Please Note: Times Are Listed As EDT | PDT

7:30 AM | 4:30 AM Preconference Virtual Networking

8:20 AM | 5:20 AM Chair’s Opening Remarks

Reflecting on a Two Decade Legacy of HER2-Targeted Therapy Data

8:30 AM | 5:30 AM Legacy of HER2-Directed Therapies: Past, Present & Future

Synopsis

• The many discoveries in the area of HER2-targeted therapies stand on the shoulders of the development of trastuzumab
• ADCs and small molecule kinase inhibitors are currently promising yet challenging modalities for treating HER2-positive cancer
• Immune- and cell-based therapies such as bispecifics, vaccines and CAR-Ts are on the horizon

Highlighting HER2 Pathology & Making the Link With Therapeutic Responsiveness

8:50 AM | 5:50 AM To Be Announced

9:10 AM | 6:10 AM HER2 / ERBB2 Gene Amplification & Overexpression as a Target for Therapy in Human Cancers

  • Michael Press Professor, Pathologist & Director of Breast Cancer Analysis Lab, USC / Norris Comprehensive Cancer Center

Synopsis

HER2 / ERBB2 gene amplification is directly associated with HER2 mRNA and HER2 protein overexpression
HER2 / ERBB2 gene amplification and overexpression is present in a variable proportion of adenocarcinomas arising in the human breast, endometrium, ovary, salivary gland, stomach, esophagus and colon
HER2 gene mutations, although infrequent, are also associated with aggressive disease behavior and responsiveness to small molecule inhibitors.
HER2 / ERBB2 gene amplification and overexpression is the primary association with therapeutic responsiveness to HER2-targeted therapies

9:30 AM | 6:30 AM Informed by the Tumor: The Power of a Personalized ctDNA Assay for Treatment Monitoring in HER2

10:00 AM | 7:00 AM Live Presenter Q&A

  • Gail Lewis Phillips Principal Scientist, Discovery Oncology, Genentech
  • Susanne Haneder Associate Principal Pathologist, AstraZeneca
  • Michael Press Professor, Pathologist & Director of Breast Cancer Analysis Lab, USC / Norris Comprehensive Cancer Center
  • Angel Rodriguez Medical Director, Natera Oncology
  • John Simmons Global Vice President, Biopharma Business Development, Natera

10:20 AM | 7:20 AM Virtual Speed Networking & Break

Showcasing the Breadth of Next Era HER2-Targeted Therapies in Development (By Drug Class) That Are Overcoming Resistance Challenges

11:00 AM | 8:00 AM A Renaissance in HER2 Companion Diagnostics

  • Janine D. Feng CDx Staff Pathologist & CAP/CLIA Medical Director, Roche Diagnostics Solutions

Synopsis

  • How flagship IHC diagnostics are evolving to support current and future
    HER2-targeted therapies
  • Advancements in developing the HER2 (4B5) IHC assay across several
    new solid tumor indications with high medical need, including biliary
    tract and colorectal carcinomas
  • Implementation of new scoring algorithms for HER2 IHC in breast
    cancer is broadening access to personalized therapies to new patient
    populations
  • New innovations in HER2 testing for non-small cell lung cancer

11:30 AM | 8:30 AM Zanidatamab (ZW25): A Bispecific Antibody With Potential to Be the Next Foundational Treatment for HER2-Expressing Cancers

Synopsis

• Overview of multiple mechanisms of action driving this novel clinical therapy that can simultaneously bind two non-overlapping epitopes of HER2, including increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients
• Review of the global development of zanidatamab as a monotherapy and in combinations in HER2+ biliary track cancer, gastroesophageal adenocarcinoma, and breast cancer

11:50 AM | 8:50 AM Enhancing Efficacy & Safety of 4-1BB Agonism With PRS-343, a Tumor-Targeted Bispecific

Synopsis

• PRS-343 is the first bispecific to enter the clinic which is engineered to specifically activate 4-1BB in the tumor microenvironment
• PRS-343 demonstrated durable anti-tumor activity in heavily pretreated patient population across multiple tumor types, including those usually not responsive to immune therapy; novel and non-redundant MoA among HER2-targeting therapies and checkpoint inhibition
• PRS-343 showed a clear increase in CD8+ T cell numbers in the tumor microenvironment of responders and increases of Soluble 4-1BB demonstrates activity of the 4-1BB arm of the molecule

12:10 PM | 9:10 AM Live Presenter Q&A

  • Markus Zettl Director, Immuno-Oncology, Pieris
  • Nina Weisser Associate Director, Oncology, Zymeworks
  • Janine D. Feng CDx Staff Pathologist & CAP/CLIA Medical Director, Roche Diagnostics Solutions

