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HEДокторантска мрежа2023–2027

ISOBIOTICS · Isotopic Labeling of Biotherapeutics

„Хоризонт Европа“ — Действия „Мария Склодовска-Кюри“

Период
2023-02-01 → 2027-01-31
Финансиране от ЕС
2 703 924 €
Участници
18
Схема
HORIZON-TMA-MSCA-DN

Линиите свързват координатора с партньорите.

Накратко на български

Биологичните лекарства се проучват чрез добавяне на специални изотопи (като въглерод-13 или флуор-18), за да бъдат по-лесно проследявани. Това помага за по-точното тестване на ефикасността и безопасността на тези терапии при хората.

Този кратък обзор е генериран от изкуствен интелект

Кратко обяснение, генерирано от езиков модел по текста на CORDIS. Оригиналът е по-долу.

Резултати накратко

Isotopic Labeling of Biotherapeutics

Biological therapeutics based on biomolecules have been skyrocketed on the drug market due to their very high specificity, excellent selectivity and resulting high efficiency with resulting reduced side-effects, lower drug attrition and lower development costs. However, there is an urgent need for isotopically-labeled biodrugs utilized for in vitro assays and in vivo (preclinical and clinical) tests. In contrast with chemical drugs, there is only a very limited number of strategies devised for the specific and selective isotopic labeling of biological molecules because of the size, fragility and complexity of biologicals and also because most of biologics are exclusively soluble in water, a medium which notably disfavors classical chemical reactions. To date, in most cases, biotherapeutics have been labeled using chemical methods that are only poorly selective and usually give a polydisperse mixture of modified biologics, a situation which makes further analysis of results more complex and prone to biases (figure 1). Therefore, there is a pressing demand from the Pharmaceutical Industry for straightforward, simple, reproducible and chemically benign strategies that enable the isotopically labeling biological molecules in particular with hydrogen and carbon stable isotopes (respectively deuterium and carbon-13), hydrogen and carbon radio-isotopes (respectively tritium and carbon-14) and fluorine-18 (radioisotope for medical imaging). There is also a lack of specialized chemists capable of devising and implementing such strategies that require an in-depth knowledge of synthetic chemistry and isotopic chemistry but also an intensive experience of biomolecules handling, engineering and analysis. In the same way, there are extremely few mixed Academic/Industrial structures that propose such a training encompassing strategic, scientific and technical aspects of the chemically-benign labeling of biologics.

Текст от CORDIS, на английски · Данни: CORDIS, © Европейски съюз

Цел на проекта

Biological drugs such as peptides, proteins, oligonucleotides and analogs provide the patients with more efficacious and less toxic treatments and have lower attrition rates than chemical drugs since 1 on 9 new biological entities entering clinical trials reaches the market (1 on 16 for chemical drugs). Consequently, 15 on 24 top blockbuster drugs were biotherapeutics in 2020 (world-market share of about 40% of $175 billion of revenue per year). In order to reduce the immunogenicity of biodrugs, to overcome their fragility and to increase their capacity to reach quickly and massively their target, reduced-size biologics are extensively developed. However, radiolabeling of large molecules by grafting bifunctional chelating agents which do not alter significantly their biological activity is thus no longer possible with smaller biodrugs. It is therefore of paramount importance to devise new radiolabeling approaches carried out on tiny quantities in aqueous media and very soft conditions. It is also crucial to train a new generation of radiochemists in order to implement these methods and to meet the needs of the European industry. ISOBIOTICS ambitions: 1) to develop new chemically-benign strategies for the last-stage radiolabeling of large peptides, small/medium-size proteins, oligonucleotides and analogs with deuterium, tritium and carbon-14 (preclinical and phase 0 clinical evaluation), and fluorine-18 (phase I-III clinical trials); 2) to educate a new generation of young talented PhD students specialized in the radiolabeling of biologics through a combination of interdisciplinary lab research, transdisciplinary and intersectorial secondments, technical taught courses, scientific lectures and complementary skills workshops; 3) to ensure the appropriate dissemination, exploitation and communication of all ISOBIOTICS outputs in order to maximize the project’s impact and radiance; 4) to secure the students employment and the sustainability of training structures.

Оригинален текст от CORDIS (на английски).

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Връзки

Данни: CORDIS, © Европейски съюз