Allogeneic Cell Therapy Summit 2022

Grand Ballroom I and II

8:00 am Registration & Coffee Room Networking

9:15 am Chair’s Opening Remarks

Blake Aftab CSO, Adicet Bio

Lessons Learned from Clinical Case Studies to Fast Track Your Pipelines to Clinical Success

9:30 am Donor Derived Gamma-Delta T Cells; Path Towards Sold Tumor Therapies

William Ho CEO, IN8Bio

Synopsis

Reviewing gamma-delta T cells; nonrestrictive lymphocytes that are thought to be attractive for allogeneic therapies
Outlining our INB-100 phase I program, which is the first to have delivered a large bolus of ex-vivo expanded and mismatched gamma-delta
T cells into lymphodepleted leukemia patients
Providing safety data to advance our donor derived INB-400 program into the solid tumor setting

10:00 am Allogeneic NK-92 Cells: Advancing from Pre-Clinical Development to Clinical Application

Hans Klingemann CSO, ImmunityBio

Synopsis

Recapping the pre-clinical development of NK-92 and its clonal ‘offsprings’
Showcasing the outcome of first clinical studies
Reviewing novel NK-92 based variants expressing FcR, CARs and immune modulators

10:30 am Characterized Starting Materials for Accelerated and Scalable Allogeneic Cell Therapies

Dominic Clarke CTO, Cell & Gene Therapy , Discovery Life Sciences

Synopsis

Leveraging access to highly annotated diseased biomaterials for enhanced target discovery
Outline how characterized donor source materials can impact consistency from process development to manufacturing
Incorporating multiomic analytics of the cell-based starting materials to enhance downstream processing

11:00 am Morning Refreshment Break & Structured Networking

Synopsis

As the allogeneic community is reunited, this valuable session will ensure you can reconnect with your peers in the room to make new and lasting connections. Also, don’t forget to enjoy some refreshments before we split off into the four different tracks: pre-clinical, translation, manufacturing and supply/storage.

Track 1: Pre-Clinical

Chair: Peggy Sotiropoulou, CSO, T-Knife
Therapeutic

Genetic Modification Strategies to Improve Persistence & Potency

Grand Ballroom I

12.00 Overall Avidity Between Tumor and Effector Cells, but Not Affinity, Predicts Downstream Function of Cellular Therapies

• Discuss how avidity measurements can determine ideal allogeneic donors
• We present data discussing how increased specific avidity, those TCR’s with strongest antigen binding with the lowest background, correlate with improved TCR function in-vitro and in-vivo
• How CAR-T and TCR-T avidity is significantly more correlative to in-vivo outcome than either cytotoxicity assays or IFN-g release

Will Singleterry, Commercial Director, Immuno-Oncology, LUMICKS

12.30 Improving T Cell Fitness with TurboCARs

• Recapitulating cytokine signaling selectively in CAR T to reduce rejection
• Delivering survival benefit selectively to CAR T cells
• Outlining preclinical data that shows improved engraftment and persistence, and delayed exhaustion

Barbra Sasu, CSO, Allogene Therapeutics

1.00 Next Generation Genome-Edited T Cell Therapies

• Overcoming the challenges associated with CAR-T cell therapies
• Tackling hematological malignancies with genome-edited allogeneic CAR-T cell therapies
• Exploring genome-editing approaches to increase persistence and suppress allograft rejection

Elizabeth Garner, Director, T Cell Therapeutics, Caribou Biosciences

1.30 Lunch Refreshment Break

1.30 Private Lunch Hosted by Cardinal Health - Attendance by Invitation Only

Genetic Modification Strategies to Improve Persistence & Potency

3.00 Generating Hypo-Immune Off-the Shelf CAR-T Cells for an Allogeneic Pipeline

• Immune systems are built to reject foreign cells, which can contribute to CAR-T cell toxicity and a lack of cell persistence (Sterner RC, Sterner RM, Blood Cancer J. 2021;11:69)
• To circumvent this, we are attempting to remove the individual fingerprint of these cells by targeting HLAs and overexpressing a “don’t attack me molecule”
• Our data show that these allogeneic CAR-T cells can overcome the adaptive and innate immune barrier while maintaining their CAR-T function against tumor cells

