8:00 am Registration & Coffee
The Evolution of Trastuzumab-Based Anti-HER2 ADC’s: Analysing the Latest Clinical Data
8:50 am Chair’s Opening Remarks – Exploring the Clinical Trials & Comparisons of the Current Trastuzumab-Based Anti-HER2 ADCs
9:00 am Exploring the HER2 Mutation as an ADC Target
Synopsis
- ENHERTU development in HER2
- Mutated HER2 as a novel target for anti-HER2 ADC
9:30 am Disitamab Vedotin: A Novel HER2 ADC
Synopsis
– Disitamab vedotin is a HER2 ADC with an antibody designed to maximize drug delivery with higher affinity and internalization rate as compared to trastuzumab in preclinical models
– Exploring DV’s encouraging monotherapy clinical data across a range of HER2 expressing solid tumors
– Understanding how DV has demonstrated combination activity preclinically and clinically with anti-PD1
10:00 am Panel Discussion: The Evolution of Development & Use Beyond Breast Cancer
Synopsis
• Sharing insights into future directions and what to anticipate as standards evolve for HER2 drugs in the clinic
• Addressing current treatment regimes and rational order of therapy
• Delving into combination thoughts and current status
• Understanding the current pitfalls in sequencing and selecting patients: how is HER2 high vs HER2 low
evolving?
• Exploring potency, side effects, efficacy ratios and discussing how we can better connect pre-clinic to the clinic
• Overviewing the status of Gastric, CRC, Biliary, Bladder, NSCLC, CNS, paediatric and other relevant tumor indications
• Defining the conventional targeting and novel approaches in terms of efficacy and use
10:30 am Speed Networking
Overcoming the Challenges of Tumor Heterogeneity to Improve Patient Stratification
11:30 am Panel Discussion: The HER2 Expression Levels Debate: HER2 High vs HER2 Low
Synopsis
• Progress towards an improved standard of HER2 expression definition
• Exploring the IHC & FISH standardization and improvement
• Understanding different requirements for expression measurement for various indications
• How does HER2 expression compare across indications?
• How does that compare for a therapeutic in terms of defining illegibility criteria?
• How to define non-HER2 positive?
• Standardizing the approach of measurement in the labs – addressing variation and variability between sample
12:00 pm HER2DX®️, The First Genomic Tool For Patients With HER2+ Breast Cancer
Synopsis
- HER2DX®️ development, validation and clinical utility
- HER2DX®️ IGG/immune signature as a key component of the test
- Delving into future directions
12:30 pm Utilizing HER2 with Immune Agents: CAR-T Approach in Advanced Hematologic Cancers & Refractory Solid Tumors
Synopsis
• Discussing patient selection and response biomarkers
• Challenges of clinical translation
• Latest data & future directions
1:00 pm Lunch
2:00 pm A Theranostic Approach to HER2 Radio-ADC Precision Medicine Using Affibody Scaffold Technology
Synopsis
• HER2-imaging is an attractive tool for characterization of tumor uptake
• High contrast tumor targeting ability demonstrated in patients with metastatic breast cancer
• Lack of tumor uptake in HER2 IHC+ tumor predicted lack of response to conventional HER2 treatment
• Imaging scaffold has been engineered to allow for molecular radiotherapy
• Preclinical molecular radiotherapy data supports clinical translation
2:30 pm A Novel Cerebral Spinal Fluid (CSF) Assay for Assessing HER2 Genetic Heterogeneity and Monitoring Treatment Response in Patients with Leptomeningeal Metastases (LM)
Synopsis
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- CNSide is a novel cerebral spinal fluid (CSF)-based assay that uses a combination of cell-based and cell-free DNA (cfDNA) analysis to evaluate patients with CNS metastasis
- Aids physicians in following:
- Identification of tumor cells in CSF
- Characterization of tumor heterogeneity in biomarker targets
- Monitoring of therapy response with serial quantitative tumor cell counts
- Can be used to identify HER2 amplification and other actionable biomarkers in patients with breast cancer and suspected or diagnosed LMD
3:00 pm Afternoon Refreshments
Unlocking the Hottest Preclinical Data & Combination Rationale for HER2 Clinical Progress
3:30 pm Exploring Zanidatamab (ZW25): A Bispecific Antibody with Potential to be the Next Foundational Treatment for HER2-Experssing Cancers
Synopsis
• Zanidatamab is a humanized, bispecific, IgG1-like antibody directed against the juxtamembrane domain (ECD4) and the dimerization domain (ECD2) of HER2
• Zanidatamab’s unique binding properties result in: receptor clustering, internalization, and downregulation; inhibition of growth factor-dependent and independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis, and complement-dependent cytotoxicity
• Zanidatamab has demonstrated durable anti-tumor activity in patients as a single agent and in combinations across different HER2 expressing tumor types including biliary tract cancer, gastroesophageal adenocarcinoma (GEA), and breast cancer
• The global development for zanidatamab will be discussed including first-line treatment in GEA in combination with chemotherapy
4:00 pm Allogeneic Natural Killer Cells Engineered to Express HER2-Directed CAR, Interleukin-15 & TGFβ Dominant Negative Receptor Effectively Control HER2+ Tumors
Synopsis
• We describe here CAT-179, a novel transposon engineered CAR-NK cell therapy for HER2+ solid tumors
• CAT-179 cells express three transgenes: a HER2-directed CAR to effectively eliminate tumor cells, a transforming growth factor (TGF) dominant negative receptor (DNR) for resistance to TGF-mediated immune suppression in the tumor microenvironment, and interleukin 15 (IL-15) to enhance NK cell persistence and activity for durable response
• CAT-179 addresses key hurdles to allogeneic cell therapy for solid tumors and is a promising new therapeutic approach for HER2 expressing breast, gastric and other tumors
4:30 pm Evorpacept in Combination with HER2-Directed Therapy for the Treatment of Advanced/Metastatic HER2+ Gastric/Gastroesophageal Junction Cancer
5:00 pm Chair’s Closing Remarks & End of Conference Day One
