Tuesday saw significant changes at Cardiff Oncology, as the company announced the departure of its CEO Mark Erlander and CFO James Levine. Mani Mohindru, a board member since 2021, will serve as interim CEO, while Brigitte Lindsay has been promoted from senior vice president of finance to chief accounting officer. The company is currently seeking permanent replacements for both positions.
The same day, Cardiff reported results from its Phase II CRDF-004 study evaluating onvansertib, a PLK1 inhibitor, in metastatic colorectal cancer (mCRC). The trial tested 20-mg and 30-mg doses of onvansertib in combination with two standard chemotherapy regimens: FOLFIRI plus bevacizumab and FOLFOX plus bevacizumab.
Patients receiving FOLFIRI plus bevacizumab had a confirmed objective response rate (ORR) of 42.1%. Adding 20-mg onvansertib to this regimen increased ORR slightly to 44.4%, while the addition of 30-mg onvansertib raised ORR to 72.2%. However, this improvement did not reach statistical significance.
The higher dose of onvansertib also improved progression-free survival by reducing the risk of death or disease progression by 62% compared to FOLFIRI plus bevacizumab alone. Analysts from William Blair noted their interest in this result but cautioned that “we emphasize the wide confidence interval of 0.12-1.17, likely attributable to the small sample size.”
Cardiff did not provide comparative data for FOLFOX plus bevacizumab but stated that adding onvansertib to FOLFIRI plus bevacizumab “performed better” than when added to the FOLFOX-based regimen. As a result, Cardiff plans to advance only the combination of 30-mg onvansertib with FOLFIRI plus bevacizumab into a registrational study for frontline RAS-mutated mCRC later this year.
Analysts at William Blair described Tuesday’s update as negative overall: “[Tuesday’s] update slants in a negative direction,” they wrote in a note following the data release. They also commented on Cardiff’s financial situation: “With $60 million cash at the end of the third quarter, the company will likely seek dilutive funding or partnership opportunities to fund the pivotal study for onvansertib.”
William Blair added, “We look forward to the detailed data release, along with longer follow-up and a biologically plausible explanation of the differences in efficacy outcome between FOLFOX- and FOLFIRI-based combination regimen.”
Cardiff Oncology’s stock closed at $2 per share Tuesday—a drop of nearly 32% from Monday’s closing price.
