7:30 am Coffee Room Opens

8:20 am Chair’s Opening Remarks

  • Gail D. Lewis Principal Scientist, Discovery Oncology, Genentech

8:30 am Low HER2 Breast Cancer: Definition & Future Plans for Management

  • Edith Perez Chief Medical Officer , Bolt Biotherapeutics

Synopsis

• Navigating clinical development for the treatment of patients with HER2-expressing solid tumors, including HER2-low tumors
• Delving into latest results and future directions

Developing a Clinically Successful HER2 ‘Low’ Agent

9:00 am Exploring Cell Therapies in HER2 Solid Tumors

  • Deyaa Adib Chief Medical Officer, Triumvira Immunologics

Synopsis

• Discussing target engagement and response biomarkers
• Targeting tumors, targeted therapies & more
• Exploring T cell Antigen Coupler (TAC) technology

9:30 am Tumor-Localized Co-Stimulatory T-Cell Engagement by the 4-1BB/ HER2 Bispecific

  • Neha Pant Global Program Lead, Cinrebafusp alfa, Pieris Pharmaceuticals

Synopsis

• Exploring the drug discovery process: target identification and validation, antitumor effect, pathway understanding, biomarkers
• Discussing potential indications
• Forecasting the future to be monotherapy and/or combination dominated
• Discussing the biomarker and patient status
• Latest data and future directions

10:00 am Trends for ERBB2 and Her2-Targeting Therapies in Real-World Multi-Modal Data

Synopsis

  • The Tempus platform supports assessment of tumor genetics, transcriptomics, imaging and clinical outcomes across our vast US clinical network
  • Integration of multiple data modalities enables integration of Her2 status in the context of most other clinical biomarkers relevant to breast cancer
  • Transcriptomics can provide a surrogate to expand the clinical utility of Her2 outside of indications tested with IHC/FISH

 

10:30 am Morning Refreshments

Overcoming Resistance Mechanisms & Addressing Metastatic Disease with Novel Applications

11:00 am AMX-818: A Next Generation Conditionally Active, Masked T-Cell Engager for the Treatment of HER2-Expressing Solid Tumors.

  • Fiore Cattaruzza Senior Director of Translational Biomarkers, Amunix Pharmaceuticals

Synopsis

• Exploring the drug discovery process: target identification and validation, antitumor effect, pathway understanding, biomarkers
• Discussing potential indications
• Forecasting monotherapy and/or combination dominated
• Latest data and future directions

11:30 am Novel Immunotoxin MT-5111 in Avoiding Competition With & Overcoming the Primary Mechanisms of Tumor Resistance to Current HER2-Targeted Therapies

Synopsis

• Exploring the drug discovery process: target identification and validation, antitumor effect, pathway understanding, biomarkers
• Discussing potential indications
• Discussing the biomarker and patient status
• Latest data and future directions

12:00 pm Resistance to Immunotherapy Caused by MUC4 Expression in HER2+ Tumors – Bench to Bedside

  • RJ Tesi Chief Executive & Medical Officer, Inmune Bio
  • Roxana Schillaci Principal Researcher, Institute of Biology and Experimental Medicine CONICET, Argentina

Synopsis

• Exploring how MUC4 expression predicts resistance to immunotherapy
• Targeting soluble TNF reverses resistance in animal models
• Understand how knowing the MUC4 status of a patient’s tumor will improve clinical decision making and should benefit patient outcome

12:30 pm Zenocutuzumab, a HER2×HER3 Biclonics® Antibody that can Overcome HER3 Mediated NRG1 Signaling in Tumor Cells by Docking on HER2

  • Cecile Geuijen Chief Scientific Officer & Vice President - Oncology, Merus

Synopsis

• Understanding the status of HER2 and NRG1 fusions
• Understanding how Merus are overcoming resistance & leveraging inhibition of signaling
• Uncovering the latest data and future directions

1:00 pm Lunch Break

Patient Selection & Management for HER2-Targeted Therapies

2:00 pm Delving into Patient Selection for HER2 Targeted Basket Trials

  • Funda Meric – Bernstam Chair, Department of Investigational Cancer Therapeutics & Medical Director, Institute for Personalized Cancer Therapy, MD Anderson Cancer Center

Synopsis

• Unique challenges in patient selection
• Lessons learned

2:30 pm Management of Patients Treated with HER2 Targeted Therapies: What to Expect & What to Protect

  • Serena Masciari Senior Medical Director, Oncology Early Development, Sanofi Genzyme

Synopsis

• Major safety concerns of HER2 targeted therapies
• Management of toxicities
• Risks & strategy for potential combinations

3:00 pm Afternoon Refreshments

3:30 pm Closing Roundtable Session: Future Directions & Implementations for Our Anti-HER2 Drug Development Efforts’

Synopsis

  • Tables thoughts and rationale on potential best combinations for own HER2 agents
  • Tables thoughts on biosimilars
  • Peers thoughts on understanding the effects and pathology on downstream signaling when resistance arises
  • Peers thoughts on the movement towards considering the entire patient journey in treatment & regulatory input
  • Are HER2 antagonists interesting to the table?
  • Thoughts on dealing with the lack of homogeneity – future directions and how to advance this space
  • Peers views on designing for approval in monotherapy vs combination therapy
  • Opinions on how to best take novel targets into the clinic
  • Tables thoughts on disease selection & challenges that come with it
  • Opinions on where is this field going?

4:00 pm Chairs Closing Remarks & Close of Summit

  • Gail D. Lewis Principal Scientist, Discovery Oncology, Genentech