Can-Fite Provides Namodenoson Patent Update
Can-Fite BioPharma (NYSE American: CANF) has announced an update on the intellectual property status of its lead drug candidate Namodenoson. The company expects broad protection for Namodenoson until at least 2044. Patents and patent applications cover methods of treating liver cancer, pancreatic cancer, and MASH using oral Namodenoson. A recent patent application protects the drug's manufacturing process.
Can-Fite has multiple approved patents and applications in various territories, including Europe and the US. The company is currently conducting a pivotal Phase III study in advanced liver cancer and a Phase IIb study in MASH, both in agreement with the FDA and EMA.
Can-Fite BioPharma (NYSE American: CANF) ha annunciato un aggiornamento sullo stato della proprietà intellettuale del suo principale candidato farmaco Namodenoson. L'azienda si aspetta una protezione ampia per Namodenoson fino ad almeno il 2044. Brevetti e domande di brevetto coprono metodi di trattamento per il cancro al fegato, il cancro pancreatico e MASH utilizzando Namodenoson orale. Una recente domanda di brevetto protegge il processo di produzione del farmaco.
Can-Fite ha numerosi brevetti approvati e domande in vari territori, inclusa l'Europa e gli Stati Uniti. L'azienda sta attualmente conducendo uno studio pivotale di Fase III nel cancro al fegato avanzato e uno studio di Fase IIb in MASH, entrambi in accordo con la FDA e l'EMA.
Can-Fite BioPharma (NYSE American: CANF) ha anunciado una actualización sobre el estado de la propiedad intelectual de su principal candidato a fármaco Namodenoson. La empresa espera una amplia protección para Namodenoson hasta al menos 2044. Las patentes y solicitudes de patente cubren métodos para tratar el cáncer de hígado, el cáncer de páncreas y MASH utilizando Namodenoson oral. Una reciente solicitud de patente protege el proceso de fabricación del fármaco.
Can-Fite tiene múltiples patentes aprobadas y solicitudes en varios territorios, incluidos Europa y Estados Unidos. La empresa está llevando a cabo actualmente un estudio pivotal de Fase III en cáncer de hígado avanzado y un estudio de Fase IIb en MASH, ambos en acuerdo con la FDA y EMA.
Can-Fite BioPharma (NYSE American: CANF)는 주요 후보 약물 Namodenoson의 지적 재산권 상태에 대한 업데이트를 발표했습니다. 이 회사는 Namodenoson에 대해 최소한 2044년까지 광범위한 보호를 기대하고 있습니다. 특허 및 특허 출원은 경구 Namodenoson을 사용하여 간암, 췌장암 및 MASH를 치료하는 방법을 다룹니다. 최근의 특허 출원은 약물의 제조 공정을 보호합니다.
Can-Fite는 유럽과 미국을 포함한 다양한 지역에서 여러 개의 승인된 특허 및 출원을 보유하고 있습니다. 이 회사는 현재 진행성 간암에 대한 중요한 3상 연구와 MASH에 대한 2b상 연구를 수행하고 있으며, 이는 모두 FDA 및 EMA의 승인에 따릅니다.
Can-Fite BioPharma (NYSE American: CANF) a annoncé une mise à jour concernant le statut de la propriété intellectuelle de son principal candidat-médicament Namodenoson. L'entreprise s'attend à une large protection pour Namodenoson jusqu'à au moins 2044. Des brevets et des demandes de brevet couvrent des méthodes de traitement du cancer du foie, du cancer du pancréas et de MASH utilisant Namodenoson par voie orale. Une récente demande de brevet protège le processus de fabrication du médicament.
Can-Fite dispose de plusieurs brevets approuvés et de demandes dans divers territoires, y compris l'Europe et les États-Unis. L'entreprise mène actuellement une étude pivot de phase III dans le cancer du foie avancé et une étude de phase IIb dans MASH, toutes deux en accord avec la FDA et l'EMA.
Can-Fite BioPharma (NYSE American: CANF) hat ein Update zum Status des geistigen Eigentums seines Hauptmedikaments Namodenoson angekündigt. Das Unternehmen erwartet einen breiten Schutz für Namodenoson bis mindestens 2044. Patente und Patentanträge decken Methoden zur Behandlung von Leberkrebs, Bauchspeicheldrüsenkrebs und MASH mit oralem Namodenoson ab. Ein kürzlich eingereichter Patentantrag schützt den Herstellungsprozess des Medikaments.
Can-Fite hat mehrere genehmigte Patente und Anträge in verschiedenen Gebieten, einschließlich Europa und den USA. Das Unternehmen führt derzeit eine pivotal Phase-III-Studie bei fortgeschrittenem Leberkrebs und eine Phase-IIb-Studie bei MASH durch, beide in Übereinstimmung mit der FDA und EMA.
