Shares OF Cardiff Oncology, Inc. (CRDF) are up over 28% at $3.14 in premarket trading Tuesday, following positive initial data from its CRDF-004 trial.
CRDF-004 is a phase II clinical trial evaluating the company's lead drug candidate Onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer. The SoC consists of FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab.
In the study, patients are assigned in a 1:1:1 ratio to receive either 20mg of Onvansertib with standard of care (SoC), 30mg of Onvansertib with SoC, or SoC alone.
According to the trial findings, patients receiving the 30 mg dose of Onvansertib in combination with standard of care, showed an objective response rate (ORR) of 64% compared to 33% in the control arm. Patients receiving the 20 mg dose of Onvansertib in combination with standard of care showed an ORR of 50%.
Onvansertib was well tolerated at both doses in the trial, noted the company.
Commenting on the study findings, Mark Erlander, Chief Executive Officer of Cardiff Oncology, said, "In addition to the efficacy signal observed, the data demonstrate that onvansertib can safely be combined with the two different chemo backbones that are currently approved as standard of care in the first-line setting, thus providing a key differentiated profile over previous generation PLK1 inhibitors.
The company expects to provide additional updates from the trial in the first half of 2025.
CRDF closed Monday's trading at $2.44, up 5.63%. In premarket trading Tuesday, the stock is up over 28% at $3.14.
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