8:00 am Preconference Virtual Networking

8:50 am Chair’s Opening Remarks

Harnessing Cutting Edge Blood Brain Barrier Penetrable Drugs to Tackle Cancer Metastases in the Brain From HER2 Positive Primary Tumors

9:00 am HER2+ Breast Cancer Brain Metastases: Current Treatments & New Frontiers

  • Reva Basho Assistant Professor, Breast Medical Oncology, Co-Director: Women’s Cancer Research Program, Cedars-Sinai Medical Center

Synopsis

• Use of TKIs for BCBM, including data from HER2Climb
• Data on efficacy of ADCs in the management of BCBM
• New therapies including immune checkpoint inhibition in the TOPAZ study

9:20 am The Use of Highly Selective TKIs for HER2+ CNS Metastases- Tucatinib in Combination With Capecitabine & Trastuzumab

  • Luke Walker Vice President – Clinical Development, Seagen

Synopsis

• Expanding clinical trials to include patients with active brain metastases
• Exploration of the use of dual HER2 inhibition
• Understanding the complexity of clinical endpoints for measuring activity of therapeutics against brain metastases

9:40 am A Novel CAR therapy for Metastatic Breast Cancer

  • Paul Rennert President & Chief Scientific Officer, Aleta Biotherapeutics

Synopsis

• Persistence and fitness are key features of successful cell therapy
• Our HER2-targeting CAR is uniquely engineered to incorporate these features
• This solution is presented in the context of CNS metastasis, and is given alongside standard of care biologics

10:00 am Augmenting HER2 Inhibition by Targeting PI3K – Lessons From Metastatic Brain Cancer

  • James Garner Chief Executive Officer & Managing Director , Kazia Therapeutics

Synopsis

• PI3K is part of the signaling cascade for HER2 and therefore drugs modulating both targets are potentially synergistic
• PI3K inhibition has been explored as a means to overcome resistance to HER2-directed therapies
• Paxalisib, a brain-penetrant PI3K inhibitor, is under investigation for HER2+ breast cancer brain metastases

10:20 am Live Presenter Q&A

  • Reva Basho Assistant Professor, Breast Medical Oncology, Co-Director: Women’s Cancer Research Program, Cedars-Sinai Medical Center
  • Luke Walker Vice President – Clinical Development, Seagen
  • Paul Rennert President & Chief Scientific Officer, Aleta Biotherapeutics
  • James Garner Chief Executive Officer & Managing Director , Kazia Therapeutics

10:50 am Virtual Speed Networking & Break

Exploring HER2 Heterogeneity in Diseases Beyond Breast Cancer to Identify Treatment Opportunities

11:50 am Development of the Keynote 811 Protocol, Biomarker Work & Future Combination Strategies

12:10 pm Investigating the Safety & Efficacy of Pembrolizumab Plus Trastuzumab in Patients With HER2-Positive Gastric Cancer (KEYNOTE 811)

  • Chie-Schin Shih Clinical Director, Sr. Principal Scientist Oncology Clinical Research , Merck Research Laboratories

Synopsis

• Phase 3 trial building on promising Phase 2 data in HER2 positive gastric cancer
• Challenges of Global Biomarker selected Clinical trial
• Impact/challenges of Practice Preferences/Standards on maintaining homogeneity of trial subjects

12:30 pm BDTX-189: A MasterKey Inhibitor of Allosteric EGFR & HER2 Mutations

Synopsis

  • The role of Black Diamond’s proprietary MAP platform to identify and validate allosteric EGFR and HER2 oncogenic driver mutations
  • Overview of the profile of BDTX-189, including a presentation of pharmacokinetic, safety, and anti-tumor activity pre-clinical data
  • The ongoing MasterKey-01 trial, a Phase 1/2 clinical trial designed to evaluate BDTX-189 for the treatment of patients with solid tumors with a range of EGFR and HER2 mutations

12:50 pm Lunch Networking Break

1:50 pm Live Presenter Q&A

  • Yelena Janjigian Medical Oncologist , Memorial Sloan Kettering Cancer Center
  • Chie-Schin Shih Clinical Director, Sr. Principal Scientist Oncology Clinical Research , Merck Research Laboratories
  • Rachel Humphrey Chief Medical Officer, Black Diamond Therapeutics

Investigating HER2-Targeted Therapies for HER2 Negative or HER2 Low Cancers

2:10 pm Considerations for HER2 Low Expressing Breast Cancer

Synopsis

• Linker in T-DxD uniquely cleaves drug conjugate
• Leaks into surrounding HER2 negative parts of the tumor, known as the bystander effect
• Opens up the potential to “target” tumors that previously weren’t considered targetable

2:30 pm Assessment of HER2 Expression: Beware of the Dynamic Range

  • David Rimm Professor & Director of Pathology Tissue Services, Yale University

Synopsis

• The current IHC companion diagnostics and why they work the way they do
• Assessing HER2 by reading pathologists and by measuring machines
• Why a new assay is needed for the new drugs

2:50 pm Live Presenter Q&A

New Frontiers for HER2-Targeted Therapies in Niche HER2 Expressing Cancers

3:05 pm HER2, Where You Do Not Think to Find It

Synopsis

• Prevalence of HER2 alterations in rare cancers and their dependence on HER2-driven signaling
• Therapeutic opportunities in previously unexplored territories
• Rational-based combinations depending of the histology

3:25 pm Targeting HER2 in Advanced Gastroesophageal Adenocarcinoma: 2nd Line & Beyond

  • Nataliya Uboha Medical Oncologist, University of Wisconsin School of Medicine & Public Health

Synopsis

• Outlining existing data on the use of anti-HER2 agents after progression on trastuzumab
• Reviewing novel agents in development and ongoing clinical trials

3:40 pm Live Presenter Q&A

  • Maurizio Scaltriti VP Translational Medicine, Early Oncology, AstraZeneca
  • Nataliya Uboha Medical Oncologist, University of Wisconsin School of Medicine & Public Health

3:55 pm Afternoon Networking Break

4:20 pm Panel Discussion: ‘Old Science – New Opportunities’: Profiling the Competitive Landscape & Accelerating Next Generation HER2-Targeted Therapies to Patients In Need

To conclude year’s meeting, we want YOU to get involved in this interactive online discussion.
During this discussion we will address:

Paul Rennert, President & Chief Scientific Officer Aleta Biotherapeutics

David Poon, VP Business Development Zymeworks

Strengths

• What are the strengths of existing HER2-targeted therapies that continue to drive its development in pharma and biotech pipelines?
• What is the therapeutic and commercial opportunity of expanding anti-HER2 drugs into multiple caner indications?

Opportunities

• What is the market opportunity versus unmet patient clinical need that needs to be addressed by emerging therapeutic approaches for HER2 expressing cancers?
• As we are working outside of orphan disease states, what will treatment costs look like and what will the patient share of costs be?

Weaknesses

• How have competing approaches reached late-stage clinical testing so quickly and why?
• How can we overcome the high bar set by standard of care?

Threats

• What does the landscape of emerging competing therapeutic approaches look like in this space? What are the challenges in regulation?
• What are the existing healthcare professional and industry attitudes towards different HER2-targeted therapies that must be taken into consideration?

4:50 pm Chair’s Closing Remarks & End of Conference