Cambridge Healthtech Institute’s Eleventh Annual
Vaccine Adjuvants
Part of the Eleventh Annual ImVacS: Immunization and Vaccine Summit
December 8-9, 2016 | Revere Hotel | Boston, MA

Many recently developed vaccines are comprised of recombinant molecules or subunits of pathogenic organisms, requiring formulation with adjuvants to increase and direct the immune response. The benefit of adjuvants is clear: they may reduce the amount of antigen and number of vaccinations needed, accelerate the immune response, increase cross-protection, and improve efficacy in populations that are poor responders. As we continue to confront emerging and re-emerging disease threats and progress toward developing new vaccines to improve global health, there is also an urgent need for the development of effective adjuvants. CHI’s Eleventh Annual Vaccine Adjuvants meeting will cover the latest advances in a range of adjuvants, including understanding mode of action, and present case studies of successful formulations against challenging diseases.

Final Agenda

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Thursday, December 8

12:00 pm Conference Registration

Innovations in Liposomal Adjuvants

12:55 Chairperson’s Opening Remarks

Carl Alving, M.D., Chief, Laboratory of Adjuvant & Antigen Research, U.S. Military HIV Research Program, Walter Reed Army Institute of Research

1:00 Liposomes as Human Vaccine Adjuvants

Carl Alving, M.D., Chief, Laboratory of Adjuvant & Antigen Research, U.S. Military HIV Research Program, Walter Reed Army Institute of Research

Liposomes are components of two of six types of adjuvants present in licensed vaccines, and research in this field continues to be innovative. The potential for new types of vaccines with liposome adjuvants will be discussed.

1:30 Cationic Liposomes (CAF01) - Mode of Action and Potential for Vaccination Strategies Targeting the Mucosa

Dennis Christensen, Ph.D., Senior Scientist & Head, Vaccine Adjuvant Research Group, Infectious Disease Immunology, Division of Vaccines, Statens Serum Institute

CAF01 liposomes containing glycolipids from the outer cell wall of mycobacteria, signal through the C type lectin receptor Mincle and are efficient vaccine adjuvants for both CMI (TH1/Th17) and humoral immune responses. I will discuss recent data that demonstrate that the TH17 component of the response can be efficiently utilized to target the immune response to the mucosal surfaces resulting in tissue resident memory T cells and high levels of IgA.

2:00 Semi-Synthetic Archaeosome Adjuvants for Induction of Cell-Mediated Immunity

Lakshmi Krishnan, Ph.D., Director, Immunobiology & Program Leader, Vaccines and Immunotherapeutics, National Research Council-Human Health Therapeutics, Canada

Archaeosomes are self-adjuvanting liposomal vesicles, traditionally composed of total polar or semi-synthetic ether glycerolipids unique to the domain of Archaea. A novel iteration of archaeosomes comprises a sulfated disaccharide group covalently linked to the free sn-1 hydroxyl backbone of an archaeal core lipid (sulfated S-lactosylarchaeol, SLA). SLA individually or mixed with uncharged glycolipid (lactosylarchaeol, LA) constitutes vesicles that are simple to formulate and retain robust adjuvant activity for multiple antigens. A key feature of archaeosomes is the ability to induce antigen-specific CD8+ T cells in murine models. This talk will outline the archaeosome technology, potent vaccine delivery systems for cell-mediated immunity.

2:30 Panel Discussion

3:00 Refreshment Break in the Exhibit Hall with Poster Viewing

Next-Generation Adjuvants

3:30 Designing and Building the Next Generation of Vaccine Adjuvants

Derek O’Hagan, Ph.D., Head, Global Discovery Support & New Technologies, GlaxoSmithKline Vaccines

Rapid progress in molecular immunology has advanced vaccine adjuvant discovery efforts, enabling the use of cellular and target-based assays to screen large collections of chemical compounds for potential use as immune potentiators. However, the question remains as to how to safely and effectively deliver these new adjuvant compounds, particularly for use in existing vaccines which commonly use insoluble aluminium salts as adjuvants. Here we describe a novel approach to enable recently discovered adjuvant active compounds called Small Molecule Immune Potentiators (SMIPs) to adsorb to aluminum hydroxide adjuvant via the mechanism of ligand exchange. A phosphonate group has been chemically linked to the compounds to enable adsorption to aluminium hydroxide and here we present extensive formulation characterization, and an overview of the in vitro and in vivo performance of the new generation adjuvants.

