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.
A diagnostic assay that enables measurement of FACT expression has been developed. This assay is being incorporated as a biomarker in our clinical trials.
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.