On February 17, 2015 Seattle Genetics reported of the initiation of a phase 1 clinical trial of SEA-CD40 for multiple types of advanced solid tumors (Press release Seattle Genetics, FEB 17, 2015, View Source [SID:1234501637]). SEA-CD40 is a novel investigational immuno-oncology agent targeted to CD40, a widely expressed stimulatory receptor found on antigen-presenting cells (APCs) which play a role in immune cell activation. SEA-CD40 utilizes Seattle Genetics’ proprietary sugar-engineered antibody (SEA) technology to produce a non-fucosylated antibody targeting CD40. Preclinical data show that SEA-CD40 stimulates the immune system to fight cancer.

“We are pleased to advance our SEA-CD40 immuno-oncology program into the clinic to evaluate it broadly in multiple types of solid tumors,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Our proprietary SEA technology builds on our expertise in empowered, targeted approaches for the treatment of cancer and represents a novel technology designed to increase the potency of monoclonal antibodies through glycoengineering which may lead to an improved antitumor immune response. We look forward to data from the phase 1 trial.”

The study is a phase 1, open-label, multi-center, dose-escalation clinical trial of SEA-CD40 in patients with advanced solid tumors who have failed current standard of care treatments. Expansion cohorts are planned to evaluate SEA-CD40 across up to three cancer indications that will be determined based on data from the dose escalation portion of the study. The primary endpoints are determination of the maximum tolerated dose (MTD) and safety profile of SEA-CD40. In addition, the trial will evaluate antitumor activity, pharmacokinetics and immunological pharmacodynamic effects. The phase 1 trial will enroll approximately 50 patients during dose escalation and up to 90 patients in the expansion cohorts at multiple centers in the United States.