Conference Day One
Tuesday 3rd October 2023
8:25 am Registration & Welcome Coffee
9:25 am Chair’s Opening Remarks
Bispecific, Trispecific & Multispecific Antibodies: Where We Are So Far
9:30 am A Review of the Bispecific Landscape: The Past, The Present & The Future of Biologics
- Flavio Lima Bianchi Research Analyst, Beacon Targeted Therapies
- Reviewing drug and trial landscape
- Discussing emerging trends in the landscape
- Briefly outlining the future of the bispecific space
10:00 am Unlocking Synergy: Harnessing Bispecific Formats for ADCs to Enhance Targeting and Efficacy
- Rakesh Dixit President & Chief Scientific Officer, Regio Biosciences | Bionavigen
- Enhancing targeting precision through bispecific ADC formats enable precise targeting of tumor cells, reducing off-target effects and enhancing therapeutic efficacy
- Harnessing the power of bispecific ADCs to overcome resistance mechanisms, opening the door to treating challenging or resistant indications
- Unlocking a broader spectrum of therapeutic possibilities by leveraging bispecific ADCs, providing a versatile platform for addressing a wide range of oncological indications
10:30 am Speed Networking Break
This session is the ideal opportunity to take advantage of informal networking time and understand who is also prioritizing and overcoming challenges within the various sectors of the bi and multispecifics world.
TARGET DISCOVERY TRACK
Data Driven Approaches for Informed Target Discovery & Validation
11:30 am Construction of a MET Bispecific Antibody Drug Conjugate
- Thomas Nittoli Senior Director, Regeneron Pharmaceuticals Inc
- Discussing antibody selection and pairing
- Evaluating naked bispecific in vitro/in vivo potency and efficacy
- Conjugated bispecific antibody lead
12:00 pm Panel Discussion: Navigating the Unknown: Strategies for Assessing Bispecific Targets Without a Clear Mechanism of Action
- Hayretin Yumerefendi Associate Director, Novartis
- Rakesh Dixit President, Chief Scientific Officer, Regio Biosciences | Bionavigen
- Christopher Mehlin Chief Scientific Officer, Link Immunotherapeutics Inc.
The development of bispecifics targeting novel or poorly understood targets can be challenging when there is no clear understanding of the underlying mechanism of action. This panel discussion will enable you to hear from experts on:
- The role of preclinical models in identifying potential targets and assessing their suitability for bispecific antibody development
- The importance of target validation and biomarker selection in guiding clinical trial design and monitoring treatment response • Strategies for optimizing dosing and administration schedules based on the limited understanding of the target and mechanism of action
- The regulatory challenges associated with developing bispecific antibodies targeting novel or poorly understood targets
PRECLINICAL & CLINICAL TRACK
Optimizing Translation into the Clinic to Maximize Bispecific Therapeutic Indexes
11:30 am Antibody-Based Multi-functional Modalities – Challenges & Opportunities
- Mingjiu Chen CEO, Biosion
- Assessing the global competitive landscape and trends of antibody-based multi-functional modalities
- Investigating diversified MOAs of antibody-based multifunctional modalities
- Reviewing FlexiBodyTM bifunctional platform and case studies
12:00 pm The Modular PreTarg-it Platform Enables RIT for Hardto-Treat Cancers by Significantly Improved Therapeutic Indexes
- Randolf Kerschbaumer Chief Executive Officer, OncoOne
- Exploring pre-targeted radioimmunotherapy
- Improving therapeutic window with this approach
- Discussing novel therapies for hard-to-teat cancers
12:30 pm Mechanistic Translational PK/RO Modeling vs MABEL to Predict First-in-Human Dose for Bispecific & Multispecific Antibodies
- Oleg Demin Jr Scientific Director, QSP Modelling in Oncology and Immuno-Oncology, InSysBio
- Minimal Anticipated Biological Effect Level (MABEL) approach is recommended to select clinical starting dose for mAbs and multispecific biotherapeutics.
- For many immune-activating antibodies first-in-human (FIH) doses identified by MABEL were low and required many dose escalation steps exposing patients to sub-therapeutic doses.
- Mechanistic translational PK/RO modeling predicts FIH dose for multispecific antibodies taking into account specific features of the candidate (affinity, avidity, targets), its concentration in tumor, and mechanism of action (trimers and other complexes in immunological synapse responsible for effect, bell-shaped dose dependence, etc.): a case of HPN536, a T-cell engager targeting mesothelin.
