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news.Seattle Genetics and Agensys, an affiliate of Tokyo-based Astellas Pharma, have jointly started a Phase I clinical trial of ASG-5ME, which is being co-developed by both the companies, for the treatment of metastatic pancreatic cancer.
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ASG-5ME Phase I study, expected to recruit about 50 patients at multiple centers in the US, is a single-agent, open-label, dose-escalation study that will assess the safety and tolerability of the drug in patients with pancreatic cancer and identify the maximum tolerated dose.
ASG-5ME Phase I study secondary objective is to evaluate the pharmacokinetics and antitumor activity of the drug and identifying a recommended dose and regimen for future clinical trials.
Seattle Genetics and Agensys said that the antibody is attached to a highly potent, synthetic agent, monomethyl auristatin E (MMAE), through an enzyme-cleavable linker using Seattle Genetics’ proprietary technology.
The new linker system is designed to be stable in the bloodstream and release the potent cell-killing agent once inside antigen-expressing cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity.
Preclinical data showed that SLC44A4 (AGS-5), a new cancer target identified by Agensys to be upregulated in a number of epithelial tumors, is expressed on more than 80% of samples derived from patients with pancreatic, prostate and gastric cancers. In addition, ASG-5ME induced long-term regressions in preclinical models of established pancreatic, prostate and colon cancers.
Jonathan Drachman, senior vice president of research and translational medicine at Seattle Genetics, said: “We believe ASG-5ME, which is an ADC designed to deliver the cytotoxic agent MMAE directly to tumor cells, can provide a new therapeutic option for this disease.”
David Stover, vice president and head of research at Agensys, said: “ASG-5ME is an ADC composed of a fully human monoclonal antibody directed to SLC44A4 (AGS-5).”