4:00 Influenza Vaccine Improvements: Adjuvants, Cell and Beyond

Ethan Settembre, Ph.D., Head, Research, Seqirus

I will talk about how improvements in the current system involve the generation of adjuvanted influenza vaccines (of which Fluad is a representative), potentially better matched vaccines and RNA-based technologies. For MF59 adjuvanted vaccines, we have human data supporting the benefits of breadth and magnitude of response, both of which are key for improved flu vaccines.

4:30 Precision Adjuvants: Employing Human in vitro Modeling, High Throughput Screening and Systems Biology to Develop Adjuvants Tailored to Vulnerable Populations

Ofer Levy, M.D., Ph.D., Director, Precision Vaccines Program, Boston Children’s Hospital; Associate Professor, Pediatrics, Harvard Medical School

Vaccine adjuvants may be most helpful for immunization of high risk populations, such as the very young and the elderly that express distinct immunity. The Precision Vaccines Program at Boston Children’s Hospital is leveraging age-specific human in vitro modeling, high throughput screening and systems biology to develop adjuvanted vaccine formulations tailored to such distinct and vulnerable populations.

5:00 Development of Novel Immune NIR Laser and MTBhsp70 Based Immune Adjuvants for Cancer and InfectiousDiseases Vaccines

Mark Poznansky, M.D., Ph.D., Associate Professor, Medicine, Harvard Medical School; Director, Vaccine & Immunotherapy Center, Massachusetts General Hospital

The Vaccine and Immunotherapy Center at MGH sets as one of its missions the accelerated development of new, safe, efficacious and broadly applicable immune adjuvants for both infectious diseases and cancer vaccines. This talk will describe the latest developments in the studies of two novel adjuvants: 1) a non-tissue damaging near infrared laser, and 2) a mycobacterial heat shock protein-based broadly immune-activating adjuvant.

5:30 End of Day

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Friday, December 9

8:00 am Morning Coffee

TLR Agonist Adjuvants

8:25 Chairperson’s Remarks

Lee M. Wetzler, M.D., Co-Director for Research, Section of Infectious Diseases, Professor of Medicine and Microbiology, Boston University School of Medicine

8:30 Activity of TLR Agonists

Dennis Klinman, M.D., Ph.D., Senior Investigator, Cancer and Inflammation Program, NCI, NIH

The ability of tumor-specific cytotoxic T cells and natural killer cells to eliminate cancers is hindered by the immunosuppressive cells present in the tumor microenvironment. Monocytic myeloid-derived suppressor cells (mMDSC) constitute the most active of these tumor-infiltrating leukocytes and are key contributors to the immunosuppressive milieu. mMDSC arise in the bone marrow from myeloid progenitors and are present at high frequency in patients with cancer. Murine mMDSC express TLR9 and respond to stimulation with CpG oligonucleotides (TLR9 agonists) by differentiating into tumoricidal macrophages. In vivo administration of CpG ODN slows/prevents the growth of tumors in mice, an outcome linked to the increased activity of tumoricidal T cells. Human mMDSC express TLRs 2, 7 and 8 (but not 9) and are induced to differentiate into macrophage when stimulated via the relevant toll-like receptors. Agonists targeting TLR 1/2 (such as PAM3) induce mMDSC to mature into immumosuppressive M2-like macrophages whereas agonists targeting TLR 7/8 (such as R848) cause the same precursors to mature into tumoricidal M1-like macrophages. My presentation will focus on the protective activity of TLR agonists alone and in combination with cancer vaccines.

