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1. Clear MoA:
(1) Depleting pathogenesis CD19 high B cells is effective in autoimmune disease treatment.
(2) Anti-CD19 in this Asset has a moderate affinity, which is beneficial to deplete pathological B cells without killing normal B cells.
(3) Anti-CD3 gently activates T cells, so it can reduce CRS.
(4) No FC segment design to reduce toxicity.
(5) PEGylated antibodies can prolong their half-life in humans.
2. Unmet clinical need.
Chinese patients are extremely lack of medicines for the autoimmune disease such as MS. 60% of Chinese MS patients in remission have no appropriate treatment.
3. Excellent safety for treating autoimmune diseases.
(1) With mild T cell activation, asset can reduce CRS.
(2) No Fc related toxicities.
4. High efficacy in-vitro and in-vivo.
(1) Selectively deplete Pathological B cells, whose CD19 is high expression.
(2) Decreased total T cells in spleen.
(3) Decreased Th1 and Th17 in CNS.
(4) pre-EAE administration: Delaying the onset of disease and reducing symptoms.post-EAE administration: Reducing symptoms, still effective after stopping dosing.
5. Extensive GLP tox studies have demonstrated high safety profile of the asset.
6. Asset’s PK is longer than Blincyto due to PEGylation. It is expected to be administrated weekly in clinic.
1. Asset type: PEGylation CD3 + CD19 bsAb
2. Indication: Autoimmune disease
3. Modality: PEG modification bsAb, no Fc
4. Research phase: FDA IND Ready
5. Cooperation demands: License-out or co-development
6. Research progress:
1. The IND application has been submitted to the FDA.
2. GLP toxicity studies in multiple animals has been completed.
3. Pre-EAE and post-EAE administration of Asset showed the effect of delaying the onset of disease and reducing symptoms. It has not been seen in the reported anti-CD20 and anti-CD19 treating EAE animal model.
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