Trovagene: Oncology Therapeutics, Precision Medicine Cancer

Delivering on the Promise
of Precision Cancer MedicineTM (PCM)

Developing onvansertib, a first-in-class, 3rd generation, oral and highly-selective Polo-like Kinase 1 (PLK1) Inhibitor for the treatment of leukemias, lymphomas and solid tumor cancers

Learn More About Onvansertib

Our Story

We are a clinical-stage oncology therapeutics company, taking a Precision Cancer MedicineTM (PCM) approach to develop drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers.

In March, 2017, we licensed global development and commercialization rights for onvansertib (PCM-075), a Polo-like Kinase 1 (PLK1) Inhibitor, from Nerviano Medical Sciences, the largest research and development company in Italy, and leader in protein kinase drug development (Polo-like Kinase Inhibitors).

Onvansertib is a first-in-class, 3rd generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like Kinase 1 (PLK1) enzyme. PLK1 is over-expressed in many cancers, including leukemias, lymphomas and solid tumors and plays a critical role in the initiation, maintenance and completion of cell division.

Our Focus – Precision Cancer MedicineTM

Pipeline within a Molecule™
3 Investigational New Drug (INDs) in place with the FDA
Preclinical
Phase 1
Phase 2
Metastatic Castration-Resistant Prostate (CRPC)
Phase 2 trial in combination with Zytiga® (abiraterone acetate)/prednisone – Ongoing
Metastatic Colorectal (mCRC)
Phase 1b/2 trial in combination with FOLFIRI + Avastin® – Ongoing
Acute Myeloid Leukemia – Orphan Drug Designation in the U.S. and Europe
Phase 2 trial in combination with Decitabine – Ongoing
Myelodysplastic Syndrome
Phase 1b/2 Investigator Initiated Trial (commencing Q1’20)
Ovarian, Breast, Pancreatic, Small-Cell Lung
Phase 1b/2 trial ready (Preclinical Data Available)
Leukemias and Lymphomas
Solid Tumors

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.

Onvansertib
High Selective for PLK1
Synergistic in Combination
Flexible Dosing and Scheduling
Ideal Pharmacokinetics
24-hour Half-Life
Oral Administration
Predictive Biomarker
Demonstrated Safety and Tolerability
Onvansertib
High Selective for PLK1
Synergistic in Combination
Flexible Dosing and Scheduling
Ideal Pharmacokinetics
24-hour Half-Life
Oral Administration
Predictive Biomarker
Demonstrated Safety and Tolerability

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

Dec 9, 2019

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…

Dec 4, 2019

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…

Nov 14, 2019

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®…