8:15 am Chair’s Opening Remarks

Advancing Allogeneic Cell therapies to Commercial Scale Production

8:30 am Allogeneic Cell Therapies as the Future of CAR-T

Synopsis

  • Exact talk details to be confirmed

9:00 am Pluripotent Stem Cell Product Platform as a Unique Means to Mass Produce Off-the-Shelf Allogeneic Cell Products

Synopsis

  • Examining how pluripotent stem cell technology represents a unique and powerful approach to make cell-based therapies available to a wide range of patients through the generation of a well-defined and uniform “off-the-shelf” source of therapeutic cells
  • Highlighting that engineered clonal master iPSC lines can be developed to manufacture hundreds to thousands of doses of the drug product in a costeffective manner
  • As a case study, describing the development of off-the-shelf CAR-NK and CAR-T cell products manufactured from a clonal engineered master iPSC line

9:30 am The Use of QTPP as a Tool in the Development of an Allogeneic Cell Therapy

Synopsis

  • The creation of a Quality Target Product Profile (QTPP) can be an important tool in
    biologics manufacturing
  • Comparisons of the opportunities and challenges in QTPP construction between cell
    therapies and recombinant proteins
  • The importance of making progress in robust product understanding to enable
    manufacturing advances

10:00 am An Allogeneic, Off-the-Shelf NK Cell Product Derived from Placental Hematopoietic

Synopsis

  • Clinical studies suggest that adoptive transfer of allogeneic natural killer (NK) cells represent a promising treatment for patients with hematological malignancies and solid tumors
  • Celularity is developing an allogeneic, off-the-shelf NK cell product that is derived from placental hematopoietic stem cells and exhibits substantial cytolytic activity against various cancer cell lines, primary AML and primary MM cells
  • Clinical and translational development of Celularity NK cell product will be discussed

10:30 am Morning Refreshments & Speed Networking

11:30 am Development of a Scalable Manufacturing Platform for Off-the-Shelf Genetically Engineered, Allogeneic Natural Killer (NK) Cell Products

Synopsis

  • Overview of Nkarta’s NK cell platform
  • Scalability of the platform
  • Path to commercialization

12:00 pm Genetically Modified NK Cells, Promises, Pitfalls and Potentials

Synopsis

  • Elucidating critical factors for long term NK cell engraftment
  • Decreasing vein to vein time
  • Bottlenecks in NK cell gene modification

Exploring Automation as a Means to Reducing Cost and Increasing Efficacy

12:30 pm Incorporation of Semi-Automated Methods for Manufacture of High Dose NK Cells Using the PM21 Platform

Synopsis

  • PM21 allows for high scale expansion of high potency NK cells to therapeutically relevant high dosages for oncology
  • CytoSen has incorporated semi-automated methods for manufacture of therapeutic NK cells
  • Automated methods are likely to aid in consistency of manufacture

1:00 pm Lunch & Networking

2:00 pm Perspectives on Developing Non-gene Edited Allogeneic CAR T Therapies

Synopsis

  • NKG2D is now a clinically validated target for AML/MDS patients
  • CYAD-101: A clinical stage NKG2D CAR T cells therapy built on TCR Inhibitory Molecule (TIM)
  • Introducing our proprietary non-gene edited shRNA platform for allogeneic CAR T therapies

2:30 pm Novel Allogeneic Cell Therapies for Treatment of Solid Cancers

Synopsis

  • What are the success factors for clinically and commercially successful treatment of
    solid cancers?
  • XPRESIDENT® antigen discovery platform for novel tumor targets and T-cell receptors
  • ACTallo® allogeneic gamma-delta T cell platform
  • Outlook: warehouse-based off-the-shelf and fully tailored immunotherapies attacking multiple tumor targets
    Examining the Regulatory Landscape for Allogeneic

Examining the Regulatory Landscape for Allogeneic Cell Therapies

3:00 pm Novel Allogeneic Cell Therapies for Treatment of Solid Cancers

Synopsis

  • What are the success factors for clinically and commercially successful treatment of solid cancers?
  • XPRESIDENT® antigen discovery platform for novel tumor targets and T-cell receptors
  • ACTallo® allogeneic gamma-delta T cell platform
  • Outlook: warehouse-based off-the-shelf and fully tailored immunotherapies attacking multiple tumor targets

3:30 pm Afternoon Refreshments

Addressing the Logistical Needs of Allogeneic Cell Therapies

4:00 pm Roundtable Discussion: Examining Logistical Challenges Specific to Allogeneic Cell Therapies

Synopsis

More practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas. A valuable chance for attendees to unite around hot topics and debate best practice. No more sitting quietly, this is a dedicated opportunity for you to voice your experience and identify unique solutions.

5:00 pm Chair’s Closing Remarks

5:15 pm End of Day One