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Cardiff Oncology Announces First Patient Dosed in ONSEMBLE Phase II Randomized Trial

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Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, has announced that the first patient was dosed last month with its investigational drug onvansertib in its Phase 2 ONSEMBLE trial (NCT05593328). The trial is designed to demonstrate a clinically meaningful difference in response and onvansertib's contribution to standard of care (SoC) FOLFIRI/bevacizumab for the second line treatment of patients with KRAS/NRAS-mutated metastatic colorectal cancer (mCRC).

"We are excited to be underway with our ONSEMBLE trial that builds on the promising efficacy and tolerability results demonstrated in our phase 1b/2 trial in mCRC," said Fairooz Kabbinavar, MD, Chief Medical Officer of Cardiff Oncology. "mCRC is a difficult-to-treat cancer and patients in the second line setting need novel therapeutic options to improve clinical outcomes. Based on our open-label phase 1b/2 trial, we believe the combination of onvansertib with FOLFIRI/bevacizumab could positively impact patients' responses to treatment and the durability of the responses. Nearly half of our planned 40 sites in the US are open to enroll patients and we've seen great enthusiasm from participating investigators."

The Phase 2 ONSEMBLE trial includes patients with mCRC who have a documented KRAS or NRAS mutation and have previously received one prior chemotherapy regimen with or without bevacizumab in the first line metastatic setting. Patients are being randomized to onvansertib plus FOLFIRI/bevacizumab versus FOLFIRI/bevacizumab (standard of care).  The primary endpoint is objective response rate determined by the Response Evaluation Criteria in Solid Tumors via an independent central review. The secondary endpoints include progression-free survival, overall survival, duration of response and safety. The trial is being led by Heinz-Josef Lenz, MD, USC Norris Comprehensive Cancer Center, who has experience with the Company's mCRC clinical program, having served as the principal investigator for the Phase 1b/2 trial.

The Company recently introduced the members of its Scientific Advisory Board, which will continue to provide insight and guidance related to the ONSEMBLE trial and its strategy to advance onvansertib through later-stage clinical development.