Norwegian cancer drug developer Clavis Pharma (OSE: CLAVIS) develops and commercializes improved cancer drugs based on its proprietary technologies.

It intends to leverage its Lipid Vector Technology (LVT) to continue the development of a strong pipeline of pre-clinical and clinical proprietary new and improved anti-cancer drugs. In addition Clavis Pharma will also explore external cancer drug opportunities to build its future pipeline.

The company’'s lead product, Elacytarabine, is in a randomized, controlled Phase III study (the CLAVELA study) that recently completed recruitment in relapsed or refractory acute myeloid leukemia.

The company is also investigating CP-4200, an azacitidine derivative, in preclinical studies for myelodysplastic syndrome, a disease that is often a precursor to leukemia. CP-4200 is a novel LVT derivative of azacytidine, which pre-dominantly acts as a modifier of gene expression (epigenetic modulator). Epigenetic modulators are intended to restore the normal function of genes that control how cells develop and grow in the human body at doses with low cytotoxic activity. Vidaza (azacitidine) is approved in the USA for all forms of myelodysplastic syndromes (MDS), while in the EU it is approved for the more severe forms of MDS as well as for certain forms of acute myeloid leukemia (AML). CP-4033 is ribavirin elaidate, the LVT derivative of ribavirin, and is currently in pre-clinical development for aggressive thyroid cancer.

The product has been out-licensed worldwide to Translational Therapeutics. Some 30% of human cancers have abnormally high levels of elongation factor F4E (elF4E), which stimulates cell growth. In preclinical studies ribavirin has brought elF4E levels back to normal and thus significantly slowed down cell growth. Aggressive thyroid cancer is a fast growing cancer known to have abnormal elF4E activity, is an ultra-orphan indication (incidence of 750 cases per year in the US), and has no currently approved standard therapy where patients have a life expectancy of 4-6 months.

Because of the high unmet medical need, Translational Therapeutics expects expedited FDA approval after a Phase IIb clinical study. In parallel, Translational Therapeutics is developing an elF4E companion diagnostic to identify cancer patients with high elF4E levels.