Advancing Bispecific Antibodies and Combination Therapy to the Clinic

 

One of the leading areas of antibody research is bispecific antibodies. The Seventh Annual Advancing Bispecific Antibodies and Combination Therapy to the Clinic conference will review recent preclinical and clinical results on a variety of bispecific and multi-specific constructs. Thought leaders in the community will review progress and discuss the best strategies for improving targeting, safety and efficacy for applications in immuno-oncology, oncology, CNS and infectious disease.

Final Agenda

 

Scientific Advisory Board

Frank Comer, PhD, Senior Scientist, AstraZeneca

Rakesh Dixit, PhD, DABT, Vice President, R&D, Global Head, Biologics Safety Assessment, Translational Sciences, AstraZeneca

TUESDAY, APRIL 9

Recommended Short Course*

SC11: Developability of Bispecific Antibodies: Formats and Applications

Nimish Gera, PhD, Director, Research and Development, Mythic Therapeutics

 

*Separate registration required.

WEDNESDAY, APRIL 10

7:15 am Registration (Commonwealth Hall) and Morning Coffee (Harbor Level)

7:25 - 8:25 PANEL DISCUSSION: Women in Science – Inspired Professional and Personal Stories (Continental breakfast provided) (Waterfront 1&2)

Moderator:

Jennifer-ChadwickJennifer S. Chadwick, PhD, Director of Biologic Development, BioAnalytix, Inc.; Co-Chair, Mentors Advisors and Peers Program, Women In Bio, Boston Chapter


Panelists:

Joanna BrewerJoanna Brewer, PhD, Vice President, Platform Technologies, AdaptImmune


Charlotte A. RussellCharlotte A. Russell, MD, DMSc, CMO, Alligator Bioscience


Susan RichardsSusan Richards, PhD, Presidential Scientific Fellow, Translational Medicine Early Development, Sanofi R&D


Kristi SarnoKristi Sarno, Senior Director, Business Development, Pfenex


WHAT IS WORKING IN THE CLINIC: NEW INNOVATIONS IN BISPECIFIC ANTIBODIES
harborview 1&2

8:30 Chairperson’s Opening Remarks

Rakesh Dixit, PhD, DABT, Vice President, R&D, Global Head, Biologics Safety Assessment, Translational Sciences, AstraZeneca

8:40 Bringing the Tumor-Directed CTLA-4 x OX40 Bispecific Antibody, ATOR-1015, into the Clinic

Russell_CharlotteCharlotte Russell, MD, PhD, CMO, Alligator Bioscience AB

ATOR-1015 is a bispecific antibody targeting CTLA-4 and OX40, designed as a next-generation CTLA-4 antibody with improved benefit-risk profile. The dual targeting directs the effect to the tumor area, allowing ATOR-1015 to induce enhanced anti-tumor effects with expected lower systemic toxicity compared to CTLA-4 monotherapy. The mode-of-action is a combination of effector T-cell activation and regulatory T cell depletion. ATOR-1015 is planned to enter clinical phase in 2018.

9:10 Design Meets Biology – Engineering a PD-1/CTLA-4 Bispecific Antibody to Improve Both Safety and Efficacy

Mazor_YarivYariv Mazor, PhD, Senior Scientist, Antibody Discovery & Protein Engineering, AstraZeneca

MEDI5752 is a monovalent bispecific IgG1 antibody (DuetMab), targeting the two clinically validated receptors, PD-1 and CTLA-4. The bispecific antibody introduces novel MOAs that may provide an improved therapeutic index when compared to the two monotherapies and mAb combinations. MEDI5752 is currently being clinically evaluated for safety and efficacy.

9:40 A Versatile Modular Bispecific Antibody Platform, BiXAb, for the Development of Innovative Therapeutics

Zhukovsky_EugeneEugene Zhukovsky, PhD, CSO, Biomunex Pharmaceuticals

BiXAb platform has a tetra-Fab IgG1 antibody structure and enables plug-and-play bispecific antibody formatting from any pair of monospecific mAbs. BiXAb antibodies possess excellent manufacturability in CHO cells and superior drug-like properties (stability, lack of aggregation, predictable PK). We will illustrate the properties of this bispecific antibody platform by presenting two case studies, in which BiXAbs target either solid tumors or hematological malignancies.