Sonja Schrepfer, Head of Hypoimmune Platform, Sana Biotechnology

3.30 Panel Discussion: Gene Engineering in Allogeneic Cell Therapy: The Next Chapter

• Gene editing vs non editing approaches and its effect on genomic instability
• Unraveling pre-clinical regulatory considerations to ensure patient safety when translated into the clinic
• Addressing suicide genes – are they necessary going forward?
• Debating how far can gene engineering take us

Joanna Brewer, SVP, Allogeneic Research, Adaptimmune
Luke Pase, CTO, Anocca
Vipin Suri, CSO, Catamaran Bio
Kate Rochlin, COO, IN8Bio

Genetic Engineering Techniques to Improve Cell Function & Safety

4.00 Refreshment Break & Poster Session

4.45 Utilizing Rag Gene Editing to Prevent GVHD and Improve Safety

• Outlining our off-the-shelf SPEAR T-cell program with the use of Rag gene editing
• Controlling the endogenous TCR to prevent GVHD and rejection
• Generating potent cells that keep their TCR specificity for future clinical success

Joanna Brewer, SVP, Allogeneic Research, Adaptimmune

5.15 Transient Fratricide-Induced MidProcess Activation Contributes to Base Edited Anti-CD7 CAR T expansion and Final Drug Product Attributes

• Avoiding extensive fratricide by silencing CD7 expression in therapeutic T cells
• Eliciting a unique stimulation event that effects cell growth and final phenotype
• Improving base editing efficiency by removing unedited and partially-edited cells from the population, thereby potentially improving the safety and efficacy profile of the product

Alden Ladd, Associate Director, Cellular Process Development, Beam Therapeutics

Track 2: Translational

Chair: Oscar Segurado, CMO, ASC Therapeutics

Navigating IND Enabling Studies to Secure Approval for First-in-Human Clinical Trials

Grand Ballroom II

12.00 Monitoring Allogeneic Cell Therapy Expansion & Persistence Using a Highly Sensitive, Accurate & Universal Solution

• Expansion and persistence of cellular therapies have been correlated with therapeutic efficacy and patient safety in various studies
• AlloCell is a next-generation sequencing (NGS) based solution that uses single nucleotide polymorphisms (SNPs) to quantify the amount of cell therapy product in the patient
• Presenting data on AlloCell use across multiple cellular therapies development programs for the measurement of cell therapy kinetics across academia and industry

Ashish Kothari, VP, Clinical Development, Cell Transplant Therapy , CareDx

12.30 Sharing Regulatory Considerations to Streamline Allogeneic Development

• Outlining the regulatory expectations to fast-track IND submission of your allogeneic product
• Examining the required data to demonstrate safety and efficacy, and perspectives on preclinical models
• Sharing requirements for quality and safety assays in IND phase, and considerations to plan for phase II

Elena Spanjaard, VP, Early Development Regulatory Affairs, Elevate Bio

1.00 Roundtable Session: How to Best Approach IND-Enabling Studies

• Preparing for a successful IND program, does this differ between autologous and allogeneic products?
• Navigating pharmacology, pharmacokinetics, toxicology assessments and more

Oscar Segurado, CMO, ASC Therapeutics

1.30 Lunch Refreshment Break

1.30 Private Lunch Hosted by Cardinal Health - Attendance by Invitation Only

Overcoming Issues with Tolerability & Toxicity to Ensure Patient Safety

3.00 Off-the-Shelf iNKT Cells in Multiple Indications with Increased Safety

• Exploring the benefits of iNKT cells, whether it be in their native form or engineered/edited for super-targeting
• Dosing with no neurotoxicity or cytokine release syndrome
• Reviewing pre-clinical and clinical data in cancer, GvHD & COVID-19

Mark Exley, SAB Member & Senior Advisor, MiNK Therapeutics Inc.

