A phase I clinical trial evaluating SGN-CD70A was initiated earlier today for the treatment of CD70-positive relapsed or refractory non-Hodgkin lymphoma (NHL) and metastatic renal cell carcinoma (RCC). SGN-CD70A is a novel antibody-drug conjugate (ADC) targeted to CD70 utilizing the company’s newest ADC technology. The phase I trial is designed to assess the safety and antitumor activity of SGN-CD70A.
“CD70 is a very promising ADC antigen, which is highly expressed in both NHL and RCC, and has minimal expression in healthy tissues,” noted Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development, at Seattle Genetics. “We are building on the single-agent activity we observed with our former SGN-75 candidate and have designed SGN-CD70A with a goal to have enhanced activity by utilizing our next-generation ADC technology. Our preclinical data demonstrate that this novel ADC is extremely potent in RCC and NHL models, and we are enthusiastic about commencing a clinical trial of SGN-CD70A in patients with a clear need for new therapeutic options.”
Seattle Genetics previously observed single-agent activity, including objective responses, in a phase I 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 or PBD dimer, a class of DNA-crosslinking agents that are significantly more potent than standard chemotherapeutic drugs. The PBD dimer is stably linked to a CD70-directed antibody via proprietary site-specific conjugation technology. Preclinical data presented at the 2014 American Association of Cancer Research (AACR) annual meeting demonstrate SGN-CD70A induces targeted cell killing via DNA damage to treated tumors in both RCC and NHL models.
The new SGN-CD70A study is a phase I, 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.
Published in: Seattle Genetics, Inc website