8:00 am Breakfast & Networking

9:00 am Chair’s Opening Remarks

9:15 am Selection of an Optimal Antibody as the Targeting Moiety of CAR-T Cells

Synopsis

  • Immunogenicity of the antibody in the CAR-T cells
  • Specificity of the antibody in the CAR-T cells
  • Tonic signaling related to the antibody structure

9:45 am Entering A New Era of Cell and Gene Therapies: Industrialization of Manufacturing

10:15 am Enriching the Benefit-Risk Equation for Solid Tumor CAR-T while Accelerating Learning: A Case for Logic-Gated, Multi-Product Umbrella Trial Designs

  • Wendy Li Chief Medical Officer, EXUMA Biotechnology

Synopsis

  • Data variability with patient population, manufacturing process, and CAR
    construct design can make comparative analyses of CAR constructs challenging;
    this novel precision medicine-directed umbrella design illustrates the strengths
    and weaknesses of such trials, and may facilitate CAR design and may
    accelerate early signal detection when conducting a first-in-human Ph1 CAR-T
    study
  • The current, ongoing IIT is a novel, two product umbrella trial investigating
    CCT301-38 AXL and CCT301-59 ROR2, two first-in-human, logic-gated CAR
    designs in one patient population: relapsed / refractory metastatic renal cell
    carcinoma
  • Preliminary results support the hypothesis that is it possible to gain actionable
    insights quickly with fewer patients in a comparative design: as of the Jan 31,
    2019 data cut seven patients have been dosed; no DLTs or on-target, off-tumor
    toxicity has been observed thus far and no patients have experienced greater
    than Grade 2 CRS

10:45 am Managing Complexity Across the Ecosystem of Cell Therapy Industrialization

  • Zoey Ni Cell & Gene Therapies Enterprise Solution Technical Leader, GE Asia

Synopsis

  • Cell and gene therapies are quickly reaching a point with great potential to change the way we treat patients
  • Challenges remain to be met before routine clinical adoption
  • Discussion on evaluating and balancing of the complex nature of the therapy and
    simplification needs, capacity limit and demand increase, risk mitigation and
    cost control, as well as how and when the digital solutions can be introduced to
    inform those decisions

11:15 am PRIME XV Chemically Defined Media for Immunotherapy applications

Synopsis

  • The use of chemically-defined media for cell culture helps meet the challenges currently faced in cell therapy area, namely the ability to generate a high number of clinical grade cells consistently
  • Fujifilm Irvine Scientific has developed chemically-defined media for ex-vivo expansion of the main cell types used in immunotherapy (T Cells, NK and dendritic cells), as part of the PRIME XV Cell Therapy product line
  • This presentation will introduce the PRIME XV product line, in particular PRIME XV T Cell CDM, and discuss how it can help in the globalization of safe and well characterized CAR-T therapies

11:25 am Morning Refreshments & Networking

Research & Development

Chair: Cedrik Britten, VP & Head, Oncology Cell Therapies Unit GSK

 

12.25pm Progress in a First-in-Class Dominant Negative PD-1 Armored CAR-T in Clinical Trials

  • First-in-class dnPD1 armored anti-CD19 CAR+ –T Cell the theory and the difference compared to traditional CAR-T cells
  • Discuss the therapeutic effect and results
  • Evaluate clinical research progress with achievements
  • International registration progress

Xiao Lei, CEO, Innovative Cellular Therapeutics

 

12.55pm TCR-Engineered T Cells for the Treatment of Solid Cancer: Maximising Scale and Benefit for NY-ESO TCR-T

  • Discussing standard vs accelerated development
  • Cross-functional alignment
  • Multi-component engineering of TCR-T cell products

Cedrik Britten, VP & Head, Oncology Cell Therapies Unit

 

 

 

 

 

 

 

 

 

 

 

 

1.25pm Treatment of Relapse or Refractory non-Hodgkin Lymphoma by CD19 Targeted Chimeric Antigen Receptor T Cells

  • CD28 and 41BB co-stimulatory domains were compared in a double arm randomized clinical study
  • Single treatment of CAR-T lead to continuous response
  • CAR-T cells could persist in peripheral blood for months after infusion

Ting He, CEO, Immunochina Pharmaceuticals

Manufacturing & Commercialization

Chair: Greg Motz, Director, Immunopharmacology Unum Therapeutics

 

12.25pm CBMG Cell Therapy Strategies

  • Building broad Immunology pipelines as well as regenerative medicines targeting unmet medical needs
  • Creating global leading manufacturing capabilities to address both internal and external demand

Yihong Yao, CSO, Cellular Biomedicine Group

 

 

