Conference Day 2

8.00 Coffee Room Opens

8:50 am Chair’s Opening Remarks

  • Damian Green Associate Professor - Clinical Research Division , Fred Hutchinson Cancer Research Center (FHCRC)

How Will the Plethora of Anti-BCMA’s Be Differentiated?

9:00 am Panel Discussion:: The Differentiating Debate: On-The-Shelf vs Off-The Shelf

  • Enrique Zudaire Senior Scientific Director Head of Cell Therapy, Oncology Translational Research, Janssen Research & Development
  • Maria-Victoria Mateos Consultant Physician, Myeloma Program & Clinical Trials Unit. Haematology Department & Associate Professor of Medicine , University of Salamanca
  • Hans Chulhee Lee Assistant Professor , MD Anderson Cancer Center
  • Chetasi Talati Medical Director , AbbVie
  • Brandon Kremer Group Senior Medical Director, Clinical Development Lead , GlaxoSmithKline

Synopsis

  • Dissecting the current state of accessibility
  • What roles separate antibody-based and cell-based therapies – can they all live together?
  • Discussing manufacturing production capabilities and scaling predictions for CAR-T: academic centers and community hospitals
  • Exploring pricing: can profitability be demonstrated?
  • Europe vs US vs global
  • Understanding age group considerations
  • How can we ensure timely CAR-T slot availability for patients in need? (Future of off-the shelf CAR-T’s or manufacturing changes?)
  • What clinical timelines are predicted: combinations, lines of therapy? What is the end goal?
  • How can we contextualize this in the competitive landscape? Competitive differentiation?

9:30 am Teclistamab (BCMAxCD3) Journey from Discovery to Filing

  • Suzette Girgis Senior Director & Head of Clinical Pharmacology & Hematologic Malignancies, Johnson & Johnson Services

Synopsis

  • Telling the story of a BCMA-targeted drug developmental success from bench to bedside
  • Exploring the latest exciting data and predicting gaps and future directions for space

10:00 am Correlates of Durable Response to Ide-Cel from the KarMMa Study

  • Nathan Martin Translational Scientist & Project Lead , Bristol Myers Squibb

Synopsis

  • Exploring baseline patient and tumor features associated with durable response
  • Understanding correlates of overall and complete response
  • Post-infusion correlates of more durable response

10.30 Morning Refreshments & Poster Session

11:30 am Zevor-cel (CT053) BCMA CAR-T Cells in Multiple Myeloma

  • Hong Ma Senior Vice President, Clinical Development , CARsgen Therapeutics

Synopsis

  • Reporting the safety and efficacy of zevor-cel CAR-BCMA T cells (CT053) utilizing a newly identified, fully-human BCMA-specific scFv with fine-tuned binding affinity
  • Zevor-cel showed low-level CD3 autophosphorylation and induced relatively lowlevel IL-6 secretion while displaying potent preclinical antitumor activities
  • Sharing results from two registration studies (LUMMICAR-1 in China and LUMMICAR-2 in US and Canada)

12:00 pm ARC-sparX Platform Technology & Novel BCMA-Targeting Binding Domain for the Treatment of Patients with RRMM

Synopsis

  • Exploring preclinical rationale, clinical trial results, and the next steps for CARTddBCMA as well as the next generation ARCsparX platform

12:30 pm Targeting Alternative T Cell Effector Pathways to Enhance the Anti-Tumor Activity of CD3-Engaging Bispecific Antibodies

Synopsis

– CD3-engaging bispecific antibodies drive potent anti-tumor activity in pre-clinical models as well as in patients
– However, not all patients respond to therapy and many relapse after initially responding
– Here, we describe novel therapeutics that engage alternative T cell signaling pathways and demonstrate combinatorial anti-tumor effects in high-bar pre-clinical models

1.00 Lunch Break

Combination Strategies & Sequencing of Therapies: Selecting Patients & Optimizing Trial Design

2:00 pm How to Select the Bi-Specific mAb For the Treatment of RRMM?

  • Maria-Victoria Mateos Consultant Physician, Myeloma Program & Clinical Trials Unit. Haematology Department & Associate Professor of Medicine , University of Salamanca

Synopsis

  • Patient and disease-based factors should drive the treatment decision making
  • Bi-specific mAbs are off the shelf-drugs that will present wide availability
  • Bi-specific mAbs might be combined wih other mABs or IMiD’s to complement the treatment strategies and improve outcomes

2:30 pm Exploring the Rational & Optimal Combinations

  • Enrique Zudaire Senior Scientific Director Head of Cell Therapy, Oncology Translational Research, Janssen Research & Development

Synopsis

  • Standardizing care: should we be more upfront with targeted therapies?
  • Exploring optimal ways to treat & overcome toxicities
  • Utilizing pre-clinical models to understand drug combinations and sequence
  • Sharing insights on the different hypothesis made for different combinations
  • BCMA CAR-T relapse, what’s next?

3.00 Afternoon Refreshments

3:30 pm Gamma Secretase Inhibitors: Potentiating BCMA-Targeted Therapies

  • Shinta Cheng Vice President Clinical Development , SpringWorks

Synopsis

  • Synergistic mechanism of action for gamma secretase inhibition on BCMA
    applies to all BCMA-targeted therapy modalities
  • Sharing an open development approach by partnering across all BCMA modalities and also broadly within each modality
  • GSI + BCMA combination synergy and potentiation as an example of translational medicine and precision medicine from proof-of-concept to validation with safety and efficacy evidence from clinical trials

4:00 pm Closing Panel Discussion: Future Directions for BCMA-Directed Therapies

  • Damian Green Associate Professor - Clinical Research Division , Fred Hutchinson Cancer Research Center (FHCRC)
  • Eric Fedyk Senior Vice President of Strategy, Relay Therapeutics
  • Suzette Girgis Senior Director & Head of Clinical Pharmacology & Hematologic Malignancies, Johnson & Johnson Services

Synopsis

  • Pricing/Cost
  • Accessibility changes
  • Is improved trial design needed?
  • How will they be commercialized?
  • What is the ultimate limit of BCMA as a target for myeloma?
  • How will cell therapy infrastructure evolve & how will this effect current situation?
  • Potential limitations to BCMA and how other targets (FcRb5/FcR115, NC28, CS1, SIRH5) could fit in the future clinical landscape
  • Long-term outlook

4:30 pm Close of Summit