Agenda

8.30 am Coffee & Networking

9:25 am Chair’s Opening Remarks

  • Lawrence Lamb Executive Vice President & Chief Scientific Officer, IN8Bio

Interrogating Clinical Updates in Solid Tumors & Highlighting Future Pipeline Opportunities

9:30 am Bispecific Vγ9Vδ2-T Cell Engagers for Immunotherapy of Solid & Hematological Malignancies

Synopsis

  • Discussing the design and preclinical work to demonstrate efficacy and safety of bispecific engagers directed against Vγ9Vδ2-T cells
  • Highlighting the tri-specific properties of a CD1d-Vδ2 bispecific T cell engager
  • Presentation of early clinical and pharmacodynamics data from phase 1 programs

10:00 am Deep-Diving into the Clinical Impacts of Different Targeted Approaches to Target Solid Tumors

Synopsis

  • Combination therapy approaches with gamma delta T cells to enhance killing in solid tumors – chemotherapy, engagers, antibodies
  • Clinical data from INB-200 Phase 1 trial in GBM and Phase 2 design
  • Targeting to solid tumors without inhibiting natural killing ability through the use of non-signaling gamma delta T cell technology
  • Dosing strategy for gamma delta T cells in solid tumors, repeat, local and systemic dosing
  • Highlighting the variation in dose requirements and resulting cell therapy dosage for different tumor type

10:30 am Morning Refreshments & Networking

Research & Translational Development

Supercharging Homing, Targeting, & Immune Surveillance to Efficiently Clear Solid Tumors

11:00 am Leveraging Antibodies to Target Gamma Delta Mediated Immunosuppression to Battle Tumors

Synopsis

  • Understanding how inflammatory processes drive immunosuppression through gamma delta T cells in the tumor microenvironment
  • Leveraging the activity of monoclonal antibodies to inhibit immunosuppression in pancreatic cancer and other solid tumors
  • Exploring gamma delta activation mechanisms and how they can modulate other T cell mechanisms

11:30 am Evaluating Toxicology and Tracking the Migration of CAR-Engineered Gamma Delta T Cells to the Tumor Site for Biodistribution Studies

Synopsis

  • Tracking the in vivo localization of gamma delta T cells, demonstrating tumor infiltration, and analyzing PK/PD data in vivo
  • Boosting the activation and cytotoxicity at the site through combination therapy
  • Developing toxicology analysis of gamma delta CAR T cells for IND-enabling studies

12:00 pm Roundtable: Comparing the Therapeutic Responses to Gamma Delta T Cells vs. Alpha Beta Cell to Demonstrate Greater Clinical Efficacy to Stakeholder

Synopsis

  • In this session we will collaborate to explore the physiological impacts of therapies, considering changes in the tumor microenvironment, anti-inflammatory and pro-inflammatory cytokines and cell types within the tumor. We will brainstorm to elucidate the best practices when demonstrating clinical efficacy of gamma delta therapies over the alpha beta approach.

Clinical & Product Optimization

Expanding & Engineering Gamma Delta T Cells to Maximize Persistence

11:00 am Benchmarking Differences in Expansion Protocols for Different Gamma Delta-Derived Subtypes to Tailor Manufacturing Protocols to Cell Subtype

  • Beau Webber Chief Scientific Officer & Founder, Luminary Therapeutics

Synopsis

  • Harnessing techniques to efficiently scale up cells while minimizing the impact of processing on the fragility of the cells
  • Engineering in an immune cloaking element, and demonstrating expansion of engineered cells in multiple subtypes
  • Balancing expansion, exhaustion, and persistence with immune cloaking technologies

11:30 am Incorporating Engineering into the Expansion Process to Minimize Cost-of-Goods & Manufacturing Turnaround Time

  • Joshua Kellner Senior Director Manufacturing Science & Technology, Kiromic Biopharma

Synopsis

  • Modifying cells in the expansion process to enhance biological function
  • Defining scalable, cost-effective manufacturing procedures to ensure that there is enough engineered product or enough to combine with antibodies
  • Streamlining recharacterization of products to test viability in an iterative process
  • Sharing challenges and future opportunities to incorporate engineering within other manufacturing procedures

12:00 pm Application of OptiALLO γδ T, A Novel GMPCompatible Method, for Generating Off‐the‐Shelf Allogeneic CAR γδ T Cells for Therapeutic Use

  • Wei Liang Associate Director, Research & Development, Ansun Biopharma

Synopsis

  • Developing a proprietary vδ2 γδ T cell expansion process –OptiALLO γδ T – that eliminates the reliance on feeder cells, antibodies, microbeads, or aminobisphosphonate‐related compounds
  • Understanding the OptiALLO γδ T cell process for its technical and economic potentials and clinical applications
  • Producing IL‐15 armored TROP2 CAR γδ T cells for solid tumor treatment using the OptiALLO γδ T cell process.
  • Evaluating the cell products in preclinical in vitro and animal studies

