Date: 2014-08-12
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Seattle Genetics (USA - WA)
Product: SGN-CD70A
Action
mechanism: antibody drug conjugate. SGN-CD70A is an antibody-drug conjugate (ADC) utilizing Pyrrolobenzodiazepine (PBD) dimers, a class of DNA-crosslinking agents that are significantly more potent than standard chemotherapeutic drugs. Seattle Genetics has been working with PBDs since 2009 under an exclusive research and licensing arrangement with Spirogen Ltd. Over the past five years, Seattle Genetics has selected and optimized specific PBD molecules for its proprietary use in ADCs. In addition, SGN-CD70A employs a novel linker system and proprietary, site-specific conjugation technology (EC-mAb) that allows uniform drug-loading of the cell-killing PBD agent to the anti-CD70 antibody. The ADC is designed to be stable in the bloodstream and to release its cytotoxic agent upon internalization into CD70-expressing cells. SGN-CD70A is Seattle Genetics’ second ADC in clinical development employing the novel PBD technology.
Disease: renal cell carcinoma
mantle-cell lymphoma
ciffuse, large B-cell, lymphoma
follicular lymphoma, Grade 3
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: 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. (NCT02216890)
Latest
news: * On August 12, 2014, Seattle Genetics announced the initiation of a phase 1 clinical trial evaluating SGN-CD70A for CD70-positive relapsed or refractory non-Hodgkin lymphoma (NHL) and metastatic renal cell carcinoma (RCC). The phase 1 trial is designed to assess the safety and antitumor activity of SGN-CD70A. Seattle Genetics 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. 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 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.
