2015 Archived Content

Cambridge Healthtech Institute’s Inaugural 

Antibody-Drug Conjugates 
抗体及药物结合物
Clinical Experience * Payloads & Linkers * Engineering Homogeneity

April 1-2, 2015

 

Although there are currently only 2 ADCs on the market, there are nearly 100 companies active in the field. Antibody-drug conjugates, with powerful and targeted tumor-killing activity and reduced side-effects for cancer patients, hold the promise as the next big thing in biotherapeutics. Among the biggest challenges for ADCs are the linker technology and conjugation chemistry. As these techniques improve, so does the demand for better physiochemical properties for ADC, such as improved homogeneity, enhanced stability and higher payloads.

CHI’s Antibody-Drug Conjugates conference brings together leaders in the world of ADCs to share their engineering and optimization strategies, as well as characterization of next-generation ADCs for better developability.

WEDNESDAY, APRIL 1


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PLENARY KEYNOTE SESSION

2:00 pm Chairperson’s Opening Remarks

Robb KahnRobb Kahn, M.D., Senior Safety Science Leader, Global Pediatric Oncology Drug Development, Genentech, a member of the Roche Group



 

2:05 ADCs: Is It Time to Rethink Some Preconceptions?

Shu-Hui LiuShu-Hui Liu, Ph.D., Assoc Research Fellow, Department of Biology, Rinat-Pfizer

In this presentation, we will discuss how site-specific conjugation technologies have allowed a deeper understanding of ADC properties.



2:35 Whose Problem is Post-Translational Modifications? Discovery, Cell Culture, Chromatography or Formulation?

 ChandrashekarGanesaShekar Ganesa, Ph.D., Senior Director, Analytical Development, Global Biotherapeutics, Sanofi

Recombinant protein post-translational modifications (PTMs) are important to monitor and control during the manufacture of biologics. However, the diversity, identification and understanding the relevance of PTMs during the product development cycle can be challenging. This presentation will examine current analytical technologies and discuss how to effectively use them in characterizing the different types of PTMs. It will also discuss various strategies to manage PTMs during various stages of therapeutic protein development.

3:05 Refreshment Break in the Exhibit Hall with Poster Viewing

3:45 Chairperson’s Opening Remarks

Robb Kahn, M.D., Senior Safety Science Leader, Global Pediatric Oncology Drug Development, Genentech, a member of the Roche Group


ADCs IN PRECLINICAL AND CLINICAL DEVELOPMENT

Featured Presentation

3:50 Current Clinical Experience with Antibody-Drug Conjugates: A View through the Therapeutic Window

Robb KahnRobb Kahn, M.D., Senior Safety Science Leader, Global Pediatric Oncology Drug Development, Genentech, a member of the Roche Group

Numerous antibody-drug conjugates (ADCs) are in clinical development and several have entered the therapeutic market. The concept of an ADC is to improve the “therapeutic window” of cancer chemotherapy. This presentation will examine the therapeutic windows for representative ADCs in clinical development, allowing us to peer into the therapeutic window of specific ADCs through a discussion of their risk-benefit profiles.

4:20 Sponsored Presentation (Opportunity Available)

UnpublishedData4:50 Superior Anti-Tumor Activity Compared to T-DM1 in Preclinical Studies of Targeted Therapies for Her2-positive Cancers by a Novel Her2-ADC

SheldonCaoSheldon Cao, Ph.D., CEO, Zova Biotherapeutics, Inc.

ZV02-1016 is a Her2-targeting ADC based on newly developed K-LockTM technology. Anti-Her2 Ab was conjugated with highly cytotoxic auristatin analogue through a non-cleavable linker to form ZV02-1016. ZV02-1016 is shown to be more potent than T-DM1 in vitro in Her2 expressing cancer cell lines and in vivo in Her2-positive cancer cell line xenografts. ZV02-1016 is currently under further evaluation as a candidate for clinical treatment of Her2-positive cancers in future.

5:20 Application of Translational PKPD in ADC Development

KedanLinKedan Lin, Ph.D., Senior Scientist, Therapeutic Area Lead for Oncology Large Molecules, Pharmacokinetics & Pharmacodynamics, Genentech, Inc.





5:50 Close of Day


THURSDAY, APRIL 2


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8:30 am Morning Coffee

8:50 Chairperson’s Opening Remarks

Thomas Pillow, Ph.D., Scientist, Discovery Chemistry, Genentech, Inc.


NOVEL PAYLOADS, LINKERS AND SITES

UnpublishedData9:00 ADCs based on RNA Polymerase II Inhibiting Toxins

AndreasPahlAndreas Pahl, Ph.D., CSO, Heidelberg Pharma GmbH

Payloads of today’s ADCs are exclusively based on compounds acting on microtubules or DNA and seem to suffer from various limitations. New generations of payloads enter the field including Heidelberg Pharma’s amanitin, a highly effective inhibitor of the eukaryotic RNA Polymerase II. Due to its unique mode of action and its hydrophilic properties, this toxin differs from well-known payloads. This presentation will summarize the current status of this new toxin.

