Ang2 x VEGF-A x PGF x IL-6R x VEGF-B

2024年7月15日，中国苏州和美国旧金山-典晶生物医药科技（苏州）有限公司（典晶生物）今天宣布其三靶点融合抗体药物EB-105在美国完成全球首例糖尿病黄斑水肿患者给药。LOTUS是一项开放标签、多中心、单次、玻璃体腔内注射、剂量递增的临床试验，目前正在美国的四家医院进行。临床前研究显示EB-105能够强效抑制 VEGF-A/VEGFR-2、Ang-2/Tie-2 和 IL-6/IL-6R 等信号传导通路。IL-6是一种炎症细胞因子，目前已知其在因血管内皮细胞屏障功能障碍所导致的血管渗漏中起作用，通常在患有糖尿病黄斑水肿、糖尿病视网膜病变、新生血管性（湿性）年龄相关性黄斑变性和视网膜静脉阻塞的患者中，其玻璃体内和房水中的IL-6水平均有升高。 典晶生物首席医学官 Charles Semba 博士说：“EB-105 是在快速崛起的多价蛋白治疗领域中的重大进展。除靶向抗血管内皮生长因子（VEGF）和抗血管生成素-2（Ang-2）之外， EB-105还抑制细胞内与炎症相关的信号传导途径，它可能会为糖尿病视网膜病变的患者带来比当前疗法更优的治疗效果。“ 美国Texas Retina Associates的临床研究主任Ashkan Abbey博士是全球首位为糖尿病黄斑水肿患者进行EB-105 注射的视网膜外科医生。他评论道：“视网膜专家非常欢迎在新的药物中增加IL-6抑制途径。我们急需新的药物来治疗通常难以治疗的患者，我们期待EB-105能够在改善视力、减少视网膜水肿和维持疗效的持久性方面有大幅的提升。” ▍关于LOTUS试验： LOTUS是一项多中心、单次玻璃体腔内注射、剂量递增的临床Ib期试验，它将在黄斑区中央凹增厚的糖尿病性黄斑水肿患者中评估EB-105的三个剂量水平。本试验计划招募大约12名患者（每个剂量4名）。主要试验目的是就EB-105的安全性、耐受性和通过影像学和视力测试的药效学评估，并选择两个最佳剂量用于预计在2025年开始的、玻璃体内重复注射的研究。这项单次注射试验的完整数据（topline data）预计将在2025年上半年公布。 ▍关于典晶生物 典晶生物成立于2020年初。公司总部、研发中心和GMP生产设施位于苏州工业园区生物医药产业园，在美国旧金山湾区设有全球临床和监管注册中心。典晶生物目前获得了礼来亚洲基金、泉创资本、高瓴创投，千骥资本，越秀产业基金，本草资本，元禾控股，元禾辰坤和苏州宜和等著名风险投资机构的支持。更多信息请访问www.eluminexbio.com。

EB-105 is the world's first pentavalent trispecific antibody targeting VEGF-A, VEGF-B, PlGF, Ang-2 and IL-6R in DME LOTUS study is the initial clinical trial of Eluminex's EB-105 being conducted in the United States SAN FRANCISCO and SUZHOU, China, July 15, 2024 /PRNewswire/ -- Eluminex Biosciences (Eluminex), a clinical stage, privately held biotechnology company focused on the development of advanced protein therapeutics for vision-threatening diseases announced the first dosing of EB-105 in patients with DME. The LOTUS trial is a first-in-human, open-label, multicenter, single injection, dose-escalation study of EB-105, Eluminex's lead ophthalmology asset being conducted at four sites in the United States. EB-105 has been shown in preclinical studies to potently inhibit VEGF-A/VEGFR-2, Ang-2/Tie-2, and IL-6/IL-6R signaling. Vitreous levels of IL-6, an inflammatory cytokine known to play a role in endothelial cell barrier dysfunction leading to vascular leakage, are elevated in patients with retinal disease including DME, diabetic retinopathy, neovascular (wet) age-related macular degeneration, and retinal vein occlusion. Dr. Ashkan Abbey, MD, Director of Clinical Research at Texas Retina Associates was the first retinal surgeon in the world to administer EB-105 treatment in the clinic. "Retina specialists welcome the addition of IL-6 pathway inhibition. We are in need of newer agents for these often difficult to manage patients. It is our hope that EB-105 will translate into incremental improvements in visual acuity, durability of response, and improved drying of the retina," he commented. "EB-105 represents a significant advance in the rapidly emerging science of polyvalent protein engineering," stated Charles Semba, MD, Eluminex's Chief Medical Officer. "For patients, it offers the promise of broader coverage of known biologic pathways associated with diabetic retinopathy and potentially better outcomes beyond currently available therapies," he added. About the LOTUS Trial LOTUS is a multicenter, single intravitreal (IVT) injection dose escalation study that will evaluate three dose levels of EB-105 in patients with center-involved diabetic macular edema and will enroll approximately 12 patients (4 per dose level). The primary objectives are safety, tolerability and pharmacodynamics (as assessed by imaging and visual acuity assessments) and to select the two best doses for a separate repeat injection study that is anticipated in 2025. Topline data from the current single injection study is anticipated in 1H 2025. In addition to Dr. Abbey are the following leading retinal surgeon investigators: Carl Awh, MD, Tennessee Retina, Nashville, TN; Veeral Sheth, MD, University Retina, Lemont, IL, and Charles Wyckoff, MD, Retina Consultants of Houston, Houston, TX. The study is being facilitated by the clinical research organization (CRO) Vial, Inc., based in San Francisco, CA. About Eluminex Biosciences Eluminex was founded in early 2020. The company headquarters, research and development (R&D) center, and Good Manufacturing Practices (GMP) manufacturing facilities are located in Suzhou Industrial Park BioBAY, China, and the US regional office is located in Mountain View, California. Eluminex is currently supported by leading venture groups including Lilly Asia Ventures, Quan Capital, Hillhouse BioVenture, Cenova Capital, and 3E BioVentures and has raised over $100M (USD) through Series B+ financing. For more information: . SOURCE Eluminex Biosciences