Explore the Agenda
8:30 am Check in & Light Breakfast
8:50 am Program Director’s Opening Remarks
8:55 am Chair’s Opening Remarks
Illuminating TCEs in the Clinic for Autoimmune Disease to Spotlight Efficacy & Safety Data & Translate Learnings to Early-Stage Candidates
9:00 am Demonstrating Deep B-Cell Reset with CLN-978 by Translating Early Clinical Insights Moving Beyond Early Development
- Presenting emerging clinical data evaluating the safety, tolerability, and cytokine release syndrome profile of the CD19 x CD3 x HSA trispecific across autoimmune patient populations, establishing benchmarks for outpatient TCE administration
- Assessing the depth, durability, and tissue-level impact of B-cell depletion achieved through enhanced target engagement and extended half-life design, providing insight into the potential for sustained disease remission
- Translating clinical learnings on dosing, safety management, and biomarker evaluation into design principles for next-generation autoimmune T-cell engagers aimed at improving efficacy while minimizing treatment burden
9:30 am Panel Discussion: Translating First-Wave Autoimmune T-Cell Engager Clinical Data into Safer, More Effective Next-Generation Therapies
As the first generation of autoimmune T-cell engagers advances through clinical development, the field is beginning to generate critical insights into safety management, depth of immune-cell depletion, patient selection, and long-term disease control. The key challenge now is determining which clinical learnings will truly differentiate successful therapies. Join clinical leaders, translational scientists, and developers of leading autoimmune T-cell engager programs as they discuss how emerging clinical evidence is reshaping drug design and development strategies by:
- Defining the clinical benchmarks for success, evaluating what early efficacy, safety, cytokine release syndrome, and durability data reveal about the therapeutic potential of T-cell engagers across different autoimmune diseases and patient populations
- Understanding the drivers of durable immune reset, exploring how depth of depletion and target biology, contribute to longterm remission, and identifying the biomarkers needed to predict sustained clinical benefit
- Translating clinical learnings into next-generation molecule design, discussing how insights from first-wave programs are informing improvements in target selection, construct engineering, dosing strategies, administration routes, and patient monitoring to enhance efficacy while minimizing treatment burden and safety risks
10:00 am Speed Networking: How does it work?
10:05 am Speed Networking
This informal session offers the perfect opportunity to connect with industry front-runners and key opinion leaders specializing in autoimmune disease within the T-cell engager field. This is your chance to build meaningful connections to carry through the rest of the conference, while gaining exclusive, first-hand insights into the latest research and developments.
10:45 am Morning Break & Networking
Accelerating Translation Through Predictive Models, In Vitro & Preclinical Biomarkers, & Early Human Data to Bridge Translational Science & Patient Benefit
11:00 am Translating Dual-Targeting T-Cell Engager Strategies into Clinical Success Through Biomarker-Driven Development & Early Human Insights
- Exploring how the dual-targeting design of LBL-051 is being leveraged to enhance therapeutic selectivity, deepen immune-cell depletion, and improve safety profiles, while addressing key translational challenges
- Evaluating predictive biomarkers, pharmacodynamic readouts, and translational immune-monitoring strategies that can validate target engagement, characterize immune-cell depletion, and support earlier assessment of clinical activity and durability
- Connecting emerging lessons from the evolving autoimmune T-cell engager clinical landscape with the development of LBL-051, using early human data and translational science to inform dose optimization, patient selection, and future clinical development strategies
11:30 am Developing Predictive Preclinical Models to Improve Translation of Autoimmune T-Cell Engagers from Discovery to First-in-Human Studies
- Building next-generation autoimmune disease models that better capture immune-cell depletion, autoantibody dynamics, and tissue-specific pathology, overcoming the limitations of traditional oncology-focused preclinical systems
- Evaluating the translational relevance of organoids, humanized platforms, and advanced in vitro immune models to improve prediction of efficacy, safety, and cytokine release syndrome risk before clinical development
- Correlating preclinical pharmacology and immune-cell depletion data with emerging clinical outcomes to establish more reliable frameworks for candidate selection and dose optimization
12:00 pm Applying Clinical Pharmacology Learnings from Late-Stage CD3 Bispecific Programs to Optimize Early Autoimmune T-Cell Engager Development
- Evaluating how clinical pharmacology insights from advanced CD3 bispecific programs can inform first-in-human study design, dose escalation strategies, cytokine release syndrome mitigation, and therapeutic window optimization in autoimmune disease settings
- Integrating pharmacokinetic, pharmacodynamic, and biomarker-driven approaches to better predict immune-cell depletion, target engagement, and early efficacy signals, enabling more informed and efficient clinical development decisions
- Leveraging translational and early human data from late-stage T-cell engager programs to refine patient selection, dosing paradigms, and safety monitoring frameworks that support accelerated development and improved patient outcomes
12:30 pm Lunch & Networking
Accelerating Translation Through Predictive Models, In Vitro & Preclinical Biomarkers, & Early Human Data to Bridge Translational Science & Patient Benefit – Continued
1:30 pm Learnings from Oncology Development Experience that May Help T-Cell Engager Development in Autoimmune Diseases
- Utilizing oncology datasets to inform autoimmune development strategies, dose selection, and overall risk mitigation
- Taking advantage of safety, pharmacokinetic, pharmacodynamic, and dose selection Oncology learnings
- Designing oncology studies with future autoimmune applications in mind by incorporating relevant translational endpoints, immune monitoring strategies, and site selection frameworks
2:00 pm Session Reserved for genOway
2:30 pm Leveraging Early Mechanistic & Translational Data to Establish Safer Next-Generation T-Cell Engager Therapies for Autoimmune Disease
- Presenting a comprehensive suite of in vitro and in vivo translational datasets characterizing the mechanism of action, immune-cell engagement dynamics, and functional activity of Synolo Therapeutics’ novel T-cell engager platform across autoimmune-relevant models
- Evaluating cytokine release, immune-cell activation profiles, and safety-associated biomarkers through advanced in vitro assays and preclinical studies to demonstrate how differentiated engager design strategies can achieve improved safety thresholds while retaining therapeutic potency
- Integrating early mechanistic insights with translational biomarker analyses to establish predictive frameworks that support candidate selection, de-risk clinical development, and accelerate the translation of safer T-cell engager therapies into human studies
3:00 pm Poster Session & Afternoon Break
Connect with peers in a relaxed atmosphere and continue building new and existing relationships
while exploring the latest advancements in T-cell engagers.
