Zymeworks Begins Human Trials for New Cancer Therapy Targeting Ovarian and Lung Tumors
Zymeworks Begins Human Trials for New Cancer Therapy Targeting Ovarian and Lung Tumors
The Phase 1 trial is a two-part, multi-center, global study that aims to enroll 145 adult patients with advanced FR⍺-expressing cancers. The Company expects to enroll patients at investigator sites in North America, Europe, and the Asia-Pacific region. Part one of the study will evaluate the safety and tolerability of ZW191 and involve dose escalation in patients with advanced ovarian, endometrial, and NSCLC cancers, with secondary endpoints assessing pharmacokinetics and confirmed objective response rate. Part two of the study will further evaluate safety and explore the potential anti-tumor activity of ZW191.Zymeworks Inc. (NASDAQ:ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that the first patient has been dosed in the company's first-in-human Phase 1 trial (NCT06555744) to evaluate the safety and tolerability of the investigational therapy ZW191 in the treatment of advanced folate receptor-⍺ (FR⍺)-expressing solid tumors including ovarian, endometrial, and non-small cell lung (NSCLC) cancers.
zymeworks公司(NASDAQ:ZYME)是一家臨床階段的生物技術公司，正在開發多樣化的新型多功能生物療法產品線，以提高治療難治疾病的標準。今天宣佈，該公司的首位患者已在公司的ZW191第一期人體試驗(NCT06555744)中接受了劑量，以評估該治療性試驗藥物ZW191在治療包括卵巢、子宮內膜和非小細胞肺癌（NSCLC）在內的表達葉酸受體⍺ (FR⍺)的固體腫瘤中的安全性和耐受性。
"Our team is excited to initiate this important clinical trial to assess the safety and tolerability of ZW191, our first antibody-drug conjugate utilizing ZD06519, our novel proprietary payload, in patients with difficult-to-treat cancers," said Jeff Smith, M.D., FRCP, Executive Vice President and Chief Medical Officer at Zymeworks. "This global study represents a significant milestone in our mission to bring innovative and urgently needed therapies to patients in need. This announcement also follows the recent initiation of our Phase 1 trial of ZW171, marking an additional important step forward in advancing the many promising therapies in our wholly-owned pipeline."
"我們的團隊很高興開展這一重要的臨床試驗，以評估ZW191的安全性和耐受性，這是我們的第一款使用ZD06519、我們新穎專有的藥物載體的抗體-藥物結合物，用於難治性癌症患者，"zymeworks的執行副總裁兼首席醫療官Jeff Smith萬. D.博士說。"這項全球性研究代表着我們的使命中的一個重要里程碑，即爲有需要的患者提供創新和迫切需要的療法。這一公告也緊隨我們啓動ZW171第一期試驗的最近消息，這是我們旗下多個有希望的療法不斷前進的另一個重要步驟。"
FRα is found in ~75% of high-grade serous ovarian carcinomas1 and ~70% of lung adenocarcinomas2. In data presented at the American Association for Cancer Research (AACR) Annual Meeting in 2024, ZW191 was associated with greater anti-tumor activity compared to benchmark in FRα-expressing tumor models and was well-tolerated in cynomolgus monkeys up to 60 mg/kg3.
FRα在大約75%的高級別卵巢漿液性癌症1和約70%的肺腺癌2中表達。在2024年美國癌症研究協會(AACR)年會上展示的數據中，與基準相比，ZW191在FRα表達的腫瘤模型中顯示出更強的抗腫瘤活性，並在長尾猴中（最高達60mg/kg）具有良好的耐受性。
The Phase 1 trial is a two-part, multi-center, global study that aims to enroll 145 adult patients with advanced FR⍺-expressing cancers. The Company expects to enroll patients at investigator sites in North America, Europe, and the Asia-Pacific region. Part one of the study will evaluate the safety and tolerability of ZW191 and involve dose escalation in patients with advanced ovarian, endometrial, and NSCLC cancers, with secondary endpoints assessing pharmacokinetics and confirmed objective response rate. Part two of the study will further evaluate safety and explore the potential anti-tumor activity of ZW191.
這一第一期試驗是一項分兩部分的、多中心、全球性研究，旨在招募145名患有先進FR⍺-表達癌症的成年患者。公司預計將在北美、歐洲和亞太地區的調查員網站招募患者。研究的第一部分將評估ZW191的安全性和耐受性，並在患有先進卵巢、子宮內膜和NSCLC癌症的患者中進行劑量遞增，次要終點包括藥代動力學和確證客觀反應率。研究的第二部分將進一步評估安全性，並探索ZW191的潛在抗腫瘤活性。
