Cardiff Oncology, Inc.

We are a clinical-stage biotechnology company focused on developing new therapies for various cancers by inhibiting PLK1, a known target in oncology. Our strategy involves combining onvansertib, our oral and highly selective PLK1 inhibitor, with standard-of-care treatments to target tumor vulnerabilities. Our clinical program primarily focuses on indications such as RAS-mutated metastatic colorectal cancer (mCRC). We also have investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), metastatic triple negative breast cancer (mTNBC), and Chronic Myelomonocytic Leukemia (CMML). Our clinical development uses tumor genomics and biomarker assays to select patients and assess their treatment response. Our lead drug candidate, Onvansertib, is an oral, small molecule drug candidate that specifically inhibits PLK1 and has a 24-hour half-life. Onvansertib is highly potent and selective against the PLK1 enzyme (IC 50 = 2nM), unlike previous PLK1 inhibitors that targeted multiple PLK targets. It showed low or no activity on 63 other kinases (IC 50 >500 nM), including PLK2 and PLK3 (IC 50 >10,000 nM). Onvansertib is orally bioavailable, offering flexible dosing. Its relatively short 24-hour half-life also allows for flexible dosing and scheduling, which has shown a favorable safety profile in multiple clinical trials. In laboratory studies, onvansertib demonstrated synergistic effects when combined with various cytotoxic agents, including microtubule-targeting agents, topoisomerase 1 inhibitors, antimetabolites, alkylating agents, proteasome inhibitors, kinase inhibitors, PARP inhibitors, BCL-2 inhibitors, and androgen biosynthesis inhibitors.