IVN201--therapy with a construct containing functional fusion peptides.

Horst Rose
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Abstract

The new concept of immunotherapy with IVN201 against cat dander allergy combines two proprietary technology platforms: Intralymphatic immunotherapy (ILIT) with Modular-Antigen-Transportation (MAT) proteins. Intralymphatic immunotherapy (ILIT) is the injection of immunotherapeutics directly into the lymph node. Lymph nodes contain a high density of antigen presenting cells together with interacting T cells, which are necessary for allergen tolerance development. Therefore, this site-directed route of administration requires fewer injections of much smaller doses of the allergen than conventional administration routes to induce a highly effective, disease modifying immune response. ILIT was recently demonstrated in a clinical study to enhance safety and efficacy of immunotherapy and to reduce treatment time from 3 years to 8 weeks with only three injections, thereby significantly improving patient compliance. Patients subjectively perceived the intralymphatic injections less painful than a venous puncture. IVN201 is a functional fusion peptide which is a tailor-made recombinant allergen for ILIT with Fel d 1 as allergen module. It is designed to be rapidly taken up by antigen presenting cells in the lymph nodes and to improve the presentation of the allergen to the immune system. IVN201 was shown to induce allergen tolerance in a murine anaphylaxis model. Stimulation assays with basophil leukocytes isolated from allergic patients suggest an increased safety profile when compared to cat extract or recombinant Fel d 1. Therefore, MAT molecules are expected to be safer and more efficacious in inducing the desired immune response than recombinant allergens or allergen extracts in allergen immunotherapy when administered via the intralymphatic route.

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IVN201——含有功能性融合肽的构建体治疗。
IVN201治疗猫皮屑过敏的新概念结合了两个专有技术平台:淋巴内免疫治疗(ILIT)和模块化抗原运输(MAT)蛋白。淋巴内免疫治疗(ILIT)是将免疫治疗药物直接注射到淋巴结。淋巴结含有高密度的抗原呈递细胞和相互作用的T细胞,这是过敏原耐受发展所必需的。因此,与传统的给药途径相比,这种部位导向的给药途径需要更少的剂量的过敏原注射,以诱导高度有效的疾病修饰免疫反应。ILIT最近在一项临床研究中被证明可以提高免疫治疗的安全性和有效性,并将治疗时间从3年缩短到8周,只需三次注射,从而显着提高患者的依从性。患者主观上认为淋巴内注射比静脉穿刺疼痛小。IVN201是一种功能性融合肽,是为ILIT量身定制的以Fel d1为过敏原模块的重组过敏原。它被设计成被淋巴结中的抗原呈递细胞迅速吸收,并改善过敏原对免疫系统的呈递。在小鼠过敏反应模型中显示,IVN201可诱导过敏原耐受。从过敏患者中分离的嗜碱性白细胞刺激试验表明,与猫提取物或重组Fel d1相比,Fel d1的安全性更高。因此,当通过淋巴内途径给药时,MAT分子有望比重组过敏原或过敏原提取物在过敏原免疫治疗中更安全、更有效地诱导所需的免疫反应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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History of specific immunotherapy. Legal status and regulation of allergenic products in the United States. Regulation of allergen products in Europe (including NPPs). Current status and regulation of allergen products in Mexico. Regulation of allergen products in Canada: an overview of the current and the proposed regulatory frameworks (draft guidance).
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