12.55pm GMP Manufacturing of Lentiviral Vectors For Clinical Applications

  • Lentiviral Vectors provides a critical pathway in enabling safe and efficacious genetic modification of target cells both in vivo and ex vivo
  • Lentiviral Vectors has a substantial clinical safety profile as well as advanced QC analytics to support its release as a product for clinical applications
  • Lentiviral vector is a critical component in CAR-T manufacture including the recently approved Kymriah CAR-T cellular therapy for ALL and DLBCL indications
  • Availability of GMP grade Lentiviral Vectors is currently a worldwide constraint in enabling the manufacture of clinical cellular therapy products
  • Manufacture of Lentiviral Vectors is a complex process due to its instability and toxicity to producer cells, which makes it a challenge to produce compliant and high yield product
  • Developers are focusing on innovative solutions to tackle these challenges in order to improve yields and accessibility of this critical product

Lucas Chan, Co-founder & CSO, CellVec

 

1.25pm Manufacturing Development of an Off-the-Shelf, Allogeneic CAR-T Platform

  • Application of gene editing in adoptive cell therapy
  • Harnessing the power of genome editing and immune regulation to develop the next-generation allogeneic CAR-T therapy
  • Off-the-shelf CAR-T product development from bench to bedside: manufacturing and commercialization
  • Perspective on the future of CAR-T therapy manufacture

Yanni Lin, CTO & Co-founder, Cure Genetics

1:55 pm Lunch & Networking

Research & Development

Chair: Cedrik Britten, VP & Head, Oncology Cell Therapies Unit, GSK

 

2.55pm Develop an Efficient CAR-T for Solid Tumor therapy by Synthetic Biology

  • CAR T-cell therapy for solid tumors: novel strategies, immunological principles and drawbacks of current genetic engineering platform
  • State of art design efficient CAR molecule by synthetic biology technology
  • Design and optimize CAR molecules for solid tumors
  • Evaluate the case study of KD-025 CAR-T in hepatocellular carcinoma and glioblastoma
  • Combining synthetic biology and immunology: hacking CARs to expand their therapeutic capabilities

Paul Dai, CEO, Kaedi

 

3.25pm Dynamic Regulation of Multiple Genes in Adoptive Cell Therapies

  • Contextual regulation of gene expression using CRISPR interference and activation
  • Integrating multiple checkpoint inhibitor biology into a single therapeutic cell
  • Programming T-cells for survival, proliferation, and cytotoxicity in the tumor microenvironment

Bing Wang, CEO, Refuge Biotechnologies

Manufacturing & Commercialization

Chair: Greg Motz, Director, Immunopharmacology, Unum Therapeutics

 

2.55pm Automated Manufacturing of Chimeric Antigen Receptor T Cells

  • Reduce the risk of contamination and production failure
  • Analyze the development trends
  • Applying an automated platform to CAR-T cell manufacturing for industrialization and clinical success

Lin Yang, CEO, Persongen

 

 

 

 

 

3.25pm CAR-T: A Chronological Survey; From Whence it Came and Opportunities for Future Patenting

  • Early generations of CAR-T patents and their relevance to FDA – approved CAR-T products
  • Alternative strategies for patenting your CAR-T invention
  • Patentability vs. Commercialization of your CAR-T product

Shawn Foley, Attorney, Intellectual Property, Burns & Levinson LLP

3:55 pm Afternoon Refreshments & Networking

4:55 pm ACTR and BOXR: Addressing the Challenges of T-Cell Therapies in Solid Tumors

  • Greg Motz Director, Immunopharmacology, Unum Therapeutics

Synopsis

  • Key challenges facing T-cell therapy in solid tumors include on-target/off tumor toxicity and immunosuppression in the tumor microenvironment. Unum has developed two novel T cell technologies to address these challenges
  • The ACTR T-cell platform allows for selective tumor antigen targeting efficiently killing tumor cells with high antigen expression while sparing normal tissues with low antigen expression
  • The BOXR T-cell platform enables engineered T-cells to overcome specific mechanisms of TME immunosuppression that include metabolic competition immunosuppressive cell types (Treg, MDSC), and exhaustion due to chronic stimulation

5:25 pm FasT CAR: A Breakthrough Cell Therapy Technology for Malignancies

Synopsis

  • Overview of CAR-T industry and discussion of remaining hurdles
  • Gracell’s FasT CAR technology only requires overnight cell manufacturing, setting up new standards
  • Preclinical study verifies Gracell’s FasT CAR-T product characteristics superior to conventional CAR-T
  • Preliminary clinical data demonstrates superior efficacy and safety profile

5:55 pm Chairman’s Closing Remarks

6:00 pm Close of Annual CAR-TCR Summit Asia