Cambridge Healthtech Institute's Fifth Annual

Advancing Bispecific Antibodies and Combination Therapy to the Clinic

( 往临床阶段前进的双特异性抗体与合并疗法 )

Creating the Killer Combo

2018年5月2-3日 | World Trade Center | 马萨诸塞州波士顿

 

One of the leading areas of antibody research is bispecific antibodies. The Sixth Annual Advancing Bispecific Antibodies and Combination Therapy to the Clinic meeting will showcase leaders sharing clinical and preclinical outcomes on a variety of bispecific and multi-specific constructs. The creation of novel formats and combination therapy is yielding very exciting results and this meeting will highlight progress and assess safety, manufacturing and developability concerns.

Scientific Advisory Board

Frank Comer, PhD, Scientist, MedImmune

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

Robert Mabry, PhD, Director, Protein Sciences and Antibody Technology, Jounce Therapeutics

 

Final Agenda

Recommended Short Course(s)*

SC9: CAR T Cell Therapy for Solid Tumors

Soldano Ferrone, MD, PhD, Division of Surgical Oncology, Surgery, Massachusetts General Hospital, Harvard Medical School

Moonsoo M. Jin, PhD, Associate Professor, Molecular Imaging Innovations Institute, Radiology, Weill Cornell Medical College

Tara Arvedson, PhD, Director, Oncology Research, Amgen


*Separate registration required.

WEDNESDAY, MAY 2

7:30 am Registration and Morning Coffee

NEXT GENERATION OF BISPECIFIC CANCER BIOLOGICS: POTENTIAL OF GREATER CLINICAL BENEFITS OVEr COMBINATIONS

8:30 Chairperson's Remarks

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

8:40 Introduction and Overview of Bispecific Antibodies

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

9:10 Using Oncolytic Viruses to Deploy Bispecific Antibodies for Targeted Cancer Therapy

Leonard Seymour, PhD, Professor, Gene Therapy, Oncology, University of Oxford

Oncolytic viruses replicate selectively within tumor cells and lyse them before spreading to infect other cells. We have 'armed' an oncolytic group B adenovirus to encode bispecific T cell engagers (BiTEs) and express them selectively within tumor cells, secreting them into the tumour microenvironment. In this way we can activate tumor-associated T cells to attack cancer cells (or cancer stromal cells) by judicious choice of BiTE specificity, whilst simultaneously avoiding any delivery-related systemic toxicities.

9:40 Bispecifics to the Rescue: Reviving Exhausted T Cells with Dual Costimulation

Raphael Clynes, MD, PhD, Vice President, Translational Biology, Xencor, Inc.

To improve therapeutic efficacy of single agent checkpoint blockade, engagement of multiple inhibitory receptors and/or agonist receptors offers the possibility to more robustly reinvigorate exhausted intratumoral T cells. Bispecific antibodies offer the potential to accomplish this with both enhanced selectivity and avidity for exhausted T cells, improving both on-target efficacy and limit off-target immunotoxicity. We will present the preclinical rationale for three bispecific antibodies anticipated to enter the clinic in 2018, including an anti-PD1/anti-CTLA4, an anti-CTLA-4/anti-LAG3, and an anti-PD1/anti-ICOS.

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

10:55 Target Expression, Generation, Preclinical Activity, and Pharmacokinetics of the BCMA-T Cell Bispecific Antibody EM801 for Multiple Myeloma Treatment

Dirk Hose, PhD, Priv.-Doz. Dr. med. Dr. biol. hom., Head, Multiple Myeloma Research Laboratory, Universitaetsklinikum Heidelberg, Medizinische Klinik V

B-cell-maturation antigen (BCMA) is a TCB-target expressed in all malignant plasma-cell samples at RNA (n=726) and protein (n=43) level, as on normal plasma-cells. The BCMA-TCB EM801 shows efficacy in 34/43 (79%) primary MM-patients' BM-samples, a H929-xenograft reconstituted NOG-mouse-model, and cynomolgus monkeys. EM801 kills malignant plasma-cells by coupling them with T-cells, inducing T-cell-activation, secretion of e.g. interferon-γ, granzyme B and perforin. The higher affinity derivative EM901 (CC-93269) is foreseen entering clinical phase I/II trials.

11:25 Non-BiTE Molecules

Zhulun Wang, PhD, Executive Director, Biologics Department, Amgen

11:55 Engineering High Affinity Tetravalent Bispecific Immune Cell Engagers to Destroy Malignant Cells with Low Target Expression

Michael Tesar, PhD, Research Program Head, Research and Development, Affimed GmbH

Affimed is a leader in NK cell directed therapies and its tetravalent bispecific immune cell engager platform utilizes a unique mode of action. Newest developments from our clinical and preclinical programs will be presented.

12:25 pm Sponsored Presentation (Opportunity Available)

 Mitra Biotech(2)12:55 Luncheon Presentation I to be Announced

1:25 Luncheon Presentation II (Sponsorship Opportunity Available) or Enjoy Lunch on your Own 

1:55 Session Break

NEXT GENERATION OF BISPECIFIC CANCER BIOLOGICS: POTENTIAL OF GREATER CLINICAL BENEFITS OVER COMBINATIONS (CONT.)

