Day One

Wednesday, September 4, 2024

7:00 am Check-In & Breakfast

8:25 am Chair’s Opening Remarks

Highlights, Opportunities & Lessons from the Bispecific Clinical Landscape

8:30 am A Review of the Bispecific Landscape: The Past, The Present & The Future of Biologics

Synopsis

  • Reviewing drug and trial landscape
  • Discussing emerging trends in the landscape
  • Briefly outlining the future of the bispecific space

9:00 am Finetuning the Potency & Safety of 4-1BB Agonist Antibodies By Targeting the Membrane Proximal Region

  • Andy Tsun Co-Founder & Chief Scientific Officer, Biotheus.Inc.

Synopsis

  • Unique anti-4-1BB VHH that binds to the membrane proximal domain to maintain potency and reduce toxicity risk
  • CLDN18.2 x 4-1BB bispecific shows good safety and preliminary efficacy in CLDN18.2+ cancer patients
  • 4-1BB bispecific platform can be further optimized with unidirectional Fc effector function towards TAAs but not 4-1BB+ cells

9:30 am Delving into ABBV-383, a Novel Bispecific Antibody with Enhanced Tumor Targeting & Optimized T-cell Engagement in Multiple Myeloma

  • Jeremy Ross Director & Head of Precision Medicine, Hematology Scientific Oncology, Abbvie

Synopsis

  • Scientific rationale for high avidity tumor antigen binding coupled with low affinity CD3 T-cell engagement by ABBV-383
  • Translation of unique design attributes of ABBV-383 to the clinic
  • Clinical updates on ABBV-383 in patient with relapsed or refractory multiple myeloma

10:00 am Singularity Sapiens: A Next-Generation Single-Domain Antibody Mouse Model for Developing Next-Generation Therapeutics

Synopsis

  • The Singularity Sapiens mouse is the latest fully human single-domain antibody (sdAb) mouse model, engineered through state-of-the-art gene editing and targeted replacement technologies
  • This model exhibits robust immune responses against various types of antigens, driven exclusively by heavy-chain-only antibodies derived from the complete human VH repertoire
  • The one-sequence-one-antibody nature of sdAbs enables sequence-driven screens to identify diverse modular binders with a broad spectrum of affinities and superior biophysical properties

10:30 am Morning Break & Speed Networking

Synopsis

The ideal opportunity to get face-to-face with many of the brightest minds working in the bispecific field and introduce yourself to the attendees that you would like to have more in-depth conversations with.

11:30 am Advancing T-cell Engagers for Solid Tumors

Synopsis

  • T cell engager molecules have demonstrated clinical benefit in hematological malignancies and there is growing evidence of activity in solid tumors
  • This presentation will highlight key findings from recent trials along with observations from nonclinical studies that inform on T cell engager molecule mechanism of action and new engineering approaches to address clinically-observed challenges

12:00 pm Face the Unknown—Accelerate Antibody Variant Screening & Development

Synopsis

  • Considerations and strategies to address during purification of bispecific antibodies.
  • Insights into process and product impurities and how to choose a specific strategy.
  • Applying surface plasmon resonance technology to detect integrity of bispecific antibody in primary clone selection

12:30 pm Lunch

Exploring the Latest Novel Formats for Widening the Applications of Bispecific Antibodies

1:30 pm XmAb541: A Selectivity Engineered XmAb 2+1 CLDN6 x CD3 Bispecific Antibody for Treatment of Ovarian Cancer & Other CLDN6+ Solid Tumors

Synopsis

  • Xencor’s XmAb® platforms allow for the rapid development of therapeutic bispecific with novel formats/binding modes that engage T cells (xCD3, xCD28) or NK cells xNKp46, xNKG2D) or act though other mechanisms in oncology, autoimmune, and inflammatory disorders.
  • Analysis of genomic/transcriptomic data to identify CLDN6 as an antigen with high expression in ovarian cancer tumors with very little expression in normal tissues & overcoming binding selectivity requirements as other similar CLDNs are expressed in normal tissue.
  • Target selection and preclinical development of XmAb541, a CLDN6xCD3 2+1 bispecific protein for treating patients with ovarian cancer and other solid tumor indications.

