2013 Archived Content

Immunogenicity Assessment and Strategies 

The impact of immunogenicity in biopharmaceuticals on efficacy is costing the industry vast amounts every year and denying patients much-needed treatment. Moreover, the danger of adverse reactions is ever present. Investigators are improving assay performance and finding means of overcoming complications such as pre-existing antibody and interfering drug, and for interpreting the data. This conference will enable investigators to work out nonclinical and clinical immunogenicity testing strategies for their particular product that satisfies themselves and the regulatory authorities that their product is safe and efficacious for taking through to the next stage.

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Monday, November 11

7:30 am Registration and Morning Coffee

8:30 Chairperson’s Opening Remarks

Steven J. Swanson, Ph.D., Executive Director, Medical Sciences (Clinical Immunology), Amgen, Inc.

Overcoming Challenges of Immunogenicity Assays 

8:35 Novel Platform Using LC-MS and Ligand Binding Assays for Characterizing PK and Immunogenicity of ADCs

Melody SauerbornMelody Sauerborn, Senior Expert, Immunogenicity and Bioanalysis, TNO, a Netherlands Applied Research Center

Bioanalysis of antibody-drug conjugates is challenging. This is partially due to the heterogeneous mixture of different antibody-drug ratio (DAR) species and the different characteristics of the drug (small molecule), linker and antibody (large molecule). This talk will give a small introduction into ADCs, how size of molecule influences characterization technique, demonstrate how different companies have used different approaches to measure ADCs and introduce a novel platform for ADC characterization and measurement.

9:05 Case Study on Assessment of Neutralizing and Cross-Reacting Antibodies

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

Neutralizing antibody assays present a challenge for many bioanalytical laboratories. The choice of assay format (competitive ligand binding vs. cell based assay, for example), the identification of a positive control, and the timing of their implementation all are critical steps in the bioanalytical support for clinical immunogenicity assessment. This talk will focus on case studies addressing these challenges, the choices we made and the lessons we learned from each assay.

9:35 Immunogenicity Assessment Challenges for Nanobody® Programs: Strategies and Case Studies to Overcome Drug and Target Interference

Lieselot Bontinck SmallLieselot Bontinck, M.Sc., Scientist, Pharmacology, Bioanalytics & Immunogenicity, Ablynx N.V.

Nanobodies® represent a novel class of biologics based on the smallest functional fragment of heavy chain antibodies naturally occurring in Camelidae. To support clinical immunogenicity assessment, bridging antibody and neutralizing antibody assays are developed. Interference of free drug represents a well know challenge in these types of assays, and additionally target interference can be an issue. Various approaches to overcome these hurdles will be discussed, including optimization of assay conditions and sample pre-treatment.

Genalyte10:05 Multiplex Assays for Simultaneous Detection and Isotyping of Anti-Drug Antibodies Using Silicon Photonic Biosensors

Martin GleesonMartin Gleeson, Ph.D., CSO, Genalyte, Inc.

Genalyte has developed a silicon chip based detection system, MaverickTM, which simultaneously measures multiple analytes from small samples in real time. The system eliminates virtually all sample preparation and has broad application in biotherapeutic research. In this presentation we will describe the principal of operation and show data generated using our multi-tier ADA assay for the simultaneous detection and isotyping of ADAs in a rapid and easy to use workflow. 

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

11:15 Identification and Mitigation of Matrix Interference inCell-Based Nab Assays

Martin Schwickart SmallMartin Schwickart, Ph.D., Scientist, Clinical Pharmacology and DMPK, MedImmune, Inc.

To support biologics development in the clinic, neutralizing antibody assays are currently mandated by the FDA. The development of cell-based assays has significant challenges, especially regarding sensitivity and specificity. We present here a case where initially matrix interference was prohibitively high. We demonstrate a hypothesis-driven approach on how the source of matrix interference was identified, and eliminated with minimal sample manipulation.

11:45 Integrated Immunogenicity Data Analysis: Clinical Trial Results from a Biotherapeutic for the Treatment of Age-Related Macular Degeneration

Kyra J. CowanKyra J. Cowan, Ph.D., Scientist, BioAnalytical Sciences, Genentech, Inc.

