Cardiff Oncology Announces New Patent with Claims for the Use of Onvansertib in Treating KRAS mutated mCRC
Cardiff Oncology (Nasdaq: CRDF) has been granted U.S. patent No. 12,144,813 by the USPTO, protecting the use of onvansertib in combination with bevacizumab for treating KRAS mutated metastatic colorectal cancer (mCRC) patients who haven't previously received bevacizumab treatment. The patent extends protection through 2043. Onvansertib, a PLK1 inhibitor, is currently being evaluated in a Phase 2 randomized trial (CRDF-004) in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab for first-line treatment of RAS-mutated mCRC patients. Initial data is expected by end of 2024.
Cardiff Oncology (Nasdaq: CRDF) ha ricevuto il brevetto statunitense n. 12.144.813 dalla USPTO, che protegge l'uso di onvansertib in combinazione con bevacizumab per il trattamento di pazienti con cancro colorettale metastatico (mCRC) mutato per KRAS che non hanno ricevuto precedentemente il trattamento con bevacizumab. Il brevetto estende la protezione fino al 2043. Onvansertib, un inibitore di PLK1, è attualmente in fase di valutazione in uno studio randomizzato di fase 2 (CRDF-004) in combinazione con FOLFIRI e bevacizumab o FOLFOX e bevacizumab per il trattamento di prima linea dei pazienti mCRC mutati per RAS. I dati iniziali sono attesi entro la fine del 2024.
Cardiff Oncology (Nasdaq: CRDF) ha recibido la patente de EE. UU. n.º 12.144.813 por parte de la USPTO, protegiendo el uso de onvansertib en combinación con bevacizumab para tratar a pacientes con cáncer colorrectal metastásico (mCRC) mutado por KRAS que no han recibido previamente tratamiento con bevacizumab. La patente extiende la protección hasta 2043. Onvansertib, un inhibidor de PLK1, se está evaluando actualmente en un ensayo aleatorio de fase 2 (CRDF-004) en combinación con FOLFIRI y bevacizumab o FOLFOX y bevacizumab para el tratamiento de primera línea de pacientes con mCRC mutados por RAS. Se esperan datos iniciales para finales de 2024.
카디프 온콜로지(Cardiff Oncology)(나스닥: CRDF)는 USPTO로부터 미국 특허 번호 12,144,813을 부여받아, 온반세르티브(onvansertib)와 베바시주맙(bevacizumab)의 병용 사용을 통해 KRAS 변이 전이성 대장암(mCRC) 환자를 치료하는 것을 보호합니다. 이 특허는 2043년까지 보호를 연장합니다. 온반세르티브는 PLK1 억제제이며, 현재 2상 임상시험 (CRDF-004)에서 FOLFIRI와 베바시주맙 또는 FOLFOX와 베바시주맙 병용으로 RAS 변이 mCRC 환자의 1차 치료를 위해 평가되고 있습니다. 초기 데이터는 2024년 말에 예상됩니다.
Cardiff Oncology (Nasdaq: CRDF) a reçu le brevet américain n° 12.144.813 de l'USPTO, protégeant l'utilisation de l'onvansertib en combinaison avec le bevacizumab pour traiter des patients atteints d'un cancer colorectal métastatique (mCRC) muté KRAS qui n'ont pas reçu de traitement au bevacizumab auparavant. Le brevet prolonge la protection jusqu'en 2043. L'onvansertib, un inhibiteur de PLK1, est actuellement évalué dans un essai randomisé de phase 2 (CRDF-004) en combinaison avec le FOLFIRI et le bevacizumab ou le FOLFOX et le bevacizumab pour le traitement de première ligne des patients mCRC mutés RAS. Les premières données sont attendues d'ici la fin de 2024.