12.30 pm Lunch & Networking

Research & Translational Development

Modulating Gamma Delta T Mechanisms of Action to Target Solid Tumors

1:30 pm Virtual Talk: Characterizing Human Vδ1+ and Vδ2+ γδ T Cells to Advance Tumor Immunotherapy Development

  • Kok Fei Chan Research Fellow, Olivia Newton-John Cancer Research Institute

Synopsis

  • Understanding the role of TCR vs NK2G receptors in mediating cytotoxic function to identify the most efficacious checkpoint therapy
  • Harnessing the synergy or negative regulation of receptor signalling between subsets to maximize therapeutic potential
  • Assessing the impact of TCR selectivity due to HLA matching to prevent the patient pool from narrowing

2:00 pm Panel Discussion: The Great Debate – Vδ1 vs. Vδ2 & Beyond. Which Will Win, Where, and Why?

Synopsis

  • Outlining the breadth of gamma delta T subsets
  • Considering existing preclinical and preclinical data for different subsets, and factors influencing their success
  • Debating the use of subsets independently vs. in combination, and how our understanding of subset mechanisms can inform drug development

2:45 pm Redirecting T Cells to Gamma Delta Ligands for Improved Tumor Trafficking

Synopsis

  • Outlining the Immunocore Platform
  • Understanding the role of gamma delta in tumors, and reviewing clinical learnings
  • Demonstrating proof of principle of T cell redirection via Vδ2 Vγ9-ImmTAC molecules

Clinical & Product Optimization

Gauging Potency & Product Purity to Secure High Quality, Regulatory Approved Clinical Products

1:30 pm Robustly Measuring Repertoire & Potency of Optimally Expanded Gamma Delta TILs for Gastrointestinal Malignancies

  • Michael Lotze Professor of Surgery, Immunology and Bioengineering, University of Pittsburgh

Synopsis

  • Measuring the diversity of gamma delta t cell subsets to review possible mechanisms of action and characterize products
  • Optimizing expansion by adjusting reagents, cytokines and antibodies to scale up high-quality cell products
  • Identifying and mitigating areas for error in potency assays to achieve consistency of readout

2:00 pm Panel Discussion: What Constitutes a Good Measure of Purity, Potency & Identity?

  • Kelly Goldsmith Professor, Emory University
  • Michael Lotze Professor of Surgery, Immunology and Bioengineering, University of Pittsburgh
  • Joshua Kellner Senior Director Manufacturing Science & Technology, Kiromic Biopharma

Synopsis

  • Discussing current measures for purity, potency and identity used for gamma deltas and their compliance with regulatory requirements
  • Assessing the differences in characterization measures between gamma deltas and alpha betas
  • Laying out steps towards analytical, process development, and manufacturing of pure and potent gamma delta T cells in a single entity

2:45 pm Considerations & Strategies for γδ T Cell Expansion & Opportunities for Intervening γδ T Cell Exhaustion

  • Yu Qian Associate Director, CMC, Cell Therapies, Takeda

Synopsis

  • Considerations and strategies for T cell expansion
  • Overview of current γδ T cell expansion strategies in the field
  • Opportunities for intervention of γδ T cell exhaustion

3.15 pm Afternoon Refreshments & Networking

Next Steps in Gamma Delta T Development

3:45 pm Taking a Proactive & Strategic Approach when Attracting, Developing, & Retaining Talent

Synopsis

  • Exploring challenges facing cell and gene therapy industry leaders from a people and culture perspective
  • Understanding and enhancing the employee value proposition
  • Providing practical takeaways you can implement regardless of role or level

4:15 pm Panel Discussion: Discussing the Application & Opportunities to Progress Gamma Delta T Therapies in a Competitive Therapeutic Landscape

  • Hunter Jonus Postdoctoral Fellow, Emory University
  • Jeff Liter President & Chief Executive Officer , Luminary Therapeutics

Synopsis

  • Discussing opportunities and challenges to achieve investor, physician, and pharmaceutical industry buy-in to progress to commercialization
  • Debating the need to embrace engineering, streamline process development and widen the patient pool to secure strong clinical results and achieve VC backing
  • Developing gamma delta T-specific technologies to enhance R&D, clinical translation, and process development to advance through the pipeline
  • Sharing VC perspectives on the gamma delta T landscape and elucidating what needs to be demonstrated to secure investment

4:45 pm Engineering Allogeneic Gamma Delta T Cell Therapies: Opportunities & Challenges, Present & Tomorrow

  • Huan Yang Associate Principal Scientist, Merck

Synopsis

  • Exploring the specific challenges of approved CD3 engagers, to pinpoint gaps for gamma delta T to help, such as cytotoxicity
  • Reviewing successes and lessons from other adoptive cell therapies and the potential for enhanced safety profiles, scalability, and indication-specific development with gamma delta T
  • Discussing the future challenges to predict and remove obstacles to progress gamma delta T cell therapy development

5:15 pm Chair’s Closing Remarks

5:30 pm End of Day Two & Close of Summit