Call for Proposals on Development of Therapeutics and Diagnostics Combatting Coronavirus Infections

Deadline: 31 March 2020

Proposals submitted under this topic are expected to advance the knowledge specifically on COVID-19 and more widely on the coronavirus family 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.

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The current coronavirus (COVID-19) outbreak has been declared by WHO as a Public Health Emergency of International Concern according to the International Health Regulation.

It is crucial to rapidly gain a better understanding of the newly identified virus, especially in relation to potential clinical and public health measures that can be put to immediate use to improve patients’ health and/or contain the spread of COVID-19.

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Collaboration of private companies, academia, international organisations, public bodies etc. has the potential to accelerate the development of therapeutics and diagnostics to tackle this current and future outbreaks. The actions resulting from this call will contribute to the pan-European efforts responding to this Public Health Emergency.

Objectives

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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 therapeutics to address a rapid response towards 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.
Development of therapeutics to address the current and/or future coronaviruses outbreaks: identification of new potential assets and approaches that could be utilised including preventive strategies and combination approaches and could also address potential resistance. This may also include optimisation of promising treatments used in rapid response (e.g. reformulation).
Development of diagnostics, ensuring rapid evaluation of candidates based on existing technologies, to allow for fast case detection and surveillance.
Development of fast and reliable detection of COVID-19 carriers and symptomatic individuals suspected of COVID-19 infection. This can be achieved through point of care (POC) testing or centralised testing.
Expected Impact

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Proposals must be timely, with rapid activation, to enable early and valuable outcomes to be established and should contribute to one or more of the following impacts:

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 the 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 for persons at risk of exposure to coronavirus or for patients suffering from coronavirus disease.
Maximisation of the IMI2 JU public-private partnership value by harnessing support from different stakeholders, including the mobilisation of resources through the inclusion of contributing partners (EFPIA companies or organisations associated to EFPIA, and Associated Partners to IMI2 JU) providing contributions (in kind and/or financial), to reflect the public-private character of IMI2 JU actions.
Expected Key Deliverables

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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 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.

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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.
Funding Information

Applicant consortia will be competing for the maximum total financial contribution from IMI2 JU up to EUR 45 000 000.

Eligibility Criteria

The following participants shall be eligible for funding from the Innovative Medicines Initiative to Joint Undertaking:

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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;
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.
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