2020年5月27日/医麦客新闻 eMedClub News/--圣迭戈，2020年5月26日/GlobeNewswire/--索伦托药业（纳斯达克：SRNE，“Sorrento”）今天宣布已经收到美国食品药品监督管理局（FDA）的批准，同意其对靶向CD38的抗体偶联药物（ADC）STI-6129的新药研究（IND）申请。STI-6129利用了索伦托药业自主开发的几个技术平台，包括从其全人源抗体库G-MAB™中筛选出的CD38特异性抗体、独有专利的小分子毒素Duostatin 5以及C-LOCK定点偶联技术。索伦托药业的董事长兼首席执行官Henry Ji博士表示：“FDA批准我们STI-6129的 IND申请进入人体临床试验，这对索伦托来说是另一个重要的里程碑。STI-6129与我们CD38 CAR-T的项目一起，为有需要的患者提供了额外的治疗选择方案。我们期待在临床试验中进一步评估STI-6129的安全性和有效性。”索伦托药业计划对晚期复发和/或难治性系统性轻链(AL)型类淀粉沉积症患者开展一项多中心、开放标签、剂量递增的一期临床试验，主要目的是根据其安全性、初步疗效和药代动力学特征确定STI-6129的二期剂量。索伦托ADC子公司-联宁生物的首席执行官李辉博士介绍：“这是索伦托-联宁生物的第一个基于C-LOCK定点偶联技术的ADC进入临床评估。与传统的非定点偶联相比，在动物模型中，STI-6129显示出了更有优势的治疗窗口，我们期待将这项技术的应用扩展到其他潜在的ADC项目中。”关于联宁生物
联宁（苏州）生物制药有限公司是由美国NASDAQ上市的Sorrento Therapeutics于2016年6月成立的全资子公司。公司总部设立在苏州，并在南京和美国加州圣迭戈设有研发中心。公司拥有全球领先的新一代定点抗体－药物偶联技术专利，并以此为依托与国内外制药公司开展新药研发的广泛合作。联宁的技术已帮助国内知名制药企业将项目成功申报中美IND，即将推进到临床二期。联宁生物致力于开发新一代抗体偶联药物，为攻克癌症，造福人类而奋斗。
联宁生物拥有顶尖的技术和管理团队，团队包含国际生物制药领域知名专家。联宁位于苏州园区生物纳米园，总建筑面积达5000平方米，拥有GMP生产车间和配套生产设备。联宁在抗体－药物偶联方面的领先技术和严谨的工艺开发能力得到了全球ADC领域的认可。2017年以来， 已经和包括中国，美国，韩国和几个欧洲的生物制药公司开展广泛的项目合作。
完整的新闻发布，请访问：
https://investors.sorrentotherapeutics.com/news-releases
SAN DIEGO, May 26, 2020 /GlobeNewswire/ -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application for STI-6129, a CD38-targeting antibody drug conjugate (ADC). STI-6129 utilizes several technology platforms that are under development by Sorrento Therapeutics, including a CD38 specific antibody identified from its fully human G-MAB™ antibody library, its proprietary drug payload Duostatin 5 and its site-specific C-LOCK conjugation technology.“That the FDA cleared our STI-6129 IND application to proceed to human trials is another important milestone for Sorrento,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. “Together with our CD38 CAR-T program, this has the potential to provide additional therapeutic options for patients in need. We are looking forward to further evaluating the safety and efficacy of STI-6129 in clinical trials.”Sorrento intends to initiate a phase I multicenter, open-label, dose-escalation clinical trial in patients with advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis with a primary objective to identify a phase 2 dose for STI-6129 based on its safety, preliminary efficacy and pharmacokinetic profile. “This is Sorrento’s first ADC utilizing our site-specific C-LOCK conjugation technology that is advancing into clinical evaluation,” said Dr. Hui Li, head of Sorrento’s ADC business unit, Levena Biopharma. “STI-6129 demonstrated an improved therapeutic index in animal models, as compared to traditional non-selective conjugates, and we look forward to potentially expanding its utilization into additional ADC programs.”For the full press release, please visit: https://investors.sorrentotherapeutics.com/news-releases