CBLB612, a clinical-stage investigational drug, is a synthetic lipopeptide. CBLB612 activates NF-kB pro-survival and immunoregulatory signaling pathways via specific binding to toll-like receptor 2 (TLR2) on a subset of body tissues and cell types that express this receptor.
Preclinical studies have shown that CBLB612 stimulates white blood cell regeneration. More recent research indicates that stimulation of these toll-like receptors may also enhance anti-tumor efficacy. We believe an opportunity may exist for CBLB612 to offer a single-dose alternative to existing hemopoietic growth factors.
A Phase 1, single-center, blind, placebo-controlled, single ascending-dose study to evaluate the safety, tolerability, and pharmacodynamic effects of CBLB612 in healthy volunteers was completed in the Russian Federation.
A Phase 2, randomized, placebo-controlled clinical study of CBLB612 as myelosuppressive prophylaxis in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy was initiated in the Russian Federation.