Explore the Agenda
8:55 am Chair’s Opening Remarks
Integrating Reliable Efficacy & PK Modeling to Predict Response of Oncology Therapy
9:00 am Analyzing RNDO-564 Efficacy with Cell Line & Syngenic Mouse Model to Deliver Robust Anti-Tumor Responses
- Harnessing affinity-tuned CD28 costimulation with high-affinity Nectin-4 targeting to maximize localized T-cell activation and potentiate anti-tumor cytotoxicity
- Demonstrating strong in vitro activity through enhanced cytotoxicity and cytokine release against Nectin-4–positive tumor cell lines under signal 1 conditions
- Achieving dose-dependent tumor growth inhibition in syngeneic models and favorable tolerability in primates to validate translational therapeutic potential
9:30 am Advancing ZW209 Trispecific Design with In Vitro & In Vivo Models to Improve DLL3-Directed Responses
- Incorporating CD28 co-stimulation with DLL3 and CD3 engagement to enhance T cell activation, proliferation, and sustained cytotoxicity beyond bispecific benchmarks
- Demonstrating superior in vitro and in vivo anti-tumor activity through serial challenge assays and xenograft models that highlight efficacy and T cell fitness
- Establishing translational confidence with PK, cytokine release, and safety profiling in primates to support clinical development of ZW209 in DLL3-positive cancers
10:00 am Poster Competition & Morning Break
Visit here for T&Cs for submitting a poster.
Addressing Patient Heterogeneity in Tumor Models to Improve Clinical Translation
11:00 am Turning Tumors into Therapeutic Protein Producers: Non-Viral Gene Delivery to Overcome Patient Heterogeneity & Drive Local Efficacy
- Utilizing a comprehensive multi-omics analysis of cancer and healthy patient’ tissues to design novel tumor-selective synthetic promoters for non-viral therapeutic protein expression
- Validating highly specific and cancer-activated vector expression across diverse PDX models, robustly addressing patient population heterogeneity
- Demonstrating tumor-tropic delivery of engineered nanoparticles, resulting in improved efficacy of expressed immune-modulators in a comprehensive panel of in vivo cancer models
11:30 am Modeling Tumor Heterogeneity to Capture Variable Patient Responses in Oncology
- Evaluating inter-patient variability by leveraging diverse preclinical models to predict the range of clinical responses and identify potential non-responders
- Incorporating prior treatment history and resistance mechanisms in models to better reflect real-world patient populations and improve translational relevance
- Designing models that address intra-tumor heterogeneity to ensure reproducible and clinically meaningful preclinical efficacy data
12:00 pm Lunch Break & Networking
1:00 pm Roundtable Discussion: Exploring the Translatability & Reproducibility of In Vitro, In Vivo, Ex Vivo & In Silico Approaches to Improve Clinical Predictability
- Comparing diverse preclinical model systems (in vitro, in vivo, ex vivo and in silico) to establish a comprehensive framework for translational relevance
- Identifying model-specific challenges and adaptive strategies to enhance reliability, overcome experimental limitations and model variability
- Optimizing the combination and number of models to accurately forecast therapeutic responses in clinical settings
Exploring FDA-Valued Tumor Models to Ensure Safety Requirements are Met
1:45 pm Leveraging Predictive Models to Enhance Safety Testing in Oncology Development
- Applying immune system predictive models to identify toxic responses early, providing confidence to accelerate development timelines
- Implementing novel in vitro approaches to generate preclinical data, offering robust evidence to reduce animal testing requirements
- Early detection of safety signals and weight-of-evidence approach to drive proactive risk mitigation strategy
2:15 pm Afternoon Break & Refreshments
2:45 pm Roundtable Discussion: Providing Guidance to In Vitro Modelling Standards for Toxicity to Align with FDA Expectation & Good Laboratory Practice
- Exploring FDA perspectives on in vitro toxicology to clarify requirements for advancing ADCs, T cell engagers, and cell therapies into clinical trials
- Designing robust in vitro models to generate translational safety data and address regulatory uncertainty in emerging therapeutic modalities
- Refining assay strategies and safety endpoints to strengthen FDA confidence in preclinical packages while minimizing reliance on animal studies
3:30 pm Applying In Vitro Tissue Models to Evaluate Target Expression & Anticipate Safety of Bispecific T Cell Engagers
- Exploring tumor models in vitro to assess target engagement, cytotoxicity, and mechanistic outcomes beyond primary tumor efficacy
- Profiling target expression across tissues to map potential off-tumor effects and guide tissue panel selection
- Alternative in vitro safety models to anticipate potential toxicity liabilities
4:00 pm Leveraging Retinal Organoids to Advance Animal-Free Drug Testing for Ocular Cancer
- Developing multi-molecular therapeutics to enhance efficacy against late-stage ocular melanoma compared to single-drug approaches
- Harnessing nature-derived compounds to discover novel anti-cancer agents for safer and more effective ocular therapeutics
- Adopting FDA-compliant organoid systems to eliminate animal testing while meeting FDA Modernization Act 2.0 requirements