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• W4362488129 abstract "<div>Abstract<p>After significant effort over the last 30 years, antibody–drug conjugates (ADC) have recently gained momentum as a therapeutic modality, and nine ADCs have been approved by the FDA to date, with additional ADCs in late stages of development. Here, we introduce dolaflexin, a novel ADC technology that overcomes key limitations of the most common ADC platforms with two key features: a higher drug-to-antibody ratio and a novel auristatin with a controlled bystander effect. The novel, cell permeable payload, auristatin F-hydroxypropylamide, undergoes metabolic conversion to the highly potent, but less cell permeable auristatin F to balance the bystander effect through drug trapping within target cells. We conducted studies in mice, rats, and cynomolgus monkeys to complement <i>in vitro</i> characterization and contrasted the performance of dolaflexin with regard to antitumor activity, pharmacokinetic properties, and safety in comparison with the ADC platform utilized in the approved ADC ado-trastuzumab emtansine (T-DM1). A HER2-targeted dolaflexin ADC was shown to have a much lower threshold of antigen expression for potent cell killing <i>in vitro</i>, was effective <i>in vivo</i> in tumors with low HER2 expression, and induced tumor regressions in a xenograft model that is resistant to T-DM1.</p></div>" @default.
• W4362488129 created "2023-04-05" @default.
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• W4362488129 date "2023-04-03" @default.
• W4362488129 modified "2023-10-12" @default.
• W4362488129 title "Data from Dolaflexin: A Novel Antibody–Drug Conjugate Platform Featuring High Drug Loading and a Controlled Bystander Effect" @default.
• W4362488129 doi "https://doi.org/10.1158/1535-7163.c.6543396.v1" @default.
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