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
Explore our catalog of therapeutic antibody solutions to find the right products for you! We are dedicated to delivering solutions designed to help you drive innovation and push the boundaries of what therapeutic antibodies can be.
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