Cardiff Oncology, Inc., a clinical-stage biotechnology company, develops novel therapies for the treatment of various cancers in the United States. Its lead drug candidate is Onvansertib, an oral and selective polo-like kinase 1 inhibitor for treating RAS-mutated metastatic colorectal cancer. The company also focuses on the clinical program in indications, such as investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, metastatic triple negative breast cancer, and chronic myelomonocytic leukemia; CRDF-004, a Phase 2 open-label randomized multi-center clinical trial of onvansertib in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab for the treatment of patients confirmed metastatic and unresectable colorectal cancer in patients with a KRAS or NRAS mutation; and TROV-054, a Phase 1b/2 single-arm clinical trial in KRAS-mutated metastatic colorectal cancer. The company was formerly known as Trovagene, Inc. and changed its name to Cardiff Oncology, Inc. in May 2012. Cardiff Oncology, Inc. was founded in 1999 and is headquartered in San Diego, California.
Cardiff Oncology Reports Second Quarter 2026 Results and Provides Business Update
Cardiff Oncology reported positive Phase 2 data for onvansertib plus FOLFIRI/bevacizumab in first-line RAS-mutated mCRC, showing a confirmed objective response rate of 72.2% compared to 42.1% for standard-of-care alone.
Following a successful End-of-Phase 2 meeting with the FDA, the company plans to initiate a registrational Phase 3 trial in Q1 2027, though the start is subject to securing additional financing.
Corporate updates include a completed $10 million registered direct offering and an ongoing licensing dispute with Nerviano Medical Sciences, which has alleged a material breach and purported to terminate the license agreement; Cardiff has filed a lawsuit seeking declaratory judgment.