Cardiff Oncology, Inc. (Nasdaq: CRDF) announced today that the United States Patent and Trademark Office (USPTO) has issued the company a second patent (U.S. patent No. 12,263,173) for its lead drug candidate onvansertib. The patent, which extends protection until at least 2043, covers the method of using onvansertib in combination with bevacizumab (bev) for treating metastatic colorectal cancer (mCRC) patients who have not previously received bevacizumab therapy.
This new intellectual property significantly broadens the potential application of onvansertib beyond the company's current clinical focus. While Cardiff's lead program targets first-line RAS-mutated mCRC patients, the new patent encompasses all bevacizumab-naïve mCRC patients, including both RAS-mutated and RAS wild-type tumors, across all lines of therapy.
"The expansion of our intellectual property portfolio strategically positions onvansertib for broader market opportunities and future growth," said Mark Erlander, Chief Executive Officer of Cardiff Oncology. "Overall, we believe the extensive applicability of onvansertib has the potential to drive widespread adoption, facilitate seamless integration into clinical practice, and potentially redefine the standard of care for the treatment of mCRC."
Expanding Patent Protection for Onvansertib
This latest patent builds upon Cardiff's existing intellectual property for onvansertib. Last fall, the USPTO issued the company a patent covering onvansertib's use specifically for first-line treatment of bevacizumab-naïve patients with KRAS mutations. The newly issued patent significantly expands this coverage to include all mCRC patients regardless of RAS mutation status.
Colorectal cancer represents a substantial clinical challenge, with approximately 151,000 new cases diagnosed annually in the United States alone. Patients with metastatic disease face particularly poor outcomes, with five-year survival rates below 15%. RAS mutations, found in approximately 45-50% of mCRC cases, are associated with resistance to many targeted therapies, highlighting the need for novel treatment approaches.
Ongoing Clinical Development
Onvansertib, a polo-like kinase 1 (PLK1) inhibitor, is currently being evaluated in a first-line Phase 2 randomized, open-label trial (CRDF-004). The study is assessing onvansertib in combination with standard chemotherapy regimens—either FOLFIRI and bevacizumab or FOLFOX and bevacizumab—for treating mCRC patients with RAS mutations.
The company announced initial data from the CRDF-004 trial in December 2024, with additional clinical results expected in the first half of 2025. These upcoming data will provide further insights into onvansertib's efficacy and safety profile in the targeted patient population.
Mechanism of Action and Broader Development Strategy
PLK1 inhibition represents a well-validated oncology target. PLK1 is a serine/threonine kinase that plays a crucial role in cell cycle regulation and is often overexpressed in various cancers, including colorectal cancer. By inhibiting PLK1, onvansertib aims to disrupt cancer cell division and proliferation.
Beyond mCRC, Cardiff Oncology is exploring onvansertib's potential in several other difficult-to-treat cancers. The company has ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple-negative breast cancer (TNBC).
Cardiff's development strategy focuses on targeting specific tumor vulnerabilities to overcome treatment resistance. By combining onvansertib with standard-of-care therapies, the company aims to deliver superior clinical benefits compared to current treatment options alone.
Market Implications and Future Directions
The expanded patent protection strengthens Cardiff Oncology's market position and potentially increases onvansertib's commercial value. With protection extending through 2043, the company has secured a significant runway for potential commercialization if clinical trials prove successful.
Dr. James Levine, Chief Financial Officer at Cardiff Oncology, noted that the company continues to focus on advancing its clinical programs while strategically building its intellectual property portfolio. The company's approach aims to address significant unmet needs in oncology while creating long-term value for shareholders.
As Cardiff Oncology continues to generate clinical data for onvansertib, the medical community will be watching closely to see if this novel PLK1 inhibitor can fulfill its promise of improving outcomes for patients with metastatic colorectal cancer and potentially other difficult-to-treat malignancies.