- Patent protection for Namodenoson expected until at least 2044
- Patents cover treatment methods for liver cancer, pancreatic cancer, and MASH
- New patent application filed for drug manufacturing process
- Multiple approved patents and applications in various territories
- Ongoing pivotal Phase III study in advanced liver cancer
- Ongoing Phase IIb study in MASH
- None.
Insights
The patent update for Can-Fite's Namodenoson is a significant development in the biotech sector. The extended patent protection until at least 2044 provides crucial market exclusivity for the company's lead drug candidate. This longevity is particularly noteworthy in the pharmaceutical industry, where patent life can make or break a product's commercial viability.
The breadth of the patent coverage is equally important. It encompasses methods of treatment for liver and pancreatic cancers, as well as MASH (Metabolic Associated Steatohepatitis). Additionally, a recent application for manufacturing protection adds another layer of IP security. This comprehensive approach to IP strategy is commendable and aligns with best practices in the industry.
However, it's important to note that patent applications don't guarantee approval. The company will need to navigate the complex patent examination process in various jurisdictions. The mention of "multiple approved patents" is encouraging, but the status of pending applications will be critical to watch.
From a competitive standpoint, this patent portfolio could serve as a significant barrier to entry for potential competitors, potentially translating to a stronger market position for Can-Fite in the coming decades. However, investors should be aware that the value of these patents is intrinsically tied to the clinical success and eventual market approval of Namodenoson.
The patent update for Namodenoson is intriguing from an oncological perspective. The drug's potential in treating advanced liver cancer and pancreatic cancer addresses critical areas of unmet medical need. These are notoriously difficult-to-treat cancers with poor prognoses, making any potential new therapy of significant interest.
The ongoing pivotal Phase III study in advanced liver cancer is particularly noteworthy. This stage of clinical development suggests that previous trials have shown promising results. If successful, it could lead to a new treatment option in a field where innovations are desperately needed. The fact that this study is being conducted in agreement with both the FDA and EMA is also encouraging, as it suggests a well-designed trial that could potentially lead to approvals in major markets.
The inclusion of pancreatic cancer in the patent coverage is also significant. Pancreatic cancer has one of the lowest survival rates among all cancers and new treatment options are urgently required. However, it's important to note that the current update doesn't mention the stage of development for this indication.
While the patent protection is certainly positive, the true value of Namodenoson will ultimately be determined by its efficacy and safety profile in these ongoing clinical trials. The oncology community will be keenly watching for the results of these studies, particularly the Phase III liver cancer trial.
The patent update for Namodenoson is particularly interesting in the context of MASH (Metabolic Associated Steatohepatitis), formerly known as NASH. This condition is becoming increasingly prevalent globally, yet there are currently no FDA-approved treatments specifically for MASH. The potential for Namodenoson to address liver steatosis, inflammation and fibrosis - key components of MASH - is therefore highly significant.
The ongoing Phase IIb study in MASH, conducted with FDA and EMA agreement, suggests that Can-Fite is making substantial progress in this area. Phase IIb studies are typically designed to determine optimal dosing and further evaluate efficacy, which means we could be approaching a pivotal phase in the drug's development for this indication.
It's worth noting that the MASH/NASH market is highly competitive, with several pharmaceutical companies vying to bring the first approved treatment to market. Namodenoson's extended patent protection could provide Can-Fite with a significant advantage if the drug proves effective in clinical trials.
However, it's important to remember that success in MASH drug development has been elusive, with several high-profile failures in recent years. The complexity of the disease and the challenges in demonstrating clinically meaningful improvements have been significant hurdles. Therefore, while the patent protection is promising, the results of the ongoing clinical trials will be the true determinant of Namodenoson's potential in this field.
Broad Protection of Namodenoson is expected till at least 2044
PETACH TIKVA, Israel, July 29, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced an update related to the intellectual property (IP) status of its lead drug candidate Namodenoson, currently being developed for advanced liver cancer, pancreatic cancer and MASH.
The patents and patent applications cover methods of treating the two solid tumors, liver and pancreatic carcinoma by administering Namodenoson in an oral formulation as well as treating MASH to improve liver steatosis, inflammation and fibrosis. A patent application protecting the manufacturing of the drug has recently been filed. Patent terms of granted patents and patent application will have expiration dates of 2044 and beyond. Can-Fite has already multiple approved patents and corresponding applications in a variety of territories around the world, including Europe and the US.
”We are delighted that the product protection of Namodenoson in the area of oncology and MASH is broad and covers the use and manufacturing of the drug for 20 years, and we look forward to expanding this to other geographies”, said Pnina Fishman, Ph.D., Can-Fite CSO and Chairperson.
Can-Fite is currently conducting a pivotal Phase III study in advanced liver cancer and a Phase IIb study in MASH, both in agreement with the FDA and EMA.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of steatotic liver disease (SLD), and the Company is planning a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment metabolic dysfunction-associated steatohepatitis (MASH), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
Contact
Can-Fite BioPharma
Motti Farbstein
+972-3-9241114
FAQ
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