SBIR Phase I: A Universal Drug Delivery System for Wet Epithelia

SBIR 第一阶段：湿上皮通用药物输送系统

• 批准号: 1938499
• 负责人: Jes Klarlund
• 金额: $ 22.5万
• 依托单位: ANKYRBIO LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1938499&HistoricalAwards=false
• 关键词: SBIR; Phase; Universal; Drug; Delivery

The broader/commercial impact of this SBIR phase I project aims to enable the use of biologics, a newer class of drugs transforming medicine due to its marked effectiveness and specificity, to treat diseases at wet surfaces of the body. Many diseases occur at wet surfaces in the body including the oral cavity, joints, lungs, and gastrointestinal tract. Local application of biologics is currently not used in these areas because the drugs are rapidly washed away before they have any benefit. Biologics are sometimes administered by infusion to treat these diseases, but this has risks of serious, even life-threatening side effects. If biologics could instead be delivered locally, side-effects would be much less of a concern and diseases at wet surfaces could be treated more aggressively and effectively than currently possible. Successful completion of the project will establish proof-of-concept for the technology and create a new platform to treat these diseases to the benefit of patients in ways that were previously impossible. The company will work with pharmaceutical partner companies to utilize their combined resources to commercialize these products and improve health outcomes.The central idea is to anchor biologics to wet surfaces so that they act for longer periods (hours or days). Traditional approaches to prolonged drug delivery use some form of problematic carrier; most cannot be used with biologics. The project will validate the technology as a treatment for common dry eye disease, using a mouse model. Antibodies are by far the largest class of biologics, and a procedure has been developed to attach anchors to antibodies while maintaining their activity. The research aims are to validate that: 1) Attaching an anchor prolongs the time an antibody resides on the cornea. The residency time on the corneal surface will be measured using fluorescently labeled antibodies with and without an anchor. 2) An anchored anti-inflammatory antibody is an effective drug to treat dry eye. The effects on the severity of dry eye disease by treating mice with antibodies with and without an anchor will be determined. These aims will test the hypothesis that attaching an anchor to a biologic increases its residency time and its therapeutic efficiency providing proof-of-concept. No other publicly known method of solving the drug washout problem in this manner to treat dry eye disease exists.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

SBIR第一阶段项目的更广泛的商业影响旨在使生物制品能够使用生物制剂，这是一种较新的药物类别，由于其显著的有效性和特异性而改变了药物，用于治疗身体湿润表面的疾病。许多疾病发生在身体的湿润表面，包括口腔、关节、肺部和胃肠道。生物制剂的局部应用目前不在这些地区使用，因为药物在产生任何益处之前很快就被冲走了。生物制品有时通过输液来治疗这些疾病，但这有严重的副作用，甚至危及生命的副作用。如果生物制剂可以在当地提供，副作用就不那么令人担忧了，潮湿表面的疾病可以比目前更积极和有效地治疗。该项目的成功完成将为这项技术建立概念验证，并创建一个新的平台，以以前不可能实现的方式治疗这些疾病，造福于患者。该公司将与制药合作伙伴公司合作，利用他们的联合资源将这些产品商业化，并改善健康结果。中心想法是将生物制剂锚定在潮湿的表面，以便它们能起更长时间(几小时或几天)的作用。延长给药时间的传统方法使用某种形式的有问题的载体；大多数不能与生物制品一起使用。该项目将使用小鼠模型验证该技术作为常见干眼病的治疗方法。抗体是迄今为止最大的一类生物制品，已经开发出一种程序，在保持抗体活性的同时将锚定在抗体上。这项研究的目的是验证：1)连接一个锚可以延长抗体在角膜上的停留时间。在角膜表面的停留时间将使用带和不带锚的荧光标记抗体来测量。2)锚定抗炎抗体是治疗干眼症的有效药物。用带锚和不带锚的抗体治疗小鼠对干眼病的严重程度的影响将被确定。这些目的将检验这样一种假设，即将锚连接到生物上会增加其停留时间和治疗效率，并提供概念证据。目前还没有以这种方式解决药物清洗问题以治疗干眼症的其他众所周知的方法。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。