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
—European Patent Office Grants New Patent Covering Use of CM-101 for the Treatment of Multiple Liver Diseases including Primary Sclerosing Cholangitis—
—歐洲專利局批准了涵蓋使用 CM-101 治療多種肝臟疾病（包括原發性硬化性膽管炎）的新專利—
—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—
—進一步擴大 CM-101 物質和方法構成所提供的保護，並使用在美國、歐洲、以色列和相關地區頒發的專利—
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.
以色列特拉維夫，2024年3月25日（GLOBE NEWSWIRE）——開發創新療法的臨床階段生物技術公司Chemomab Therapeutics Ltd.（納斯達克股票代碼：CMMB）今天報道說，歐洲專利局已經批准了Chemomab的首款單克隆抗體 CM-101 的新專利，該單克隆抗體可中和 CCL24，這是一種新型疾病靶標已被證明在驅動纖維化和炎症的過程中起着至關重要的作用。用於治療原發性硬化性膽管炎 (PSC) 的全球 2 期 SPRING 試驗目前正在對 CM-101 進行評估。該試驗的患者入組已經完成，預計將在2024年年中公佈頭條數據。
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.
這項新的歐洲專利涵蓋了使用 CM-101 和與序列相關的抗 CCL24 抗體來治療肝臟（肝臟）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 是一種潛在的致命疾病，缺乏任何 FDA 批准的療法，通常需要肝移植。與其他正在開發的PSC藥物不同，CM-101 具有獨特的雙重作用機制，可同時阻斷纖維化和炎症。在臨床和臨床前研究中，這種獨特的方法已被證明可以抑制纖維化並干擾核心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."
“除了歐洲已經批准的 CM-101 物質組成專利外，這項涵蓋在肝臟疾病中使用 CM-101 的新專利還爲歐洲主要市場提供了額外的知識產權保護。它進一步補充了美國、以色列、中國和其他主要地區頒發和允許的多項專利所提供的廣泛保護。” Chemomab聯合創始人、首席執行官兼首席科學官阿迪·莫爾博士說。“對於Chemomab來說，這是一個重要時刻，因爲我們正在爲年中發佈的2期PSC試驗的主要數據做準備，這可能會爲 CM-101 的治療活性提供首次實質性的臨床概念驗證，也是該公司潛在的主要催化劑。”
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.
歐洲專利申請編號爲18717135.0 “用於治療肝臟疾病的抗 CCL24（eotaxin2）抗體” 的批准日期爲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.
結合全球主要地區已頒發或正在申請的五個 CM-101 物質組成和用途專利系列，這些新專利有望在 2038 年之前在多種適應症中爲 CM-101 提供保護，並可能在市場批准後延長至五年。CM-101 已在美國和歐盟被授予孤兒藥稱號，美國食品藥品管理局已授予 CM-101 快速通道稱號，用於治療成人 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.
關於 CM-101
CM-101 是一種單克隆抗體，可中和 CCL24，這是一種可溶性蛋白，有助於驅動許多纖維炎性疾病的核心炎症和纖維化途徑。CCL24 作爲治療靶標的作用已在廣泛的臨床和非臨床研究中得到證實，CM-101 的概念驗證已在多項動物和患者樣本研究中得到證實。在四項 1 期和 2 期臨床試驗中，CM-101 安全且耐受性良好。一項針對非酒精性脂肪肝炎（NASH）患者的已完成的2a期肝纖維化試驗的數據顯示，炎症和纖維化相關的關鍵生物標誌物持續得到積極改善，其中包括幾種可能作爲PSC活性潛在橋樑的生物標誌物。正在進行的 CM-101 二期PSC試驗的患者入組工作已經完成，預計將在2024年年中公佈主要數據。
譯文內容由第三人軟體翻譯。