2:00 pm Meeting Evolving Needs in Oncology & Immunotherapy

Synopsis

Biologics landscape trends and analysis

Quick overview and updates on BSP’s services and solutions

2:15 pm Leveraging AzymetricTM to Optimally Format T-Cell Engagers & Bispecific ADCs

Synopsis

  • Azymetric provides a robust Fc heterodimer solution enabling high throughput functional screening of multispecific antibody panels to select those optimally formatted for a therapeutic application
  • The most advanced Azymetric molecule, zanidatamab, a bi-paratopic anti-HER2 antibody undergoing pivotal clinical studies, exemplifies the opportunity afforded to enhance antitumor responses beyond that achieved through combination of antibody components
  • Data illustrating the utility of Azymetric for two additional applications will be shared: (A) Development of multi-functional T-cell engagers including incorporation of conditional co-stimulation and (B) Format screening of bispecific antibodies to support delivery of small molecule payloads simultaneously to two independently expressed cancer targets

2:45 pm Bispecific Antibodies and the Quantification of Their Activity Using iLite Bioassays

  • Ulrich Mayer Technology Manager, Cell Based Solutions, Svar Life Science AB

Synopsis

  • Introducing T-cell activation assays with superior performance
  • Outlining customization possibilities for CD3/Target X bi-specific Ab´s assay
  • Orthogonal assay toolbox for when assessing Bi-specific Ab

3:00 pm Afternoon Break & Poster Session

Synopsis

This is an informal session to help you connect with your peers in a relaxed atmosphere and forge new and beneficial relationships. With an audience of bispecific experts eager to hear the latest innovations and positive movement, you will have the opportunity to display a poster presenting your own work. Additionally, you will have the chance to review others’ posters displaying cutting-edge work from drug discovery right through to exciting clinical trial updates.

4:00 pm Delving into Chugai Pharmaceutical’s Multidimensional Optimization Process to Improve Both the Therapeutic Potential & the Manufacturability

Synopsis

  • Exploring FAST-Ig™, designed for efficient production of bispecific antibodies and ACTFc®, to improve antibody pharmacokinetics
  • Applying these unique technology platforms to NXT007, a next-generation version of emicizumab for hemophilia A
  • Discussing future directions for creating novel bispecific antibodies and beyond

4:30 pm Innovating Bi-specific T Cell Engagers with Nona Biosciences’ HBICE Platform

  • Jiyong Zhang Business Development Director, Nona Biosciences

Synopsis

  • HCAb Harbour Mice® is the world’s leading fully human heavy chain only transgenic mice platform, producing highly developable fully human VH, offering versatile building blocks for bispecific antibody development
  • Nona’s CD3-targeting HBICE® (HCAb-based Bispecific Immune Cell Engager) is a plug-and-play platform for rapidly developing CD3 bispecific antibodies for both oncology and immunology indications

4:45 pm Eliciting Potent & Safe Innate & Adaptive Immune Responses to Cancer with Bispecific Antibody Approaches to CD47 or CD28

  • WALTER FERLIN Chief Scientific Officer & Head of Exploratory Science & Translational Medicine Department, Light chain Biosciences

Synopsis

  • Bispecific antibodies (bsAbs) were developed to selectively target CD47 on tumor cells and regulate CD28-mediated T-cell co-stimulation, overcoming tolerability challenges encountered with monoclonal antibody (mAb) approaches while avoiding systemic toxicities associated with CD47 and CD28 targeting, respectively
  • CD47bsAbs with fully competent IgG1-Fc domains show potent anti-tumor activity in vitro and in vivo, prompting human trials due to favorable tolerability and PK profiles
  • The lead preclinical CD28-program, a PD-L1xCD28 bsAb, demonstrates anti-tumor efficacy and synergizes with TCEs in controlling tumor growth, showing promising PK and tolerability profiles for clinical translation

5:15 pm Chair’s Closing remarks

5:20 pm Drinks Reception