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B7-H3×CD3 BsAb for solid tumor

BLA Filing
  • Project profile
    Project name: B7-H3×CD3 BsAb for solid tumor
    Indications: Solid tumor
    Research phase: IND
    Cooperation demands: License-out or co-development
  • Highlights

    1. Novel anti-tumor strategy

    Clear MOA

    Picarda, Elodie et al. “Molecular Pathways: Targeting B7-H3 (CD276) for Human Cancer Immunotherapy.” Clinical cancer research : an official journal of the American Association for Cancer Research vol. 22,14 (2016): 3425-3431.

    Clear MOA

    Data access from TCGA.

    (1) B7-H3 are high expressed in many different types of solid tumor, but is low expressed in normal tissue. B7-H3 plays an important role in inhibiting T-cell function and promoting cancer progression and invasion. B7-H3 high expression remains poor prognosis and patient survival.

    (2) B7-H3×CD3 bispecific antibody can mediate cytotoxic activities against B7-H3-positive tumor cells by improving T cell activation.

    2. Asset binds to CD3 and B7-H3 antigen simultaneously.

    Asset binds to CD3 and B7-H3 antigen simultaneously

    3. Excellent anti-tumor efficacy in vitro and in vivo.

    Excellent anti-tumor efficacy in vitro and in vivo

    (1) The asset redirected T-Cell activation to kill B7-H3+ AsPC-1 (pancreatic cancer) and NCI-N87 (gastric cancer).

    (2) The asset suppresses tumor growth in NCI-N87 xenograft model

    4. Good safety in preclinical study.

    (1) The asset shows positive safety profile in toxicity studies with Cynomolgus Monkeys.

    ✓ There were no animal death and no adverse effects
    ✓ No liver impairment was observed, compared to other BsAb
    target CD3 and B7-H3.
    ✓ Asset induced very low cytokine release(IL-2, IL-6, TNF-α, IFN-γ) in Cynomolgus monkeys.

    (2) The asset is well-tolerated in Cyno monkeys and the NOAEL is the highest dose tested at 3.6 mg/kg once weekly for 4 consecutive weeks (5 doses in total).

    5. Innovative BsAb development platform

    (1) After reasonable design of heavy and light chains, the mismatch probability of asset is greatly reduced.

    (2) Creative CMC, which greatly simplified production and purification process, through one step affinity chromatography the purity can be higher than 95%.

    (3) The platform brings a much lower cost of production.

  • Project Introduction

    1. Asset type: B7-H3×CD3 BsAb

    2. Indication: Solid tumor

    3. Modality:BsAb

    4. Research phase: IND

    5. Cooperation demands: License-out or co-development

    6. Research progress:

    1. IND stage
    2. Good anti-tumor efficacy in animal model
    3. Good safety
    4. Innovative CMC that lowers the cost of production

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