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.
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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