Cardiff Oncology (Nasdaq: CRDF) wurde von der USPTO US-Patent Nr. 12.144.813 gewährt, das die Verwendung von onvansertib in Kombination mit bevacizumab zum Behandeln von Patienten mit KRAS-mutiertem metastasiertem Kolorektalkrebs (mCRC), die zuvor keine bevacizumab-Behandlung erhalten haben, schützt. Das Patent verlängert den Schutz bis 2043. Onvansertib, ein PLK1-Inhibitor, wird derzeit in einer randomisierten Phase-2-Studie (CRDF-004) in Kombination mit FOLFIRI und bevacizumab oder FOLFOX und bevacizumab zur Erstlinientherapie von RAS-mutierten mCRC-Patienten evaluiert. Erste Daten werden bis Ende 2024 erwartet.
- Patent protection secured until 2043 for onvansertib combination therapy
- Phase 2 trial data readout expected by end of 2024
- None.
Insights
The patent issuance for onvansertib combination therapy in KRAS-mutated metastatic colorectal cancer (mCRC) represents a significant intellectual property milestone. The protection extends through 2043, providing nearly 20 years of market exclusivity for this novel treatment approach.
The patent specifically covers combining onvansertib with bevacizumab in treatment-naïve patients, strategically positioning Cardiff Oncology in the lucrative first-line therapy space. This is particularly valuable as KRAS mutations occur in approximately 40% of mCRC cases, representing a substantial market opportunity.
With Phase 2 trial data expected by year-end 2024, the timing of this patent protection is optimal. If the trial demonstrates positive results, Cardiff will have a strong competitive advantage in the mCRC treatment landscape. The combination with standard-of-care treatments (FOLFIRI/FOLFOX + bevacizumab) could potentially establish onvansertib as an essential component of first-line therapy.
This patent issuance significantly strengthens Cardiff Oncology's intellectual property portfolio, providing robust protection for their lead candidate's key application. The specific method claims covering onvansertib's use in combination with bevacizumab create a strong barrier to entry for potential competitors.
The timing through 2043 is particularly strategic, as it extends well beyond the typical development and initial commercialization period, allowing for substantial market exclusivity if the treatment gains approval. The patent's focus on treatment-naïve patients in combination with standard-of-care creates a comprehensive protection strategy that could be important for future partnering or licensing opportunities.
- Protects the use of onvansertib in combination with standard of care in the KRAS mutated mCRC setting through 2043 -
SAN DIEGO, Nov. 19, 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 the United States Patent and Trademark Office (USPTO) has issued to Cardiff Oncology U.S. patent No. 12,144,813 with an expected expiration date of no earlier than 2043. The claims of the patent cover the method of using onvansertib in combination with bevacizumab (bev) for the treatment of KRAS mutated metastatic colorectal cancer (mCRC) patients who have not previously been treated with bev.
“We are pleased to announce the strengthening of our intellectual property portfolio for onvansertib, an important milestone in our mission to advance this innovative therapy to the first-line setting in combination with standard of care for RAS-mutated mCRC patients,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “This newly issued patent underscores the groundbreaking nature of our discovery—demonstrating that onvansertib has the potential to significantly enhance treatment efficacy for KRAS mutated mCRC patients who have not been previously treated with bev.”
Onvansertib, a PLK1 inhibitor, is currently being evaluated in a first-line Phase 2, randomized, open-label trial (CRDF-004) in combination with FOLFIRI and bev or FOLFOX and bev for the treatment of mCRC patients with a RAS mutation, and an initial data readout is expected by the end of 2024.
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), as well as in ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), 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 an epidemic or pandemic such as the 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, 2023, 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:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
Kiki@gilmartinir.com
Media Contact:
Grace Spencer
Taft Communications
609-583-1151
grace@taftcommunications.com
FAQ
When does Cardiff Oncology's new patent for onvansertib (CRDF) expire?
What is the current development stage of onvansertib for KRAS mutated mCRC (CRDF)?
When will Cardiff Oncology (CRDF) release initial data from the Phase 2 trial of onvansertib?
