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BLA Filing
  • Project profile
    Project name: BAFFR×CD3 bsAb
    Indications: B cell malignancies/ autoimmune diseases
    Research phase: Ready for CMC development
    Cooperation demands: License-out or co-development
  • Highlights

    1. Clear MoA. T cells are activated to eliminate tumor cells by targeting BAFFR. BAFFR×CD3 bsAb treats the CD19-resistant or CD20-resistant B-cell malignancies.
    2. Significant clinical efficacy and low toxicity & side effects.
    a) 2:1(TAA:CD3) structure, high binding to TAA, relative low affinity to CD3, reduce non-specific T cell activation.
    b) Human single domain antibody for TAA, stable as Nano antibody, with low immunogenicity.
    c) High efficacy in-vitro and in-vivo.

    d) Long PK in-vivo with Fc (t1/2=13.7 days).

    3. Global competitiveness.
    a) FIC potential. No similar competing drugs, and few study on BAFFR antibody in B lymphocyte carcinoma indications. The guideline for the treatment of B-lymphocyte cancer has great side effects and is easy to be resistant to drugs.
    b) Stable enough for downstream development.

  • Project Introduction

    1. Asset type: BAFFR×CD3 bsAb

    2. Modality: bsAb, fully human antibody

    3. Indication: B cell malignancies/autoimmune diseases

    4. Research phase: CMC development

    5. Research progress:
       1) Complete the anti-BAFFR Screening.
       2) BAFFR-CD3 bsAb cytotoxic activity in vitro shows the killing activity against jeko-1-luci cells.
       3) BAFFR-CD3 bsAb cytotoxic activity in vivo. In the PBMC transplanted tumor model, showed excellent in vivo efficacy in both high and low dose groups (10 mg/kg;1 mg/kg). After four doses, the tumors of both mice disappeared.

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