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 and Nerviano Medical Sciences Amend their 2017 Exclusive License Agreement
Cardiff Oncology and Nerviano Medical Sciences settled all outstanding disputes over global rights to onvansertib and amended their 2017 Exclusive License Agreement, with a full mutual release of claims and a plan to jointly dismiss the Southern District of California litigation with prejudice.
The amendment clarifies and expands the royalty structure and adds development objectives tied to Cardiff's upcoming Phase 3 program in first-line RAS-mutated metastatic colorectal cancer; NMS also gains the right to appoint a board observer and join Cardiff's Scientific Advisory Board.
The settlement de-risks Cardiff's lead oral PLK1 inhibitor ahead of its registrational trial, which follows randomized Phase 2 data showing dose-dependent improvements in overall response rate and progression-free survival versus standard-of-care alone using the selected 30 mg dose with FOLFIRI/bevacizumab.