Ranibizumab (Lucentis®) is a humanized anti-VEGF F(ab) approved by the FDA for the treatment of vision loss due to wet AMD, macular edema following retinal vein occlusion, and diabetic macular edema.  The HARBOR study was designed to evaluate its safety and efficacy with intravitreal injection for the treatment of wet AMD over a two-year period. This talk will describe the approaches taken for the analysis of anti-therapeutic antibodies (ATAs) in sera from 1097 patients, and how the data interpretation informed the impact of ATAs on clinical endpoints.

Lonza12:15 pm Preclinical Immunogenicity Risk Assessment Incorporated into a Developability Platform for Optimal Lead Selection

Noel SmithNoel Smith, Ph.D., Lead Scientist, Lonza Biologics

The ability to assess the “developability” of a therapeutic candidate in early preclinical and clinical phases of development can be a very powerful tool to enhance the chance of success. This presentation will focus on how immunogenicity risk assessment can be incorporated into a wider developability platform that includes in silico and in vitro tools to predict immunogenic responses as well as the potential manufacturability issues (aggregation, post translational modifications) that themselves have the potential to impact immunogenicity.

12:45 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

Immunogenicity Road Map/Change Implementation 

2:15 Chairperson’s Remarks

Kyra J. Cowan, Ph.D. Scientist, BioAnalytical Sciences, Genentech, Inc.

2:20 Developing a Strategy for Immunogenicity Assessment

Francesca Civoli, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.

2:50 TV-5010 and Efforts to Modify COPAXONE®: A Case Study on the Immunogenicity Impact on Safety and Regulatory Considerations for Complex Drugs

Jill B. ConnerJill B. Conner, Ph.D., Director, Global Specialty Medicines, Teva Pharmaceuticals

COPAXONE® is approved for the treatment of relapsing-remitting multiple sclerosis. COPAXONE® is a highly complex heterogeneous mixture of synthetic proteins /polypeptides with immunomodulatory activity. Teva had pursued development of a higher molecular weight version of COPAXONE® (TV-5010) by introducing changes to the COPAXONE® downstream synthesis procedure. The treatment with TV-5010 in animals led to severe side effects. This case study will examine both products and the differences in their immunogenicity profiles.

3:20 Refreshment Break in the Exhibit Hall with Poster Viewing

Concerns about Immune Complexes 

4:00 A Case Study: Immune Complexes without Anti-Drug Antibodies. What Does it Mean?

Deborah FincoDeborah Finco, Ph.D., Senior Principal Scientist, Drug Safety R&D, Pfizer, Inc.

Immune complexes may form in animals/people who receive protein biotherapeutic drugs, as a result of the development of anti-drug antibodies or due to other factors. Immune complexes can pose safety issues if they are not adequately cleared from the body. Often vasculitis or glomerular deposition are hallmarks of excessive amounts of immune complexes or deficiencies in the ability to remove them from circulation. This talk will highlight a nonclinical case study involving immune complexes with a biotherapeutic drug that did not induce anti-drug antibodies.

4:30 Problem Solving Roundtable Discussions

Table 1: Regulatory Expectations Regarding Immunogenicity Assessment

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

Table 2: Challenges in Developing Neutralizing Antibody Assays

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

Table 3: Dealing with Pre-existing Positive ADA Activity in Study Patients

Moderator: Steven J. Swanson, Ph.D., Executive Director, Medical Sciences (Clinical Immunology), Amgen, Inc.

Table 4: Practical Application of Immunogenicity Preclinical Risk Assessment

Moderator: Kyra J. Cowan, Ph.D. Scientist, BioAnalytical Sciences, Genentech, Inc.

Table 5: Detection of Immune Complexes and Their Impact on Immunogenicity Assessment

Moderator: Deborah Finco, Ph.D., Senior Principal Scientist, Drug Safety R&D, Pfizer, Inc.

Table 6: Immunogenicity Testing During Clinical Trials

Moderator: Martin Schwickart, Ph.D., Scientist, Clinical Pharmacology and DMPK, MedImmune, Inc.

Table 7: Concerns Regarding Immunogenicity of PEGylated Proteins

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

5:30 Welcome Reception in the Exhibit Hall with Poster Viewing

6:30 End of Day One of Immunogenicity Assessment & Strategies

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