Cardiff Oncology, Inc. (CRDF) has presented new clinical data from an investigator-sponsored Phase 1 dose escalation trial evaluating onvansertib, a novel oral PLK1 inhibitor, in patients with relapsed/ refractory chronic myelomonocytic leukemia (CMML), on December 8, 2025, at the 67th American Society of Hematology (ASH) Annual Meeting in a poster session led by Dr. Mrinal Patnaik of Mayo Clinic.
CMML is a rare hematologic malignancy characterized by features of both myelodysplastic syndromes and myeloproliferative neoplasms, leading to progressive cytopenias and risk of transformation to acute myeloid leukemia.
Onvansertib is designed to selectively inhibit Polo-like kinase 1 (PLK1), a key regulator of cell division, and has shown potential to overcome tumor resistance mechanisms across both hematologic and solid tumors.
The Phase 1 study enrolled nine patients. Onvansertib as a monotherapy was shown to be relatively well-tolerated, with most treatment-emergent adverse events reported as manageable.
Importantly, preliminary efficacy was observed in approximately 40% of patients, including one patient who achieved an optimal marrow response at the 9 mg/m2 dose level.
These findings validate onvansertib's single-agent activity in hematologic malignancies, complementing previously reported data in small cell lung cancer.
Cardiff Oncology noted that while it does not currently plan to develop onvansertib further in CMML, the results reinforce the drug's potential across both hematologic and solid tumor indications.
Cardiff Oncology's broader pipeline strategy focuses on leveraging PLK1 inhibition in combination with standard-of-care therapies in RAS-mutated metastatic colorectal cancer, as well as in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple-negative breast cancer.
CRDF closed yesterday's trading at $2.34, up 10.90%, and rose further in the afterhours to $2.35, up 0.42%. Over the past 12 months, the stock has traded between $1.90 and $5.64.
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