Agensys commences AGS-16M8F ADC Phase I clinical trial for renal cancer

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to target a toxin in tumor cells, resulting in selective tumor cell killing.

"Despite the availability of several therapies for the treatment of metastatic renal cancer, there is a significant need for new renal cancer therapies," said Leonard Reyno, M.D., Senior Vice President and Chief Medical Officer at Agensys. "We believe AGS-16M8F, which is an ADC designed to deliver the potent cytotoxic agent MMAF directly to tumor cells, has the potential to provide a new therapeutic option for this disease."

The single-agent, Phase I, open-label, dose-escalation study will evaluate the safety and tolerability of AGS-16M8F in patients with renal cancer and identify the maximum tolerated dose. Secondary objectives include assessing the pharmacokinetics and antitumor activity of AGS-16M8F and identifying a recommended dose and regimen for future clinical trials. The study is designed to enroll approximately 50 patients at multiple centers in the United States.

Dr. David Stover, Vice President and Head of Research at Agensys, noted that AGS-16M8F is an ADC composed of a fully human monoclonal antibody directed to ectonucleotide pyrophosphatase/phosphodiesterase 3 (ENPP3), a novel cancer target identified by Agensys to be upregulated in the majority of renal cancers.

The antibody is attached to a highly potent, synthetic agent, monomethyl auristatin F (MMAF), via a non-cleavable linker using Seattle Genetics' proprietary technology. The novel 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.

SOURCE Astellas Pharma Inc.