12.08.2014 15:10:39

Seattle Genetics Begins Phase 1 Trial Of SGN-CD70A For NHL And RCC - Quick Facts

(RTTNews) - Seattle Genetics Inc. (SGEN) announced Tuesday that it has initiated a phase 1 clinical trial evaluating SGN-CD70A for CD70-positive relapsed or refractory non-Hodgkin lymphoma or NHL and metastatic renal cell carcinoma or RCC.

SGN-CD70A is a novel antibody-drug conjugate or ADC targeted to CD70 utilizing the company's newest ADC technology. The phase 1 trial is designed to assess the safety and antitumor activity of SGN-CD70A.

Seattle Genetics noted that it previously observed single-agent activity, including objective responses, in a phase 1 clinical trial with an initial CD70-targeted ADC called SGN-75 but did not observe enough activity to support further clinical development. To build on that experience, the company developed a next-generation anti-CD70 ADC utilizing its newest technology comprising a highly potent cytotoxic agent, called a pyrrolobenzodiazepine (PBD) dimer, stably linked to a CD70-directed antibody via proprietary site-specific conjugation technology.

The new SGN-CD70A study is a phase 1, open-label, multi-center, dose-escalation clinical trial. The primary endpoints are to estimate the maximum tolerated dose and to evaluate the safety of SGN-CD70A.

In addition, the trial will evaluate the antitumor activity and pharmacokinetics in patients with CD70-positive metastatic RCC or relapsed or refractory NHL, including mantle cell lymphoma and diffuse large B-cell lymphoma. The study is designed to evaluate SGN-CD70A administered every three weeks and will enroll approximately 95 patients at multiple centers in the United States.

ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. This approach is intended to spare non-targeted cells and reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.

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