2:10 Chairperson's Remarks

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

2:15 The Promise and Challenge of T-Cell-Redirecting Bispecific Antibodies Made by the DNL Platform

Chien-Hsing Ken Chang, PhD, Vice President, Research & Development, Immunomedics, Inc.

Accumulating evidence has indicated the antitumor immunity of T cells induced upon ligation with a bsAb to target tumor cells also incurs a concurrent activation of various cell-bound as well as -secreted factors to promote tumor growth. Elucidating the relative contribution of each of these factors to the destruction and protection of tumor presents a challenge, and provides insights into selecting optimal combination therapy with T cells redirected by bsAbs.

2:45 PANEL DISCUSSION: Bispecific Oncology Biologics Efficacy and Safety: Do the Platforms of Bispecifics Matter?

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

Panelists: Jacintha Shenton, PhD, Scientific Director, Biologics Toxicology, Janssen BioTherapeutics, Janssen R&D

Raphael Clynes, MD, PhD, Vice President, Translational Biology, Xencor, Inc.

  • Challenges of more than 50 bispecific platforms
  • Impact of effector function, half-life, bispecific targets (soluble vs. membrane bound antigens)
  • Heme vs. non-heme tumors
  • CMC, Manufacturing Considerations

Applied Biomath3:15 Presentation to be Announced


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

4:45 Problem-Solving Breakout Discussions

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

7:00 End of Day

THURSDAY, MAY 3

8:00 am Morning Coffee

ENGINEERING THE NEXT WAVE OF BISPECIFICS: MORE THAN A SUM OF ITS PARTS

8:30 Chairperson's Remarks

Frank Comer, PhD, Scientist, MedImmune


8:35 KEYNOTE PRESENTATION: Bispecific Antibodies for the Treatment and Prevention of HIV/AIDS

David D. Ho, MD, Aaron Diamond AIDS Research Center, The Rockefeller University; Beth Israel Deaconess Medical Center, Harvard Medical School

The plasticity of HIV-1 demands additional improvements to these mAbs to better ensure their clinical utility. This talk will discuss engineered bispecific antibodies that are the most potent and broad HIV-neutralizing antibodies to date such as 10E8V2.0/iMab which reduced virus load substantially in HIV-1-infected humanized mice and also provided complete protection when administered prior to virus challenge. These bispecific antibodies hold promise as novel prophylactic and/or therapeutic agents in the fight against HIV-1.

9:05 Bispecific Antibodies and Antibody-Drug Conjugates (ADCs) Bridging HER2 and Prolactin Receptor Improve Efficacy of HER2 ADCs

Julian Andreev, PhD, Senior Staff Scientist, Oncology and Angiogenesis, Regeneron Pharmaceuticals

There is a need for HER2-directed ADCs effective in patients expressing low/moderate levels of HER2. Cross-linking HER2 to constitutively internalizing PRLR, using a HER2xPRLR bispecific ADC, dramatically enhances lysosomal degradation of HER2. Accordingly, bispecific ADCs improve upon T-DM1 efficacy in cells expressing intermediate levels of HER2. These results demonstrate that coupling a tumor-specific ADC target to a rapidly internalizing protein may be a useful approach to enhance efficacy of ADCs.

9:35 Sponsored Presentation (Opportunity Available)

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

11:05 Application of DART® Platform to Reverse Checkpoint Blockade and Enhance Immune Effector Function

Ross La Motte-Mohs, PhD, Scientist III, Cell Biology and Immunology, MacroGenics, Inc.

T cell exhaustion in cancer is associated with the expression of checkpoint molecules, including PD-1, CTLA-4 and LAG-3, that cooperate in inducing loss of immune cell effector function, leading to disease progression. Dual blockade of checkpoint molecules can overcome limitations associated with single molecule inhibition. Here we present an update on PD-1 x CTLA-4 (MGD019) and PD-1 x LAG-3 (MGD013) DART molecules as dual checkpoint inhibitors for restoring and/or enhancing T cell effector function.

11:35 PANEL DISCUSSION: Safety and Efficacy of Bispecific Antibodies vs. CAR T

Moderator: G. Jonah Rainey, PhD, Executive Director, Head of Antibody Research, MabVax Therapeutics Holdings, Inc.

Panelists: Carl Uli Bialucha, PhD, Oncology Biotherapeutics, Novartis Institutes for BioMedical Research, Inc.

Adrian Bot, MD, PhD, CSO, Kite Pharma, Inc.

Tara Arvedson, PhD, Director, Oncology Research, Amgen, Inc.

Bob Valamehr, PhD, Vice President, Cancer Immunotherapy, Fate Therapeutics

  • Comparison of efficacy: approved and pipeline molecules. What is the best clinical endpoint?
  • Costimulation: included as part of the CAR, but what about bispecifics?
  • Toxicity: mechanisms of CRS/cytokine storm and ways to prevent and manage them
  • On/off target activation: runaway CAR T proliferation, off-target effects, and antigen-independent T-cell activation

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

* 活动内容有可能不事先告知作更动及调整。

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