10:10 Coffee Break in the Exhibit Hall with Poster Viewing (Commonwealth Hall)

10:15 Women in Science Speed Networking in the Exhibit Hall (Commonwealth Hall)

10:55 KEYNOTE PRESENTATION: The Need for More Effective Combination Therapies

Herbst_RonRonald Herbst, PhD, Vice President and Head, Oncology Research, AstraZeneca

Combination approaches are key to improving clinical response. From preclinical immune-oncology mouse models to patients enrolled in clinical trials, novel high throughput technologies enable us to understand the mechanisms underlying the complex interactions between the immune system and cancer, identify predictive biomarkers for the patients who will most likely benefit from current immunotherapies, avoid immune-related adverse events, and guide the future combination cancer immunotherapy.

11:25 Bispecific Antibodies for Cancer-Directed Blockade of the PD-1/PD-L1 Immune Checkpoint

Helfrich_WijnandProf. Dr. Wijnand Helfrich, Professor of Translational Surgical Oncology, Department of Surgery, University Medical Center Groningen

On-target/off-tumor activity of current PD-L1-blocking antibodies potentially reduces tumor accretion and promotes autoimmune-related toxicity. Therefore, we constructed human bispecific antibody (bsAb) PD-L1xEGFR which simultaneously binds to PD-L1 and EGFR resulting in enhanced avidity towards PD-L1+/EGFR+ cancer cells. Importantly, PD-L1xEGFR blocks PD-1/PD-L1 interaction in an EGFR-directed manner, blocks oncogenic EGFR-signaling, and promotes ADCC of EGFR+ tumor cells. BsAb PD-L1xEGFR may be useful to enhance selectivity, efficacy and safety of PD-1/PD-L1 checkpoint inhibition.

11:55 Development of Novel Fully Human Bispecific Antibodies for Oncology

Smith_EricEric Smith, PhD, Director, Bispecifics, Regeneron Pharmaceuticals

This presentation will describe Regeneron’s bispecific platform and present pre-clinical data on several new bispecifics being developed for solid and liquid tumor indications. In addition, status updates on Regeneron’s clinical stage bispecific antibodies (REGN1979, REGN4018, and REGN5458) will be presented.

Wuxi_Biologics 12:25 WuXiBody™, an Innovative and Versatile Bispecific Antibody Format Opens a New Era for Therapeutic Antibody Development

Li_JingJing Li, Senior Vice President, Discovery, WuXi Biologics

Bispecific antibodies are a growing area of biotherapeutics but with many development challenges.  Many of the  new platforms have limitations in yield, purity, stability, solubility, half-life, and immunogenicity. Thus, a one-size-fit-all solution is still desired.  Aiming to solve those issues, WuXi Biologics has generated WuXiBodyTM, a flexible, proprietary bispecific antibody format that can reduce the development time by 6 -18 months and can decrease cost of goods by 90%.

12:55 Luncheon Presentation I: CANscript™: A Phenotypic-Based, Tumor Modeling Platform for Drug Discovery and Development

Mark Paris, PhD, Associate Director, Translational Application, Mitra Biotech

Delineation of an intra-tumor microenvironment in a dynamic spatio-temporal setting is required owing to its clinical relevance in many cancer indications. Majority of solid cancers represent a highly complex tumor microenvironment wherein a dysregulated phenotypic context impacts treatment outcomes at a personalized level. We have developed and validated an ex-vivo platform technology (CANscript™) using patient material (tumor, autologous ligands and immune cells) to predict tumor efficacy in the clinic across several drug classes.

GenScript-CRO 1:25 Luncheon Presentation II: Design and Development of Innovative Bispecific Antibodies

Xia_TimothyTimothy Xia, PhD, Vice President, Biologic Discovery & Development, GenScript, Inc.

