Conference Day Two
Thursday, June 12

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7:45 am Check-In & Coffee

8:25 am Chair’s Opening Remarks

  • Enrique Zudaire Senior Vice President - Translational Sciences & Therapeutics Discovery, Caribou Biosciences

Optimizing Patient Dosing & Treatment for Enhanced & Lasting Therapeutic Outcomes

8:30 am Panel Discussion: Ensuring Lasting Therapeutic Responses from Allogeneic Therapy – Is Redosing the Way to Go?

Synopsis

  • Examine the role of redosing in sustaining therapeutic efficacy and preventing disease relapse in patients receiving allogeneic therapies
  • How do we determine if multiple doses are needed and if so, how do we determine how many?
  • Is it better to use a one and done model or plan for multiple doses?
  • Analyze the impact of treatment schedules and regiments such as lymphodepletion on patient outcomes when scheduling multiple doses

9:00 am Maximizing Treatment Outcomes Through Strategic Patient Selection by HLA Matching

  • Enrique Zudaire Senior Vice President - Translational Sciences & Therapeutics Discovery, Caribou Biosciences

Synopsis

  • Explore the criteria for identifying patients who are most likely to benefit from allogeneic therapies, focusing on genetic, clinical, and demographic factors
  • How can we determine which patient is more likely to have increased allogeneic rejection?

9:30 am Morning Break & Speed Networking

Preclinical

  • Enrique Zudaire Senior Vice President - Translational Sciences & Therapeutics Discovery, Caribou Biosciences

Synopsis

Track Chair: Enrique Zudaire, Senior Vice President of Translational Sciences & Therapeutics Discovery, Caribou Biosciences

Achieving Reliable & Effective Genetic Engineering to Transform Allogeneic Cells

10:30 am Leveraging a TALEN Engineering Platform to Generate Potent & Safe Armored CAR-Ts

  • Laurent Poirot Senior Vice President - Immunology & Translational Research Lead, Cellectis

Synopsis

  • Discussing the use of TALEN for advanced gene editing of T-cells
  • Creating smart CAR-Ts that can respond to their environment and have efficient activity when encountering the tumor micro-environment

11:00 am Leveraging the Latest Allo-Evasion Technologies for Prolonged Therapeutic Effects

  • Tim Guo Senior Scientist, GentiBio

Synopsis

  • Examine cutting-edge allo-evasion technologies designed to minimize immune rejection and prolong the efficacy of allogeneic therapies
  • Discuss the mechanisms behind these technologies and their potential impact on patient outcomes and treatment longevity

11:30 am Panel Discussion: Understanding the Merits & Feasibilities of HLA Matching

  • Enrique Zudaire Senior Vice President - Translational Sciences & Therapeutics Discovery, Caribou Biosciences
  • Cokey Nguyen President & Chief Executive Officer, Atara Biotherapeutics Inc.
  • Tim Guo Senior Scientist, GentiBio

Synopsis

  • Explore the importance of HLA matching in improving patient outcomes and reducing the risk of allogeneic rejection in allogeneic therapies
  • Evaluate the feasibility and logistical considerations of implementing HLA matching in clinical settings to optimize donor-recipient compatibility
  • Discuss recent advancements and tools that facilitate HLA matching processes, enhancing the overall efficacy of allogeneic treatments

Manufacturing & Process Development

Laying the Foundations for a Seamless Transition into Large Scale Manufacturing

10:30 am Upscaling & Transferring Manufacturing of an Allogeneic Active Immune Therapy in Preparation for Commercialization

Synopsis

  • Discussing key strategies to upscale manufacturing of an allogeneic dendritic cell cancer vaccine by partnering with CDMOs
  • Vididencel is a maintenance immunotherapy designed to improve relapse-free and overall survival in AML
  • Sharing strategies for a smooth tech transfer to take product manufacture to a larger level

11:00 am Expanding & Differentiating HSCs into NK Cells Using Stir Tanks for Large Scale Commercial Manufacturing