3.30 Panel Discussion: Abrogating Host Immune Rejection to Achieve Lasting Responses

• Showcasing translatable data outlining the mechanism of rejection
• Evaluating possible modifications to prevent rejection

Austin Bigley, VP, Director of Research & Development, Indapta Therapeutics
Eric Halioua, CEO, PDC*Line Pharma
Evren Alici, Head of Cell & Gene Therapy, Karolinska Institutet

4.00 Refreshment Break & Poster Session

Translating Allogeneic Platforms & Technologies to the Clinic

4.45 Characterization and Translation of Novel Allogeneic Cell Therapies

• Design and characterization of multiple targeting technologies for allogeneic cell therapies
• Translational opportunities for CAR, multifunctional enhancements, and allogeneic cell platforms
• Insights from first-in-human experiences with non-gene modified allogeneic cell therapies

Blake Aftab, CSO, Adicet Bio

5.15 Next Generation Allogeneic Modality for Solid Tumors: Beyond T-cells or NK cells

• Learning about the role of critical macrophages in the tumor microenvironment
• Presenting preclinical models of various solid tumors demonstrating strong antitumor activity of Allocetra: allogeneic cellbased therapy
• Translating Allocetra into the clinic in 2022 as a promising novel cell based therapy for solid tumors

Oren Hershkovitz, CEO, Enlivex Therapeutics

Track 3: Manufacturing

Chair: Christina Coughlin, CEO, Cytoimmune Therapeutics

Scalable Manufacturing Platforms

North Shore Ballroom B

12.00 Applying the Manufacturing by Design Approach to Allogeneic Cell Therapy Process Development

• Scaling up vs scaling out for allogeneic production and fill/finish
• Using DOE as part of a Manufacuring by Design (MbD) approach to process design

Michael Francis, Process Development Scientist, Catalent Cell & Gene Therapy

12.30 Starting with the End in Mind: Deploying Fit-for-Growth Capabilities to Drive Operational Scalability

• Understanding how early CMC decisions can impact cell therapy manufacturing scalability
• Weighing the pros and cons of developing in house vs outsourcing manufacturing capacity
• Leveraging automation to increase consistency and throughput
• Driving continuous improvement across, processes, materials and equipment

Bradley Glover, CTO, Celularity

1.00 Utilizing the Appropriate Process & Equipment to Achieve Scalable Manufacture

• Outlining Rubius’ unique platform technology
• Utilizing bioreactors to expand in large quantities to require fewer donors
• Discussing downstream technologies to enable improved cell capture vs protein capture

Spencer Fisk, SVP & CTO, Rubius Therapeutics

1.30 Lunch Refreshment Break

1.30 Private Lunch Hosted by Cardinal Health - Attendance by Invitation Only

Scalable Manufacturing Platforms

3.00 Considerations for the Design of a Scalable Manufacturing Facility for Off the-Shelf Products

• Developing a scalable process that maximizes cell output
• Utilizing closed system processing to reduce cleanroom requirements and ensure quicker turnover
• Optimizing process flow and facility design to maximize facility and equipment utilization

Ralph Brandenberger, VP, Development & Operations, Nkarta Therapeutics

3.30 Panel Discussion: Process Development for Scalable Manufacture

• Exploring cell and phenotype selection, material type and chromosome stability – how do they influence scalable expansion?
• Addressing the challenges associated with large scale expansion
• Are iPSCs the way forward?

James Glover, SVP, Commercial Manufacturing, Athersys
Bradley Glover, CTO, Celularity
Martin Giedlin, VP, Head of Technical Operations, Senti Biosciences
Benjamin Gysi, Director, Cell Therapy Operations, Takeda
Robert Margolin, VP, Sales, Akron Biotech

4.00 Refreshment Break & Poster Session

Manufacturing Considerations Dependent on Starting Material

4.45 Manufacture of “Off-the-Shelf” Immunotherapy: Gene-edited iNK Cells for Solid Tumors

• What are the important features for product-centric allogeneic immunotherapy, and how can we create this using iPSCs?
• Lessons learned and implementation of gene-editing, and manufacture of effective iPSC derived natural killer cells
• Product development: translational studies toward the clinic with CTH-401

Nicholas Boyd, Chief Development Officer, Cartherics

5.15 Manufacturing Considerations for a Donor Derived NK Product

• Donor-derived starting materials: how much variability can be tolerated?
• Nonviral engineering methods provide significant benefits for payload delivery, multiplexed edits, and COGs
• Exploring expansion impacts

