Conference Day Two - Thursday, July 31, 2025
7:50 am Morning Refreshments
8:50 am Program Director’s Opening Remarks
8:55 am Chair’s Opening Remarks
Engineering the Fc-Region to Tailor Properties, Including Selectivity & Affinity, for Improved Clinical Outcomes
9:00 am Discovery & Development of S-4321, a Novel PD-1 FcgRIIb Dual Cell Bidirectional (DcB) Agonist Antibody
Synopsis
• Current approaches to checkpoint agonism in autoimmunity
• Concept of Dual Cell Bidirectional antibodies
• Discovery and development of S-4321, a novel PD-1 FcgRIIb dual cell bidirectional (DcB) agonist antibody
9:30 am Alteration of Binding Affinity to FcGRs to Modulate Effector Function
Synopsis
• Analysis of library of known mutants to either increase or decrease effector functions
• Translatability of SPR binding to cellular assay activity (ADCC, ADCP, CDC)
• Influence of mutations in library on binding to FcRn
10:00 am Roundtable Discussion: Optimising Fc-Engineered Antibody Stability & Developability to Improve Manufacturability & Shelf-Life for Reduced Development Costs & Improved Product Quality
Synopsis
• Implementing computational tools and predictive algorithms to identify potential stability and developability issues in the design process to reduce the risk of costly downstream failures and improve the efficiency of antibody development
• Utilising biophysical characterization techniques, such as differential scanning calorimetry (DSC) and dynamic light scattering (DLS), to accurately assess antibody stability and aggregation propensity to optimize manufacturability and shelf-life
• Develop optimized formulation strategies and manufacturing processes, and improve antibody stability and minimise degradation during production and storage to ensure consistent product quality and reduced development cost
11:00 am Morning Break & Networking
Exploring Fc-Related Mechanisms Identified to Extend Antibody Half-Life for Advancing Cancer & Autoimmune Disease Therapies
11:30 am Discovery of a Novel Trifunctional Inhibitor for B Cell Driven Diseases
Synopsis
• Trifunctional target inhibition to address the root causes of B cell-driven diseases
• Engineering best-in-class pH-dependent binding to FcRn for clearance of IgG and extended 1/2-life
12:00 pm Inhibition of IgG Multimer & Hexamer Formation Using an Fc Silent Extended Half-life Fc Fusion Protein
Synopsis
• Design and structure of Fc silent artificial rheumatoid factor
• Review of IgG hexamer formation after immune complex formation
• Review of FcRn structure and function and how that can be used to extend the half-life of Fc proteins and monoclonal antibodies. Very brief discussion on FcRn being a cofactor of CD32a
12:30 pm Lunch
Evaluating Immunogenicity and Safety in Fc-Based Therapies Minimizing Risks to Translate More Treatments to Clinic
1:30 pm Roundtable Discussion: Addressing Safety Concerns in Fc-Targeted Therapies for Improved Patient Safety to Enhance Clinical Confidence
Synopsis
• Investigating potential off-target effects and cytokine release syndromes to identify and mitigate potential safety risks to develop well-tolerated and safe Fc-based therapies
• Implementing robust preclinical safety studies and clinical monitoring strategies to proactively address safety concerns to build clinical confidence in the use of Fc-targeted therapies
• Analysing real-world safety data and patient-reported outcomes to understand the long-term safety profile of Fc-based therapies to provide evidence-based guidance for patient management and treatment decisions
Illuminating Case Studies of Innovative Research & Clinical Applications to Expand the Frontiers of Fc-Mediated Therapeutics
2:30 pm Delve Into IgG & Fc Engineering, Specifically Focusing on Modulation of Antibodies Interaction to FcgRIIB
Synopsis
• Consequence of engagement of IgG Fc by the inhibition FcgRIIB expressed by immune cells, non-immune cells, and cancer cells
• Binding characteristics of IgG Fc engineered for modulation of FcgRIIB interaction
• Highlight on pre-clinical studies
3:00 pm Panel Discussion: Examining the Future of Fc-Mediated Therapeutics for the Strategic Design of Studies to Enter Into the Next Era of Innovation
Synopsis
• Forecasting the integration of AI and machine learning in Fc engineering to accelerate discovery and optimisation for speed and precision in creating next-generation Fc-based therapies
• Discussing the potential of personalized Fc-based therapies, including the use of patient-specific biomarkers to pioneer precision medicine for diverse patient populations, whilst optimising the balance of safety and efficacy for patients
• Analysing the emerging trends in Fc-based therapies to expand the therapeutic reach and efficacy of Fc mediated interventions, whilst assessing and mitigating potential safety risks associated with complex therapeutic approaches