Pharmacology, PK/PD, and Exploratory Toxicity

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  • Mouse, rat, monkey SC, IP, IV bolus, IV infusion
  • Bio-analytical development
  • PK/PD modeling and simulation
  • In vitro stability in biological matrices
  • Single dose, repeated dose, dose range finding in rats and monkeys
  • Efficacy studies
  • 160+ cell line xenografts and 270+ patient derived xenografts
  • Biodistribution
  • Imaging with labeled mAb or ADC
  • Ex vivo tissue concentration analysis

 

In Vivo Efficacy Study with Target Positive Xenograft Model

Tumor Volume Changes in SCID Mice Bearing NCI-N87 Xenografts

In-house prepared Trastuzumab-DM1 was tested in comparison with trastuzumab (Herceptin) in an in vivo study using gastric tumor cell Line NCI-N87 xenograft model of NOD-SCID mice.    The tumor growth curves demonstrate tumor growth inhibition and complete regression after 3 doses i.v. of T-DM1 (3mg/kg and 15 mg/kg) compared to insignificant efficacy of naked antibody (n = 10 per group).

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