Immunovia files US patent application to protect its next-generation test
Immunovia (Nasdaq Stockholm: IMMNOV) has filed a US provisional patent application for its next-generation test to detect stage 1 and 2 pancreatic cancer. The application covers methods of diagnosing pancreatic ductal adenocarcinoma (PDAC) using a unique combination of five specific biomarkers. The company plans to submit additional clinical data to strengthen the application and file a PCT application within a year for international protection.
Immunovia aims to launch the new test in the US market in 2025, following a large, independent clinical validation study in Q4 2024. The company estimates that 1.8 million individuals in the USA are at high risk for pancreatic cancer and could benefit from annual surveillance testing.
Immunovia (Nasdaq Stockholm: IMMNOV) ha presentato una domanda di brevetto provvisorio negli Stati Uniti per il suo test di nuova generazione per la rilevazione del cancro pancreatico di stadio 1 e 2. La domanda riguarda i metodi di diagnosi dell'adenocarcinoma duttale pancreatico (PDAC) utilizzando una combinazione unica di cinque biomarcatori specifici. L'azienda prevede di presentare ulteriori dati clinici per rafforzare la domanda e di depositare una domanda PCT entro un anno per la protezione internazionale.
Immunovia punta a lanciare il nuovo test nel mercato statunitense nel 2025, dopo un ampio studio divalidazione clinica indipendente nel Q4 2024. L'azienda stima che 1,8 milioni di persone negli USA siano ad alto rischio di cancro pancreatico e potrebbero beneficiare di test di sorveglianza annuali.
Immunovia (Nasdaq Estocolmo: IMMNOV) ha presentado una solicitud de patente provisional en EE. UU. para su prueba de próxima generación para detectar cáncer pancreático en etapas 1 y 2. La solicitud cubre métodos para diagnosticar adenocarcinoma ductal pancreático (PDAC) utilizando una combinación única de cinco biomarcadores específicos. La empresa planea presentar datos clínicos adicionales para fortalecer la solicitud y presentar una solicitud PCT dentro de un año para la protección internacional.
Immunovia tiene como objetivo lanzar la nueva prueba en el mercado estadounidense en 2025, tras un amplio estudio de validación clínica independiente en el cuarto trimestre de 2024. La empresa estima que 1.8 millones de individuos en EE. UU. están en alto riesgo de cáncer pancreático y podrían beneficiarse de pruebas de vigilancia anuales.
Immunovia (나스닥 스톡홀름: IMMNOV)는 1기 및 2기 췌장암을 감지하기 위한 차세대 테스트에 대한 미국 임시 특허 출원을 했습니다. 이 출원은 5개의 특정 바이오마커의 독특한 조합을 사용하여 췌장 관절 선암(PDAC)을 진단하는 방법을 포함합니다. 회사는 출원을 강화하기 위해 추가 임상 데이터를 제출할 계획이며, 국제 보호를 위해 1년 이내에 PCT 출원을 할 예정입니다.
Immunovia는 2025년 미국 시장에 신규 테스트를 출시하는 것을 목표로 하고 있으며, 2024년 4분기에는 대규모 독립 임상 검증 연구가 진행될 예정입니다. 이 회사는 미국에서 180만 명이 췌장암의 고위험군에 해당하며, 연간 감시 검사를 통해 혜택을 받을 수 있다고 추정하고 있습니다.
Immunovia (Nasdaq Stockholm: IMMNOV) a déposé une demande de brevet provisoire aux États-Unis pour son test de nouvelle génération visant à détecter le cancer du pancréas au stade 1 et 2. La demande couvre des méthodes de diagnostic de l'adénocarcinome canalaire pancréatique (PDAC) à l'aide d'une combinaison unique de cinq biomarqueurs spécifiques. L'entreprise prévoit de soumettre des données cliniques supplémentaires pour renforcer la demande et de déposer une demande PCT dans un an pour une protection internationale.
Immunovia vise à lancer le nouveau test sur le marché américain en 2025, après une étude de validation clinique indépendante de grande envergure au quatrième trimestre 2024. L'entreprise estime que 1,8 million de personnes aux États-Unis sont à haut risque de cancer du pancréas et pourraient bénéficier d'un dépistage annuel.
Immunovia (Nasdaq Stockholm: IMMNOV) hat einen US-amerikanischen vorläufigen Patentantrag für seinen Test der nächsten Generation zur Erkennung von Stadium 1 und 2 Bauchspeicheldrüsenkrebs eingereicht. Der Antrag umfasst Methoden zur Diagnose des duktalen Adenokarzinoms der Bauchspeicheldrüse (PDAC) mithilfe einer einzigartigen Kombination aus fünf spezifischen Biomarkern. Das Unternehmen plant, zusätzliche klinische Daten einzureichen, um den Antrag zu stärken, und innerhalb eines Jahres einen PCT-Antrag zur internationalen Schutz zu stellen.
