Day One Agenda

8:00 am Check-In & Coffee

8:45 am Chair’s Opening Remarks

  • Ronnie Yeager Project Director, Emerging Therapeutic Platforms, Abbvie

Overcoming In Vivo Toxicity Challenges to Improve Prediction of Toxicities to the Clinic

9:00 am Improving Predictability – Deciding on the Best in vivo Model in Order to Replicate Toxicities Clinically

  • Natalie Keirstead Senior Vice President - Nonclinical Development, Mersana Therapeutics

Synopsis

  • Optimizing an ADC platform to minimize platform off-target toxicity
  • Comparing two NaPi2b ADCs produced using two different platforms, improving safety and efficacy both pre-clinically and clinically
  • Leveraging the rat versus NHPs, for investigative mechanistic studies

9:30 am Unveiling the Differences in Toxicity in NHPs when Using an Identical Linker and Payload but Harnessing Different Targets

  • Werner Rubas Vice President, Preclinical Development, Sutro Biopharma

Synopsis

  • Evaluating toxicities in rodents and NHPs with two different linkers
  • Determining the difference in toxicity in NHP for identical linker and payload but different targets
  • Comparing the highest non severely toxic dose of a vcMMAE against b-GLU exatecan in NHP on a high expression target

10:00 am Targeting Sortilin (SORT1) to Unlock the Potential of Peptide Drug Conjugates (PDCs) in Oncology: Rapid Internalization Within Minutes with Unique Multimodal MOA and Safety Profile

Synopsis

  • Understand the rationale for targeting the SORT1 receptor in cancer
  • Discuss the unique toxicity profile of sudocetaxel zendusortide (TH1902), the lead PDC from Theratechnologies’ SORT1+ Technology™ platform, that differs substantially from the safety profile of taxanes, due to the multimodal MOA of the conjugate and the low levels of free circulating docetaxel
  • Discuss how this multifaceted MOA with improved safety profile can lead to prolonged regression of disease and enable combinations with ADCs, PDCs and other anti-cancer therapies
  • Discuss the ongoing phase I clinical development of sudocetaxel zendusortide, focusing on dose optimization 

10:30 am Morning Break & Networking

Synopsis

This session is an opportunity to connect with peers working within the ADC Toxicity world, to have important conversations to overcome shared challenges, and plot paths to see future successes within the field

Mitigating Risks & Managing ADC Toxicities Within the Clinical Landscape to Improve Tolerability

11:30 am Looking into Ocular Challenges: Mitigating and Managing ADC Ocular Surface Toxicity

Synopsis

  • Overview of ocular surface toxicities associated with ADCs
  • Case study: clinical presentation and management of corneal adverse events associated with a maytansine ADC
  • Evaluating preclinical models to evaluate ADC ocular toxicity

12:15 pm Investigating the Possibility of Biomarkers in Order to Correctly Prescribe ADCs Dependent on Individual Patient Response to Toxicities

Synopsis

  • Discovering the possibility of biomarkers to understand amount/application of ADC dosing dependent on patient screening results
  • Looking at patient-dependent liabilities to toxicities to decide on whether the prescription of an ADC would be beneficial.
  • Identifying which biomarkers are indicative of higher toxicity levels

12:45 pm Lunch & Networking

Showcasing Cutting-Edge In Vitro Assays to Facilitate Higher ADC Toxicity Prediction

1:45 pm Development of in vitro Assays for Off-Target ADC Hematotoxicity

Synopsis

  • Summarizing potential mechanisms driving off-target ADC hematotoxicity 
  • Developing in vitro approaches to differentiate ADCs based on toxicity to neutrophils and megakaryocytes
  • Investigating mechanisms of off-target hematotoxicity including the role of FC receptor mediated uptake

2:15 pm Slot Reserved for AxoSim

Synopsis

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2:30 pm Translating In Vitro Toxicity Assays to Streamline ADC Development and Mitigate Toxicities

Synopsis

  • Validating in vitro toxicity models allows for early identification and mitigation of potential adverse effects associated with ADC development.
  • Profiling toxicity across different concentrations provides insights into the cytotoxic effects of ADC candidates and may aid into dose optimization and risk assessment.
  • Investigating mechanistic insights sheds light on the underlying cellular and molecular pathways involved in ADC-induced toxicities, guiding the development of safer ADCs

3:00 pm Afternoon Break & Poster Session

Synopsis

This is an informal session to help you connect with your peers in a relaxed atmosphere and forge new and beneficial relationships. With an audience of experts in toxicology eager to discuss shared challenges, you will have the opportunity to display a poster presenting your own work. Additionally, you will have the chance to review others’ posters.

To submit a poster, please contact info@hansonwade.com

Assessing Novel Approaches for Toxicity Prediction to Overcome NHP Supply Chain Challenges

4:00 pm Optimizing Non-Clinical Safety Strategies for Use of NHPs: Facilitating Internal Decision Making and Regulatory Acceptance

  • Ronnie Yeager Project Director, Emerging Therapeutic Platforms, Abbvie

Synopsis

  • Refining platform toxicity study designs due to limited availability of NHPs
  • Leveraging internal and external information to maximize data outputs to support Go/No Go decisions and select/advance candidate ADCs toward GLP toxicity 

4:30 pm Assessing the Application of Humanized Mouse Models for Improved Clinical Toxicity Prediction

Synopsis

  • Reviewing the available humanized models for prediction of ADC toxicities
  • Outlining the benefits and drawbacks of utilization of humanized mouse models in ADC discovery and toxicity evaluation
  • Discussing the onboarding and validation of models preclinically

5:00 pm Differentiating Between a Healthy Monkey & An Unhealthy Human, What Role Does the Immune System Have to Play?

Synopsis

  • Understand the immune factors that need to be taken into account when translating ADC toxicities from pre-clinical to clinical
  • Decipher why inflammatory changes seen clinically could be different from preclinical NHP models 
  • Delving into ways to increase the predictability of toxicities through understanding immunological responses

5:30 pm End of Scientific Program Day One