Deadline: 31 March 2020
The Innovative Medicines Initiative (IMI) has launched a new fast-track Call for proposals on the development of therapeutics and diagnostics to tackle current and future coronavirus outbreaks.
IMI is looking for proposals that address:
- The development of treatments to rapidly respond to the current COVID-19 outbreak and/or future coronavirus outbreaks – this could include potential drugs that are already at a very advanced stage of development, or an existing, approved drug that could be ‘repurposed’ to treat COVID-19. It could also include drugs that are in the earlier stages of development, as well as strategies to address drug resistance;
- The development of diagnostic tests to rapidly and reliably identify people infected with the coronavirus that causes COVID-19, and for use in clinical trials of new drugs.
Preventive vaccines are not included in the Call, as IMI does not want to duplicate the work of other organisations in this area.
Topic
Development of therapeutics and diagnostics combatting coronavirus infections.
Scope
Proposals submitted under this topic are expected to advance knowledge of SARS-CoV-2 specifically and the wider coronavirus family in general with the aim of contributing to an efficient patient management and/or public health preparedness and response to current and future outbreaks of coronavirus infection.
Considering that this is a newly-identified virus, the scope of this topic remains broad and must address at least one of the following objectives:
- Development of antivirals as well as other types of therapeutics to address a rapid response to the current COVID-19 outbreak: Relevant “clinical ready”-assets include approved therapies or compounds in development, which could be repurposed for use in treating patients with the coronavirus. For example, this could include (but is not limited to), angiotensin-converting-enzyme (ACE) inhibitors, protease inhibitors or immunotherapies (for example antibodies/antibody-like molecules) that could be relevant in the context of CoV. If repurposing is proposed, this should be supported by a preliminary rationale of the compound’s potential efficacy against COVID-19. Where relevant, evidence of regulatory and ethics approvals for the investigational products included in the study(ies) must be presented.
- Development of therapeutics to address the current and/or future coronavirus outbreaks: Identification of new potential assets and approaches that could be utilised including preventive strategies and combination approaches, and that could also address potential resistance. This may also include the optimisation of promising treatments used in rapid response (e.g. reformulation).
- Development of diagnostics, ensuring rapid evaluation of candidates based on existing technologies: Diagnostic tests will be essential for clinical trials of new or repurposed drugs, to help stratify patients and assess treatment efficiency (surrogate endpoint such as viral clearance).
- Development of fast and reliable tools that go beyond the state of the art for detection of COVID-19 carriers and symptomatic individuals suspected of COVID-19 infection: These are essential and of utmost importance to manage the outbreak, isolate patients at risk and treat people accordingly. It is crucial to differentiate and identify respiratory pathogens with similar clinical symptoms (e.g. flu, respiratory syncytial virus, other viruses or bacteria) and/or detect emerging pathogens such as SARSCoV-2. This can be achieved through point-of-care (POC) testing or centralised testing.
For increased impact, proposals should build on promising avenues from previous or ongoing research, taking into account the recommendations from the WHO and ensuring complementarity and ideally synergy with the work carried out under the auspices of Coalition for Epidemic Preparedness Innovations (CEPI), Wellcome, Biomedical Advanced Research and Development Authority (BARDA), the Bill and Melinda Gates Foundation, Global Research Collaboration for Infectious Disease Preparedness (GloPID-R) and H2020 Call SC1-PHECORONAVIRUS-2020.
Expected key Deliverables
Each proposal must include at least one of the following key deliverables:
- Antivirals as well as other types of therapeutics to be used in the current outbreak, including preventive and symptomatic treatments;
- Novel therapeutics including combination treatments to ensure appropriate treatment for current and/or future outbreaks and/or to prevent resistance;
- Diagnostics
In the context of achieving the above deliverables, i.e. development of therapeutics and diagnostics, it is recognised that studies related to the understanding of the mechanism of action will generate new knowledge on the virology, immunology and pathogenesis of the coronavirus, and that new analytical technologies and reagents may be developed.
When relevant, deliverables should include:
- Hit identification of suitable assets (e.g. existing libraries, approved drugs and assets that have passed phase 1 for repurposing; protease and (non)-nucleoside inhibitors) against SARS-CoV-2 and/or pan-coronavirus; implementation of high-throughput screening assays in collaboration with Europe-based centres of excellence.
- Lead optimisation: initiating target-based discovery programmes based for instance on literature for the identification of promising approaches. Proof of Concept: pre-clinical animal studies and clinical studies including at least first in human (FIH) and phase 2A and/or 2B studies for both repurposed and new molecular entities. For the clinical studies applicants should consider the Therapeutic Trial Synopsis in the WHO’s Global Research and Innovation Blueprint on the novel Coronavirus COVID-19.
- Diagnostics and associated enablers (e.g. production of antibodies and viral proteins); characterisation of nCoV strains and evolution; sustainability plans for data repositories, sample repositories etc.; documentation supporting regulatory submission.
Expected Impact
Proposals must be timely, with rapid activation, to enable early and valuable outcomes to be established. On the basis of the proposed activities, applicants should describe how the outputs of the project will contribute to the following impacts and include wherever possible targets and metrics to measure them:
- Fast-track development and availability of therapeutics and/or diagnostics to be used in the clinical management of patients infected by COVID-19 and/or future outbreaks of coronaviruses, and to ensure that a variety of drugs are available for patients, including tackling resistance, and combination therapy;
- Contribution to public health preparedness and response in the context of the ongoing epidemic of COVID-19 and/or future outbreaks of pan-coronaviruses;
- Significant impact on global health, both at the individual and the public health level by leading to results that have a direct impact on people at risk of exposure to coronavirus or on patients suffering from coronavirus
disease. - To ensure maximum impact for patients, applicants should demonstrate their operational capacity as well as their readiness and access to asset(s) to progress through clinical development and reach patients as rapidly as
possible. - Although actions to be funded should be centred around SARS-CoV-2 and CoV, applicants should explain how the knowledge and new concepts arising from the action can be applied in more general terms to the preparedness strategy that could be applied to new outbreaks as a rapid response.
Funding Information
- Applicant consortia will be competing for the maximum total financial contribution from IMI2 JU up to EUR 45 000 000.
- Proposals should include a proposed duration for the action in relation to the activities and expected impact.
Eligibility Criteria
- Legal entities established in a Member State or an associated country, or created under Union law; and which fall within one of the following categories:
- Micro, small and medium-sized enterprises and other companies with an annual turnover of EUR 500 million or less, the latter not being affiliated entities of companies with an annual turnover of more than 500 million; the definition of ‘affiliated entities’ within the meaning of Article 2(1)(2) of Regulation (EU) No 1290/2013 shall apply mutatis mutandis,
- Secondary and higher education establishments,
- Non-profit organisations, including those carrying out research or technological development as one of their main objectives or those that are patient organisations;
- The Joint Research Centre;
- International European interest organisations.
For more information, visit https://www.imi.europa.eu/news-events/press-releases/imi-launches-eur-45m-call-proposals-coronavirus