Development of antibodies and antibody-derived proteins for the prevention and treatment of infectious diseases with epidemic potential

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all the following expected outcomes:

• The scientific and clinical communities have a better understanding of prophylactic and treatment options complementary to low molecular weight antiviral therapeutics for viruses with epidemic potential.
• The scientific and clinical communities have access to experimental antibodies and antibody-derived proteins for the prevention and treatment of emerging or re-emerging viral infections, as well as for further clinical investigation.
• Candidate antiviral therapies, including potentially those of broad spectrum are available for emerging and re-emerging viral infections, increasing therapeutic options for clinical deployment in case of an epidemic or pandemic.

Scope

As shown by the COVID-19 pandemic, infectious diseases remain a major threat to health and health security in the EU and globally. Viral disease emergence is expected to accelerate due to among other, climate change, and thus a proactive approach to the development of antiviral prophylactics and therapeutics in preparedness for future infectious disease outbreaks is needed. The availability of antibodies and antibody-derived proteins would provide a critical preparedness measure against future health threats, due to infectious disease epidemics or pandemics.

Proposals should exclusively pursue the development of existing antiviral and prophylactic and therapeutic candidates that are based on antibody and/or antibody-derived proteins targeting at least one of the priority viruses:

• Arenaviridae: Junin mammarenavirus, Lassa mammarenavirus
• Hantaviridae: Hantaan virus, Andes virus, Sin Nombre virus
• Poxviridae: Variola major
• Paramyxo: Hendra, Nipah virus
• Togaviridae: Venezuelan equine encephalitis virus

Proposals are expected to conduct preclinical studies of antibodies and antibody-derived proteins, prepare Good Manufacturing Practice (GMP)[1] quality test batches and carry out first in human clinical safety studies. Proposals should include a critical discussion of to what extent the antibodies and antibody-derived proteins would be expected to be amenable to production and distribution at an affordable cost and at a scale sufficient to meet demand in a pandemic.

Proposals should thus aim to diversify and accelerate the global prophylactic and therapeutic research and development portfolio for emerging and re-emerging viral infections, and to strengthen the leading role of the EU in prophylactic and therapeutic research and development.

Proposals may focus either on antibody or on antibody-derived proteins, or both.

Proposals should address all the following areas:

• If necessary, finalisation of the in vitro characterisation of the existing antibody and antibody-derived protein candidates with regard to target specificity, epitope recognised, and their ability to impair or inactivate viral functions.
• In vivo tests in at least one animal model or, if available in humanised immune system animal models, to demonstrate the protective function of the antibodies and antibody-derived therapeutics deemed sufficient for moving to first clinical trials.
• If requested by regulators as enablers for clinical studies, in vivo tests in a non-human primate model.
• Production of GMP quality test batches of the most promising candidates for antibodies and antibody-derived proteins in the EU or the European Economic Area.
• First in human clinical safety studies of the antibody and antibody-derived proteins, demonstrating a clear regulatory pathway for market authorisation. Attention should be paid to critical biological and social factors such as sex, age, ethnicity and disability.

Participation of third countries where viruses addressed in the proposal are endemic or where outbreaks have occurred or are ongoing is encouraged.

The participation of start-ups, micro, small and medium-sized enterprises (SMEs)[2] is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation.

Applicants are expected to engage with regulatory bodies in a timely manner to ensure adequacy of the actions from a regulatory point of view.

Proposals should advance research by leveraging already existing and emerging state-of-the-art research infrastructures such as those having contributed to the services developed under the ISIDORe project[3].

Applicants should provide details of their clinical studies[4] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.

[1] https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/gmp

[2] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361

[3] https://isidore-project.eu

[4] Please note that the definition of clinical studies (see introduction to this work programme part) is broad and it is recommended that you review it thoroughly before submitting your application.