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Friday, May 29, 2020
Cardiff Oncology (CRDF)
Lead Drug Gets Fast Track Designation by FDA
Cardiff Oncology (formerly Trovagene, Inc.) is a clinical-stage biotechnology company with the singular mission of developing new treatment options for cancer patients in indications with the greatest medical need. Our goal is to overcome resistance, improve response to treatment and increase overall survival. We are developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics. Our clinical development programs incorporate tumor genomics and biomarker technology to enable assessment of patient response to treatment. We have three ongoing clinical programs that are demonstrating the safety and efficacy of onvansertib: a Phase 1b/2 study of onvansertib in combination with FOLFIRI/Avastin® in KRAS-mutated metastatic colorectal cancer (mCRC); a Phase 2 study of onvansertib in combination with Zytiga® (abiraterone)/prednisone in Zytiga-resistant metastatic castration-resistant prostate cancer (mCRPC); and a Phase 2 study of onvansertib in combination with decitabine in relapsed or refractory acute myeloid leukemia (AML). For more information, please visit https://www.cardiffoncology.com.
Cosme Ordonez, MD, Ph.D., Senior Life Sciences Analyst, Noble Capital Markets, Inc.
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Cardiff Oncology Fast Track Designation. Cardiff yesterday announced that the U.S. FDA granted Fast Track Designation to onvansertib, which will likely expedite development and FDA review of the drug. The Fast Track Designation was given to onvansertib for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC).
Lead drug effective in 88% of mCRC patients. Interim results recently presented at ASCO 2020 from a Phase Ib/II clinical trial on the use of onvansertib for the treatment of metastatic colorectal cancer (mCRC) patients carrying KRAS mutations showed that seven out of eight patients (88%) responded to…
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