Quince Therapeutics Receives Notice of Allowance Covering Innovative Method of Use for Lead Indication Ataxia-Telangiectasia
Quince Therapeutics (NASDAQ: QNCX) has received a Notice of Allowance from the USPTO for a patent application covering their method of treating Ataxia-Telangiectasia (A-T) using the EryDex process. The patent, extending to 2036, covers the preparation of erythrocytes loaded with pharmaceutical substances.
The new patent application supplements existing U.S. Patent No. 10,849,858 and features broader claims than the parent patent. Once issued, the patent will be listable in the FDA's Orange Book, requiring generic applicants to certify against Quince's patent, providing notice of future generic applications and stay provisions under the Hatch-Waxman Act.
This protection complements the market exclusivity provided by Orphan Drug Designation in both the U.S. and Europe. The company plans to pursue similar claims with the European Patent Office.
Quince Therapeutics (NASDAQ: QNCX) ha ricevuto un Avviso di Concessione dall'USPTO per una domanda di brevetto che copre il loro metodo di trattamento dell'Atassia-Telangiectasia (A-T) utilizzando il processo EryDex. Il brevetto, che si estende fino al 2036, copre la preparazione di eritrociti caricati con sostanze farmaceutiche.
La nuova domanda di brevetto integra il brevetto statunitense esistente n. 10.849.858 e presenta rivendicazioni più ampie rispetto al brevetto parentale. Una volta emesso, il brevetto sarà elencabile nel Libro Arancione della FDA, richiedendo ai candidati generici di certificare contro il brevetto di Quince, fornendo notifica delle future domande generiche e disposizioni di sospensione ai sensi del Hatch-Waxman Act.
Questa protezione completa l'esclusività di mercato fornita dalla Designazione di Farmaco Orfano sia negli Stati Uniti che in Europa. L'azienda prevede di perseguire rivendicazioni simili con l'Ufficio Europeo dei Brevetti.
Quince Therapeutics (NASDAQ: QNCX) ha recibido un Aviso de Concesión de la USPTO para una solicitud de patente que cubre su método para tratar la Ataxia-Telangiectasia (A-T) utilizando el proceso EryDex. La patente, que se extiende hasta 2036, cubre la preparación de eritrocitos cargados con sustancias farmacéuticas.
La nueva solicitud de patente complementa la Patente de EE. UU. No. 10,849,858 y presenta reclamaciones más amplias que la patente principal. Una vez emitida, la patente será incluida en el Libro Naranja de la FDA, lo que requerirá que los solicitantes genéricos certifiquen contra la patente de Quince, proporcionando aviso sobre futuras solicitudes genéricas y disposiciones de suspensión bajo la Ley Hatch-Waxman.
Esta protección complementa la exclusividad en el mercado proporcionada por la Designación de Medicamento Huérfano tanto en EE. UU. como en Europa. La empresa planea buscar reclamaciones similares con la Oficina Europea de Patentes.
퀸스 테라퓨틱스(NASDAQ: QNCX)는 EryDex 프로세스를 사용하여 운동실조-확장증(A-T)을 치료하는 방법에 대한 특허 출원에 대해 USPTO로부터 허가 통지를 받았습니다. 이 특허는 2036년까지 연장되며, 약리 물질이 로드된 적혈구의 준비를 포함합니다.
새로운 특허 출원은 기존 미국 특허 제 10,849,858호를 보완하며, 모 특허보다 더 폭넓은 주장 내용을 포함하고 있습니다. 특허가 발급되면 FDA의 오렌지 북에 등재될 것이며, 이는 일반 의약품 신청자들이 퀸스의 특허에 대해 증명해야 하고, 향후 일반 의약품 신청에 대한 통지를 제공하며, Hatch-Waxman 법에 따른 유예 조항이 요구됩니다.
이 보호 장치는 미국과 유럽 모두에서 고아 약물 지정에 의해 제공되는 시장 독점성과 보완됩니다. 회사는 유럽 특허청과 유사한 주장을 추구할 계획입니다.
Quince Therapeutics (NASDAQ: QNCX) a reçu un Avis de Concession de l'USPTO pour une demande de brevet couvrant leur méthode de traitement de l'Ataxie-Télangiectasie (A-T) utilisant le processus EryDex. Le brevet, valable jusqu'en 2036, couvre la préparation d'érythrocytes chargés de substances pharmaceutiques.
La nouvelle demande de brevet complète le brevet américain n° 10.849.858 et présente des revendications plus larges que le brevet principal. Une fois délivrée, la patente sera inscrite dans le Livre Orange de la FDA, exigeant des candidats génériques qu'ils certifient contre le brevet de Quince, fournissant un avis sur les futures demandes génériques et des dispositions de suspension en vertu de la loi Hatch-Waxman.
Cette protection complète l'exclusivité du marché accordée par la Désignation de Médicament Orphelin tant aux États-Unis qu'en Europe. L'entreprise prévoit de poursuivre des revendications similaires auprès de l'Office Européen des Brevets.
Quince Therapeutics (NASDAQ: QNCX) hat eine Zulassungsmitteilung vom USPTO für eine Patentanmeldung erhalten, die ihr Verfahren zur Behandlung von Ataxia-Telangiectasia (A-T) mit dem EryDex-Prozess abdeckt. Das Patent, das bis 2036 gültig ist, umfasst die Herstellung von mit pharmazeutischen Substanzen beladenen Erythrozyten.
