Immunogenicity Summit
Immunogenicity and Bioassay Summit
2013 Archived Content

Immunogenicity Assessment and Strategies 

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Tuesday, November 12

8:30 am Chairperson’s Remarks

Jim McNally, Ph.D., Senior Principal Scientist, Biotherapeutics research, Pfizer, Inc.

Focus on Specific Products: ADCs and PEGylated Proteins 

8:35 Immunogenicity Assessment for Antibody-Drug Conjugates

Marta Starcevic ManningMarta Starcevic Manning, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.

Biotherapeutics containing multiple domains, such as antibody-drug conjugates (ADCs), require careful assessment of the immunogenicity monitoring strategy. ADC administration may result in antibody responses against the monoclonal antibody and/or linker/cytotoxin portions of the molecule. Immunogenicity assays should be able to detect antibodies against all components. Epitope characterization may be useful in ascertaining whether different types of responses have unique impact. Risk assessment, method development challenges and preliminary nonclinical and clinical immunogenicity results will be presented.

9:05 Regulatory Expectations and Experiences Regarding Immunogenicity of PEGylated Proteins

Laura Salazar-Fontana SmallLaura Salazar-Fontana, Ph.D., Senior Staff Fellow and Immunogenicity Program Coordinator, Therapeutic Proteins, CDER/FDA

Pegylation of therapeutic proteins is believed to reduce their immunogenic potential. Published clinical data shows that antibodies directed against the PEG moiety pre-exist in the normal population and can be further induced upon exposure to pegylated therapeutics. Furthermore, the detection of these antibodies correlates, in certain instances, with increased drug clearance and adverse reactions. The impact of anti-PEG antibodies in the efficacy and safety of currently approved pegylated therapeutics will be presented to facilitate the understanding of current regulatory recommendations.

9:35 Potential Immunological Response to a PEGylated Protein Therapeutic after Chronic Administration

Anu Cherukuri, Ph.D., Senior Scientist, Pharmacological Sciences, BioMarin, Inc.

Pegylation was first introduced as a way to extend the half-life of protein therapeutics and reduce immune-mediated clearance. Despite this original intention, there have been several reports of anti-PEG antibody development associated with decreased therapeutic half-life and increased hypersensitivity reactions.  The immunologic mechanism of the anti-PEG antibody response will be reviewed in this presentation. Understanding and anticipating the anti-PEG antibody response may help guide the clinical dosing regimen of some PEGylated proteins and increase the likelihood of these drugs moving forward in the clinical development process.

Tandem Labs10:05 Innovative Uses of Acid Treatment to Improve Immunogenicity Testing and LBA for Pharmacokinetic Assessment

 Manju SaxenaManju Saxena, Ph.D., Group Leader, Principal Scientist, Tandem Labs, a LabCorp Company

Complementary methods with acid treatment will be discussed to mitigate 1) interference by anti-drug antibodies (ADA) on ligand-binding pharmacokinetic (PK) assays, and 2) masking of ADA activity in immunogenicity assays due to high concentrations of biologic drug.  These methods are applicable to the bioanalysis of peptide drugs and anti-drug antibodies.

10:20 Poster Presentation 

10:35 Coffee Break in the Exhibit Hall with Poster Viewing    


Pre-Existing Antibodies 

11:10 Impact of Pre-Existing Antibodies on the Safety and Clinical Pharmacology of a Novel Anti-TNF Alpha Receptor 1 Therapeutic.

Claire Holland, Ph.D., Senior Manager, Biopharm R&D, Clinical Immunology, GlaxoSmithKline

Pre-existing antibodies are frequently encountered during immunogenicity assessments. However, their relevance in terms of the safe and effective administration of a therapeutic protein is still poorly understood. Here we present a case study where pre-existing antibodies altered the safety and clinical pharmacology of a novel TNF alpha receptor 1 therapeutic in a preliminary clinical trial involving healthy subjects. We will discuss the in vitro and clinical investigations that were conducted and the risk factors that contributed to the clinical outcome.

US and EU Regulatory Concerns 

11:40 EU Perspectives on Assessing Unwanted Immunogenicity of Non-Innovator Products and Biosimilars

Christopher J. Holloway, Ph.D., Dr.rer.hum.biol.habil., Group Director, Regulatory Affairs & Chief Scientific Officer, ERA Consulting Group



12:10 FDA Perspectives on Issues Regarding Immunogenicity for Monoclonal Antibodies

Kathleen ClouseKathleen Clouse, Ph.D., Director, Division of Monoclonal Antibodies,FDA/CDER

This talk will address challenges with pre-existing antibody; how excess drug interferes with the assays; novel issues that are not anticipated by clinicians; the potential of emerging antibody products for greater immunogenicity; attempts to increase half-life that may render products more immunogenic; overcoming Immunogenicity to TNF antagonists; and the importance of post-licensing monitoring.

12:40 End of Immunogenicity Assessment & Strategies

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