Entolimod (CBLB502) Oncology
Entolimod (CBLB502) is a clinical stage targeted oncology biologic. This recombinant protein is an agonist of toll-like receptor 5 (TLR5), an innate immunity receptor, that acts by mobilizing antitumor immune response and reducing treatment side effects on normal tissues. Unlike other TLRs, TLR5 does not induce a septic shock-like syndrome or a "cytokine storm."
Preclinical studies have shown that Entolimod (CBLB502) has a suppressive effect on growth of TLR5 expressing tumors. Entolimod (CBLB502) has also been shown to have an effect on several animal models of liver metastasis, regardless of TLR5 expression. Additionally, Entolimod (CBLB502) evidences a supportive care benefit in preclinical models when combined with radiation treatment and cytotoxic agents with adverse gastrointestinal (GI) effects. Tissue protective effects of TLR5 agonists are limited to normal tissues and do not involve protection of tumors from treatment.
A Phase I advanced solid tumor study is currently ongoing at Roswell Park Cancer Institute. The Principal Investigator for this trial is Alex Adjei, M.D., Ph.D., FACP, Chair of the Department of Medicine and Senior Vice President of Clinical Research at Roswell Park Cancer Institute. For more information on this trial, please refer to Clinicaltrial.gov: http://clinicaltrial.gov/ct2/show/NCT01527136?term=196111&rank=1.
In two completed clinical studies in 150 healthy subjects, Entolimod (CBLB502) appeared to be safe at a certain range of doses sufficient to induce significant response. The most frequent adverse event associated with Entolimod (CBLB502) administration was a transient flu-like syndrome, which is consistent with the mechanism of action of the compound.
We are developing a companion diagnostic to identify patient tumors which express TLR-5. The companion diagnostic will be developed in parallel with the clinical development of Entolimod, with the goal of filing a premarket approval (PMA) application with the FDA in a time frame that would allow for regulatory approval of the companion diagnostic concurrent with Entolimod approval.
A series of Phase II studies to follow the ongoing Phase I trial are currently being planned.
The market for targeted biologics in cancer is estimated to be $60B and growing.