Our Focus – Precision Cancer MedicineTM
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 PCMTM 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 three active clinical trials:
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);
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);
Phase 1b/2 open-label trial of onvansertib in combination with FOLFIRI + Avastin® for second-line treatment of metastatic Colorectal Cancer (mCRC) with a KRAS mutation – (NCT03829410).
Recent News
Efficacy, Durability of Response and Safety of Onvansertib Demonstrated in Completed Phase 1b Trial in AML Patients Presented in Oral Session at ASH
Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine™ oncology therapeutics company developing drugs that target cell division (mitosis), for the treatment of various cancers including leukemia, prostate and colorectal, today announced the presentation of final results from…
Trovagene Announces Data Showing Ability of Onvansertib to Rescue Venetoclax-Resistance in Acute Myeloid Leukemia (AML)
Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine™ oncology therapeutics company developing drugs that target cell division (mitosis) for the treatment of various cancers including leukemia, prostate and colorectal, today announced new in-vitro and in-vivo data suggesting that onvansertib may provide…
Trovagene Presents Positive Data in Metastatic Prostate Cancer Phase 2 Trial Showing Clinical Response in Patients Resistant to Zytiga®
Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine™ oncology therapeutics company developing drugs that target cell division (mitosis), for the treatment of various cancers including prostate, colorectal and leukemia, today announced new positive data from its Phase 2 trial evaluating onvansertib in combination with Zytiga®…