Cardiff Oncology Announces First Patient Dosed in Randomized First-line RAS-mutated Metastatic Colorectal Cancer Trial (CRDF-004)
Cardiff Oncology, Inc. initiates Phase 2 trial CRDF-004 for RAS-mutated mCRC patients with the drug onvansertib in combination with standard-of-care (SoC) treatment, aiming to provide a new therapy option after almost two decades. Pfizer Ignite is overseeing the trial execution, with encouraging Phase 1b/2 results supporting the potential efficacy of onvansertib. The trial will assess safety, efficacy, and dose confirmation for onvansertib in the first-line setting, with anticipated Phase 3 trial CRDF-005 and FDA accelerated approval considerations based on interim ORR results.
Positive
Initiation of Phase 2 trial CRDF-004 for RAS-mutated mCRC patients with onvansertib and SoC treatment.
Pfizer Ignite managing the trial execution, leveraging encouraging Phase 1b/2 results for onvansertib efficacy.
Evaluation of safety, efficacy, and dose confirmation for onvansertib in the first-line setting.
Anticipated Phase 3 trial CRDF-005 and potential FDA accelerated approval based on interim ORR results.
The initiation of a Phase 2 clinical trial assessing the efficacy and safety of onvansertib in combination with standard-of-care for RAS-mutated metastatic colorectal cancer (mCRC) is a significant event for stakeholders in Cardiff Oncology. The trial's design aims to establish a foundation for a subsequent Phase 3 registrational trial, with the intent of demonstrating a potential improvement in treatment outcomes for a patient population with limited advancements over the past two decades.
Onvansertib, a Polo-like kinase 1 (PLK1) inhibitor, represents a novel therapeutic approach in the oncology field. PLK1 is a protein that plays a key role in cell division and its inhibition can lead to the selective killing of cancer cells. The combination of onvansertib with FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab could enhance the efficacy of these regimens, as suggested by preclinical data and earlier phase trials.
The trial's primary endpoint, the objective response rate (ORR), directly measures tumor shrinkage, while secondary endpoints such as progression-free survival (PFS) and duration of response provide additional data on the drug's impact on disease progression. The potential for accelerated approval based on interim ORR data could expedite onvansertib's path to market, subject to positive outcomes.
The collaboration with Pfizer Ignite for clinical trial execution underscores a strategic move by Cardiff Oncology to leverage Pfizer's established infrastructure and expertise in drug development. This partnership could enhance the trial's efficiency and potentially accelerate the time to market for onvansertib, should the results prove favorable.
From a market perspective, the focus on RAS-mutated mCRC, a patient group with significant unmet medical needs, positions Cardiff Oncology in a niche but critical segment of the cancer treatment market. The success of onvansertib could disrupt the current standard-of-care and lead to significant market share capture. However, the competitive landscape, including other targeted therapies and the entry of biosimilars, must be monitored closely as they can influence Cardiff Oncology's market positioning and pricing strategies.
Investors and stakeholders will be closely watching the initial topline results expected in mid-2024. Positive data could lead to stock price appreciation and increased investor confidence, while any setbacks could have the opposite effect. The anticipation of these results will likely introduce volatility in the company's stock.
The financial implications for Cardiff Oncology hinge on the successful progression of onvansertib through clinical trials. The capital-intensive nature of clinical development in biotechnology necessitates a critical evaluation of the company's financial health and runway. The costs associated with the Phase 2 trial and the subsequent Phase 3 trial, should be weighed against the company's current funding and future financing needs.
Cardiff Oncology's partnership with Pfizer Ignite could potentially reduce some clinical execution risk, which might be favorably viewed by investors. Moreover, the FDA's agreement on the use of ORR for accelerated approval provides a regulatory pathway that could lead to earlier revenue generation if the drug is approved. However, investors should also consider the risks of clinical trials, as any negative results or adverse events could impact the company's financial position and stock performance.
Long-term implications include the cost of commercialization, should onvansertib receive approval. Cardiff Oncology would need to either build out its commercial infrastructure or seek partnerships to market the drug effectively. These strategic decisions will have significant financial repercussions.
02/29/2024 - 04:05 PM
- Phase 2 trial in patients with RAS-mutated mCRC will evaluate onvansertib plus SoC versus SoC alone in the first-line setting -
- Pfizer Ignite is responsible for the clinical execution of the trial -
- Initial topline results expected in mid-2024 –
- Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT -
SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that the first patient was dosed in its randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer (mCRC). The trial, whose clinical execution is being conducted by Pfizer Ignite, Pfizer’s new end-to-end service for biotech companies, is designed to confirm the dose of onvansertib for a subsequent registrational trial, and generate safety and efficacy data for onvansertib when added to standard-of-care (SoC) vs. SoC alone.
“Today’s announcement represents an important milestone for Cardiff Oncology and for patients with RAS-mutated mCRC, who have had no new therapies approved in almost 20 years,” said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. “Based on the encouraging results from our Phase 1b/2 trial in second-line KRAS-mutated mCRC and our preclinical data demonstrating the powerful impact of combining onvansertib and bevacizumab, we believe the addition of onvansertib in the first-line setting has the potential to provide a meaningful improvement to the efficacy of SoC for mCRC patients with a RAS-mutation. We are especially pleased with the opportunity to leverage Pfizer Ignite’s execution capabilities to advance the development of onvansertib. We strongly believe that we are on the cusp of a transformative advance in the treatment landscape for mCRC.”
The Phase 2 trial includes patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib will be added to SoC FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. A total of 90 patients will be randomized in a 1:1:1 ratio to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is objective response rate (ORR), and the secondary endpoints include progression-free survival (PFS), duration of response and safety.
“We are pleased that the CRDF-004 trial is underway and look forward to providing clinical development support to advance onvansertib in RAS-mutated mCRC, which we believe has the potential to make an impact in patients with metastatic colorectal cancer,” said Adam Schayowitz, Ph.D., MBA, Head, Product Teams, Portfolio & Program Management at Pfizer Oncology, and member of Cardiff Oncology’s Scientific Advisory Board.
Contingent upon the results of CRDF-004, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent. The FDA has agreed that ORR at an interim point is an acceptable endpoint to pursue accelerated approval of onvansertib from the CRDF-005 trial, with PFS and trend in overall survival being the endpoints for full approval.
Conference Call and Webcast
Cardiff Oncology will host a conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on February 29, 2024. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company's website at www.cardiffoncology.com . A webcast replay will be available in the investor relations section on the company's website following the completion of the call.
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com .
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Cardiff Oncology Contact: jlevine@cardiffoncology.com
Investor Contact: Kiki@gilmartinir.com
Media Contact: richa@taftcommunications.com
What is the purpose of Cardiff Oncology's Phase 2 trial CRDF-004?
The trial aims to evaluate onvansertib in combination with standard-of-care (SoC) treatment for RAS-mutated mCRC patients.
Who is responsible for overseeing the clinical execution of the trial?
Pfizer Ignite, Pfizer's end-to-end service for biotech companies, is managing the trial execution.
What are the primary and secondary endpoints of the Phase 2 trial?
The primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS) and safety.
What is the potential outcome of the trial for Cardiff Oncology?
Positive results from CRDF-004 may lead to the initiation of a Phase 3 trial, CRDF-005, with potential FDA accelerated approval based on interim ORR results.
When are the initial topline results of the trial expected?
The initial topline results are anticipated in mid-2024.
