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Quince Therapeutics收到关于铅适应症共济失调毛细血管扩张症创新使用方法的许可通知

Quince Therapeutics Receives Notice of Allowance Covering Innovative Method of Use for Lead Indication Ataxia-Telangiectasia

businesswire 等信源发布 2025-02-05 04:05

可切换为仅中文


SOUTH SAN FRANCISCO, Calif.--(

加利福尼亚州南旧金山--(

BUSINESS WIRE

商业热线

)--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No.

)--Quince Therapeutics,Inc.(纳斯达克股票代码:QNCX)是一家致力于释放患者自身生物学能力以治疗罕见疾病的晚期生物技术公司,该公司宣布美国专利商标局(USPTO)已发布美国专利申请许可通知书。

17/083,771 entitled .

17/083771标题。

Process for the Preparation of Erythrocytes Loaded With One or More Substances of Pharmaceutical Interest and So Obtained Erythrocytes

制备载有一种或多种药用物质的红细胞和由此获得的红细胞的方法

. The newly allowed application covers the method of treating patients with Ataxia-Telangiectasia (A-T) and provides patent coverage for preparing erythrocytes loaded with one or more substances of pharmaceutical interest using the EryDex process. The first independent claim of this application is not limited to any particular pharmaceutical product and is broader than currently granted parent patent claims.

。新允许的申请涵盖了治疗共济失调毛细血管扩张症(A-T)患者的方法,并提供了使用EryDex方法制备载有一种或多种药物感兴趣物质的红细胞的专利范围。本申请的第一个独立权利要求不限于任何特定的药品,并且比目前授予的母专利权利要求更广泛。

Supplementing the company’s existing U.S. Patent No. 10,849,858, Quince now has issued patents directed to the process for encapsulating erythrocytes with a therapeutic drug as well as a method of treating a patient with encapsulated erythrocytes..

作为该公司现有美国专利号10849858的补充,Quince现在已经发布了针对用治疗药物包封红细胞的方法以及用包封的红细胞治疗患者的方法的专利。。

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.

Quince总裁兼公司法律活动和知识产权投资组合负责人Charles Ryan,J.D.博士表示:“我们不断增长的知识产权投资组合增强了我们领先资产EryDex的长期市场地位,并进一步验证了我们专有的AIDE技术平台。

Importantly, this allowance strengthens market exclusivity and extends our patent claims to 2036 in the U.S. We are very pleased with this Notice of Allowance and intend to continue to prosecute additional patent applications to protect EryDex and our proprietary encapsulation technology.”.

重要的是,这一津贴加强了市场排他性,并将我们在美国的专利申请扩展到2036年。我们对这一津贴通知非常满意,并打算继续起诉其他专利申请,以保护EryDex和我们的专有封装技术。”。

Quince expects that the resulting patent will be listable in the U.S. Food and Drug Administration’s publication

昆斯预计,由此产生的专利将在美国食品和药物管理局的出版物中列出

Approved Drug Products with Therapeutic Equivalence Evaluations

经批准的具有治疗等效性评估的药品

(Orange Book). As a result, any generic applicant that references EryDex for the treatment of A-T would be required to certify against the company’s patent. This will provide Quince notice of future generic applicants and give the company other stay provisions under applicable provisions of the Hatch-Waxman Act.

(橘皮书)。因此,任何引用EryDex治疗a-T的通用申请人都将被要求针对该公司的专利进行认证。这将为未来的通用申请人提供Quince通知,并根据哈奇-瓦克斯曼法案的适用条款为公司提供其他逗留条款。

This protection is in addition to the expected market exclusivity provided by Orphan Drug Designation in the U.S. and Europe..

这种保护是对孤儿药指定在美国和欧洲提供的预期市场排他性的补充。。

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 U.S. patent to be issued after administrative processes are complete.

