Cardiff Oncology's Onvansertib Enters Phase 2 Trial for KRAS/NRAS-Mutated Metastatic Colorectal Cancer
Key Insights
Cardiff Oncology has initiated a Phase 2 randomized trial (ONSEMBLE) of onvansertib in patients with KRAS (search)/NRAS (search)-mutated metastatic colorectal cancer (search) (mCRC).
The company's Scientific Advisory Board (SAB) has been expanded with full membership, enhancing expertise for clinical development.
Fairooz Kabbinavar, MD, FACP, has been appointed as Chief Medical Officer, bringing extensive experience to guide clinical programs.
Cardiff Oncology, Inc. (NASDAQ:CRDF) has announced the dosing of the first patient in its ONSEMBLE Phase 2 randomized trial evaluating onvansertib in patients with KRAS (search)/NRAS (search)-mutated metastatic colorectal cancer (search) (mCRC). This trial marks a significant step in the development of onvansertib, a PLK1 (search) inhibitor, as a potential novel therapy for this challenging cancer subtype.
The ONSEMBLE trial is designed to assess the efficacy and safety of onvansertib in combination with standard-of-care chemotherapy in patients with mCRC whose tumors harbor KRAS (search) or NRAS (search) mutations. These mutations are present in a substantial proportion of colorectal cancers and are often associated with resistance to conventional therapies. The trial aims to address a critical unmet need for effective treatments in this patient population.
Scientific Advisory Board and Leadership Changes
In addition to the clinical trial advancement, Cardiff Oncology has expanded its Scientific Advisory Board (SAB) with full membership. The SAB comprises leading experts in oncology and drug development, providing strategic guidance and scientific insights to support the company's clinical programs. The company also announced the appointment of Fairooz Kabbinavar, MD, FACP, as Chief Medical Officer. Dr. Kabbinavar brings extensive experience in oncology drug development and clinical research, further strengthening Cardiff Oncology's leadership team.
Financial Position
Cardiff Oncology reported a strong financial position, with approximately $97 million in cash, cash equivalents, and short-term investments as of March 31, 2023. This financial runway is projected to extend into 2025, providing the company with ample resources to advance its clinical programs and explore additional development opportunities. The company believes that its current financial resources are sufficient to fund its planned operations and achieve key milestones in the coming years.
About Onvansertib
Onvansertib is an investigational, orally administered inhibitor of polo-like kinase 1 (PLK1 (search)). PLK1 is a serine/threonine kinase that is highly expressed in many human cancers and plays a critical role in cell division, tumor proliferation, and resistance to chemotherapy. By inhibiting PLK1, onvansertib aims to disrupt cancer cell division and enhance the effectiveness of other cancer therapies. Cardiff Oncology is currently evaluating onvansertib in multiple clinical trials across a range of cancer types, including mCRC, small cell lung cancer, and hematologic malignancies.