Day Two

• Understanding the different avenues of innovation of masked and conditionally active ADCs to highlight ability to reduce on-target, off-tumor toxicity
• Breaking down the principles and advantages of bispecific ADC logic gates including AND gate EGFR-cMET ADCs
• Analyzing the maturing pipeline of multispecific ADCs to set the context of how antibody-led ADC innovation will translate to the clinic

• Understanding the level of innovation needed in bispecific ADC development to lead to differentiation against classical ADCs
• Forecasting translational considerations to set up novel target, bispecific, and antibody innovation-led innovation to success in the clinic
• Debating how antibody and alternative format ADC innovation will generate improved therapeutic profiles and patient impact versus novel payloads and mechanisms

• Evaluating rationale for targeting DLL3 with an ADC, laying out selective overexpression in SCLC and neuroendocrine cancers
• Describing design and development of XB773 highlighting humanized VHH Fc antibody conjugated to Topo1 payload via AJICAP conjugation
• Laying out preclinical characterization across in vitro cytotoxicity and internalization and in vivo efficacy in CDX and PDX models 

• Presenting a cell signaling network-based computational model of cytotoxic payloads
• Showcasing predicted response from test samples across cancer subtypes, including SLFN11 and SN38-Prexasertib
• Demonstrating the value of cell simulations to predict drug perturbations and reveal mechanistic insights

• Presenting development of a novel antifolate linker-payload platform, leveraging a toxin class with a clinically validated mechanism of action
• Exploring in vitro and in vivo preclinical development and physicochemical properties of frontrunner antifolate ADC program
• Laying out pharmacology studies and dose range finding investigation in the lead up to antifolate ADC IND studies 

• Leveraging fully integrated ADC platform to enable comprehensive discovery and preclinical characterization
• Directly comparing SG and Dato-DXd with pH-sensitive and protease-specific linkers • Assessing how linker-driven payload release influences efficacy, in vitro and in vivo bystander effects, dosing and safety
• Completing physicochemical, structural, in vitro, in vivo, DMPK and toxicology assessments

• Developing a modular and adaptable linker design to allow rapid production of a wide range of dual payload ADCs
• Designing a preclinical framework to give confidence in translation of efficacy and safety of dual payload ADCs against different targets
• Utilizing approach to derisk the development of a pipeline of dual payload ADCs focusing on CLIO-8221 and CLIO-84XY

• Laying out CAN016 preclinical profile including monkey tox data supporting dual payload ADC IND approval
• Contextualizing pre-IND filing approach as an emerging ADC modality, and strategy for HER2 refractory patient treatment
• Highlighting ongoing first in-human development of CAN016 and potential impact in HER2 refractory patients resistant to Enhertu 

This is your opportunity to present newly published first-in human and Phase I clinical data in front of our specialized audience of industry experts. Data must be published and available to be presented ahead of the deadline of Friday, September 4. Email info@hansonwade.com to register your interest.

• Exploring human data generated from Gallium-68 imaging studies with Bicycle molecules
• Laying out the latest preclinical data of Bicycle Drug Conjugates
• Delving into Gallium-68 PET imaging with Bicycle Molecules to guide clinical development of therapeutic conjugates

• Benchmarking against traditional ADCs: What are the transferable learnings and additional challenges in early development of ADCs with novel MoAs or design?
• Discussing best approaches to set up novel ADC development for success in a crowded and competitive clinical landscape
• Debating the level of proof-of concept and early clinical data to approach partnership and dealmaking conversations for non-traditional ADCs

• Evaluating opportunities for ADCs with novel design to deliver differentiated clinical outcomes
• Reviewing early-stage clinical results from LCB14 to understand the impact of bioconjugation and linker within the HER2 targeting ADC space
• Delving into the early clinical profile of LCB71, a pro-PBD bearing ROR1 targeting ADC, demonstrating differentiated clinical safety and efficacy

• Presenting Phase I clinical data of Varseta-M targeting EpCAM in colorectal cancer
• Connecting masked ADC design correlation to compelling preclinical and clinical profile
• Exploring Varseta-M future clinical development pathway with first-in-class ADC potential in late-line colorectal cancer

• Outlining the developing clinical profile of JK06 from dose escalation to Phase I/II expansion cohort data
• Contextualizing the maturing clinical profile of JK06 across efficacy and safety profile in lung and breast cancer cohorts
• Explaining the differentiated clinical impact of JK06 through dual epitope binding and site specific conjugation for a novel ADC activity and safety profile

• Understanding the challenges of ADC development in an increasingly crowded clinical environment
• Evaluating opportunities to demonstrate differentiation across ADC trial design, patient selection and combination approaches
• Debating the opportunities to improve ADC clinical execution to reduce development costs and improve ADC clinical trial

• Breaking down survey results for solvent and reagent purging in post conjugation ultrafiltration
• Assessing general guidance for purge factors of small molecule impurities based on survey results
• Putting forward proposals for nominal purging factors for reagents and solvents in regulatory context 

• Contextualizing case study of a new ADC impurity identified by reducing CE-SDS in late process development
• Delving into impurity characterization and process control to mitigate risk to ADC quality
• Recapping feedback from Health Authorities to assess if impurity presence was appropriately characterized to mitigate analytical comparability risk

• Describing a simple partial reduction/stochastic conjugation process to outline approaches to process characterization
• Discussing characterization of sequential reactions in a ‘one pot’ process, establishing scale down models, appropriate analytics, TFF purification and linking filtration
• Briefly describing two unexpectedly discovered critical parameters

• Laying out the path for optimal ADC speed to clinic leveraging early phase manufacturing strategies
• Understanding important factors for considering and selecting the right starting CDMO
• Contextualizing regulatory best practices to set manufacturing specifications in early-stage ADC development

• Breaking down the complex pathway, key activities and rate-determining steps to advance ADCs from candidate selection to first-in-human clinical trials
• Sharing strategies used to ensure timely production of ADC toxicology material and readiness for GMP manufacture
• Contextualizing approaches and learnings to promote speed and success in ADC development and technology transfer

• Understanding fundamental cleaning strategies in multiproduct isolators for ADC manufacturing
• Explaining the importance of payload cleaning to ensure safety, quality and regulatory compliance
• Case study: Navigating analytical capabilities for detecting residual payloads at nanogram levels