Trovagene: Oncology Therapeutics, Precision Medicine Cancer

Delivering on the Promise
of Precision Cancer Medicine

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 medicine 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.

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Our Focus

Preclinical
Phase 1
Phase 2
Acute Myeloid Leukemia – Orphan Drug Designation in the U.S. and Europe
Phase 1b/2 trial in combination with low-dose cytarabine (LDAC) or Decitabine
Leukemias & Lymphomas
Metastatic Castration-Resistant Prostate (CRPC)
Phase 2 trial in combination with Zytiga® (abiraterone acetate)/prednisone
Colorectal (CRC)
Phase 1b/2 trial in combination with FOLFIRI + Avastin®
Pancreatic
Phase 1b/2 trial ready
Ovarian
Phase 1b/2 trial ready
Breast
Phase 1b/2 trial ready
Solid Tumor Cancers
Small Cell Lung
Phase 1b/2 trial ready
A Phase 1 trial has been completed in advanced or metastatic solid tumor cancers, including colorectal, lung, and ovarian, and published in Investigational New Drugs in 2017

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.

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

May 23, 2019

Trovagene Announces Research Collaboration with Nektar Therapeutics to Evaluate Efficacy of the Combination of Onvansertib and ONZEALD™ in Models of Colorectal Cancer

Trovagene, Inc. (Nasdaq: TROV), a clinical-stage oncology therapeutics company, using a precision medicine approach to develop drugs that target cell division (mitosis) for the treatment of …

May 13, 2019

Trovagene Announces Equity Investment of $1.5 Million at Premium to Market Price from Institutional Investor, Lincoln Park Capital

Trovagene, Inc. (Nasdaq: TROV), a clinical-stage oncology therapeutics company, taking a precision medicine approach to develop drugs that target cell division (mitosis) for the treatment of …

Apr 23, 2019

Trovagene Announces Data Demonstrating Significant Synergy of Onvansertib in Combination with Venetoclax in Cell Model of Venetoclax-Resistant AML

Trovagene, Inc. (Nasdaq: TROV), a clinical-stage oncology therapeutics company, taking a precision medicine approach to develop drugs that target cell division (mitosis) for the treatment of …