To submit a poster, please contact info@hansonwade.com
Solving Deep Tissue Penetration & Immune Cell Depletion to Drive Durable Disease Remission by Addressing Key Biological Barriers
4:00 pm Think Lab: How to Improve Translational Predictability & Shorten the Path from Discovery to Clinical Success
As autoimmune T-cell engagers rapidly advance into clinical development, one of the field’s greatest challenges remains the ability to accurately predict clinical efficacy, durability, and safety before large-scale patient studies. Traditional preclinical models often fail to capture the complexity of autoimmune disease biology, creating urgent demand for more predictive translational tools, mechanistic biomarkers, and early human readouts that can de-risk development and accelerate patient benefit. This interactive session will discuss how the industry can improve translational predictability and shorten the path from discovery to clinical success by:
- Building more predictive translational models for autoimmune T-cell engagers, evaluating how advanced in vitro systems, humanized models, patient-derived assays, and mechanistic immune profiling can better predict efficacy, cytokine release syndrome risk, tissue depletion, and long-term immune reconstitution.
- Identifying the biomarkers that matter most for early clinical decision-making, discussing how pharmacodynamic biomarkers, cytokine signatures, immune-cell depletion kinetics, tissue-level readouts, and translational immune-monitoring strategies can support dose optimization, patient selection, and earlier validation of therapeutic activity
- Integrating early human data to accelerate development and reduce clinical risk, exploring how first-in-human studies, adaptive trial designs, and translational datasets can be leveraged to refine therapeutic hypotheses, improve safety management, and establish clearer pathways toward durable patient benefit and regulatory success
4:30 pm Engineering Autoregulatory T-Cell Engagers to Preserve T-Cell Fitness, Prevent Exhaustion & Expand the Therapeutic Window in Autoimmune Disease
- Developing autoregulatory T-cell engager architectures designed to modulate T-cell activation dynamics, preserving T-cell fitness and functionality while reducing the risk of excessive immune activation, cytokine release, and treatment-related toxicity
- Investigating how controlled and self-regulating immune engagement strategies can prevent T-cell exhaustion, enhance persistence, and maintain potent immunecell depletion across chronic autoimmune disease settings requiring sustained therapeutic activity
- Leveraging translational immune profiling, functional T-cell assays, and preclinical safety models to optimize therapeutic windows and establish differentiated approaches that balance efficacy, durability, and long-term immune tolerability
5:00 pm Panel Discussion: How to Overcome the Biological Barriers Limiting Deep & Durable Immune Reset
While early autoimmune T-cell engager programs have demonstrated promising peripheral immune-cell depletion, many developers are now confronting a critical challenge: durable remission may require eliminating pathogenic immune cells thatreside deep within tissues, lymph nodes, bone marrow, and inflamed disease sites. Achieving meaningful tissue penetration while balancing safety, persistence, and immune preservation has emerged as one of the defining scientific hurdles for the next generation of autoimmune therapies. This panel will discuss how the field can overcome the biological barriers limiting deep and durable immune reset by:
- Understanding the mechanisms limiting tissue penetration and depletion, exploring how immune-cell localization, tissue architecture, inflammatory microenvironments, and target accessibility influence the ability of T-cell engagers to reach and eliminate pathogenic cell populations
- Advancing therapeutic strategies to improve deep tissue activity, evaluating innovations in molecule design, multispecific targeting, dosing strategies, half-life engineering, and immune-cell trafficking approaches that enhance tissue penetration while maintaining manageable safety profiles
- Developing biomarkers and translational tools to measure true immune reset, discussing how imaging, tissue biopsies, molecular profiling, and next-generation biomarker platforms can be used to assess tissue-level depletion, predict durable remission, and guide clinical development decisions