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 plays a central role in cell-cycle regulation, and its dysregulation can permit 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 indication addresses metastatic CRC, onvansertib has potential in other indications. Future studies may explore combinations with chemotherapy, checkpoint inhibitors, and PARP inhibitors.
