Cardiff is a clinical-stage, oncology-focused biotechnology company developing onvansertib against solid tumors including subsets of colorectal (CRC), pancreatic, lung and breast cancers. The company's primary indication is first line metastatic CRC in patients with Rat Sarcoma (RAS) mutations. Onvansertib is an oral Polo-like kinase 1 (PLK1)-selective inhibitor that has synergies with bevacizumab & various chemotherapy regimens. It is the subject of a Ph2 dose confirmation trial and is anticipated to begin a Ph3 study in 2026. PLK1 is associated with the cell cycle and when dysregulated can allow for uncontrolled mitosis. When inhibited, the cell cycle can be arrested & synthetic lethality can occur especially in combination with other anti-angiogenesis agents and chemotherapy. While the lead target is in mCRC, onvansertib has potential in other indications. Combination studies with chemotherapy, checkpoint and PARP inhibitors may emerge in future iterations.
