On July 22, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company, reported the acceptance of three abstracts for presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference to be held from Sept. 27 to Oct. 1, 2019, in Barcelona (Press release, Trovagene, JUL 22, 2019, View Source [SID1234537649]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Having our AML clinical trial abstract chosen for an oral presentation by the ESMO (Free ESMO Whitepaper) Scientific Committee, indicates that we have achieved, with this trial, a level of interest in onvansertib that warrants a high profile venue for communicating its potential as a novel, first-in-class, PLK1 inhibitor to address this difficult-to-treat cancer," said Tom Adams, PhD, Chief Executive Officer and Chairman of Trovagene. "Additionally, onvansertib’s extension into solid tumor cancers will be showcased in a poster presentation providing an overview of our Phase 1b/2 trial in KRAS-mutated mCRC. As we continue evaluating onvansertib in other indications, we are also pleased to have a poster that will present preclinical data showing synergy in combination with paclitaxel in TNBC. ESMO (Free ESMO Whitepaper) is the ideal forum at which to present these data as this conference gathers leading experts across the oncology field."
The abstract accepted for an oral presentation (Abstract #2411), "Polo-like Kinase Inhibitor, Onvansertib, in Combination with Low-Dose Cytarabine or Decitabine in Patients with Relapsed/Refractory Acute Myeloid Leukemia in Phase 1b," will be presented by Amer Zeidan, MBBS, MHS, Yale University, and will feature safety and preliminary efficacy data, including patients who achieved a complete response, as well as biomarker data and correlation with treatment response.
In addition, there will be two poster presentations at the conference. The first poster presentation (Abstract #3695), "A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation," will be presented by Heinz-Josef Lenz, MD, USC Norris Comprehensive Cancer Center, and will feature preliminary safety and efficacy data, as well as biomarker data showing changes in the KRAS mutation burden in patients treated in the initial dose level cohort.
The second poster presentation (Abstract #5818), "Polo-like Kinase 1 Inhibitor Onvansertib Synergizes with Paclitaxel in Breast Cancer Carrying p53 Mutation," will be presented by Antonio Giordano, MD, PhD, Medical University of South Carolina, and will feature preclinical in vivo data demonstrating synergy of onvansertib in combination with paclitaxel in xenograft models of triple-negative breast cancer carrying the p53 mutation.
About Onvansertib
Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.
Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Trovagene believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.
Trovagene has an ongoing Phase 1b/2 clinical trial of onvansertib in combination with low-dose cytarabine or decitabine in patients with relapsed or refractory AML that was accepted by the National Library of Medicine (NLM) and is now posted to www.clinicaltrials.gov, with a NCT number of NCT03303339. Onvansertib has been granted orphan drug designation by the FDA in the U.S. and by the EC in the European Union for the treatment of patients with AML.
Trovagene has an ongoing Phase 2 clinical trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga. The trial was accepted by the NLM and is now posted to www.clinicaltrials.gov, with a NCT number of NCT03414034.
Trovagene has an ongoing Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation. The trial was accepted by the NLM and is now posted to www.clinicaltrials.gov, with a NCT number of NCT03829410. The trial is being conducted at three prestigious cancer centers: USC Norris Comprehensive Cancer Center, Hoag Cancer Center and The Mayo Clinic.
Trovagene licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.