Microneedle Based Targeted Allergen Specific Immunotherapy for Treatment of Peanut Allergies
基于微针的靶向过敏原特异性免疫疗法治疗花生过敏
基本信息
- 批准号:9899934
- 负责人:
- 金额:$ 29.78万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-04-01 至 2021-03-31
- 项目状态:已结题
- 来源:
- 关键词:Adverse reactionsAffectAllergen ImmunotherapyAllergensAllergicAllergy to peanutsAnaphylaxisAnimalsApplications GrantsCessation of lifeChildCyclic GMPDevelopmentEuropeFamilyFood HypersensitivityFoundationsHealthcareHypersensitivityImmunotherapyInvestigational New Drug ApplicationMindPainlessPatientsPhaseProceduresProcessProductionProteinsQuality of lifeReproducibilitySkinSmall Business Technology Transfer ResearchSurveysTherapeuticToxic effectbasecGMP productiondesensitizationefficacy studyfirst-in-humangood laboratory practiceminimally invasivemouse modelnovelpeacepre-clinicalquality assuranceskin patchsocialsuccess
项目摘要
Microneedle Based Targeted Allergen Specific Immunotherapy for Treatment of Peanut Allergies
Food allergies affect 15 million people in the USA and 17 million in Europe. Six million children, roughly 1 in 13,
in the USA have at least one food allergy; this equates to at least 1 in every classroom. Currently, there are no
approved therapies for food allergies anywhere in the world. Food allergies are expected to grow 10% annually
until 2022. It is also common for someone to have more than one allergy. This is a growing, underserved
global market that has few treatment options. A meaningful initial therapy would be one that reduces the
chance for anaphylactic reaction after accidental exposure. Based on surveys, allergists and patients believe a
therapy that reduces the chance for anaphylactic reaction from accidental exposure is meaningful and
worthwhile. Such a therapy will help bring peace of mind to families, allow for children affected by food
allergies to have better quality of life, feel less socially out casted and most importantly reduce the potential for
death from accidental procedure. The approximate healthcare burden per patient is $3,000-4,000 per year.
Moonlight Therapeutics is developing a targeted way to administer peanut allergens into the top skin layers to
desensitize an allergic patient. Delivery is achieved using microneedles, which are minimally invasive and
painless. Importantly microneedles can deliver into topmost skin layers with high precision and reproducibility.
Because the delivery is in top and superficial skin layers, the approach is expected to produce little to no
systemic adverse reactions. We have demonstrated efficacy of our approach in a pre-clinical mouse model of
peanut sensitization. In this STTR Fast-Track grant application Moonlight Therapeutics has proposed aims that
will allow it to file an investigational new drug (IND) application with the FDA for first-in-human trials. In Phase
1, four aims are proposed to develop processes for producing peanut allergen proteins and coated MNs with
strict quality assurance and operating procedures that can be transferred to cGMP production. An efficacy
study in animals is also proposed in Phase 1. Appropriate milestones and success criteria have been
established for Phase-1. In Phase-2, four aims are proposed so as to perform non-GLP (good laboratory
practices) and GLP toxicity studies, and establish production under cGMP. In addition, animal studies will be
done to compare microneedles to a conventional skin patch. At the conclusion of Phase-2 an IND application
will be submitted to the FDA.
Overall, these studies will provide the foundation to support the development of a novel and safer peanut
allergy immunotherapy treatment.
针靶向变应原特异性免疫治疗花生过敏的研究
食物过敏影响着美国1500万人和欧洲1700万人。600万名儿童,大约每13人中就有1人,
在美国,至少有一个食物过敏;这相当于每个教室至少有一个。目前没有
食物过敏的治疗方法。食物过敏预计每年增长10%
直到2022年它也是常见的人有一个以上的过敏。这是一个不断增长的,服务不足的
全球市场几乎没有治疗选择。一个有意义的初始治疗将是一个减少
意外暴露后过敏反应的可能性。根据调查,过敏症专家和患者认为,
减少意外暴露引起过敏反应的可能性的治疗是有意义的,
worthwhile.这种疗法将有助于给家庭带来心灵的平静,
过敏症有更好的生活质量,感觉不那么社会排斥,最重要的是减少潜在的
意外手术死亡。每位患者每年的医疗负担约为3,000 - 4,000美元。
月光治疗公司正在开发一种有针对性的方法,将花生过敏原注入皮肤表层,
使过敏病人脱敏使用微针实现递送,微针是微创的,
无痛的重要的是,微针可以以高精度和可重复性递送到最顶层的皮肤层中。
