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
Trovagene Announces Positive Response to Treatment in Phase 1b/2 Trial of Onvansertib in Patients with KRAS-Mutated Metastatic Colorectal Cancer
Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer MedicineTM oncology therapeutics company developing drugs that target cell division (mitosis) for the treatment of various cancers including prostate, colorectal and leukemia, today announced data demonstrating positive response to treatment in patients…
Data Presented at ESMO Provides Rationale for Clinical Trial of Onvansertib in Subset of Patients with Highly-Aggressive Triple Negative Breast Cancer (TNBC)
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 breast, prostate, colorectal and leukemia, today announced the presentation of preclinical data…
Trovagene Presents Overview of Phase 1b/2 Trial of Onvansertib in Patients with KRAS-Mutated Metastatic Colorectal Cancer (mCRC) at ESMO
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 the presentation of its Phase 1b/2 trial evaluating onvansertib in combination with FOLFIRI and Avastin®…