Immunology for Biotherapeutics

Understanding and Manipulating the Immune System for Therapeutic Advantage

October 3, 2022 ALL TIMES EDT

Many of the exciting advances in drug discovery and development today concern the immune response and its manipulation and control. Our understanding of immune involvement in therapeutic disorders and their treatment is developing rapidly. T and B lymphocyte subsets, innate lymphoid cells (ILCs), macrophages, dendritic cells, and cytokines are all involved in a complex manner. There is the potential for manipulation for therapeutic advantage, yet the danger of disastrous consequences if not well understood. At this symposium, attendees will find out how to utilize the immune system and overcome inhibitory factors without overlooking potential safety issues.

Monday, October 3

Registration and Morning Coffee (Arlington Foyer)8:30 am

CURRENT UNDERSTANDING OF IMMUNE MECHANISMS

ROOM LOCATION: Arlington Salon V

10:00 am

Chairperson's Opening Remarks

Ethan Shevach, MD, Senior Investigator, Cellular Immunology, Laboratory of Immune System Biology, National Institutes of Health National Institute of Allergy and Infectious Diseases

10:10 am KEYNOTE PRESENTATION:

Current Understanding of the Role of T Regulatory Cells and Their Modulation

Ethan Shevach, MD, Senior Investigator, Cellular Immunology, Laboratory of Immune System Biology, National Institutes of Health National Institute of Allergy and Infectious Diseases

The major role of the immune system is to provide protective responses to pathogenic microorganisms. The immune system consists of several distinct cell types and each type plays a unique role. Dysregulation of the immune system can result in responses against self-antigens and in the development of autoimmune diseases. A specialized subset of T lymphocytes, termed T regulatory (Treg) cells, functions to suppress anti-self-responses. Modulation of Treg function with drugs or biologics represents a major approach to the treatment of autoimmune disease.

10:40 am

Antigen Processing and Presentation: The Basis of T Cell Activation

Kannan Natarajan, PhD, Staff Scientist, National Institutes of Health National Institute of Allergy and Infectious Diseases

Antigen Presenting Cells process protein antigens into peptides for binding by either Major Histocompatibility Class I (MHC-I) or Class II (MHC-II) molecules which are then displayed at the cell surface as peptide/MHC complexes, where they are recognized by T cell receptors leading to T cell activation. Cell biological, biochemical, and structural details of these processes as we now understand them will be discussed.

11:10 am

The Role of the Innate Immune System and Implications for Biotherapeutics

Han-Yu Shih, PhD, Investigator, NeuroImmune Regulome, National Institutes of Health National Eye Institute

The field of innate lymphoid cell (ILC) biology has progressed rapidly, with appreciation of these cells’ role in immunity, barrier tissue integrity, and homeostasis. Unlike Th cells, ILCs respond to pathogens promptly without the need of antigen-specific receptor recognition. Understanding how ILCs differentiate and contribute to the immunoregulation in health and diseases is fundamentally important for the development of new strategies to treat autoimmunity, infection, and cancer.

11:40 amNetworking Coffee Break
12:00 pm

Role of IgE and IgG/IgG4 in Modulating Type 1 Hypersensitivity Reactions in Human Allergic Disease

Robert Hamilton, Professor, Medicine & Pathology, Clinical Immunology & Allergy, Johns Hopkins University

This presentation will overview the 4 areas of hypersensitivity: immediate-type 1-IgE-mediated, type II-antibody-dependent cytotoxicity, type III-immune-complex-mediated, and delayed-type hypersensitivity. Type 1 human allergic disease will then be examined, covering its pathophysiology, current diagnostic strategies, 4 modes of disease management, and special caveats relating to food, drug, venom, and respiratory allergic disease. Finally, the new discipline of molecular allergology will be highlighted with an emphasis on 10 cross-reactive allergen families and how allergenic molecules have improved the accuracy of allergy diagnosis.

HARNESSING THE IMMUNE SYSTEM FOR BIOTHERAPEUTICS

12:30 pm

CANCELLED: Harnessing the Body’s Natural Immune Response to Fight Cancer

Daron Forman, PhD, Principal Scientist, Discovery Biotherapeutics, Bristol Myers Squibb Co.

Checkpoint inhibitors have shown remarkable response rates in some previously hard-to-treat cancers by redirecting the body’s own immune system to recognize and eliminate tumor cells. Here, we will discuss the current state of checkpoint inhibitors in the clinic, challenges related to toxicities, biomarker approaches for patient stratification, and future directions of the field.

1:00 pmEnjoy Lunch on Your Own

2:25 pm

Chairperson's Remarks

Simone Nicholson, PhD, DABT, Director Toxicology, Biohaven Pharmaceuticals

2:30 pm

Immunology Safety Considerations for Biotherapeutics

Simone Nicholson, PhD, DABT, Director Toxicology, Biohaven Pharmaceuticals

Biotherapeutics are currently used in the treatment of numerous diseases which encompass oncology and autoimmune inflammatory disorders. Safety concerns arise both with modality and with each different mechanism of action of the biotherapeutics. Investigators are challenged to predict, monitor and mitigate if possible, potential adverse effects in patients while ensuring efficacy and satisfying the regulatory requirements for drug approval. Examples of these safety concerns and how their challenge is met and managed are the subject of this presentation.

3:00 pm

Biopharmaceutical Product Immunogenicity: What Causes It and What Are the Safety and Efficacy Consequences?

Bonnie Rup, PhD, Biotechnology Consultant, Bonnie Rup Consulting

Biopharmaceuticals represent a diverse class of therapeutics, contributing significantly to advancing treatment of serious diseases, including chronic inflammatory and autoimmune diseases, genetic deficiencies, and cancer. Unfortunately, unwanted immunogenic responses against some of these products can occur, often reducing efficacy and sometimes causing safety consequences, such as hypersensitivity, immune complex disease, and autoimmune syndromes. In this overview, factors that affect the degree to which the immune system responds, and the degree to which the response affects the efficacy and safety, are discussed.

3:30 pm PANEL DISCUSSION:

Harnessing the Immune System for Biotherapeutics

PANEL MODERATOR:

Simone Nicholson, PhD, DABT, Director Toxicology, Biohaven Pharmaceuticals

PANELISTS:

Bonnie Rup, PhD, Biotechnology Consultant, Bonnie Rup Consulting

Han-Yu Shih, PhD, Investigator, NeuroImmune Regulome, National Institutes of Health National Eye Institute

Close of Symposia4:10 pm

Dinner Short Course Registration5:30 pm

Dinner Short Courses*6:00 pm

SC3: Recent Advances with Gene and Cell Therapy

SC4: Validation of ADA Assays and Cut Point Calculations

*Separate registration required. See Short Course Page for details






Register

CONFERENCE PROGRAMS