UnpublishedData9:30 Cancer Stem Cell Targeting with Antibody-Drug Conjugate Payloads and Linker Technologies

RileyEnnisRiley Ennis, MSc, Thiel Fellow, Cell and Molecular Biology, Dartmouth College

A challenge with current antibody-drug conjugates (ADCs) is to improve patient outcomes by circumventing drug resistance, disease recurrence, and cancer stem cells. We explore a novel cytotoxic payload, Azonafides, that can be integrated into ADC platforms. This cytotoxin is more stable in circulation, has unique mechanisms of action, and is derived from natural products. Azonafides create an exciting clinical opportunity to improve the therapeutic window, efficacy, and safety of ADCs.

10:00 New Linker Chemistries for Expanding the Utility of ADCs

ThomasPillowThomas Pillow, Ph.D., Scientist, Discovery Chemistry, Genentech, Inc.

This presentation will describe the use of potent anthracycline and PBD payloads for second generation HER2-targeted ADCs, and how different linkers to these payloads can be used to tune the therapeutic activity. A new linker that takes advantage of the site-specificity of THIOMABTM technology will be described. Additionally, the presentation will describe the application of ADCs to non-oncology indications.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

UnpublishedData11:10 Engineering Homogeneous ADCs with Single or Combination Warheads

AaronSatoAaron Sato, Ph.D., Vice President, Research, Sutro Biopharma, Inc.

Using Xpress CF+, hundreds of non-natural amino acid antibody variants are made within a day. Using fast, quantitative conjugation chemistries, antibodies are conjugated within hours with low molar excess of linker warhead. The best sites are selected based on expression, cell binding, conjugation efficiency (DAR), and cell killing. In vivo efficacy, PK/PD, and stability studies further winnow to our best ADC candidates. Multiple ADC examples will be provided.

UnpublishedData11:40 Bidentate Linkers for Site-Specific Conjugation and Improvement of Homogeneity and Other Druggabilities in ADC

BruceNianheHanBruce Nianhe Han, Ph.D., CSO, Research & Development, NewBio Therapeutics, PR China

We have discovered new linkers, bis(maleimde)derivatives which can conjugate small molecule toxins to antibodies in site-specific manner. With this technology, no antibody engineering is required and we only need to use the interchain disulfide bonds of IgG to perform conjugation. The resulting final products have high percentage of ADC with defined antibody-drug ratios. These homogeneous ADCs have also shown improved in vitro and in vivo stability, and other related druggabilities.

12:10 pm Sponsored Presentation (Opportunity Available.

12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing

2:00 Chairperson’s Remarks

Thomas Pillow, Ph.D., Scientist, Discovery Chemistry, Genentech, Inc.


SITE-SPECIFIC CONJUGATIONS FOR PRODUCTION OF HOMOGENEOUS ADCs

2:05 Site-Specific Conjugations for Well-Defined and Stable ADCs

ChangshouGaoChangshou Gao, Ph.D., Fellow, R&D, Department of Antibody Discovery & Protein Engineering, MedImmune, LLC.

Significant effort has been devoted recently to developing site-specific conjugations for producing homogenous ADCs with well-defined drug to antibody ratios. This presentation will discuss our approaches to generate ADCs with different conjugation chemistries that allow precise control of conjugation site and stoichiometry. Upon conjugation to a drug, the site-specific ADCs showed enhanced stability, increased in vivo anti-tumor efficacy, and decreased off-target toxicity.

2:35 Overcoming Challenges and Enhancing Production of Antibody for Site-Specific Antibody-Drug Conjugates

MarieZhuMarie Zhu, Ph.D., Director, Process Sciences, Agensys, Inc./Astellas, Inc.

ADCs have been emerging as a new class of anticancer therapeutics, in which monoclonal antibodies are designed to deliver a cytotoxic drug selectively to antigen expressing cells. The site-specific ADC technology we are using results in ADCs with a homogenous drug-antibody ratio. In this study, we investigate how the cell line development process impacts on antibody expression, and how feed media components and cell culture processes affect cell growth and antibody production.

3:05 Sponsored Presentation (Opportunity Available)

3:35 Refreshment Break



Joint Closing Session - ChARACTERIZING ADC for better developability

4:00 Chairperson’s Remarks

Gayathri Ratnaswamy, Ph.D., Director, Analytical & Formulation, Agensys, Inc.

 

4:05 Analytical Strategies and Characterization of Antibody-Drug Conjugates

 GayathariRatnaswamyGayathri Ratnaswamy, Ph.D., Director, Analytical & Formulation, Agensys, Inc.

This presentation will focus on the challenges of analytical method development and characterization for ADCs in comparison with that of mAbs using case studies. Strategies for the analytical development for early stage versus late stage will be presented.

 

4:35 ADCs: Biophysical Characteristics and Impact on Product and Process

 SatishSinghSatish K. Singh, Ph.D., Research Fellow, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.

The biophysical characteristics of ADCs are strongly impacted by the chemistry and associated linker-payload. A strong understanding of these characteristics is therefore important for robust product and process development. This talk will cover some examples illustrating these aspects for ADCs.

5:05 Close of Conference



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Celebrating 25 Years


Track 1

Protein & Antibody Engineering

Track 2

Protein Aggregation & Stability

Track 3

Immuno-Oncology

Track 4

Analytical Characterization of Biotherapeutics