Liusong Yin, PhD, Director, Antibody Drug Discovery, GenScript, Inc.

GenScript is the world leader in biotechnology and has 15 years of experience in discovery and development services. Provides One-Stop solution, offering target discovery to IND application that aligns conformity to the regulations for applications to FDA/CFDA/EMA. Our scientists have in-depth understanding of industrial standards of biological drug discovery and development. Mature development platform that saves expenses and reduces operation risks. We offer flexible collaboration modes to fulfill a wide spectrum of customer needs. The World's top pharmaceuticals and academic Institutes use GenScript`s discovery services to accelerate basic and discovery research for target validation, lead generation, lead characterization and optimization. Our proprietary technology platforms in a variety of domains make us very competitive in the biologics space. In this talk, key discovery services will be discussed, that includes hybridoma and phage display therapeutic mAb generation against multi-transmembrane proteins, capable of making any bispecific format like  single-domain monoclonal antibody (SMAB) production, humanization, developability assessment and affinity maturation. At GenScript Biologics, we pride ourselves on our flexible options for you in drug discovery and development.

1:55 Session Break

WHAT IS WORKING IN THE CLINIC: NEW INNOVATIONS IN BISPECIFIC ANTIBODIES (CONT.)
harborview 1&2

2:10 Chairperson’s Remarks

Rakesh Dixit, PhD, DABT, Vice President, R&D, Global Head, Biologics Safety Assessment, Translational Sciences, AstraZeneca

2:15 Preclinical and Clinical Development of Best-in-Class Anti-HER2 Bispecifics and Bispecific ADCs

Polverino_TonyTony Polverino, PhD, Executive Vice President of Early Development and CSO, Zymeworks, Inc.

ZW25 is a bispecific antibody directed against two distinct epitopes (biparatopic) on HER2 that has been successfully engineered using the Azymetric™ IgG1 antibody scaffold. In clinical studies, ZW25 is well tolerated and has demonstrated promising single-agent anti-tumor activity in heavily pretreated HER2-expressing breast, gastric, and other cancers. Preclinical development of ZW49, a biparatopic antibody-drug conjugate based on the unique design of ZW25 and armed with our proprietary ZymeLink™ cytotoxic payload, will also be discussed.

2:45 Development of a Novel T-Cell Engager Platform Based on DARPin® Molecules

Grimm_SebastianSebastian Grimm, PhD, Senior Scientist, Lead Generation, Molecular Partners AG

T-cell-engaging therapies have shown high therapeutic efficacy in hematological malignancies and promising early clinical data in solid tumors. Favorable biophysical properties and high format flexibility enable T-cell engager formats that may address limitations of current engagers in the clinic, such as tumor selectivity or antigen coverage. We have developed a flexible T-cell engager platform based on Designed Ankyrin Repeat Proteins binding to human CD3. The characterization of different multispecific formats with tailored serum half-life will be presented.

3:15 Highlighted Poster Presentation: Efficient in vivo Tumor Clearance and Minimal Cytokine Release with a Novel T-Cell Engaging Bispecific Antibody Platform

Nathan D. Trinklein, PhD, CTO, TeneoBio Inc.

3:45 Refreshment Break in the Exhibit Hall with Poster Viewing (Commonwealth Hall)

4:45 Problem-Solving Breakout Discussions - Click here for details (Commonwealth Hall)

5:45 Networking Reception in the Exhibit Hall with Poster Viewing (Commonwealth Hall)

7:00 End of Day

 

THURSDAY, APRIL 11

8:00 am Registration (Commonwealth Hall) and Morning Coffee (Harbor Level)

BISPECIFIC ANTIBODIES OFF THE BEATEN PATH: FUSIONS, NON-ANTIBODY SCAFFOLDS, ETC.
harborview 1&2

8:30 Chairperson’s Remarks

Frank Comer, PhD, Senior Scientist, AstraZeneca


8:35 KEYNOTE PRESENTATION: Overview of Bispecific Antibodies

Kontermann_RolandRoland Kontermann, PhD, Professor, Biomedical Engineering, Institute of Cell Biology and Immunology, University of Stuttgart

Bispecific antibodies have experienced a dramatic interest and growth for therapeutic applications, with more than 70 molecules in clinical development, e.g. in oncology, immuno-oncology, but also for non-oncology applications. An overview will be given on the making of bispecific antibodies and the various therapeutic concepts and applications, e.g. for dual targeting strategies, retargeting of immune effector cells, and substitution therapy by mimicking the function of natural proteins.

