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news.US-based biotechnology firm Seattle Genetics has started a Phase I clinical trial evaluating SGN-CD70A for CD70-positive relapsed or refractory non-Hodgkin lymphoma (NHL) and metastatic renal cell carcinoma (RCC).
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SGN-CD70A is a new antibody-drug conjugate (ADC) targeted to CD70 using the company’s new ADC technology.
The open-label, multi-center, dose-escalation Phase I trial is designed to evaluate the safety and antitumor activity of SGN-CD70A.
The primary endpoints of the trial are to estimate the maximum tolerated dose and to assess the safety of SGN-CD70A.
Additionally, the trial will assess 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.
About 95 patients at multiple centers in the US will be enrolled in trial, which is designed to evaluate SGN-CD70A administered every three weeks.
Seattle Genetics chief medical officer and executive vice president of Research and Development Jonathan Drachman said CD70 is a very promising ADC antigen, which is highly expressed in both NHL and RCC, and has minimal expression in healthy tissues.
"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," Drachman said.
"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."
The company 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.
In order to build on that experience, the company developed a next-generation anti-CD70 ADC using 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.
Image: SGN-CD70A is a new antibody-drug conjugate (ADC) targeted to CD70 using Seattle Genetics’ new ADC technology. Photo:courtesy of Grant Cochrane/ freedigitalphotos.net