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In vivo efficacy and PK/PD

So far, Alphamab has established several tumor models, Xenograft or Syngenic, to assess the function of novel anti-tumor biologics. In infertility area, we have used ovary weight gain assay to assess the PD of glyco-hormones, such as FSH and its engineered version. TDAR assay system has been well established to evaluate the immuno modulator, for example, CTAL-4-Fc fusion proteins.

We have also initiated the effort for humanized mouse with Cas9-CRISPR technology. For antibodies with limited cross species activity and absence of surrogate molecules, the humanized mouse could be the best option for in vivo function study.

PK in Rodents are routinely performed in Alphamab as the integrated part for drug like property evaluation and also used to support SAR for engineered antibodies and proteins. At later stage, candidates are also tested in cyno monkeys to get more precise read out of PK and also a glimpse of ADA generation.