  • Rui Tostoes Vice President - Chemistry, Manufacturing, & Controls, ImmuneBridge

Synopsis

  • Employing a unique molecule to effectively expand HSCs into NKs and various desired cell types
  • Discussing the process of manufacturing in large quantities using bioreactors

11:30 am Panel Discussion: Key Considerations for Commercial Scale Manufacturing

Synopsis

  • Dive into key factors required to realize commercial scale manufacturing
  • Understanding when the right time for process lock is
  • Discuss whether to involve CDMOs, when to do so, and how to assess readiness for external manufacturing

12:15 pm Lunch Break & Networking

Leveraging Cell Engineering to Maximize Anti-Tumor Properties of Allogeneic Cells

1:15 pm Harnessing Allogeneic NK Cells: Non-Engineered, Engineered, & Combination Approaches in Oncology & Autoimmune Disorders

  • Monica Raimo Director - Product & Process Development, Glycostem Therapeutics

Synopsis

  • Clinical development of non-engineered NK cells in hematological malignancies
  • Preclinical innovations in engineered and combination NK cell therapies for oncology and autoimmunity

1:45 pm Engineering Next-Generation CAR cell Therapies to Navigate Challenges in Liquid & Solid Tumors

Synopsis

  • SENTI-202 is a CAR-NK cell therapy that uses logic gated gene circuits to address these challenges and has shown positive preliminary clinical data in AML
  • Solid tumors pose additional challenges. Senti has leveraged high throughput screening and machine learning to engineer next generation gene circuits, which work in both T and NK cells, designed for improved performance against solid tumors

Addressing Critical Bottlenecks to Manufacturing Larger Cell Batches to Unlock Mass Production

1:15 pm Approaches for Scalable Manufacturing of Engineered B-Cell Medicines: A New Class of Cellular Medicines

Synopsis

  • Be Biopharma has developed a new class of cellular medicines – Engineered B-Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable and administered without pre-conditioning
  • B-Cell Medicines (BCMs) are produced with ex vivo precision engineering of B-cells using CRISPR/Cas9 and homology directed repair-mediated transgene insertion followed by ex vivo differentiation towards plasma cell lineage
  • Process development, optimization and scalable manufacturing strategies will be discussed

1:45 pm Maximizing Cell Viability by Preventing Exhaustion During Cell Expansion

Synopsis

  • Explore innovative techniques to monitor cellular health and functionality throughout the expansion process
  • Discover the impact of culture media and environmental factors on preventing cell fatigue and maintaining robust performance

2:15 pm Afternoon Break & Networking

Building Allogeneic Therapies for Commercial Success Through Purposeful Product Development & Regulatory Expertise

3:00 pm Case Study: Comparing & Contrasting Product Development of Allogeneic Therapies Versus Autologous from Preclinical All the Way to Clinical

Synopsis

  • Sharing lessons learned from commercializing autologous CAR-T products and the application of these to allogeneic development
  • Discussing new challenges and considerations that arise with allogeneic products

3:30 pm Panel Discussion: Navigating the Regulatory Landscape in Allogeneic Product Development to Gain Clarity & Advance the Future of Universal Cell Therapies

  • Shirley Bartido Global Director, Regulatory Affairs, Cell Therapy Oncology, Takeda Pharmaceutical
  • Vibha Jawa Chief Scientific Officer, EpiVax
  • Janet Lambert Advisor, Alliance for Regenerative Medicine
  • Enrique Zudaire Senior Vice President - Translational Sciences & Therapeutics Discovery, Caribou Biosciences

Synopsis

  • Exploring the historical perspective that “your process is your product” and the implications of frequent process changes on regulatory submissions
  • Examining key differences in regulatory expectations for allogeneic versus autologous therapies
  • Discussing strategies for maintaining open communication with regulators to foster understanding and facilitate smoother approvals

4:00 pm Closing Remarks

  • Enrique Zudaire Senior Vice President - Translational Sciences & Therapeutics Discovery, Caribou Biosciences

4:10 pm End of Conference