Joseph Gold, VP, Technical Operations & Manufacturing, Catamaran Bio

Track 4: Supply/Storage

Chair: Michael Leek, Co-Founder & Executive Chairman, TC BioPharm

Cold-chain Supply Considerations for End-to-End Success

North Shore Ballroom C

12.00 Ensuring Starting Material Availability & Consistency for Success in Development & Commercial Manufacturing of Allogeneic Cell Therapies

• Reducing starting material variability in the healthy donor cells used in the manufacture of cellular therapies
• Sourcing cells from a single, geographically broad network of donor collection sites to ensure donor base diversity, starting material flexibility and supply
• Recognizing and overcoming challenges in scaling up cell sourcing during progression through clinical trial phases and into commercial launch

Melissa Sebok, Senior Director, Product Management, Direct Patient Care & Emerging Offerings, American Red Cross

12.30 Standards and Strategies for Establishing Fit-For-Purpose Cell Viability Assays: Considerations for Post-Thaw Viability

• Reviewing relevant standards and standards under development for evaluating cell viability in cell therapy products
• Describing technical strategies for establishing and controlling fit-for-purpose cell viability assays
• Discussing specific considerations for evaluating cell viability post-thaw

Sumona Sarkar, Biomedical Engineer, National Institute of Standards & Technology

1.00 If You Build It, Will They Come? Vertical Integration of the Starting Material Supply Chain

• Leveraging Gift of Life’s large donor registry to provide diversity and depth of selection for specialized starting material needs
• Vertically integrating the donor management, collection, processing and cryopreservation supply chain to provide high quality, consistent, GMP compliant starting material
• Utilizing closed systems for processing and cryopreservation

Francesca Gullo, Scientific Director, Gift of Life Biologics

1.30 Lunch Refreshment Break

1.30 Private Lunch Hosted by Cardinal Health - Attendance by Invitation Only

Standardizing Cryopreservation to Ensure Your Product Remains Efficacious

3.00 Cryobiology & Formulation Considerations for Best-in-Practice Allogeneic Cell Therapy Manufacturing

• Formulation impact to cellular therapy stability
• Fill-finish and container closure considerations for allogeneic scale cellular therapies
• Cold chain handling impact to cells, and cold chain considerations for large cell banks

Katie Pollock, Head of Formulation & Cryobiology, BMS

3.30 Panel Discussion: Achieving Long Lasting Potency with Optimal Storage Conditions

• Outlining the pros and cons of fresh vs frozen
• Determining the best culture to maintain cell quality
• Discussing the difference in cryopreservation conditions for different cell types

Yuechen Zhu, Process Development Scientist, Bayer
Chia-Hsing Pi, Scientist II Process Development, BlueRock Therapeutics
Katie Pollock, Head of Formulation and Cryobiology, BMS
Jason Acker, Professor, University of Alberta
Allison Hubel, Professor, University of Minnesota

4.00 Refreshment Break & Poster Session

On Site Logistic Considerations at Banks & Hospitals

4.45 The Last Mile to the Patient in Allogeneic Cell Therapy

• Unique requirements for the preparation and delivery of allogeneic cell therapies to patients
• Emerging developments in industry capabilities – logistics, equipment, service providers
• Considerations and choices for the clinicalstage allogeneic cell therapy company

Maia Hansen, SVP & Head of Operations & Supply Chain, Athersys

5.15 Standardizing On-Site Handling Out of the Deep Freeze

• Preparing for extenuating circumstances: how does rough handling and partial thawing effect the product?
• Rethinking how to train on-site personnel for best delivery during clinical operations
• Exploring how to support sites that aren’t used to frozen cell therapy products

This Meeting has Run

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Day One

Day Two

Grand Ballroom I and II

8:00 am Registration & Coffee Room Networking

9:15 am Chair’s Opening Remarks

Lessons Learned from Clinical Case Studies to Fast Track Your Pipelines to Clinical Success

9:30 am Donor Derived Gamma-Delta T Cells; Path Towards Sold Tumor Therapies

Synopsis

10:00 am Allogeneic NK-92 Cells: Advancing from Pre-Clinical Development to Clinical Application

Synopsis

10:30 am Characterized Starting Materials for Accelerated and Scalable Allogeneic Cell Therapies

Synopsis

11:00 am Morning Refreshment Break & Structured Networking

Synopsis

5:45 pm Closing Remarks & Close of Conference

6:00 pm Drinks Reception

Synopsis

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