Conference Day One - Wednesday, July 30, 2025
8:15 am Morning Refreshments & Check In
9:15 am Program Director’s Opening Remarks
9:20 am Chair’s Opening Remarks
Evaluating Fc Biology to Determine the Foundations for Therapeutic Innovation for More Efficacious Cancer & Autoimmune Disease Treatments
9:30 am Targeting FcRn for the Generation of Therapeutics
Synopsis
- Cell biological insight into the subcellular trafficking behavior of FcRn and IgG has informed the design of therapeutics
- FcRn inhibitors are now approved for the treatment of antibody-mediated disease
- Different classes of FcRn inhibitors can have distinct behavior at the level of subcellular trafficking
10:00 am Step-Wise Optimization of a Next Generation FcRn Inhibitor Fused to an Albumin-Binder for Improved IgG Clearance
Synopsis
• Development of next-generation FcRn blockers with improved pharmacodynamic effects and reduced frequency of dosing could be highly beneficial for patient quality of life and patient satisfaction
• Fc-ABDEG and albumin-binding VHH were combined to develop next-generation FcRn blockers with improved IgG clearance
• Step-wise engineering was used to optimize the position and number of VHHs, their affinity to albumin, and the linker connecting it to Fc-ABDEG
10:30 am Impact of Antibody Fc Engineering on Translational Pharmacology & Safety: Insights From Industry Case Studies
Synopsis
Balancing Efficacy and Safety through Fc Engineering:
• Fc engineering significantly alters antibody interactions with FcγRs and C1q, enabling enhancement or silencing of ADCC, ADCP, and CDC. These modifications, however, may also lead to undesired effects, such as inappropriate immune activation, cytokine release, platelet activation, and increased risk of thrombotic events. Hence, careful assessment of the pharmacology and potential safety concerns is critical in nonclinical models before clinical trials
Species Differences Influence Translational Pharmacology:
• Translational pharmacology is highly affected by species-specific differences in Fc receptor expression and function. Non-human primates closely resemble humans but lack certain human-specific receptors such as FcγRIIIB. Rodent models exhibit significant differences in receptor expression and function, complicating their predictive value for human responses. Thus, understanding species differences is essential for the choice and interpretation of nonclinical pharmacology and safety studies of Fcengineered monoclonal antibodies
Importance of Nonclinical Model Selection and Testing Strategy:
• Effective translation to clinical outcomes heavily relies on selecting appropriate nonclinical in vitro and in vivo models that accurately represent human Fc receptor biology and effector functions. The document emphasizes rigorous assessment strategies including receptor binding assays, effector cell-based assays, and cytokine release studies. Industry case studies highlight the necessity of a well-informed model choices, considering both pharmacological relevance and regulatory insights, to mitigate risks associated with Fc-modified antibodies
11:00 am Speed Networking
Synopsis
Put a face to a name – this session is the perfect opportunity to get face-to-face time with key opinion leaders, leading companies, and innovative researchers in Fc-mediated drug development. Establish meaningful connections to build upon for the rest of the conference and gain individual insight beyond the papers and press releases into the pioneering research and therapeutic development.
11:45 am Morning Break & Networking
Enhancing Preclinical Translatability to Connect Findings to Successful Clinical Outcomes for Fc-Mediated Drugs
12:00 pm Engineering Antibody Fc to Reduce Viscosity for Subcutaneous Delivery
Synopsis
• Subcutaneous delivery of high-concentration antibody drug therapeutics is becoming increasingly prevalent due to several significant advantages including improved patient convenience, comfort, compliance, and healthcare cost
• Antibody self-associations through Fab-Fc interactions are likely contributing to viscosity significantly more than the literature, which is dominated by evidence of Fab-Fab interactions would suggest
• We show that applying functional Fc variants to omalizumab, known for its high viscosity, can lead to drastic increases and decreases in viscosity at high concentration
12:30 pm Preclinical humanized models for assessment of Fc Receptor Pathways Targeted Therapies
Synopsis
- Recapitulating human Fc receptors expression pattern in mice
- Investigating biologics’ Fc modifications on effector function and pharmacokinetics in humanized models
- Showcase of mouse models expressing human Fc receptors as tools for translational assessment of Fc receptor-targeted therapies
1:00 pm Lunch
Optimising Antibody Design to Refine Fc Functionality for Maximizing Therapeutic Potential
2:00 pm Tripod Engineering to Enhance Fc Mediated Activity
Synopsis
• Developing a differentiated TPP for an anti-cancer agent
• Selection of binding arms for a tri-specific antibody
• Fc engineering for complementary mechanisms of action against tumor cells
2:30 pm Unlocking the Power of Fc: Guiding Antibody Development with Deep Effector Function Insights
Synopsis
- Comprehensive profiling to align Fc functionality with therapeutic goals and patient outcomes
- Derisking development through strategies that mitigate the unpredictability of Fcmediated functions
- Leveraging functional insights to inform candidate selection, engineering strategies, and regulatory submissions at every development stage for data-driven decision making
3:00 pm Drug Format Mechanisms of Action to Treat Immunoglobulin Related Diseases: FcRn & FcGR Blockers, Ig DJegraders & Sweepers
Synopsis
• Illustrate the increasing number and diversity of current and future therapeutic modality options for immunoglobulin-related diseases
• Selected examples will be highlighted to illustrate the main axes of FcRn and FcGR blockers, immunoglobulin degrades, and antigen-specific approaches
• Overview of key assets in the clinic and late-stage pre-clinical
3:30 pm Poster Session & Networking
Synopsis
Connect with peers in a relaxed atmosphere and continue to forge new and existing relationships while exploring the latest in FC-mediated research and advancements. To submit a poster, please contact info@hansonwade.com