Onvansertib represents a pipeline within a molecule. It is a highly-selective inhibitor of a proven cancer target, PLK1, which is over-expressed in most cancers, it is synergistic in combination with most chemotherapies and targeted therapeutics, and orally administered. Collectively, the characteristics of onvansertib are enabling clinical development across a wide variety of cancers where there is a significant need for new treatment options.
We are taking a precision cancer medicine approach to developing onvansertib by integrating a predictive clinical biomarker strategy, which we believe will help us identify sub-populations of patients who are most likely to respond to treatment.
Onvansertib is being developed as part of a combination regimen with already approved therapies to treat leukemias, lymphomas and solid tumor cancers. In-vitro and in-vivo preclinical data has demonstrated synergy (the interaction of two or more agents produces a combined effect greater than the sum of their individual effects) when onvansertib is part of a combination regimen, which we believe has the potential to improve efficacy, extend the duration of response to treatment and have a positive impact on clinical outcomes.
Onvansertib – Expanding Treatment Options for Patients
We are advancing clinical development of onvansertib for indications where there is a significant medical need to provide new cancer treatment options for patients.
PLK1 is essential for precisely regulating the cell division and maintaining genome stability in mitosis (cell division), spindle assembly, and DNA damage response. Studies have shown that PLK1 is highly expressed in most cancers, and its over-expression is associated with poor prognosis in patients. Data has shown that blocking the expression of PLK1 by kinase inhibitors can effectively inhibit the proliferation of and induce apoptosis (death) of tumor cells.
Currently, we have two ongoing clinical trials: A Phase 1b/2 open-label trial of onvansertib in combination with either low-dose cytarabine (LDAC) or decitabine for the treatment of Acute Myeloid Leukemia (AML) – (NCT03303339) and a Phase 2 open-label trial of onvansertib in combination with Zytiga® (abiraterone acetate)/prednisone for the treatment of metastatic Castration-Resistant Prostate Cancer (mCRPC) – (NCT03414034).