Allergo JournalPub Date : 2024-12-12DOI: 10.1007/s15007-024-6408-9
Ludger Klimek
{"title":"Empfehlungen des AeDA zur Auswahl von Therapieallergenen","authors":"Ludger Klimek","doi":"10.1007/s15007-024-6408-9","DOIUrl":"10.1007/s15007-024-6408-9","url":null,"abstract":"","PeriodicalId":7418,"journal":{"name":"Allergo Journal","volume":"33 8","pages":"74 - 75"},"PeriodicalIF":1.1,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142810896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Allergo JournalPub Date : 2024-12-12DOI: 10.1007/s15007-024-6396-9
Clara Pignard, Hannah Schiller, Alisa Seyffer, Stefan Schülke
{"title":"Mannan-, VLP-, and flagellin-based adjuvants for allergen specific immunotherapy: a review of the current literature","authors":"Clara Pignard, Hannah Schiller, Alisa Seyffer, Stefan Schülke","doi":"10.1007/s15007-024-6396-9","DOIUrl":"10.1007/s15007-024-6396-9","url":null,"abstract":"<div><p>Currently, allergen-specific immunotherapy (AIT) with active ingredients derived from the causative allergen source is the only disease-modifying treatment for allergic patients. However, compared to, e. g., live-attenuated vaccines for the prevention of infectious diseases, purified allergens for AIT in many cases display only a low immunogenicity. This reduces treatment efficacy and prolongs treatment duration. Here, adjuvants may be a promising tool, allowing for dose reduction of the respective allergen while increasing immunogenicity of co-applied allergens and/or modulating allergen-specific immune responses toward T helper 1 (Th1) or regulatory phenotypes or the production of blocking antibody isotypes. Currently available adjuvants can be distinguished into first-generation adjuvants (promoting immune responses via aggregation and controlled release of co-applied allergens from a depot) and second-generation adjuvants (triggering immune responses via the activation of pattern recognition receptors expressed by immune cells). This review summarizes the mechanisms and effects of adjuvants currently or previously used for AIT (aluminum hydroxide, calcium phosphate, microcrystalline tyrosine, and monophosphoryl lipid A [MPLA]) and focuses on novel developments using mannan-, virus-like particle(VLP)-, and flagellin-based adjuvants and therapeutics for the treatment of allergic diseases.</p><p><b>Cite this as</b> Pignard C, Schiller H, Seyffer A, Schülke S. Mannan-, VLP-, and flagellin-based adjuvants for allergen specific immunotherapy: a review of the current literature. Allergo J Int 2024;33:289-303</p><p><b>https://doi.org/10.1007/s40629-024-00298-5</b></p></div>","PeriodicalId":7418,"journal":{"name":"Allergo Journal","volume":"33 8","pages":"34 - 47"},"PeriodicalIF":1.1,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142810900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Allergo JournalPub Date : 2024-12-12DOI: 10.1007/s15007-024-6397-8
Hilke Zander, Jörg Engelbergs
{"title":"Requirements for regulatory acceptance of biomarkers","authors":"Hilke Zander, Jörg Engelbergs","doi":"10.1007/s15007-024-6397-8","DOIUrl":"10.1007/s15007-024-6397-8","url":null,"abstract":"<div><p>Generally, biomarkers could increase the success rate of medicinal product developments and as a consequence accelerate the availability of new therapeutics with an improved benefit-risk relationship. Therefore, patient identification based on predictive biomarkers is becoming increasingly important in all therapeutic areas [1]. The increasing use of predictive biomarker-guided-personalized (precision) medicine warrants the discovery of novel biomarkers as measurable indicators of physiopathological conditions [2]. Biomarkers can be used for diagnostics and prognostics, monitoring disease progression, but also to select the most effective therapy and to predict the treatment outcome [3, 4]. The current article provides a short focus on the regulatory definition of a biomarker and the biomarker qualification process of the European Medicines Agency (EMA). With the evolving landscape, the new Regulation (EU) 2017/746 on in vitro medical devices (IVD) [5] introduces important changes in the EU legal framework for IVDs especially by legally defining for the first time “companion diagnostic” devices (CDx). Challenges in the codevelopment of CDx and medicinal products are highlighted to provide scientific-regulatory considerations in this complex regulatory field.</p><p><b>Cite this as</b> Zander H, Engelbergs J. Requirements for regulatory acceptance of biomarkers. Allergo J Int 2024;33:309-12</p><p><b>https://doi.org/10.1007/s40629-024-00312-w</b></p></div>","PeriodicalId":7418,"journal":{"name":"Allergo Journal","volume":"33 8","pages":"54 - 57"},"PeriodicalIF":1.1,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142810975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}