CBL0137 is a clinical stage oncology drug that interferes with a novel molecular target. It is a proprietary small molecule suitable for oral and intravenous administration and being developed by our subsidiary, Incuron, LLC.
The interaction of CBL0137 with FACT (Facilitates Chromatin Transcription) complex results in simultaneous NF-kB suppression, Heat Shock Factor 1 suppression and p53 activation. This modulation of three key cellular pathways causes suppression of cancer cell growth. CBL0137 has been shown in preclinical studies to have a beneficial effect in multiple solid tumor animal models.
In 2012, an IND was submitted in the Russian Federation and a Phase I study of oral administration of CBL0137 in patients with advanced solid tumors was initiated. In early 2013, the FDA allowed an IND for intravenous administration of CBL0137 and a Phase I trial with patients with advanced solid cancers is being prepared.
We are collaborating with leaders in the Diagnostic field on the development and commercialization of a companion diagnostic to identify patient tumors with the FACT expression. The companion diagnostic will be developed in parallel with the clinical development of CBL0137, 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 CBL0137 approval.
The market for solid tumor, small molecule agents is estimated in the billions of dollars. Novel cancer therapeutics will continue to be an important area of oncology drug development and treatment.