Cardiff Oncology, a US-based clinical-stage biotechnology company, has released encouraging initial data from its randomized Phase II clinical trial evaluating onvansertib in combination with standard-of-care (SoC) for patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). The results indicate a significant improvement in objective response rate (ORR) for patients receiving a 30mg dose of onvansertib.
Table Content:
Promising ORR and Deeper Tumor Regression
The Phase II trial (NCT06106308), with a primary endpoint of ORR and secondary endpoints including progression-free survival (PFS), duration of response (DOR), and safety, enrolled 30 evaluable patients randomized in a 1:1:1 ratio. Patients received either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone.
As of the November 26th data cutoff, the 30mg onvansertib arm demonstrated a 64% ORR, significantly higher than the 33% ORR observed in the control arm receiving SoC alone. The 20mg onvansertib arm showed a 50% ORR. Furthermore, the 30mg dose group exhibited deeper tumor regression compared to the other groups.
Positive Safety Profile and Future Developments
According to Cardiff Oncology’s Chief Medical Officer, Fairooz Kabbinavar, onvansertib was well-tolerated at both the 20mg and 30mg doses, with similar safety profiles observed for both. He emphasized the deeper tumor responses seen in the 30mg dose group. The company plans to release additional clinical data from the trial in the first half of 2025.
Stock Surge and Oversubscribed Offering
Following the positive data release, Cardiff Oncology’s stock price surged by 50% on December 10th, reaching $3.60, and continued to climb to $3.94 by December 11th, a 64% increase from December 9th. Capitalizing on this momentum, the company announced an oversubscribed offering of 15,384,619 shares of common stock at $2.60 per share, raising approximately $40 million. The proceeds will fund ongoing clinical trials of onvansertib in first-line RAS-mutated mCRC, as well as working capital and general corporate purposes.
Onvansertib’s Expanding Role in Oncology
Beyond this promising Phase II trial, Cardiff Oncology is actively involved in six other ongoing studies exploring onvansertib’s potential in various oncology indications. These studies underscore the company’s commitment to advancing onvansertib as a potential treatment option for a range of cancers. The positive results from this mCRC trial provide significant validation for onvansertib’s therapeutic potential and pave the way for further clinical development.
