- The stock price of Cardiff Oncology Inc (NASDAQ: CRDF) fell by 31.22% on Friday, January 15. This is why it happened.
The stock price of Cardiff Oncology Inc (NASDAQ: CRDF) — a clinical-stage biotechnology company that develops new treatment options for cancer patients in indications with the greatest medical need, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia — fell by 31.22% on Friday, January 15. One of the reasons why the stock price fell is due to the results from a presentation of data from its Phase 1b/2 study in KRAS-mutated metastatic colorectal cancer (mCRC) as part of the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) and the company also provided an additional data update from its mCRC clinical program and initial findings from its Expanded Access Program. Of the 12 Phase 1b patients evaluable for efficacy as of the ASCO-GI data cut-off date (November 1, 2020), 5 (42%) had achieved a partial response (PR) and 8 (67%) showed a durable response ranging from 6.1 to 13.7 months.
The recommended Phase 2 dose (RP2D) of onvansertib was established at 15mg/m2 and the Phase 2 segment of the ongoing trial is open to full enrollment of 26 patients across 6 sites in the U.S. And it was determined in the study that onvansertib in combination with FOLFIRI/bevacizumab is safe and well tolerated with only 9% of all adverse events (AEs) being grade 3 or 4
“The Phase 1b data show that a significant percentage of patients had tumor shrinkage, achieved clinical benefit and, importantly, that the response appears durable with two-thirds of the patients having been on treatment for at least six months. This highlights the promise of onvansertib plus standard-of-care as an effective second-line treatment for patients with KRAS-mutated mCRC. We look forward to building on these promising data during the Phase 2 portion of the trial.”
— Daniel H. Ahn, D.O., lead investigator and medical oncologist, Mayo Clinic Cancer Center, Arizona
“We are pleased with the continued advancement of our KRAS-mutated mCRC clinical study and are excited to initiate enrollment in the Phase 2 segment of this trial. Additionally, our EAP is being very well received by clinicians and patients who would otherwise not have access to onvansertib because they don’t meet the strict eligibility criteria for our trial. We are encouraged by the initial observations and, in particular, the duration of response we are seeing, which is consistent with the data from our clinical trial. Of note, the key difference in the patients enrolled in our EAP is that several had received and progressed on prior FOLFIRI-based treatment and with the addition of onvansertib we are seeing tumor shrinkage and durable stable disease.”
— Dr. Mark Erlander, chief executive officer of Cardiff Oncology
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