Pre-Conference Seminar Day

The first half of the seminar day explores how cutting-edge technologies and design strategies are reshaping the molecular architecture and functional engineering of bi- and multispecifics.

Attendees will gain insights into high-throughput approaches such as protein trans-splicing for combinatorial multispecific generation, alongside AI-guided design of next-generation T-cell engagers to optimize specificity and efficacy.

Grounded in real-world case studies, these sessions connect early molecular design decisions with downstream functional performance, equipping attendees with practical, data-driven insights to inform more effective multispecific development.

• Protein trans-splicing is a novel method for the generation of multispecific antibodies
• Spliced antibodies can be made in a wide array of formats and recapitulate the biophysical and functional properties of conventionally produced molecules
• This technology enables the discovery of binder pairs with unique biology by facilitating the high-throughput production and screening of combinatorial libraries of multispecific antibodies

• Exploring why new TCE designs such as dual targeting or avidity-based formats are required to overcome the challenges to TCE efficacy posed by solid tumors
• Building a deeper understanding of the affinity and epitope requirements that maximize tumor selectivity which will be critical to unlock the potential of dual targeting TCEs
• AI integration is profoundly impacting therapeutic discovery, enabling delivery of optimized candidates at breakthrough speed

• Demonstrating an integrated AI and synthetic biology platform that routinely achieves high clonal titers across antibody formats, from mAbs to complex multispecifics.
• Overview of Asimov’s Rapid Pools platform, which generates high-throughput stable CHO expression pools to provide early, CLD-relevant expression and product quality data for better decision making.
• Case studies spanning vector design, cell line development, and protein engineering showing how computational methods reduce empirical iteration and accelerate manufacturing readiness.

• Roundtable discussions are designed to be interactive, deep dives where attendees break into smaller groups to explore a focused topic through candid, peer-led conversation. Each group will exchange experiences, challenges, and practical insights before reconvening to share key takeaways with the wider audience and with the conversation being facilitated by our seminar day leaders.

The second half of the seminar day investigates how formulation and CMC strategies informed by FDA-approved bispecific and multispecific antibodies can accelerate development and derisk downstream challenges.

Attendees will gain insights into defining optimal formulation design space, mitigating aggregation risks, and applying stability-first approaches to streamline CMC readiness. Complementing this, the session will examine potency assay development for complex biologics, highlighting analytical challenges, assay robustness, and how data-driven insights can guide formulation and process decisions, equipping attendees with practical lessons for more efficient, developable multispecific programs.

• Leveraging insights from FDA-approved Bispecific and Mult Specific Antibodies as a reference to define realistic pH ranges, protein concentrations, excipients and formulation design space from the outset
• Proactively understanding the aggregation risks and atypical stability profiles of complex formats to better anticipate and mitigate key developability challenges
• Applying a stability-first formulation strategy to support faster development by reducing the need for late-stage reformulation and streamlining overall CMC readiness

• Strategies for designing and optimizing cell based potency assays for complex multi target biologics
• Case studies highlighting analytical challenges, assay robustness, and orthogonal approaches
• Lessons learned on how analytical data can inform formulation and process development decisions

• Accelerating biologics CMC timelines through strategic, risk-based development approaches
• Balancing purification efficiency, manufacturability, and product variant control
• De-risking late-stage development through early product and process understanding

• Adding IMiDs (e.g., lenalidomide) to bispecifics deepens response in RRMM, but severe (Grade 3/4) neutropenia, thrombocytopenia, and infections lead to discontinuations or dose reductions
• STAR-LLD’s continuous SC delivery avoids toxicity by maintaining lenalidomide above the efficacy threshold (26 ng/mL) for target degradation without reaching peak levels that cause bone marrow suppression as seen with oral lenalidomide
• Phase 1b data (AACR 2025) for STAR-LLD showed a 100% ORR with zero Grade 3/4 drug-related hematologic toxicity or infections; a Phase 1 trial with elranatamab is underway to confirm enhanced responses without added toxicity

• Roundtable discussions are designed to be interactive, discursive deep dives where delegates break into smaller groups to explore a focused topic through candid, peer-led conversation. Each group will exchange experiences, challenges, and practical insights before reconvening to share key takeaways with the wider audience and with the conversation being facilitated by our seminar day leaders.