the target strains with high efficacy.

3:30  Refreshment Break


VACCINE DELIVERY INNOVATIONS

3:45  Interbilayer-Crosslinked Multilamellar Vesicles: A System for Co-Delivery of Antigen and Adjuvant

AdrienneLiAdrienne V. Li, Ph.D., Senior Scientist, Vedantra Pharmaceuticals, Inc.

Vedantra Pharmaceuticals has been developing a ‘toughened’ liposome for enhancing vaccine delivery. Our technology, Interbilayer-Crosslinked Multilamellar Vesicles (ICMVs), is formed by crosslinking of adjacent lipid bilayers within a liposome. ICMVs show enhanced protein antigen loading and extended drug release kinetics allowing efficient vaccine delivery. When the malaria antigen VMP001 is loaded into ICMVs, immunized animals generated higher titer, higher avidity, and more durable antibody response with broader epitope recognition by immune sera, compared to animals that received the soluble VMP001 protein.

4:15  Tuning the Direction and Magnitude of the Immune Response with New Nanomaterial-Based Vaccines

TarekFahmyTarek Fahmy, Ph.D., Associate Professor, Biomedical Engineering, Engineering & Applied Science, Yale University

Vaccine development has progressed significantly since Jenner and Pasteur, moving from whole microorganisms towards subunit vaccines containing only their antigenic proteins. Nanoparticulate-based vaccines have tunable physical properties, allowing for encapsulation and controlled delivery of multivalent antigen, immunostimulatory factors and incorporation of pathogen associated molecular patterns (PAMPs) targeting dendritic cells. Overall, immune responses can both quantitatively and qualitatively, be tuned efficiently using such systems. Here we discuss advances in both immunology and nanomaterials that have brought particulate-based vaccines to clinical applications.

4:45  Exploring the Role of Size and Shape Impact on Immune Response through PRINT Technology 

MicheleStoneMichele Stone, Ph.D., PMP, Director, Vaccines, Liquidia Technologies
Particle technology is becoming increasingly prominent as a vaccine delivery system. PRINT technology allows for independent manipulation of particle, size, shape, charge, hydrophobicity, and composition. A variety of particles ranging from 80 to 10,000 nm were produced to explore controlled delivery of antigens and immunostimulants. Using a broad range of matrix materials formulated with active antigens and adjuvants, PRINT technology has defined specific sizes and shapes that appear to have superior effects on B cell and T cell immune responsess.   

 

5:15  Close of Conference