细胞疗法

Cell therapy

#Global Cell Therapy R&D Pipelines Development

#China Cell Therapy Companies Layout

1,Approved by NMPA:

  • Jun 2021 FosunKite(复星凯特)CD19 200K USD;
  • Sep 2021 JW Therapeutics(药明巨诺)CD19 200K USD

2,Aurora/NL Users:

  • FosunKite(复星凯特)
  • Unicar-therapy(优卡迪)
  • ImmunoChina(艺秒神州)
  • GracellBio (亘喜)
  • Xiangxue Pharmaceutical(香雪制药)
  • LegendBiotech(传奇生物)

#Cell Therapy Market Trends

  • Car-NK:B-ALL, Breast Cancer, HCC
  • TIL :Melanoma, Cervical cancer
  • TCR-T: Melanoma, sarcoma
  • γδ T
  • Crisp- Car-T
  • Car- Treg

#Car-NK Potential Advantages

1,Better Safety

No GVHD and low CRS

2,Keep natural anti-tumor cell toxicity

NKp46、NKp44 and NKp30

3,“universal” product potential

From PBMC, UCB, HESC, IPSC

#Car-NK Targets in Hematological and Solid Tumors

#TCR-T for Solid Tumors

#TCR-T develop rapidly in 2021

#TIL Advantages in Solid Tumors

  • Good tumor invasion
  • Targeted non-selective, tumor-specific killer T cells
  • Specific recognition of tumor antigens only
  • No genetic engineering, cost saving

#Flow application in cell therapy

  • Immune therapy biomarkers screening and evaluation
  • Cell therapy products evaluation
  • Patients immune function determination
  • Monitoring MRD

#Immune therapy biomarkers screening and evaluation

#Cell therapy products evaluation

  • Evaluation of transfection efficiency
  • Knockout efficiency evaluation
  • Tumor killing effectiveness evaluation

#Patients immune function determination

  • Immune function database
  • TBNK population
  • T cell subsets —— dynamic observation

#Guiding Opinions for Clinical Trials of Cellular Immunotherapy Products (Trial)

Test  ItemsPlatform
PKVCN, Virus Vector Copy NumberqPCR/dPCR
Car+ cell numberFCM
PDCytokineELISA/FCM
ImmunogenicityDrug resistance antibody, ADA/HAMA, Anti-Drug AntibodyELISA/FCM
CTL, Cytotoxic T- LymphocyteFCM
SafetyRCL/RCR Replication Competent LentivirusqPCR
Virus integration site detectionNGS
Lentiviral p24 protein detectionELISA
Car-T cell phenotypingLymphocyte subsets, TSCMFCM
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