12:30 PM | 9:30 AM Lunch Networking Break

1.30 PM | 10.30 AM Acceleration of HER2-Targeted Therapy Development Using Liquid Biopsy

Synopsis

• The added value of liquid biopsy in trials and in the clinic
• Liquid biopsy identification of patients with HER2 amplifications and mutations
• Emerging applications of liquid biopsy

2:00 PM | 11:00 AM Therapeutic Potential of Anti-HER2 Antibody-Drug Conjugates Across Cancers

Synopsis

• Trastuzumab Emtansine and Trastuzumab Deruxtecan are effective in HER2-altered non-breast tumors such as lung cancer, colorectal cancer, pancreatic cancer and osteosarcoma
• Combination with irreversible tyrosine kinase inhibitors, such as neratinib, increase HER2 ubiquitination and internalization, thus enhancing the efficacy of anti-HER2 ADCs
• Switching to a different ADC may overcome resistance to the payload

2:20 PM | 11:20 AM A Novel Immune Stimulating Antibody Conjugate for HER2 Expressing Tumors

  • Edith Perez Chief Medical Officer , Bolt Biotherapeutics

Synopsis

• Exploring the biology of toll like receptor activation in cancer
• Activation of the innate and then adaptive immune systems
• Sharing data from the global phase I/II first-in-human trial using BDC- 1001 in advanced HER2-expressing solid tumors

2:40 PM | 11:40 AM Live Presenter Q&A

3:00 PM | 12:00 PM CAR-Macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Synopsis

• Tackling the HER2 overexpressing tumor heterogeneity with CAR-macrophages
• A day in the life of a First-in-Human, First-in-Class cell therapy clinical trial
• Always striving for more: accelerating, combining, improving…

3:20 PM | 12:20 PM Walking on a Tight Rope of On-target Effectiveness/Toxicity & the HER2 Model

  • Zhifen Yang Director, Preclinical Development, Refuge Biotech

Synopsis

• HER2 represents a good example of a CAR T cell target shared by benign and neoplastic tissues
• Effectiveness, is determined by several aspects of T cell biology that precede the differential recognition of neoplastic cells upon encounter with the target antigen and its expression
• Novel synthetic biology approaches such as CRISPR-activation/ interference can fine tune the balance required to adjust the deployment of CAR-T cells specifically against neoplastic tissues sparing normal ones

3:40 PM | 12:40 PM T Cells Engineered With the T Cell Antigen Coupler (TAC) to Treat HER2-Positive Solid Tumors

  • Andy Bader Chief Scientific Officer, Triumvira Immunologics

Synopsis

• The TAC technology leverages endogenous T cell signaling for more efficacious and safer T cell applications
• Autologous and allogeneic TAC T cells effectively eliminate HER2+ tumor cells in preclinical studies
• Initiation of a first-in-human clinical trial

4:00 PM | 1:00 PM Live Presenter Q&A

  • Debora Barton Chief Medical Officer , Carisma Therapeutics
  • Zhifen Yang Director, Preclinical Development, Refuge Biotech
  • Andy Bader Chief Scientific Officer, Triumvira Immunologics

4:20 PM | 1:20 PM Afternoon Networking Break

4:40 PM | 1:40 PM Targeting Somatic HER2 Mutations Across Multiple Cancers With the Pan-HER Kinase Inhibitor, Neratinib: Lessons From the Phase 2 SUMMIT ‘Basket’ Trial

  • Lisa Eli Sr. Director, Translational Medicine & Diagnostics, Puma Biotechnology Inc.

Synopsis

• Somatic HER2 mutations are oncogenic driver mutations across a broad spectrum of cancers
• HER2 mutations are clinically actionable with HER2 directed therapies
• Neratinib demonstrates encouraging clinical efficacy either as a single agent or in combination in HER2 mutant breast, cervical, bile duct and lung cancers

5:00 PM | 2:00 PM Exploring the Potential of a HER2-Targeted Thorium-227 Conjugate in HER2 Expressing Solid Tumors

Synopsis

• Targeted thorium conjugates (TTCs) represent a new class of therapeutic radiopharmaceuticals for the targeted alpha therapy (TAT) of cancer
• TTCs are highly cytotoxic due to the high linear energy transfer of the alpha-particle emitting radionuclide which induces complex DNA double-strand breaks in the targeted tumor cell
• Preclinical evidence supports the development of a HER2-TTC for the treatment of T-DM1/trastuzumab resistant disease and offer potential for the population of patients with low HER2 expression

5:20 PM | 2:20 PM Live Presenter Q&A

  • Lisa Eli Sr. Director, Translational Medicine & Diagnostics, Puma Biotechnology Inc.
  • Jenny Karlsson Head of TRP Biochemistry, Bayer

5:40 PM | 2:40 PM Chair’s Closing Remarks & End of Conference Day One