Seattle Genetics Begins Phase1 Trial For Multiple Types Of Advanced Solid Tumors

(RTTNews) - Seattle Genetics Inc. (SGEN) announced initiation of a phase 1 clinical trial of SEA-CD40 for multiple types of advanced solid tumors. 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.

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.