Entolimod (CBLB502) Oncology

Entolimod is a clinical-stage investigational drug with potential application as a cancer treatment. This recombinant protein is an agonist of toll-like receptor 5 (TLR5), an innate immunity receptor. Entolimod activation of TLR5 triggers NF-kB signaling, mobilizing an innate immune response that drives expression of numerous genes. Unlike activation of some other TLRs, activation of TLR5 does not induce a septic shock-like syndrome or a "cytokine storm."

In preclinical models, administration of entolimod shows a direct cytotoxic effect on tumors expressing TLR5. In addition, entolimod activation of an innate immune response can induce potent antitumor activity in animal models of liver metastasis, regardless of TLR5 expression. Additionally, a supportive care benefit has been demonstrated in preclinical studies of entolimod when the drug has been administered in combination with radiation or cytotoxic agents with adverse hematopoietic or gastrointestinal effects. Preclinical studies suggest that the tissue protective effects of entolimod do not extend to tumors.

In two completed clinical studies in 150 healthy subjects, administration of entolimod was associated with a transient mild to moderate flu-like syndrome, which is consistent with the mechanism of action of the compound. Transient decreases in blood pressure and elevation of liver enzymes were also observed.

A Phase 1 study of entolimod in patients with advanced solid tumors at Roswell Park Cancer Institute was completed and results were presented at the 2015 annual meeting of the American Society of Clinical Oncology (ASCO) (see press release dated June 1, 2015).

A second Phase 1 study of entolimod in patients with advanced cancer was initiated in the Russian Federation to expand upon clinical observations made at the higher dose levels in the Roswell Park study and to gather further statistics on immune response to administrations of entolimod.

A Phase 2, single-blind, randomized, placebo-controlled clinical study of the safety and tolerability of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer who are recommended for surgery was initiated in the Russian Federation.

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