1. Clear MoA:
(1) HER2 is overexpressed or mutated in 25% of breast cancer patients, according to TCGA data. Herceptin, a HER2 mAb, targeting HER2 overexpressing cancers have proven to be beneficial. However, approximately 70% of patients develop resistance to Herceptin, and some patients present with primary resistance, who are seeking for an after-Herceptin solution.
(2) The resistance of immunotherapy in HER2+ breast cancer occurs because of the formation of immunosuppressive TME primarily or secondarily. Her2xCD3 BsAb is an ideal strategy to overcome the immunosuppressive TME barrier.
(3) Her2xCD3 BsAb redirect T cells to target HER2-expressing tumor cells and to eradicate HER2+ cancer cells. The advantage of the BsAb strategy is that T cell activation is independent of antigen specificity, and a large fraction of the T cells are activated.
2. Excellent pre-clinical result:
(1) This asset could bind to HER2 and CD3 simultaneously.
(2) Excellent safety and efficacy. 1) induces lower ADCC on HER2+ tumor cells and has no cytotoxic on CD3+ Jurkat Cell, comparing with anti-HER2 or anti-CD3 antibody, respectively. 2) able to kill HER2+ tumor cell lines and has little effect in HER2- tumor cell line. 3) dose-dependent induced IL-6 and TNFa in day 1 treatment, and no cytokine release was detected in the longer 72 days treatment in cyno monkey. 4) showed dose-dependent anti HER2+ tumor efficacy in vivo.
3. Excellent clinical result:
Good tolerance and effective in anti-HER2 resistance patients in phase 1 study. 1) All the patients were refractory or relapsed from multiple lines of anti-HER2 treatment. 2) No patients experienced DLT. Only 1 out of 7 patients experienced Gr1 CRS and no CRS occurred after priming dose; 3) No neurotoxicity and immune suppression were observed during the DLT period, much safer than ADC; 4) DCR@100 ug cohort = 66% (n=3); 1 PD, 2 SDs.
1. Asset type: Her2xCD3 BsAb
2. Indication: HER2+ Cancer
3. Research phase: Phase I
4. Cooperation demands: License-out and co-development
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