Cleveland BioLabs, Inc. announced updates on oncology clinical development of entolimod. Entolimod is a toll-like receptor 5 (TLR5) agonist that has shown preclinical potential in the immunotherapy of cancer. Entolimod administration activates innate and adaptive immune responses and mobilizes immunocytes to organs -- such as the liver, intestine, and bladder -- that have high TLR5 expression.

Enrollment in a Phase 1 open-label, dose-escalation trial of entolimod in patients with advanced cancer was completed in September 2014 at Roswell Park Cancer Institute (RPCI) in the United States. The study was designed to evaluate the safety, pharmacokinetic, and immunoactivation profiles of entolimod. Assessments for evidence of anticancer activity were also performed.

Preliminary evaluations of the study indicate that the tolerability profile in patients with advanced cancer was similar to that observed in two previously conducted studies in 150 healthy volunteers. Initial assessments of immunological response were consistent with TLR5 activation. Early analyses indicate that stable disease was observed in several patients with heavily pretreated cancers.