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)是一家临床阶段的生物技术公司，正在开发多样化的新型多功能生物疗法产品线，以提高治疗难治疾病的标准。今天宣布，该公司的首位患者已在公司的ZW191第一期人体试验(NCT06555744)中接受了剂量，以评估该治疗性试验药物ZW191在治疗包括卵巢、子宫内膜和非小细胞肺癌（NSCLC）在内的表达叶酸受体⍺ (FR⍺)的固体肿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."
"我们的团队很高兴开展这一重要的临床试验，以评估ZW191的安全性和耐受性，这是我们的第一款使用ZD06519、我们新颖专有的药物载体的抗体-药物结合物，用于难治性癌症患者，"zymeworks的执行副总裁兼首席医疗官Jeff Smith万. D.博士说。"这项全球性研究代表着我们的使命中的一个重要里程碑，即为有需要的患者提供创新和迫切需要的疗法。这一公告也紧随我们启动ZW171第一期试验的最近消息，这是我们旗下多个有希望的疗法不断前进的另一个重要步骤。"
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在大约75%的高级别卵巢浆液性癌症1和约70%的肺腺癌2中表达。在2024年美国癌症研究协会(AACR)年会上展示的数据中，与基准相比，ZW191在FRα表达的肿瘤模型中显示出更强的抗肿瘤活性，并在长尾猴中（最高达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.
这一第一期试验是一项分两部分的、多中心、全球性研究，旨在招募145名患有先进FR⍺-表达癌症的成年患者。公司预计将在北美、欧洲和亚太地区的调查员网站招募患者。研究的第一部分将评估ZW191的安全性和耐受性，并在患有先进卵巢、子宫内膜和NSCLC癌症的患者中进行剂量递增，次要终点包括药代动力学和确证客观反应率。研究的第二部分将进一步评估安全性，并探索ZW191的潜在抗肿瘤活性。
