Cardiff Oncology(US:CRDF)2020-01-23 19:28Company Overview - Trovagene Oncology is a clinical-stage oncology therapeutics company developing onvansertib, a selective Polo-like Kinase 1 (PLK1) inhibitor[4] - Onvansertib selectively targets PLK1, which is overexpressed in most cancers, stopping cancer cell division while limiting impact to normal cells[4] - The company plans to present efficacy data from all 3 Phase 2 clinical trials in 2020[4, 6] Onvansertib & Clinical Trials - Onvansertib is a 1st-in-class, 3rd-generation, safe, well-tolerated, oral PLK1 inhibitor that selectively targets the PLK1 enzyme and blocks cancer cell division[5] - Clinical trials have demonstrated efficacy in patients with resistance to standard-of-care or relapsed disease[5] - Onvansertib is being evaluated in combination with standard-of-care therapies in metastatic colorectal cancer (mCRC), metastatic castrate-resistant prostate cancer (mCRPC), and acute myeloid leukemia (AML)[5] Colorectal Cancer (mCRC) - In mCRC, approximately 20% of patients achieved clinical response with Onvansertib + FOLFIRI®/Avastin®[15] - KRAS mutation decreased in all 6 patients completing their 1st cycle of onvansertib treatment[17] - Mutations identified in these patients account for nearly 100% of those associated with CRC[17] Prostate Cancer (mCRPC) - In mCRPC, approximately 20% of patients achieved the primary efficacy endpoint of disease control at 12 weeks (PSA stabilization or decrease) with Onvansertib + Zytiga®[25] - To date, 3 of 5 patients in this cohort have met the efficacy endpoint[27] - To date, 3 of 5 patients have exceeded 6 months of RPFS[27] Acute Myeloid Leukemia (AML) - In AML, approximately 30% of patients achieved complete response (CR + CRi) with Onvansertib + Decitabine[35]