7:30 am Coffee Room Opens

8:50 am Chair’s Opening Remarks

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 Progress in BDC-1001, HER2 Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC)

  • 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

10:00 am Tumor-Localized Co-Stimulatory T-Cell Engagement by the 4-1BB/ HER2 Bispecific

  • Shane Olwill Chief Development Officer, Senior Vice President & Head of Translational Science, 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

10:30 am Morning Refreshments

Overcoming Resistance Mechanisms & Addressing Metastatic Disease with Novel Applications

11:30 am Exploring HER2-Targeted Therapies with Masking Technology

  • Fiore Cattaruzza Senior Director - Pharmacology & Preclinical Development 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

12:00 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

12:30 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

1:00 pm 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

1:30 pm Lunch Break

Optimizing Basket Trial Design for HER2-Targeted Therapies

2:30 pm Designing & Carrying Out a Successful Basket Trial for a HER2 Agent

Synopsis

• Site selection, tumor indication selection
• Patient recruitment and selection: aligning everyone on the trial testing-wise
• Exploring the benefits and drawbacks to basket trials – presenting them to regulators, budgets, implementation, planning, results, potential
• Understanding the similarities and differences between tumors in study and why it’s important

3:00 pm Delving into the Currently Active MyPathway Basket Trial – Design, Patient Selection, Plan & More

  • 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

3:30 pm Afternoon Refreshments

Improving Safety Profile / Potency Balance & Treatment Regimes

4:00 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

4:30 pm Closing Panel Discussion: Thoughts & Future Directions for HER2

  • Wendy Hauck Global Associate Medical Director, Women’s Cancer Care, Eisai
  • Debora Barton Chief Medical Officer , Carisma Therapeutics
  • Serena Masciari Senior Medical Director, Oncology Early Development, Sanofi Genzyme

Synopsis

• Thoughts and rationalizing on potential best combinations for HER2 targets
• Reviewing the various combination approaches and new targets coming in thought experiment based on pathway
• Thoughts on biosimilars
• Understanding the effects and pathology on downstream signaling when resistance arises – along the
development and progress
• Understanding the movement towards considering the patient journey not just one resistance mechanism
• Antagonists
• Dealing with the lack of homogeneity – future directions and how to advance this space
• Designing for approval in monotherapy vs combination therapy
• Placement rationale
• Advice on selecting the right tests in trials which you will then be approved with
• Advice on how to take novel targets into the clinic
• Where is this field going?

5:00 pm Close of Summit