Immunovia beabsichtigt, den neuen Test im US-Markt im Jahr 2025 einzuführen, nach einer umfassenden unabhängigen klinischen Validierungsstudie im vierten Quartal 2024. Das Unternehmen schätzt, dass 1,8 Millionen Menschen in den USA ein hohes Risiko für Bauchspeicheldrüsenkrebs haben und von jährlichen Überwachungstests profitieren könnten.
- Filing of US provisional patent application to protect intellectual property for next-generation pancreatic cancer detection test
- Plans to file PCT application for international patent protection
- Completion of test development with launch planned for 2025 in the US market
- Large independent clinical validation study scheduled for Q4 2024
- Estimated 1.8 million high-risk individuals in the USA could benefit from annual testing
- Clinical validation study results not yet available
- Patent approval not guaranteed
- Commercialization timeline extends to 2025, potentially impacting near-term revenue
Insights
As a Biotech Patent Attorney, I find Immunovia's patent application for their next-generation pancreatic cancer detection test highly significant. The filing of a US provisional patent application is a strategic move that provides Immunovia with a 12-month priority period to further develop their invention before filing a full patent application.
The patent claims cover both the unique combination of five biomarkers and the method for combining these biomarkers to generate test results. This dual protection strategy is robust, potentially creating a strong barrier to entry for competitors. The planned PCT application within the next year is a cost-effective approach to secure international patent rights.
However, it's important to note that the success of this patent application will largely depend on the novelty and non-obviousness of Immunovia's biomarker combination and analysis method. The company's plan to submit additional clinical data to the USPTO is wise, as it can strengthen their claims and improve the chances of patent grant.
From an investor's perspective, this patent application, if granted, could provide Immunovia with a significant competitive advantage in the pancreatic cancer diagnostics market for up to 20 years from the filing date. However, investors should be aware that the patent process is lengthy and uncertain and competitors may challenge the patent or develop alternative methods.
As an Oncology Researcher, I'm intrigued by Immunovia's approach to early pancreatic cancer detection. Their focus on stage 1 and 2 pancreatic ductal adenocarcinoma (PDAC) is crucial, as early detection significantly improves survival rates in this aggressive cancer type.
The use of a five-biomarker panel is noteworthy. Most current pancreatic cancer screening methods rely on imaging or single biomarkers like CA19-9, which have limitations in sensitivity and specificity. A multi-biomarker approach could potentially offer improved accuracy, especially for early-stage detection.
However, the true value of this test will be determined by the results of the large, independent clinical validation study planned for Q4 2024. Key factors to watch for will be the test's sensitivity, specificity and positive predictive value, particularly in comparison to existing screening methods.
The estimated 1.8 million high-risk individuals in the USA represent a significant market opportunity. If Immunovia's test proves effective for annual surveillance in this population, it could be a game-changer in pancreatic cancer management.
Investors should note that while promising, the path from patent application to clinically validated and widely adopted test is long and often challenging. The 2025 launch target is ambitious and regulatory hurdles, particularly FDA approval, will be critical milestones to monitor.
The patent application claims methods of diagnosing pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. The company is seeking patent protection for the unique combination of five specific biomarkers used in its test, as well as the method for combining these biomarkers to generate a positive or negative test result.
Immunovia filed the provisional patent application with the Patent and Trademark Office (PTO) in
Immunovia also plans to file a single PCT (Patent Cooperation Treaty) application within the next year, enabling the company to seek patent protection for its invention across dozens of countries at one time. Immunovia will later pursue patents in specific high-value commercial markets outside the US.
"Our scientists have invented a breakthrough approach to detecting pancreatic cancer and it's vital we protect that invention," said Jeff Borcherding, CEO of Immunovia.
As previously announced, Immunovia has completed development of its next-generation test to detect stage 1 and 2 pancreatic cancer. Immunovia will conduct a large, independent clinical validation study in fourth quarter 2024 to confirm the accuracy of the Immunovia test. The company is on track to launch the new test in the US in 2025.
For more information, please contact:
Jeff Borcherding
CEO and President
jeff.borcherding@immunovia.com
Karin Almqvist Liwendahl
Chief Financial Officer
karin.almqvist.liwendahl@immunovia.com
+46 709 11 56 08
Immunovia in brief
Immunovia AB is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer.
Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com
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SOURCE Immunovia AB
FAQ
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