9:05 M7824, a Novel Therapeutic Inhibiting PDL1 and Sequestering TGF-Beta

Gulley_JamesJames L. Gulley, MD, PhD, FACP, Chief, Genitourinary Malignancies Branch, Head, Immunotherapy Group, GMB Director, Medical Oncology Service, Center for Cancer Research, NCI, NIH

M7824 is a first-in-class bifunctional fusion protein composed of a TGFβ trap fused to an anti-PD-L1 antibody. A first-in-human dose escalation study demonstrated safety, saturation of peripheral PD-L1 and sequestration of all released plasma TGFβ1, -β2, and -β3 throughout the dosing period at doses >1 mg/kg. M7824 1200 mg IV has been tested in multiple cohorts including in HPV-associated cancers (ORR 35%) and NSCLC (ORR 28% with ORR 41% in patients with ≥1% of tumor cells PDL1+).

9:35 Highlighted Poster Presentation: CB307, a Novel T-Cell Costimulatory Humabody Therapeutic for PSMA-Positive Tumours

Brian McGuinness, PhD, MBA, Senior Director, Business Development, Crescendo Biologics Ltd.

10:05 Coffee Break in the Exhibit Hall with Poster Viewing (Commonwealth Hall)

11:05 A Highly Efficacious Antibody Mixture against MET-Dependent Tumors

TuxenPoulsen_ThomasThomas Tuxen Poulsen, PhD, Principal Scientist, Symphogen A/S

Activation of the receptor tyrosine kinase MET is associated with poor clinical outcome in certain cancers. To target MET more effectively, we developed the antagonistic antibody mixture Sym015 consisting of two humanized antibodies directed against non-overlapping epitopes of MET. Sym015 is well tolerated and strongly inhibits growth of MET-dependent preclinical tumor models. An ongoing clinical trial of Sym015 demonstrates promising signals of clinical activity in a subset of MET-dependent patients.

11:35 Engineering Bispecific Antibodies for Specific Targeting of Tumor Cells

Ganesan_RajkumarRajkumar Ganesan, PhD, Director, Antibody Engineering, Janssen Biotherapeutics

Bispecific antibodies can redirect immune cells such as natural killer cells or cytotoxic T cells to lyse tumor cells by releasing the pro-apoptotic agents. Excessive levels of released cytokines can lead to a series of immune-related adverse events. To circumvent toxicity issues, we adopted several design strategies such as modulation of binding affinity, geometry and valency to engineer bispecifics antibodies to discriminate healthy versus tumor cells.

12:05 pm Oncolytic Vaccines to Augment BiTE Efficacy against Solid Tumors

Engeland_ChristineChristine E. Engeland, MD, PhD, Head of Laboratory, Virotherapy, National Center for Tumor Diseases

Challenges in treating solid tumors with bispecific antibodies include increasing response rates and decreasing toxicity. We have developed tumor-selective oncolytic vectors for delivery of immunomodulators to avoid systemic exposure and mitigate toxicity. Furthermore, vector-mediated oncolysis serves as an in situ tumor vaccine, inducing synergistic anti-tumor immune responses. This talk highlights the versatility of our vector system and avenues for clinical translation.

12:35 End of Advancing Bispecific Antibodies and Combination Therapy to the Clinic


Recommended Short Course*

SC12: Design Strategies and Development of ADCs

Robert Lutz, PhD, Principal Consultant, Crescendo Biopharma Consulting

 

*Separate registration required.

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