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Thursday, August 23
7:30 Registration and Morning Coffee
(Breakfast Workshop Sponsorship Available)
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Immunotherapeutics for Cancer and Autoimmune Diseases |
8:30 Chairperson's Remarks
| Featured Presentation |
8:35 Cross Currents in Oncology: Selecting the Right Study Population and Matching it to a Regulatory Pathway
Stephen D. Litwin, M.D., Senior Clinical Consultant, Biologics Consulting Group, Inc. |
9:05 Antibody-Targeted Vaccines
Tibor Keler, CSO, VP R&D, Celldex Therapeutics
The specificity and high affinity binding of antibodies provides these molecules with ideal properties for delivering a payload to target cells. Exploiting these characteristics of antibodies, antibody-targeted vaccines (ATV) are designed to deliver disease-specific antigens to professional antigen presenting cells (APCs), thus enabling the host’s immune system to recognize and eliminate malignant or infected cells through adaptive immunity. The concept of ATVs has been in development for many years, and recently has entered clinical trials. Early studies with ATVs focused on the ability to induce humoral immunity in the absence of adjuvants. More recently, ATVs targeted to
C-type lectin receptors have been exploited for induction of potent helper and cytolytic
T cell responses. To maximize their stimulatory capacity, the ATVs are being evaluated with a
variety of adjuvants or other immunostimulatory agents. In the absence of co-administered
immunostimulatory signals, APC-targeting can induce antigen-specific tolerance and, thus, may also be exploited in developing specific treatments for autoimmune and allergic diseases, or for preventing transplant rejection. The successful clinical application of this new class of antibody-based products will clearly depend on using appropriate combinations with other strategies that influence the immune system.
9:35 Immunocytokines Targeting Melanoma and Containing TNF
Michael Rosenblum, M.D., Professor of Medicine, Department of Experimental Therapeutics, M.D. Anderson Cancer Center
This is a "first in class" molecule. We have performed all characterization and pre-IND studies and have moved this construct from "Concept to Clinic" in an Academic setting. The scFvMEL/TNF immunocytokine has been demonstrated to generate highly cytotoxic effects against target cells resistant to TNF itself. The construct modulates a series of genes which are unique compared to TNF. The efficacy of this construct against melanoma tumor xenografts is impressive.
10:05 Networking Coffee Break, Poster &
Exhibit Viewing Networking
10:45 Effector and Suppressor Immune Responses Co-Exist in Cancer Patients: Implications for Immunotherapy
Gilberto Filaci, M.D., Associate Professor, Internal Medicine, University of Genoa
This presentation
- Shows the possibility of applications but also potential limits of telomerase-specific vaccination in cancer patients;
- Makes a parallel analysis on effector and suppressor T cell responses in cancer patients;
- Pin- points phenotypic and functional roles of a population of regulatory cells, the CD8+ T suppresssor lymphocytes, whose activity in human cancer has been less characterized with respect to that of CD4+CD25+ regulatory T lymphocytes
11:15 Technology Trends (Sponsorship Available)
11:45 Engineered Cellular Therapeutics: A Paradigm shift in Development of Potent Biological Immunotherapeutics
Madhusudan Peshwa, Ph.D., Vice President, Research & Development, MaxCyte, Inc.
The ability to specifically tailor and augment biological activity (potency) of cellular immunotherapeutic products utilizing robust and scalable manufacturing processes compliant with regulatory requirements represents a significant unmet need. Such control over cellular physiology and function also lends itself improved product characterization, expands / extends intellectual property, drives down technology / clinical / regulatory risks, reduces developmental cost / time, and leads to accelerated clinical / commercial delivery for cancer immunotherapies with enhanced potency / efficacy and favorable process economics. Specific examples outlining pre-clinical development experiences with engineered cancer immunotherapy products and initial results from phase I / II human trials will be discussed.
