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Chemomab Awarded New European Patent for CM-101, Its First-in Class Monoclonal Antibody in Phase 2 Clinical Development for Primary Sclerosing Cholangitis

Chemomab Awarded New European Patent for CM-101, Its First-in Class Monoclonal Antibody in Phase 2 Clinical Development for Primary Sclerosing Cholangitis

Chemomab 获得了 CM-101 的新欧洲专利,这是其在原发性硬化性胆管炎二期临床开发中的首个单克隆抗体
GlobeNewswire ·  03/25 07:06

—European Patent Office Grants New Patent Covering Use of CM-101 for the Treatment of Multiple Liver Diseases including Primary Sclerosing Cholangitis—

—欧洲专利局批准了涵盖使用 CM-101 治疗多种肝脏疾病(包括原发性硬化性胆管炎)的新专利—

—Further Extends Protections Afforded by CM-101 Composition of Matter and Methods and Use Patents That Have Issued in the U.S., Europe, Israel and Related Territories—

—进一步扩大 CM-101 物质和方法构成所提供的保护,并使用在美国、欧洲、以色列和相关地区颁发的专利—

TEL AVIV, Israel, March  25, 2024  (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics to treat rare fibro-inflammatory diseases with high unmet need, today reported that the European Patent Office has granted a new patent for CM-101, Chemomab's first-in-class monoclonal antibody that neutralizes CCL24, a novel disease target that has been shown to play a critical role in the processes that drive fibrosis and inflammation. CM-101 is currently being assessed in the global Phase 2 SPRING trial for the treatment of primary sclerosing cholangitis (PSC). Patient enrollment in the trial has been completed, with a topline data readout expected midyear 2024.

以色列特拉维夫,2024年3月25日(GLOBE NEWSWIRE)——开发创新疗法的临床阶段生物技术公司Chemomab Therapeutics Ltd.(纳斯达克股票代码:CMMB)今天报道说,欧洲专利局已经批准了Chemomab的首款单克隆抗体 CM-101 的新专利,该单克隆抗体可中和 CCL24,这是一种新型疾病靶标已被证明在驱动纤维化和炎症的过程中起着至关重要的作用。用于治疗原发性硬化性胆管炎 (PSC) 的全球 2 期 SPRING 试验目前正在对 CM-101 进行评估。该试验的患者入组已经完成,预计将在2024年年中公布头条数据。

The new European patent covers the use of CM-101 and sequence-related anti-CCL24 antibodies for the treatment of hepatic (liver) diseases, including PSC.

这项新的欧洲专利涵盖了使用 CM-101 和与序列相关的抗 CCL24 抗体来治疗肝脏(肝脏)疾病,包括 PSC。

PSC is a potentially lethal condition that lacks any FDA-approved therapies and frequently requires liver transplantation. Unlike other drugs in development for PSC, CM-101 has a unique dual mechanism of action that simultaneously blocks fibrosis and inflammation. In clinical and preclinical studies, this distinctive approach has been shown to inhibit fibrogenesis and interfere with core PSC pathways.

PSC 是一种潜在的致命疾病,缺乏任何 FDA 批准的疗法,通常需要肝移植。与其他正在开发的PSC药物不同,CM-101 具有独特的双重作用机制,可同时阻断纤维化和炎症。在临床和临床前研究中,这种独特的方法已被证明可以抑制纤维化并干扰核心PSC通路。

"This new patent covering the use of CM-101 in liver diseases provides additional intellectual property protection in key European markets in addition to the CM-101 composition of matter patent that has already been granted in Europe. It further supplements the extensive protections afforded by the multiple patents issued and allowed in the U.S., Israel, China and other major territories," said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. "This is an important time for Chemomab as we prepare for the midyear release of topline data from our Phase 2 PSC trial, which could provide the first substantial clinical proof-of-concept of CM-101's therapeutic activity and represents a potential major catalyst for the company."

“除了欧洲已经批准的 CM-101 物质组成专利外,这项涵盖在肝脏疾病中使用 CM-101 的新专利还为欧洲主要市场提供了额外的知识产权保护。它进一步补充了美国、以色列、中国和其他主要地区颁发和允许的多项专利所提供的广泛保护。” Chemomab联合创始人、首席执行官兼首席科学官阿迪·莫尔博士说。“对于Chemomab来说,这是一个重要时刻,因为我们正在为年中发布的2期PSC试验的主要数据做准备,这可能会为 CM-101 的治疗活性提供首次实质性的临床概念验证,也是该公司潜在的主要催化剂。”

European Patent Application No. 18717135.0 "Anti CCL24 (eotaxin2) Antibodies for Use in the Treatment of Hepatic Diseases" has a grant date of March 20, 2024.

欧洲专利申请编号为18717135.0 “用于治疗肝脏疾病的抗 CCL24(eotaxin2)抗体” 的批准日期为2024年3月20日。

In combination with the five families of CM-101 composition of matter and use patents that are either issued or pending in major territories worldwide, these new patents are expected to provide protection of CM-101 across a number of indications until 2038, with the possibility of up to five years extension upon market approval. CM-101 has been granted Orphan Drug designation in the U.S. and the E.U. and the FDA has awarded CM-101 Fast Track designation for the treatment of PSC in adults.

结合全球主要地区已颁发或正在申请的五个 CM-101 物质组成和用途专利系列,这些新专利有望在 2038 年之前在多种适应症中为 CM-101 提供保护,并可能在市场批准后延长至五年。CM-101 已在美国和欧盟被授予孤儿药称号,美国食品药品管理局已授予 CM-101 快速通道称号,用于治疗成人 PSC。

About CM-101
CM-101 is a monoclonal antibody that neutralizes CCL24, a soluble protein that helps drive the inflammatory and fibrotic pathways central to many fibro-inflammatory diseases. CCL24's role as a therapeutic target has been validated in extensive clinical and nonclinical studies and proof-of-concept for CM-101 has been demonstrated in multiple animal and patient sample studies. CM-101 was safe and well tolerated in four Phase 1 and Phase 2 clinical trials. Data from a completed Phase 2a liver fibrosis trial in nonalcoholic steatohepatitis (NASH) patients showed consistent, positive improvements in key inflammatory and fibrogenesis-related biomarkers, including several that may serve as a potential bridge to activity in PSC. Patient enrollment has been completed in an ongoing CM-101 Phase 2 PSC trial and a readout of topline data is expected midyear 2024.

关于 CM-101
CM-101 是一种单克隆抗体,可中和 CCL24,这是一种可溶性蛋白,有助于驱动许多纤维炎性疾病的核心炎症和纤维化途径。CCL24 作为治疗靶标的作用已在广泛的临床和非临床研究中得到证实,CM-101 的概念验证已在多项动物和患者样本研究中得到证实。在四项 1 期和 2 期临床试验中,CM-101 安全且耐受性良好。一项针对非酒精性脂肪肝炎(NASH)患者的已完成的2a期肝纤维化试验的数据显示,炎症和纤维化相关的关键生物标志物持续得到积极改善,其中包括几种可能作为PSC活性潜在桥梁的生物标志物。正在进行的 CM-101 二期PSC试验的患者入组工作已经完成,预计将在2024年年中公布主要数据。

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