In 2017 the San Diego area-based biotech made the first step in its transformation into a drug development-focused organization, licensing rights to an investigational cancer drug from Italy’s Nerviano Medical Sciences. Now that drug, onvansertib, is being evaluated as a potential treatment—in combination with other drugs—for patients with colorectal cancer, acute myeloid leukemia, and prostate cancer.
Along with the name change, the company is getting a new chief executive. Mark Erlander, who has been with the company since 2013 as its chief scientific officer and played a key role in its reinvention as a drug developer, on Friday was promoted from chief scientific officer to CEO. He succeeds Thomas Adams, who has served on the company board since 2009 and as CEO since June 2018. Adams becomes executive chairman.
Erlander says onvansertib is designed to block the protein PLK1, which is overexpressed in a variety of cancers and research shows may be a key regulator of cellular processes needed for tumor growth.
Recently the company reported that seven of eight evaluable patients in its ongoing Phase 1b/2 study of onvansertib in combination with the chemotherapy combination FOLFIRI- bevacizumab (Avastin) responded to the treatment, with one going on to have successful curative surgery.
Patients enrolled in the trial have cancers with KRAS mutations, forms of which are associated with certain cancers. Currently a hot target in cancer drug research, the KRAS gene has long been considered “undruggable.”
“There’s a whole cemetery devoted to failures in the KRAS world in drug development,” Erlander said.
Recently, however, data from studies of small molecule drugs being advanced by Amgen (NASDAQ: AMGN) and Mirati Therapeutics (NASDAQ: MRTX) that target a specific such mutation, KRAS-G12C, have reignited interest in the field. Merck has also placed bets on potential KRAS drugs in development. Erlander says Cardiff’s drug aims to address a range of such mutations.
“Our drug really is downstream of KRAS mutations, so in other words, irrespective of the KRAS mutation, it will have an effect and be able to kill the tumor cell,” he said.
The company is also studying the drug in combination with abiraterone (Zytiga), which is used to block androgens, in a Phase 2 study in patients with metastatic castration-resistant prostate cancer that has become resistant to the hormone therapy, and in a Phase 2 study of patients with relapsed or refractory acute myeloid leukemia in combination with decitabine, a chemotherapy.
In addition to dropping the Trovagene name, the company is changing its Nasdaq ticker symbol to “CDRF” to reflect its new moniker, which references the San Diego beachfront enclave of Cardiff-by-the-Sea.
Image: iStock/Marcel Fuentes