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Plenary
Session – Focus on Adjuvants |
1:40 Chairperson's Remarks
| Keynote Presentation |
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1:45 An FDA Perspective: Regulatory Considerations in the Non-clinical Safety Assessment of Adjuvanted Preventive Vaccines
Elizabeth M. Sutkowski, Ph.D., Scientific and Regulatory Reviewer, Office of Vaccines Research & Review (OVRR), Center for Biologics Evaluation & Research, US Food & Drug Administration
The Office of Vaccines Research and Review (OVRR) is responsible for regulatory review of new Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) for preventive vaccines and therapeutic vaccines for infectious disease indications. Through this review process, OVRR ensures that vaccines are safe, effective, pure, and potent, as specified in Title 21 of the Code of Federal Regulations, Sections 312, 600, and 610. This presentation will review key components in non-clinical safety assessment of preventive vaccines regulated by OVRR, with a focus on toxicity study design considerations for vaccines with novel adjuvants. In addition, relevant clinical trial considerations and the utility of the pre-IND meeting will be discussed briefly. |
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Featured Presentation |
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2:30 GSK Adjuvant Portfolio: A Global Perspective
Nathalie Garcon, Pharm.D., Ph.D., Vice President, Research and North America R&D, GlaxoSmithKline Biologicals
During the past decade, GSK biologicals has developed a portfolio of adjuvant systems aiming at inducing the most appropriate immune response against various diseases, in order to overcome medical challenges (flu elderly, malaria), induce a longer and sustained protection (HPV), a broader protection (pre-pandemic flu) and allow for potential dose sparing of antigen (pandemic flu). These adjuvant systems have also opened the way to a new family of vaccines, the so-called therapeutic vaccines such as the oncology vaccines. We will present today, the history of these adjuvants and clinical results supporting their efficacy and potential toward protection and control of diseases. |
3:15 Networking Refreshment Break, Poster &
Exhibit Viewing
(Last Chance for Viewing)
4:00 Inducing anti-tumor immunity by activating Toll-like receptor 9
Arthur M. Krieg, M.D., Founder & Chief Scientific Officer, Coley
Pharmaceutical Group Inc.
The immune system detects infectious agents using a family of ten Toll-like
receptors (TLR), each of which is specific for a type of molecule expressed in
pathogens. TLR9 is specific for unmethylated CpG dinucleotides in pathogen DNA,
and can be activated with synthetic oligodeoxynucleotides such as PF-3512676. In
animal models and in human clinical trials, PF-3512676 activates dendritic cells
and induces the generation of tumor-specific CD8+ T cells. PF-3512676 has
anti-tumor activity as a monotherapy, or in combination with other approaches,
including tumor vaccines, radiotherapy, and chemotherapy, with which it is
currently in two phase III clinical trials in NSCLC.
4:30 The New Generation Iscom-Matrix Adjuvant – A Safe and Potent Adjuvant for
Demanding Applications
Karin Lövgren Bengtsson, Ph.D., Head R&D, Isconova AB
ISCOMs and the ISCOM technology has been applied in immunological research as
well as in experimental and commercial vaccines for about twenty years. The
technological developments during these years have been considerable, and the
technology that was always regarded as highly efficacious but technically
difficult, expensive, and not always satisfactorily safe, has matured into a
promising candidate for broad use. Isconova’s contribution to technology
developments include four animal vaccines on the market, products for laboratory
animal applications, large-scale production of purified saponin fractions and
Iscom-Matrix, and the new potent LowTox adjuvant with a comfortable safety
profile, e.g., for human use.
5:00 A phase Ib study of FolateImmune (EC90 with GPI-0100 adjuvant followed by
EC17) with low dose cytokines interleukin-2 (IL-2) and interferon - alpha; (IFN
- alpha) in patients with refractory or metastatic cancer
Robert J. Amato, D.O., Medical Director, Genitourinary Oncology Program, The
Methodist Hospital Research Institute
FolateImmune is a novel therapy that induces an immune response against tumor
cells by marking tumor cells with a folate-hapten conjugate targeted to folate-receptor.
FolateImmune therapy is comprised of 1) a vaccine containing EC90, 2) an
adjuvant (GPI-0100) and 3) a folate-hapten conjugate (Folate-FITC). The
folateImmune treatment begins with subcutaneous injections of EC-90 vaccine with
GPI-0100 adjuvant to stimulate the production of antibodies to the flourescein
hapten. Patients will then receive subcutaneous injections of EC17, an agent
intended to form a molecular “bridge” between the tumor cell and the
endogenous circulating anti-flourescein immunoglobulin G antibody. This may
initiate an Fc-mediated immune response leading to the removal of the
antibody-coated tumor cells by a mechanism commonly referred to as an
antibody-dependent cellular cytotoxicity and/or phagocytosis.
5:30 PREPS and L-particles- A Novel Herpes Simplex Based Virus Like Particle for Delivery of a Wide Range of Therapeutic
Proteins
Ian Pardoe, Ph.D., MB, ChB, MRCGP, Chief Executive and Medical Director, Henderson Morley
plc.