因为输送是在顶部和浅表皮肤层,该方法预计将产生很少或没有
全身不良反应。我们已经证明了我们的方法在临床前小鼠模型中的有效性。
花生致敏在这个STTR快速通道赠款申请月光治疗提出的目标,
将允许它向FDA提交研究性新药(IND)申请,进行首次人体试验。同相
1,提出了四个目标来开发用于生产花生过敏原蛋白质和用以下物质包被的MN的方法:
严格的质量保证和操作程序,可以转移到cGMP生产。疗效
在第1阶段中还拟定了动物研究。适当的里程碑和成功标准已经
为第一阶段设立。在第二阶段,提出了四个目标,以执行非GLP(良好实验室
实践)和GLP毒性研究,并在cGMP下建立生产。此外,动物研究将
是为了比较微针和传统的皮肤贴片。在第2阶段结束时,IND申请
将提交给FDA。
总的来说,这些研究将为支持开发一种新型和更安全的花生提供基础。
过敏免疫治疗
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Samirkumar Patel其他文献
Samirkumar Patel的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Samirkumar Patel', 18)}}的其他基金
Safety and Tolerability of TASIS-Peanut (Targeted Allergen Specific Immunotherapy within the Skin) patch for the Treatment of Peanut Allergy
TASIS-花生(皮肤内靶向过敏原特异性免疫疗法)贴剂治疗花生过敏的安全性和耐受性
- 批准号:
10551184 - 财政年份:2023
- 资助金额:
$ 29.78万 - 项目类别:
Development of a Novel Animal Model for Spinal Cord Injury with Sepsis
脓毒症脊髓损伤新型动物模型的开发
- 批准号:
10665862 - 财政年份:2023
- 资助金额:
$ 29.78万 - 项目类别:
Enhanced Mitochondrial Viability via Engineered Hyrdogels for Intrathecal Spinal Cord Delivery
通过用于鞘内脊髓输送的工程水凝胶增强线粒体活力
- 批准号:
10447178 - 财政年份:2020
- 资助金额:
$ 29.78万 - 项目类别:
Enhanced Mitochondrial Viability via Engineered Hyrdogels for Intrathecal Spinal Cord Delivery
通过用于鞘内脊髓输送的工程水凝胶增强线粒体活力
- 批准号:
10647848 - 财政年份:2020
- 资助金额:
$ 29.78万 - 项目类别:
Enhanced Mitochondrial Viability via Engineered Hyrdogels for Intrathecal Spinal Cord Delivery
通过用于鞘内脊髓输送的工程水凝胶增强线粒体活力
- 批准号:
10093663 - 财政年份:2020
- 资助金额:
$ 29.78万 - 项目类别:
Enhanced Mitochondrial Viability via Engineered Hyrdogels for Intrathecal Spinal Cord Delivery
通过用于鞘内脊髓输送的工程水凝胶增强线粒体活力
- 批准号:
10266098 - 财政年份:2020
- 资助金额:
$ 29.78万 - 项目类别:
Microneedle Based Targeted Allergen Specific Immunotherapy for Treatment of Peanut Allergies
基于微针的靶向过敏原特异性免疫疗法治疗花生过敏
- 批准号:
10368182 - 财政年份:2019
- 资助金额:
$ 29.78万 - 项目类别:
Microneedle Based Targeted Allergen Specific Immunotherapy for Treatment of Peanut Allergies
基于微针的靶向过敏原特异性免疫疗法治疗花生过敏
- 批准号:
10407661 - 财政年份:2019
- 资助金额:
$ 29.78万 - 项目类别:
相似海外基金
How Does Particle Material Properties Insoluble and Partially Soluble Affect Sensory Perception Of Fat based Products
不溶性和部分可溶的颗粒材料特性如何影响脂肪基产品的感官知觉
- 批准号:
BB/Z514391/1 - 财政年份:2024
- 资助金额:
$ 29.78万 - 项目类别:
Training Grant
BRC-BIO: Establishing Astrangia poculata as a study system to understand how multi-partner symbiotic interactions affect pathogen response in cnidarians
BRC-BIO:建立 Astrangia poculata 作为研究系统,以了解多伙伴共生相互作用如何影响刺胞动物的病原体反应
- 批准号:
2312555 - 财政年份:2024
- 资助金额:
$ 29.78万 - 项目类别:
Standard Grant
RII Track-4:NSF: From the Ground Up to the Air Above Coastal Dunes: How Groundwater and Evaporation Affect the Mechanism of Wind Erosion
RII Track-4:NSF:从地面到沿海沙丘上方的空气:地下水和蒸发如何影响风蚀机制
- 批准号:
2327346 - 财政年份:2024
- 资助金额:
$ 29.78万 - 项目类别:
Standard Grant
Graduating in Austerity: Do Welfare Cuts Affect the Career Path of University Students?
紧缩毕业:福利削减会影响大学生的职业道路吗?
- 批准号:
ES/Z502595/1 - 财政年份:2024
- 资助金额:
$ 29.78万 - 项目类别:
Fellowship
感性個人差指標 Affect-X の構築とビスポークAIサービスの基盤確立
建立个人敏感度指数 Affect-X 并为定制人工智能服务奠定基础
- 批准号:
23K24936 - 财政年份:2024
- 资助金额:
$ 29.78万 - 项目类别:
Grant-in-Aid for Scientific Research (B)
Insecure lives and the policy disconnect: How multiple insecurities affect Levelling Up and what joined-up policy can do to help
不安全的生活和政策脱节:多种不安全因素如何影响升级以及联合政策可以提供哪些帮助
- 批准号:
ES/Z000149/1 - 财政年份:2024
- 资助金额:
$ 29.78万 - 项目类别:
Research Grant
How does metal binding affect the function of proteins targeted by a devastating pathogen of cereal crops?
金属结合如何影响谷类作物毁灭性病原体靶向的蛋白质的功能?
- 批准号:
2901648 - 财政年份:2024
- 资助金额:
$ 29.78万 - 项目类别:
Studentship
Investigating how double-negative T cells affect anti-leukemic and GvHD-inducing activities of conventional T cells
研究双阴性 T 细胞如何影响传统 T 细胞的抗白血病和 GvHD 诱导活性
- 批准号:
488039 - 财政年份:2023
- 资助金额:
$ 29.78万 - 项目类别:
Operating Grants
New Tendencies of French Film Theory: Representation, Body, Affect
法国电影理论新动向:再现、身体、情感
- 批准号:
23K00129 - 财政年份:2023
- 资助金额:
$ 29.78万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
The Protruding Void: Mystical Affect in Samuel Beckett's Prose
突出的虚空:塞缪尔·贝克特散文中的神秘影响
- 批准号:
2883985 - 财政年份:2023
- 资助金额:
$ 29.78万 - 项目类别:
Studentship