Conference Day Two

8:00 am Registration Open & Coffee Networking

8:50 am Chair’s Opening Remarks

Maximizing Manufacturing Development to Achieve Clinical & Commercial Success for Next Generation Therapies

9:00 am Defining Critical Quality Attributes (CQAs) of TIL Products

Synopsis

• Discuss an overview of CQAs of TIL products

• Explore how CQAs can be tailored to specific product in hand – Development and validation of assays, establishing acceptance criteria

• Examine CQAs as parameters to understand the clinical effect of TIL products

9:30 am Decentralized Approach to Autologous Cell Therapy Manufacturing – Advantages of Harmonized TILs Manufacturing at a Point of Care

  • Moran Meiron Senior Director of Advanced Therapies, Orgenesis Inc.

Synopsis

• Maintaining high quality by harmonized approach at decentralized Point of Care

• Increasing TIL therapy accessibility using mobile processing units for global deployment and scale out

• Developing a closed system for TIL manufacturing at point of care to both reduce contamination risk and production cost

10:00 am Using AI-Powered Bioinformatics & Antigen Presenting Cells to Create a Measurable & Trackable Precision TIL Product Targeting Clonal Neoantigens

  • Sergio Quezada Co-Founder & Chief Scientific Officer, Achilles Therapeutics Limited

Synopsis

• Discover using AI-powered bioinformatics and knowledge of cancer evolution to target clonal neoantigens

• Explore clonal antigens as the ideal solid-tumor targets

• Decipher potential potency assay benefits to a trackable, measurable product

10:30 am Morning Break & Speed Networking

Gene Editing Spotlight & the Potential to Increase Efficacy & Potency in TIL

12:00 pm Rational Design of CRISPR/Cas9-engineered TIL Therapies

  • Micah Benson Senior Vice President & Head of Research, KSQ Therapeautics

Synopsis

• Harnessing CRISPR to identify TIL-enhancing targets

• Analyzing designing and manufacturing next-gen TIL therapies with increased anti-tumor potency

• Examining KSQ-001 and KSQ-004 as single- and dual-edited CRISPR/Cas9- engineered TIL products

12:30 pm Utilizing Multiplex CRISPR Gene Editing to Assess New Classes of Intra Cellular Immune Checkpoint Molecules for Application in TIL

Synopsis

• Comparing the function of CISH deletion relative to both extracellular and intracellular immune checkpoints in neoantigen cytolysis models

• Demonstrating intra-cellular immune checkpoint protein CISH can potentially enhance anti-tumor responses against a broad range of cancer types regardless of PD-L1 biomarker status

• Considering next generation checkpoints and the application to TIL

1:00 pm Engineering an IL2-Free, Potent & Persistent TIL With Regulated Membrane-Bound IL15

Synopsis

• Sidestepping capillary leak syndrome associated toxicity and Treg effects

• Removing the need for toxic and costly IL2 therapy associated with conventional TILs

• Uncovering clinical potential as a novel TIL product with enhanced safety and efficacy

1:30 pm Lunch Break & Speed Networking

2:00 pm Are Tumor-Reactive TIL Really Exhausted or Can They Be Rescued For Adoptive T cell Therapy: Clinical Implications

Synopsis

• CD8 TIL that express both CD39 and CD103 are highly enriched for tumor reactivity and appear to have an exhausted phenotype

• The CD39/CD103 double CD8 TIL can be expanded into the billions during a 3-4 week expansion phase. Once expanded they have the capacity to kill tumors in vitro and in vivo and survive long-term in tumor-bearing hosts

Integrating Potency Assay Strategies to Facilitate Regulatory Success

3:30 pm Round Table Discussion – Facilitating Discussion, Debate & Collaboration Around Potency Assay Design & Implementation to Front Load for Regulatory Success

Synopsis

TIL therapies without question pose unique and multifaceted problems when considering the development of potency assays. This round table discussion will provide the opportunity for group participation surrounding the ideas and theories around potency assay development to address the common problems and challenges associated with potency assays for TIL therapies.

3:30 pm Chair’s Closing Remarks & End of Conference