Merus Announces U.S. FDA Acceptance And Priority Review Of BLA For Zeno For The Treatment Of NRG1+ NSCLC And PDAC
Merus Announces U.S. FDA Acceptance And Priority Review Of BLA For Zeno For The Treatment Of NRG1+ NSCLC And PDAC
Merus N.V. (NASDAQ:MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer.
開發創新型全長多特異性抗體（Biclonics和Triclonics）的臨床階段腫瘤公司Merus N.V.（納斯達克股票代碼：MRUS）（Merus，公司，我們或我們的）今天宣佈，美國食品藥品監督管理局（FDA）已接受雙特異性抗體zenocutuzumab（Zeno）的生物製劑許可申請（BLA）的優先審查。) 用於神經調節素 1 融合 (NRG1+) 非小細胞肺癌 (NSCLC) 和 NRG1+ 胰腺癌 (PDAC) 患者。
"FDA acceptance of our first BLA represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1+ cancer, a disease with poor prognosis and high unmet need," said Dr. Andrew Joe, Chief Medical Officer at Merus. "Zenocutuzumab has the potential to be the first and only targeted therapy for patients with NRG1+ lung and pancreatic cancer, and may offer a substantial improvement over currently available therapies."
梅魯斯首席醫學官安德魯·喬博士說：“美國食品藥品管理局對我們的第一個BLA的接受代表了梅魯斯的一項重要成就，對於NRG1+癌症患者來說，這是一個重要的潛在治療機會，這種疾病預後不佳，需求未得到滿足。”“Zenocutuzumab有可能成爲第一種也是唯一一種針對NRG1+肺癌和胰腺癌患者的靶向療法，並且可能比目前可用的療法有實質性的改善。”
The BLA includes a comprehensive clinical data package, including data from the phase 1/2 eNRGy trial, which is investigating the safety and anti-tumor activity of Zeno monotherapy in NRG1+ NSCLC, PDAC and other solid tumors. Data from the open-label trial were presented previously at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, and subsequently updated at ASCO 2022 and the European Society for Medical Oncology (ESMO) Congress 2023.
BLA包括全面的臨床數據包，包括來自1/2期enrGy試驗的數據，該試驗正在研究Zeno單一療法在NRG1+ NSCLC、PDAC和其他實體瘤中的安全性和抗腫瘤活性。開放標籤試驗的數據此前曾在美國臨床腫瘤學會（ASCO）2021年年會上公佈，隨後在ASCO 2022年和2023年歐洲腫瘤內科學會（ESMO）大會上進行了更新。
The FDA has granted Breakthrough Therapy Designation (BTD) to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. Additionally, the FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ NSCLC, following progression with prior systemic therapy.
美國食品藥品管理局已授予Zeno突破性療法稱號（BTD），用於治療在先前的全身治療進展後晚期不可切除或轉移的NRG1+胰腺癌患者或沒有令人滿意的替代治療選擇的患者。此外，在先前的全身治療進展後，美國食品和藥物管理局已批准Zeno使用BTD治療晚期不可切除或轉移性NRG1+非小細胞肺癌患者。
Zeno is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
Zeno目前正在臨床開發中，其安全性和有效性尚未經過任何監管機構的全面評估。
About Zeno
關於芝諾
Zeno is a Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions (NRG1+ cancer). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancer. In preclinical studies, Zeno potently inhibits HER2/HER3 heterodimer formation thereby inhibiting oncogenic signaling pathways, leading to inhibition of tumor cell proliferation and blocking tumor cell survival. In clinical studies, Zeno has demonstrated anti-tumor activity in multiple types of NRG1+ cancer, including NRG1+ NSCLC and NRG1+ PDAC.
Zeno是一種利用Merus Dock & Block機制來抑制NRG1融合（NRG1+癌症）實體瘤中的神經調節劑/HER3腫瘤信號通路的雙克隆藥物。通過其與HER2結合並有效阻斷HER3與其配體NRG1或nrg1融合蛋白相互作用的獨特機制，Zeno有可能對NRG1+癌症特別有效。在臨床前研究中，Zeno有效抑制HER2/HER3異二聚體的形成，從而抑制致癌信號通路，從而抑制腫瘤細胞增殖並阻斷腫瘤細胞存活。在臨床研究中，Zeno已在多種類型的NRG1+癌症中顯示出抗腫瘤活性，包括NRG1+ NSCLC和NRG1+ PDAC。
About NRG1 Fusions
關於 NRG1 Fusions
The NRG1 gene encodes neuregulin (also known as heregulin), the ligand for HER3. Fusions between NRG1 and partner genes are rare, tumorigenic genomic events occurring in certain cancer types including NSCLC and PDAC.
NRG1 基因編碼神經調節素（也稱爲 heregulin），這是 HER3 的配體。NRG1 和伴侶基因之間的融合是罕見的致癌基因組事件，發生在某些癌症類型中，包括 NSCLC 和 PDAC。
譯文內容由第三人軟體翻譯。