Die neue Patentanmeldung ergänzt das bestehende US-Patent Nr. 10.849.858 und enthält umfassendere Ansprüche als das Hauptpatent. Nach der Erteilung wird das Patent im Orange Book der FDA aufgeführt, was von generischen Bewerbern verlangt, gegen das Patent von Quince zu zertifizieren und Benachrichtigungen über zukünftige generische Anwendungen sowie Aussetzungsvorschriften gemäß dem Hatch-Waxman-Gesetz bereitzustellen.
Dieser Schutz ergänzt die Marktexklusivität, die durch die Orphan Drug Designation sowohl in den USA als auch in Europa gewährleistet wird. Das Unternehmen plant, ähnliche Ansprüche beim Europäischen Patentamt zu verfolgen.
- Patent protection for EryDex process extended to 2036
- Broader patent claims than parent patent, enhancing IP protection
- Orange Book listing eligibility providing additional generic competition protection
- Dual market protection through patent and Orphan Drug Designation in US and Europe
- None.
Insights
The USPTO's Notice of Allowance for Quince Therapeutics represents a significant strategic victory that substantially strengthens their market position. The new patent protection, extending to 2036, creates multiple layers of market exclusivity:
- Broader claim scope than the parent patent, potentially enabling additional commercial applications of their proprietary technology
- Orange Book listability, which triggers mandatory generic applicant certifications and potential 30-month stays under Hatch-Waxman
- Complementary protection to existing Orphan Drug Designation in both U.S. and European markets
The expanded patent claims covering their EryDex process are particularly valuable as they're not to specific pharmaceutical products, potentially allowing Quince to leverage their technology platform across multiple therapeutic applications. This could create additional revenue streams and licensing opportunities.
The timing is strategically important as Quince positions EryDex as a late-stage asset for A-T treatment. The robust IP protection through 2036 provides a clear runway for commercialization and helps secure market exclusivity well beyond initial market entry. The parallel pursuit of similar claims in Europe indicates a comprehensive global IP strategy that could maximize the technology's commercial potential across major markets.
The patent allowance validates Quince's innovative AIDE technology platform, which leverages engineered erythrocytes as drug delivery vehicles - a potentially game-changing approach in rare disease treatment. This technology offers several key advantages:
- Extended drug release capabilities, potentially improving therapeutic efficacy
- Natural drug delivery system using patient's own cells, potentially reducing adverse effects
- Versatile platform technology applicable to multiple therapeutic compounds
For Ataxia-Telangiectasia, a rare genetic disorder affecting approximately 1 in 40,000-100,000 people worldwide, this represents a significant advancement. The broad patent claims covering the EryDex process strengthen Quince's position as a pioneer in erythrocyte-based drug delivery, potentially creating high barriers to entry for competitors in this space.
The extension of patent protection to 2036, combined with Orphan Drug Designation benefits, provides Quince with a substantial window to maximize the commercial potential of their lead program while developing additional applications of their proprietary technology platform. This comprehensive IP protection is particularly valuable in the rare disease space, where development costs are high and market exclusivity is important for return on investment.
Allowance to extend into 2036 patent claims related to method of treating patients with A-T using the company’s proprietary EryDex process
Charles Ryan, J.D., Ph.D., Quince’s President and head of the company’s corporate legal activities and intellectual property portfolio, said, “Our growing intellectual property portfolio strengthens the long-term market position for our lead asset EryDex and further validates our proprietary AIDE technology platform. Importantly, this allowance strengthens market exclusivity and extends our patent claims to 2036 in the
Quince expects that the resulting patent will be listable in the
A Notice of Allowance is issued after the USPTO determines that the prosecution on the merits of a patent has been completed and grants the patent upon payment of the patent issuance fee. As such, Quince expects the
Quince plans to pursue claims having a similar claim scope in related cases pending before the European Patent Office as well.
About Ataxia-Telangiectasia
A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the
About EryDex for A-T
EryDex is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient’s own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The EryDex System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment.
EryDex leverages Quince’s proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient’s own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince’s AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response.
About Quince Therapeutics
Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube.
Forward-looking Statements
Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “anticipate,” “plan,” “believe,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words. Examples of forward-looking statements include, among others, statements relating to the company’s patent portfolio, the issuance of patents and related implications for the company; plans to pursue claims, including those currently pending with regulatory agencies, current and future clinical development of EryDex; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; the company’s future development plans and related timing; the company’s focus, objectives, plans, and strategies; and the potential benefits of EryDex, AIDE technology and the company’s market opportunity. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 13, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250204400822/en/
Media & Investor Contact:
Stacy Roughan
Quince Therapeutics, Inc.
Vice President, Corporate Communications & Investor Relations
ir@quincetx.com
Source: Quince Therapeutics, Inc.
FAQ
When does Quince Therapeutics' (QNCX) new patent for EryDex expire?
What disease treatment is covered by QNCX's new patent allowance?
How does the Orange Book listing benefit QNCX's EryDex patent?
What additional market protection does QNCX have for EryDex besides the patent?
What is the scope of QNCX's new patent application compared to its existing patent?