12:45 pm Lunch Break
Selectivity & Specificity: Role of Immunology & Tumor Biology in Identifying Promising Bispecific Antibody Targets
1:45 pm Overcoming T-cell Engager Challenges Using Albumin Biomolecular Multispecific Designs & Patient Stratification
- Ken Howard Associate Professor, Aarhus University
- Requirement for combination therapies and differing cancer receptor expression effector T-cell levels between patients are challenges for effective T-cell engager treatment
- A T-cell engager modular nucleic acid format allows combinations of immuno-oncology biologics in the single design Identification of a high-risk prostate cancer patient subset with high PSMA and infiltrating T-cell levels for treatment with T-cell engagers
2:15 pm Maskless T-cell Engaging Bispecific Antibodies Designed for Proteolytic Activation in The Tumor Microenvironment
- Christoph Rader Chief Technology Officer, Aethon Therapeutics
- Review the design of a dual variable domain (DVD)-Fab format that opens a T cell-engaging inner Fv after partial proteolytic cleavage from a tumor cell-engaging outer Fv
- Analyze proof-of-concept validation for an EGFR x CD3 DVDFab in vitro and in vivo
- Discuss the utilization of patient-derived tumor fragments for ex vivo validation in an autologous system
2:45 pm Session Reserved for Carterra
- Daniel Bedinger Application Science Manager, Carterra
Balancing Affinity vs. Avidity to Mitigate Toxicity & Safety Challenges
1:45 pm Safety of Bispecific Antibodies, ADCs and CAR-T cells
- Rakesh Dixit President & Chief Scientific Officer, Regio Biosciences | Bionavigen
- Safety of Bispecific Antibodies, ADCs and CAR-T cells
- Safety challenges in development of bispecific and CAR-T cells
- Preclinical models to evaluate safety
- Challenges to preclinical to clinical translation
- Mitigating toxicities and improving therapeutic index
2:15 pm Using Mathematical Modeling to Find a Balance Between Affinity & Avidity for an Optimal Therapeutic Window
- Fei Hua PhD Vice President of Modeling and Simulation Services, Applied BioMath
- For cis-binding bispecific molecules, weaker single-target binding affinity with stronger avidity is used as a strategy to reduce the chances of the drug binding to off-target cells, thereby increasing the therapeutic window.
- However, the development of a molecule is more complicated once multiple targets are involved. Binding affinities to multiple targets can be optimized; in addition, the expression levels of multiple targets need to be considered when translating from preclinical to clinical.
- Mechanistic PKPD models that capture the biophysics of binding and avidity are a powerful tool to guide compound selection and clinical translation. We will demonstrate how to develop a mechanistic PKPD model for bispecifics and how to use the model to predict an optimal therapeutic window
2:45 pm Minimizing Toxicity While Preserving Efficacy Through Micellar Encapsulation of T-cell Engaging Bi-specific Antibodies
- Ruolan Han Vice President - Nonclinical & Translational Medicine, OncoNano Medicine
- Establishment of tumor-specific pH sensitive micelle technology
- Encapsulation of multiple modalities, including bi-specific antibodies
- Encapsulated bi-specific antibodies show an improved therapeutic window: decreased toxicity with preserved efficacy, in pre-clinical models
3:15 pm Afternoon Break
Grab a coffee and explore our exhibition booths, networking and more!
Revolutionizing Therapeutic Development: Forward-Planning Clinical Stage Assets: Setting Your Bispecific Pipeline Up for Clinical Success
4:00 pm Looking to Satisfy the Growing Demand of Capacity & Capabilities for Biologics
- Giorgio Salciarini Senior Manager - Technical Business Development, BSP Pharmaceuticals
- Biologics landscape trends and analysis
- Outsourcing or In-House?
- Quick overview and updates on BSP’s services and solutions
4:15 pm Regulatory Considerations for the Development of Bispecific Antibodies
- Marjorie Shapiro Supervisory Biologist, FDA/CDER/Office of Biotechnology Products
- Trends in BsAb development
- Regulatory considerations for BsAb development
- FDA guidance document
4:45 pm Multispecific Antibody Generation Using Building Blocks That Facilitate Selection & Functional Screening of Therapeutic Leads
- Brad Lunde Group Leader, Adimab LLC
- Multispecific antibodies represent a promising class of therapeutic agents that may provide more effective alternatives to monospecific antibodies in a variety of diseases. However, they can be difficult to produce without unwanted side products, and this challenge is exacerbated by increasingly complex multispecific formats.
- We describe a platform of building blocks that allow for engineering of multispecific antibodies. These include format-based solutions to the LC-pairing problem, novel Fc and Fab pairing solutions, and validated production and purification approaches.
- We highlight how each of these building blocks have been used to generate a panel of novel CD28 T-cell engagers. This panel includes CD28 antibodies isolated from IgG libraries containing kappa, lambda, and common light chains as well as single domain antibody libraries. We will demonstrate how we have used our Fc pairing solutions to facilitate construction of anti-CD28 multispecifics. Finally, we will demonstrate how anti-CD28 multispecifics synergize with CD3 agonism to enhance T-cell stimulation and target cell killing. We will also address some key learnings exploring how antigen binding domain format can influence the quality of the multispecific antibody.
5:15 pm End Of Conference Day One
5:35 pm Drinks Reception & Scientific Poster Session
- After the formal presentations have finished, the scientific Poster Session is an informal part of the conference agenda, allowing you to connect with your peers in a relaxed atmosphere. Continue to forge new and cement existing relationships while learning about the latest developments and breakthroughs in this field.