在美国专利商标局(USPTO)确定已完成对专利实质的起诉并在支付专利发行费后授予专利后,将发布许可通知。因此,昆斯预计美国专利将在行政程序完成后发布。

Quince plans to pursue claims having a similar claim scope in related cases pending before the European Patent Office as well.

Quince计划在欧洲专利局(European Patent Office)正在审理的相关案件中也寻求类似索赔范围的索赔。

About

关于

Ataxia-Telangiectasia

共济失调毛细血管扩张

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.

A-T是由ATM基因突变引起的遗传性常染色体隐性神经退行性疾病和免疫缺陷疾病,负责细胞稳态和细胞分裂功能,包括但不限于双链DNA修复。通常,A-T首先在五岁之前被诊断出来,因为儿童开始改变步态并以更高的频率跌倒。

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.

神经系统症状恶化,A-T患者经常因青春期而坐轮椅。A-T患者的青少年时期通常以反复感染,肺损伤和恶性肿瘤为特征。中位寿命约为25至30岁,因感染和恶性肿瘤而死亡。

Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T..

根据IQVIA Medical Claims(Dx),PharmetricsPlus(P+)和IQVIA Analytics信息,美国约有4600名确诊的A-T患者。Quince估计,英国和欧盟4个国家约有5000名A-T患者。目前,全球任何A-T市场都没有批准的治疗方法。。

About EryDex for A-T

关于A-T的EryDex

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由包裹在患者自身红细胞(自体红细胞)中的地塞米松磷酸钠(DSP)组成。DSP是一种皮质类固醇,因其抗炎特性以及肾上腺抑制引起的剂量限制性毒性而闻名。EryDex系统旨在提供皮质类固醇的功效,并减少或消除长期使用皮质类固醇治疗带来的重大不良反应。。

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.

EryDex利用Quince专有的自体细胞内药物封装或AIDE技术平台,这是一种新型药物/设备组合,使用自动化过程将药物封装到患者自己的红细胞中。红细胞具有几个特征,使其成为药物递送的潜在有效载体,包括潜在更好的耐受性,增强的组织分布,降低的免疫原性和延长循环半衰期。

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..

Quince的AIDE技术旨在利用这些优势,允许长期服用由于毒性,生物分布不良,药代动力学不理想或免疫反应而受到限制的药物。。

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

Quince Therapeutics,Inc.(纳斯达克:QNCX)是一家晚期生物技术公司,致力于释放患者自身生物学的力量,用于治疗罕见疾病。有关该公司及其最新消息的更多信息,请访问

www.quincetx.com

www.quincetx.com

and follow Quince on social media platforms

并在社交媒体平台上关注Quince

LinkedIn

LinkedIn

,

,

Facebook

脸书

,

,

X

, and

,以及

YouTube

YouTube

.

.

Forward-looking Statements

前瞻性声明

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.

本新闻稿中的声明包含《1995年私人证券诉讼改革法》(见修订后的《1933年证券法》第27A节)和修订后的《1934年证券交易法》第21E节)所指的“前瞻性声明”,这些声明受这些条款所设“安全港”的约束。

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.

除历史事实陈述外,所有陈述都可能是前瞻性陈述。。

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.

前瞻性陈述的例子包括与公司专利组合、专利发行和对公司的相关影响有关的陈述;计划寻求索赔,包括目前正在与监管机构进行的索赔,EryDex的当前和未来临床开发;计划的监管机构提交和临床试验以及时间表,前景和里程碑预期;;公司的重点、目标、计划和战略;以及EryDex、AIDE技术和公司市场机会的潜在益处。

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.

前瞻性陈述基于Quince当前的预期,并受到难以预测的固有不确定性、风险和假设的影响,并可能导致实际结果与公司预期存在重大差异。此外,某些前瞻性陈述基于对未来事件的假设,这些假设可能不准确。

Factors that could cause actual results to differ include, but are not limited to, the ris.

可能导致实际结果不同的因素包括但不限于ris。