As part of the natural infectious cycle, herpes simplex viruses produce virus like particles. These particles contain all of the surface and tegument proteins of the parent virus, but completely lack the nucleocapsid. These so called L-particles facilitate the natural infection of HSV, so are able to enter cells as if they were viruses. Because of the total lack of DNA, they are unable to replicate. PREPS particles are a modification of L-particles. Non native proteins that have been engineered into the parent virus, can be delivered functionally intact to cells using PREPS and L-particles. It is possible to engineer the virus to express several antigens simultaneously, so a multivalent cancer vaccine is therefore possible. L-particles also enhance naked DNA transfection, and its use as an adjuvant for DNA vaccines is being explored. This talk will briefly highlight the technology and its potential applications.5:45 Networking Reception, Poster & Exhibit Viewing
5:45
End of Day Two
Friday, August 24
7:30am Morning Coffee (Breakfast Workshop Sponsorship Available)
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Biologics for Autoimmune Diseases
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8:30 Chairperson's Remarks
8:35 Paving the Way for Autologous Cell Therapy for Autoimmunity
Jim Williams, Ph.D. Chief Operating Officer, Research & Development, Opexa Therapeutics
Opexa Therapeutics’ T-cell and Stem cell technologies are at the forefront of autologous cellular therapy, engaged in developing patient-specific immunotherapies for the treatment of various autoimmune diseases. Opexa's initial disease targets are autoimmune diseases amenable to T-cell based vaccination therapies, such as multiple sclerosis (MS), rheumatoid arthritis (RA), and diabetes mellitus. The T-cell vaccination platform is unique in that the subcutaneous administration of attenuated pathogenic T-cells induces a dual immune response against the pathogen T-cell receptor and ergotopes such as the IL-2 receptor molecule.
9:05 Regulation and Function of Inflammatory T- cells in Autoimmune Disease
Chen Dong, Ph.D., Associate Professor, Department of Immunology, MD Anderson Cancer Center
CD4+ T cells are major mediators in autoimmune diseases. Upon activation, they differentiate into different subsets of cytokine-producing effector T cells. Recently, we and others have characterized a novel subset of T cells producing IL-17, IL-17F and IL-22. Growing evidence has supported an important role of this inflammatory T cell in autoimmune and inflammatory diseases. I will discuss the regulation of inflammatory T cell generation and the function of their cytokines in autoimmune diseases.
9:35 The Role of IL-21 Inhibition in a Lupus-Prone Mouse Model
Deborah Herber, Ph.D., Inflammation, Wyeth Research
10:05 Networking Coffee Break
10:45 Anti-IL 6 Monoclonal Antibodies and their Role in Lupus Treatment
Bailin Liang, Ph.D., Department of Immunbiology, Centochor
11:15 Biologics in Dermatology
Nicole Selenko-Gebauer, MD, Dermatology, Division of Immunology, Allergy and Infectious Diseases (DIAID), General Hospital Vienna, Medical University
Psoriasis is a common inflammatory skin disease that can be physically and emotionally debilitating and which in moderate to severe cases can require life-long treatment. Classical systemic therapies of this disease include phototherapy, ciclosporin, methotrexate and retinoids, which show satisfactory clinical responses, however have limitations on their use due to serious long-term adverse effects. Advances in molecular research have resulted in the development of biologics, a new class of therapies designed specifically against immunopathologic hallmarks of a chronic inflammatory disease. 4 different biologic drugs have been available for the treatment of psoriasis patients, efalizumab, etanercept, infliximab and adalimumab. Since those drugs have been available for the treatment of psoriasis patients, the outpatient work of the Division of Immunology in our Department has been focussed towards this topic. In a special outpatient care unit of Bio-Immunotherapy we are currently combating more than 650 patients on biologic treatments. This outpatient clinics has developed to one of the largest competence centers in biologic therapies worldwide. Most of our patients are suffering from psoriasis, however patients with recalcitrant dermatomyositis, systemic lupus erythematodes (SLE) and Behcet´s disease are also a part of our dedication off label.In this presentation we would like to give an overview of postmarketing experience on and off label at our center, focussing on the niches and specialities of each respective drug, not forgetting to put a focus on upcoming side events.
11:45 Panel Discussion: The Challenge of Targeting T-cells
12:15 Lunch on Your Own (Lunch Workshop Sponsorship Available)
1:45 Chairperson's Remarks
1:50 TBA
Leonard H. Sigal, M.D., Pharmaceutical Research Institute, Bristol-Myers Squibb (tentatively)
2:20 YourDex™ - a truly Autoimmune Specific Immunosuppressant
Stephen Megit, Ph.D., License Manager, MediGene
YourDex is a soluble variant of the naturally occurring human immune-suppressor protein ILT-2 which has been engineered to display pM affinities for class I HLA proteins. YourDex binds class I HLA proteins with a dissociation time in excess of 7 days and sterically blocks engagement and signalling of the CD8 co-receptor. Whilst CD8 T-cells recognising self-derived epitopes are dependant upon signalling via the CD8 co-receptor for activation, those that recognise viral epitopes are invariably CD8 independent. This inherent ability of T-cells to recognize viral derived epitopes over self affords a unique mechanism which YourDex exploits to create a truly autoimmune specific CD8 T-cell inhibitor.
YourDex is in late pre-clinical evaluation as both Fc-fusion and albumin fusion variants with a view to delivering a dosing schedule allowing patients to self-administer at two-weekly intervals or longer.
2:50 Refreshment Break
3:30 Moderated Roundtable Discussions
Topics for Discussion:
(1) TNF alpha (2) Interleukin antagonists (3)
T-Cell Regulation
5:00 End of Conference
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