Advancing Bispecific Antibodies to the Clinic for Oncology

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Cancer is one of the most intractable diseases and challenging areas of drug discovery, but bispecific antibody approaches are gaining widespread adoption by offering a multi-pronged and versatile approach for addressing cancer targets.  This meeting will review preclinical and clinical results as well as investigate the remaining challenges for moving bispecific antibodies to the clinic.

Scientific Advisory Board
Rakesh Dixit, Ph.D., DABT, Vice President, R&D, Global Head Biologics Safety Assessment, MedImmune
David M. Hilbert, Ph.D., CSO and Head, R&D, Zyngenia, Inc.


 

WEDNESDAY, MAY 7

7:00 am Registration and Morning Coffee


Bispecific Antibodies, Combinations and Mixtures 

8:00 Chairperson's Opening Remarks


Rakesh Dixit, Ph.D., DABT, Vice President, R&D, MedImmune (AstraZeneca Biologics)



8:10 Keynote Presentation:

Smart Strategies for Developing Bispecifics, Combinations and Mixture of Antibodies

RakeshDixitRakesh Dixit, Ph.D., DABT, Vice President, R&D, MedImmune (AstraZeneca Biologics)

This talk will cover an overview of bispecifics biologics, combinations and mixtures. It will also review technological advances in developing bispecific biologics and will discuss what distinguishes mixtures from combinations. CMC and regulatory considerations as well as strategies to develop bispecifics vs. combinations or mixtures will be shared.

9:10 Dual Variable Domain – Ig (DVD – Ig™) Platform: Some Opportunities and Challenges for Developing the Next Generation of Cancer Therapies

TariqGhayurTariq Ghayur, Ph.D., Senior Principal Scientist & Research Fellow, AbbVie Bioresearch Center





9:40 An Efficient Route to Generate Bispecific Antibodies with Natural Architecture from Distinct Half-Antibodies

Christoph SpiessChristoph Spiess, Ph.D., Scientist, Antibody Engineering and Structural Biology, Genentech, Inc.

The presentation will cover a technology to use the knobs-into-holes technology to generate bispecific antibodies with non-common light chains. Individual half-antibodies are purified, combined and finally the bispecific antibody purified. The versatility and robustness of the approach will be demonstrated by a broad set of bispecific antibodies.

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

11:10 Multispecific T Cell Products for Cancer Immunotherapy

NabilAhmedNabil M. Ahmed, M.D., MPH, Associate Professor, Pediatrics Center for Cell and Gene Therapy, Baylor College of Medicine

Targeted T cells are emerging as effective non-toxic therapies for cancer. Multiple elements, however, contribute to the overall pathogenesis of cancer through both distinct and redundant mechanisms. Hence, targeting multiple cancer-specific markers simultaneously could result in better therapeutic efficacy by offsetting antigen escape tumor cell variants and by providing a holistic approach by simultaneously targeting elements of the tumor microenvironment.

11:40 Challenges and Opportunities in Developing Highly Effective Antibody Mixtures

MIkklePedersonMikkel Wandahl Pedersen, Ph.D., Director, Cancer Biology, Symphogen A/S

Antibody mixtures are emerging as a promising alternative to monoclonal and bi-specific antibodies. This talk will address some of the opportunities and challenges associated with development of highly effective antibodies mixtures.


 

12:10 pm Enjoy Lunch on Your Own

1:40 Session Break


CHECKPOINT REGULATION: 

Multi-Specifics and Their Potential Use as Immune Checkpoint Regulators 

2:00 Chairperson's Remarks

David M. Hilbert, Ph.D., CSO & Head, R&D, Zyngenia, Inc.


2:05 Keynote Presentation:

Engineering Antibodies for Cancer Immunotherapy

Louis WeinerLouis M. Weiner, M.D., Director, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center

Contemporary antibody engineering has long focused on improving cancer therapy through the manipulation of protein structures. This remains important, but it is more important than ever to consider tumor targets, immune targets and how tumors adapt to immune attack or signaling perturbation initiated by antibody therapy. These issues will be discussed with a particular emphasis on targeting the EGF receptor network in human cancer.

2:35 Bispecific Antibody Targeting CD47 Aiming at Increasing Phagocytosis of Cancer Cells

Nicolas FischerNicolas Fischer, Ph.D., Head, Research, Novimmune SA

CD47 is a ubiquitously expressed transmembrane receptor with multiple functions in cell-to-cell communication. Its interaction with SIRPα expressed in macrophages and DCs inhibits their phagocytic function. Overexpression of CD47 in cancer cells is often observed and it is believed to help cancer cells escape immune surveillance. We have generated bispecific antibodies (BsAbs) that preferentially neutralize CD47-SIRPα interaction on cancer cells.

3:05 Development and Manufacturing of a Common Light Chain Bispecific Antibody: MCLA-128 as a Case Study

Lex BakkerLex Bakker, Ph.D., Chief Development Officer, Merus

MCLA-128 is an ADCC-enhanced human common light chain bispecific IgG1 antibody targeting HER2 and HER3. MCLA-128 demonstrates potent inhibition of HER2:HER3 heterodimer signaling and robust anti-tumor activity in a trastuzumab-resistant xenograft model. It is produced in CHO cells using low fucose expression technology and Merus’ proprietary CH3 engineering to force bispecific IgG heterodimerization. A robust purification process was developed resulting in ultra pure MCLA-128 at high process yields. MCLA-128 is currently undergoing cGMP manufacturing to allow clinical evaluation in a planned first in human phase I study.
 

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing


4:20 Problem Solving Breakout Discussions  

These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.  

Challenges and Opportunities in Developing Highly Effective Antibody Mixtures Challenges and Opportunities in Developing Highly Effective Antibody Mixtures 

Moderator: Mikkel Wandahl Pedersen, Ph.D., Director, Cancer Biology, Symphogen A/S
• Single vs. multitarget mixtures
• How to select the right antigens for co-targeting – rational or empirical approach?
• How to define ratio of the individual antibodies?
• Manufacturing strategies – single batch vs. separate productions
• Regulatory hurdles
 


Smart Strategies for Developing Bispecifics, Combinations and Mixture of Antibodies
 

Moderator: Rakesh Dixit, Ph.D., DABT, Vice President, R&D, MedImmune (AstraZeneca Biologics)
• What are some of the technological advances in the field?
• What distinguishes mixtures from combinations?
• What are the CMC and regulatory considerations?
• What are the strategies to develop bispecifics vs. combinations or mixtures?
 

 

Broad Spectrum Targeting of Cancer  

Moderator: Nabil M. Ahmed, M.D., MPH, Associate Professor, Pediatrics Center for Cell and Gene Therapy, Baylor College of Medicine
• Justification for using multiple on-target approaches
• Candidate biologics to achieve broad spectrum targeting
• Safety issues associate with engaging multiple targets
• The Boolean argument: can an “AND and OR” argument predict maximum efficacy but also create a safety check
 


 
 

5:20 Networking Reception in the Exhibit Hall with Poster Viewing

6:30 End of Day


RECOMMENDED TUESDAY DINNER SHORT COURSE*

Production Challenges for Complex Biologics – ADCs, Bispecifics & Fusion Proteins - View Detailed Agenda 

*Separate registration required


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