Cambridge Healthtech Institute’s 2nd Annual

Symposium: Immunology for Biotherapeutics

Understanding and Manipulating the Immune System for Therapeutic Advantage


Final Agenda

9:30 am – 5:45 pm | Tuesday, October 15, 2019

Many of the exciting advancements 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.

8:30 am Registration and Morning Coffee


9:30 Chairperson’s Opening Remarks

Ethan M. Shevach, MD, Senior Investigator, Laboratory of Immune System Biology, National Institute of Allergy and Infectious Diseases, NIH

9:40 Keynote Presentation: Current Understanding of the Role of T Regulatory Cells and their Modulation

Shevach_EthanEthan M. Shevach, MD, Senior Investigator, Laboratory of Immune System Biology, National Institute of Allergy and Infectious Diseases, NIH

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.

10:10 Antigen Processing and Presentation: The Basis of T Cell Activation

Natarajan_KannanKannan Natarajan, PhD, Staff Scientist, National Institute of Allergy and Infectious Diseases, NIH

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.

10:40 The Role of the Innate Immune System and Implications for Biotherapeutics

Shih_Han-YuHan-Yu Shih, PhD, MS, Research Fellow, National Institute of Arthritis and Musculoskeletal and Skin Disease (NIAMS), NIH

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.

11:10 Networking Coffee Break

11:30 Role of IgE and IgG/IgG4 in Modulating Type 1 Hypersensitivity Reactions in Human Allergic Disease

Hamilton-RobertRobert Hamilton, PhD, Professor, Medicine and Pathology, Division of Clinical Immunology and Allergy, The Johns Hopkins University School of Medicine

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.


12:00 pm Applying Bispecific Technology to Modulate the Immune Response for Therapeutic Intervention

Moore_PaulPaul Moore, PhD, Vice President, Immunology and Cell Biology, Macrogenics, Inc.

Bispecific antibody-based molecules afford therapeutic opportunities not feasible with single-target antibodies or combinations. The most advanced clinical strategy in oncology exploits the ability of bispecific molecules to co-engage T cells with tumor cells resulting in tumor cell lysis and T-cell expansion. Additional approaches to leverage immune cells through bispecific targeting are being explored in oncology, autoimmunity, and infectious diseases. These approaches will be summarized in the context of molecule design and target selection.

12:30 Immunology Safety Considerations for Biotherapeutics

Nicholson_SimoneSimone Nicholson, PhD, DABT, Principal Toxicologist, Clinical Pharmacology and Safety Sciences, AstraZeneca

In this presentation, I shall examine the challenges of biotherapeutics impacting the immune response, and the challenges investigators face managing dose, scheduling, and satisfying the regulatory requirements. The checkpoint inhibitors used for immunotherapy have a natural role in controlling autoimmune diseases, such as Type 1 Diabetes and Lupus. Immunotherapies in general, and technologies modifying T-cell function and those involving cytokines, present dangers of autoimmune disease, cardiovascular disorders, and additional challenges, especially when used in combination.

1:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:30 Session Break

2:25 Chairperson’s Remarks

Simone Nicholson, PhD, DABT, Principal Toxicologist, Clinical Pharmacology and Safety Sciences, AstraZeneca

2:30 Biopharmaceutical Product Immunogenicity: What Causes It and What are the Safety and Efficacy Consequences?

Rup_BonnieBonita (Bonnie) Rup, PhD, Biopharmaceutical Consultant, Bonnie Rup Consulting LLC

Biopharmaceuticals represent a rapidly growing class of therapeutic product, 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 talk, 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.

3:00 Can Immune Humanized Mouse Models Inform Pre-Clinical Immunogenicity Testing?

Howard_KristinaKristina E. Howard, DVM, PhD, Research Veterinary Medical Officer, Division of Applied Regulatory Science (DARS), OCP/OTS/CDER/FDA

3:30 Vaccines: Understanding the Mode of Action, Progress to Date, and On-Going Challenges

Lacy_MichaelMichael Lacy, PhD, Director, Nonclinical Immunology and Bioanalysis, Emergent BioSolutions

Complex immune responses result from the complexity of whole pathogen vaccines. Vaccines can be simplified to 3 general components, each of which is supplied by whole pathogens in a convenient package or can be mimicked using more defined components. Emerging safety issues may lead to purified and quantified vaccine components, such as synthetic immune stimulants and antigens, leading to more focused immunity. Formulations may preserve epitopes and control unwanted immunity. Selection of conserved epitopes may bypass rapid mutational rates of pathogens and bypass the unwanted effects of nontarget immunity.

4:00 Networking Refreshment Break


4:20 Harnessing the Body’s Natural Immune Response to Fight Cancer

Forman_DaronDaron Forman, PhD, Principal Scientist, Bristol-Myers Squibb

Checkpoint inhibitor as cancer treatment has shown remarkable response rates in 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 I-O agents in the clinic, challenges related to toxicities, biomarker approaches for patient stratification, and future directions of the field.

4:50 Adoptive T Cell Therapy

Melenhorst_JosJ. Joseph (Jos) Melenhorst, Ph.D., Director, Product Development & Correlative Sciences, Center for Cellular Immunotherapies, University of Pennsylvania

I will discuss the evolving field of adoptive T cell therapy, and compare and contrast tumor targeting efforts with allogeneic, autologous minimally manipulated to the TCR and CAR-redirected T cells. Topics to discuss are safety, efficacy, toxicity; clinical trials in hematologic and solid tumors; and future directions to enhance immunogene therapy of cancer.

5:20 Discussion

5:45 End of Symposium

6:15 Dinner Short Course Registration

6:30 pm – 9:30 pm Recommended Dinner Short Course*

SC3: Validation of ADA Assays and Cut Point Calculations

*Separate registration is required.