9:00 Induction of Robust and Diverse T Cell Responses by the TLR2 Ligand-Based Adjuvant, Meningococcal PorB

Lee M. Wetzler, M.D., Co-Director for Research, Section of Infectious Diseases, Professor of Medicine and Microbiology, Boston University School of Medicine

There is an unmet clinical need for vaccine adjuvants that induce T cell responses to achieve protection against malignancies and intracellular pathogens such as HIV, TB and Hepatitis C virus where a humoral response alone is not adequate. We have shown that meningococcal PorB, a TLR2 ligand-based adjuvant, has broad and potent adjuvant activity, with induction of robust germinal center and T cell responses, including high levels of Th1 and Th2 type cytokines and antigen specific Th1, Th2, TC2 and TC1 cells. The functionality of the induced CD8 T cells was demonstrated by protection in a Listeria mouse model. PorB is a potent new adjuvant, which is able to induce both a humoral response and strong diverse T cell response.

9:30 Evaluation of the Antibody Threshold of Protection Conferred by a Next-Generation Anthrax Vaccine Candidate Adjuvanted with the Immunostimulatory CPG 7909 TLR9 Agonist

Mario Skiadopoulos, Ph.D., Senior Director, Non-Clinical Development, Emergent BioSolutions

The anthrax vaccine candidate AV7909, is comprised of the Biothrax® (Anthrax Vaccine Adsorbed, AVA) drug substance and the adjuvant CPG 7909, a TLR9 agonist, and is being developed as a next-generation anthrax vaccine candidate for post-exposure prophylaxis that would confer protection earlier and would require fewer immunizations than AVA. AV7909 protected animals against lethal challenge with Bacillus anthracis spores in a dose-dependent manner. Analysis of the TNA threshold associated with protection in AVA or AV7909 immunized guinea pigs and cynomolgus macaques revealed that addition of the CPG 7909 adjuvant to AVA not only improved the kinetics and magnitude of the immune response, but also resulted in a lower TNA level that was required to confer protection, as compared to AVA alone.

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

Regulatory Challenges

10:30 Regulatory Challenges in the Evaluation of Vaccine Adjuvants

Richard Siggers, Ph.D., Senior Scientific Regulator, Health Canada

11:00 Developing Adjuvants: Challenges and Opportunities

Robert Johnson, Ph.D., Director, Office of Regulatory Affairs, Acting Director, Office of Clinical Research Resources, DMID/NIAID/NIH

11:30 pm Enjoy Lunch on Your Own

Mode of Action of Vaccine Adjuvants

1:30 Chairperson’s Remarks

Arnaud Didierlaurent, Ph.D., Director, Translational Research & Adjuvant, GlaxoSmithKline Vaccines

1:35 Mode of Action of Adjuvant System AS01

Arnaud Didierlaurent, Ph.D., Director, Translational Research & Adjuvant, GlaxoSmithKline Vaccines

The mode of action of Adjuvant System AS01, a liposome-based vaccine adjuvant containing both monophosphoryl lipid A (MPL) and the sapoinin QS-21, will be described. AS01 is used in several candidate vaccines including the RTS,S malaria and zoster candidate vaccines.

2:05 Uncovering Innate Immune Pathways that Contribute to the Efficacy of Lipid Nanoparticle-Based Vaccine Formulations

Gokul Swaminathan, Ph.D., Senior Scientist, Infectious Diseases & Vaccines, Merck Research Laboratories, Merck & Co., Inc.

Emerging evidence suggests that bioengineered nanoparticles can be used as immunomodulatory agents. We have identified novel cationic lipid nanoparticles (LNPs) that significantly enhance antigen-specific B-cell, CD4+T cell, and most notably, CD8+ T-cell responses. Importantly, we found that LNP-containing vaccine formulations resulted in protective efficacy in a virus challenge model, as well as, in syngeneic murine tumor models. By employing in vitro systems, transgenic mice models, and in vivo imaging, we have uncovered innate immune pathways that contribute to LNP-based vaccines. Such detailed understanding of its mechanism of action will significantly influence the future design of LNPs for vaccines and immune-oncology applications.

2:35 Close of Conference

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