(By Balaseshan) Seattle Genetics Inc. (NASDAQ:SGEN), which develops monoclonal antibody-based therapies for cancer, said it has started a phase 1b trial evaluating SGN-75 in combination with everolimus to treat kidney cancer.
Renal cell carcinoma (RCC) forms in the kidney, which filters and cleans the blood. Metastatic RCC occurs when the cancer has spread to other parts of the body. RCC is the most common type of kidney cancer in adults, representing about 90% of cases.
The trial is designed to assess the safety and antitumor activity of SGN-75 in combination with everolimus. SGN-75 is an antibody-drug conjugate (ADC) composed of an anti-CD70 antibody attached to a synthetic cytoxic cell-killing agent, monomethyl auristatin F (MMAF), using Seattle Genetics' proprietary technology.
The ADC is designed to be stable in the bloodstream, and to release its cytoxic agent upon internalization into CD70-expressing tumor 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.
The study is a phase Ib, open-label, dose-escalation clinical trial to evaluate the safety and antitumor activity of SGN-75 in combination with everolimus, an mTOR inhibitor, in patients with CD70-positive metastatic RCC.
Everolimus is an oral prescription medication used to treat advanced RCC when certain other medicines, such as sunitinib or sorafenib, have not worked. The trial is enrolling patients who have previously been treated with one or two tyrosine kinase inhibitors (TKIs).
The primary endpoint of the trial is safety, with key secondary endpoints of best clinical response, progression-free survival (PFS) and overall survival (OS). The study is expected to enroll up to 40 patients at multiple centers in the United States.
SGEN is trading up 0.34% at $26.86 on Friday. The stock has been trading between $14.61 and $28 for the past 52 weeks.
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