Kort beskrivelse
This call for tenders aims at purchasing services to speed up the development of and support the access to medical countermeasures which address HERA’s priority threats. To accelerate development and support access to MCMs, the requested services include the provision of clinical and concurrent non-clinical development services and the priority right to purchase the promising products (Investigational Medicinal Product – IMP for lots 1, 2 and 3 and product for lot 4), that shall allow bringing innovative products to the market and ensure EU/EEA access to them.
Vaccines to Combat Antimicrobial Resistance (AMR)
Lot 1 of this call aims to speed up the development of vaccine candidates targeting bacterial infections as an alternative treatment strategy to address the rising incidence of AMR.
The identified vaccine candidates shall be designed to target bacteria belonging to at least one of the twelve bacterial families classified as ‘priority pathogens’ in the 2017 WHO Bacterial Priority Pathogens List. These families encompass Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacteriaceae, Enterococcus faecium, Staphylococcus aureus, Helicobacter pylori, Campylobacter spp., Salmonellae, Neisseria gonorrhoeae, Streptococcus pneumoniae, Haemophilus influenzae, Shigella spp. The tender may also target Mycobacterium tuberculosis.
Vaccine candidates must have shown promising biological activity based on immunogenicity data of Phase I and safety data from Phase I clinical trials. Lot 1 aims at supporting the advancement of vaccine candidates that have successfully completed at least Phase I clinical studies.
Broad Spectrum Antivirals against Respiratory Diseases
Lot 2 will support the development of broad-spectrum antivirals targeting respiratory RNA viral families, such as Paramyxo-, Orthomyxo and Coronaviridae.
The antivirals subject of this call shall aim toȘ
1. directly block viral targets and function (direct-acting antivirals);
2. have an anticipated efficacy against multiple species or genera in at least one, but preferably several viral families;
3. be preferably new chemical entities which include small molecules and small biotherapeutics like nucleic acids or peptides that are directly acting against viral targets and functions, i.e., not through the modulation of the host responses;
4. and preferably have safety profiles and suitable routes of administration (e.g., oral or intranasal) for broad use in the outpatient setting to treat early stages of infection by reducing viral burden.
Broad spectrum antivirals candidates supported under the scope of these two lots under this call for tenders have finalised pre-clinical data (proof of principle), which means that the medicine design can meet the pharmaco-therapy challenge established, as well as first-in-man studies characterising pharmacokinetics, potential effective concentration and/or dose ranges.
Broad Spectrum Antivirals Targeting Viral Families Known for Causing Viral Haemorrhagic Fever (VHF)
Lot 3 will support the development of broad-spectrum antivirals targeting viral families known for causing viral haemorrhagic fever (VHF), such as Arena-, Bunya-, Flavi-, Filoviridae.
The antivirals subject of this call shall aim to:
1. directly block viral targets and function (direct-acting antivirals);
2. have an anticipated efficacy against multiple species or genera in at least one, but preferably several viral families;
3. be preferably new chemical entities which include small molecules and small biotherapeutics like nucleic acids or peptides that are directly acting against viral targets and functions, i.e., not through the modulation of the host responses;
4. and preferably have safety profiles and suitable routes of administration (e.g., oral or intranasal) for broad use in the outpatient setting to treat early stages of infection by reducing viral burden.
Broad spectrum antivirals candidates supported under the scope of these two lots under this call for tenders have finalised pre-clinical data (proof of principle), which means that the medicine design can meet the pharmaco-therapy challenge established, as well as first-in-man studies characterising pharmacokinetics, potential effective concentration and/or dose ranges.
Point of Care Metagenomic Sequencing for Universal Pathogen Detection
Lot 4 supports the development of a metagenomic next-generation sequencing (mNGS)-based test that can detect any respiratory viral pathogen, including novel and emerging, from human respiratory samples. This lot targets MGS-based solutions optimised for infectious disease diagnostics and early outbreak detection.