CN / EN
OUR SCIENCE

We pursue novel, cutting-edge technologies and platforms, aiming to deliver transformative medicine for patients.

Therapeutic Focus Area

Our focus is CAR-based cell therapy for cancer patients,
with either hematologic malignancies or solid tumors.

Simnova has a rich R&D pipeline, including both clinical and
pre-clinical programs. We are developing proprietary off-the-shelf
CAR-NK and BiTE-armed CAR-T cell therapies.

Therapeutic Focus Area

Key Technology Platforms

  • Technology platform on NK product

    Technology platform on NK product

    · Innovative CAR design maintains in-vivo persistence and function of CAR-NK cells

     

    · Mature donor screening methods for PBMC to achieve high and stable biological activity

     

    · Outstanding performance on CAR expression and cell expansion

     

    · Strictly controlled iPSC-NK platform with multiple gene editing to enhance specific targeting and persistence of NK cells

  • BiTE CAR-T Platform

    BiTE CAR-T Platform

    · Strategically combine CARs with BiTEs into a single gene-modified T-cell product

     

    · Address critical barriers blocking effective immune therapy of solid tumors, including antigen escape and tumor heterogeneity

     

    · Redirect non-specific bystander T cells against tumors

CMC Capabilities

  • Analytical Development

    Product identification, quality purity

    • Cell surface marker expression,viability
    • Comprehensive flow cytometric-based characterization

    Product activity, potency

    • Cytokine secretion via ELISA or Bead-based multi cytokine detection
    • Number of cells secreting cytokine of interest by ELISPOT
    • Luminescence based cytotoxicity assays
    • Gene expression, genotyping, copy number

    Product stability, safety

    • Stability bioassay with product characterization
    • Safety testing to include endotoxin, mycoplasma, and bioburden

  • Release Testing

    Unprocessed bulk and purified bulk

    • Mycoplasma, sterility, product titer, identity, purity, and concentration
    • Residual DNA, DNA size, host cell protein, process residual

    Final product

    • General safety, confirmation of potency, purity, stability, and efficacy

  • Process development and manufacturing

    Process development and manufacturing

    • We have capabilities to develop a robust, reproducible and scalable manufacturing process
    • We have experience handling different cell type, culture system, and gene delivery methods in autologous and allogeneic programs
    • Our team are skilled in variety of technology platforms with insight on best practice and scale-up to not only improve safety, but decrease costs of good for patients and industry as a whole
    • We have established a CGMP Process Development team to ensure the projects meets NMPA and FDA regulatory requirement with reduced costing going forward and high quality standards

Our Pipeline

Therapy
Type		 Program Target Indication Research Preclin IND PhaseⅠ PhaseⅡ
CAR-NK SNC103 CD19 B-cell maligancies
SNC112 BCMA
GPRC5D		 Multiple myeloma
SNC113 Undisclosed Solid tumor
SNC115 Undisclosed Solid tumor
CAR-T SNC109 Her2，IL13Rα2
EGFR，EGFRvIII		 Glioblastoma
multiforme
SNC102 BCMA Multiple myeloma
Program Research Preclin IND Phase
Ⅰ		 Phase
Ⅱ
CAR-NK

SNC103

  • Target

    CD19

  • Indication

    B-cell maligancies

SNC112

  • Target

    BCMA GPRC5D

  • Indication

    Multiple myeloma

SNC113

  • Target

    Undisclosed

  • Indication

    Solid tumor

SNC115

  • Target

    Undisclosed

  • Indication

    Solid tumor
CAR-T

SNC109

  • Target

    Her2，IL13Rα2
    EGFR，EGFRvIII

  • Indication

    Glioblastoma
    multiforme

SNC102

  • Target

    BCMA

  • Indication

    Multiple myeloma