Monoclonal antibody-based therapeutics for new variants of emerging viruses

6. Monoclonal antibody-based therapeutics for new variants of emerging viruses

Background and scope:

Pandemics and large-scale outbreaks can claim millions of lives and cause significant levels of social and economic disruption. mRNA-based prophylactic vaccines and therapeutics played a critical role in enabling a return to normalcy following the global SARS-CoV2pandemic. However, the pandemic exposed global vulnerabilities to future such events with the emergence of new variants of the virus of high concern. This calls for the development of variant-proof antiviral therapeutics that can maintain treatment efficacy even as viruses evolve.

Current evidence suggests that monoclonal antibodies (mAbs), have the potential to deliver such targeted antiviral therapies that can complement vaccination in the event of future outbreaks. mAbs-based therapies can deliver high specificity in the treatment of viral infections and provide immediate protection, in the case of immunosuppressed individuals who are often at the highest risk of infection.

Several mAbs received emergency use authorisation (EUA) from regulatory agencies worldwide during the SARS-CoV2 pandemic and work underway through the World Health Organisation (WHO) sees their potential being explored in areas such as HIV, influenza, respiratory syncytial virus (RSV) alongside their preventative potential in the case of HIV. Researchers are also exploring the use of mAbs for infections such as Malaria and Leishmaniasis. Despite the increasing use of mAbs-based therapeutics for a wide range of diseases, the emergence of new variants of high concern for known or emerging pathogens remains a major challenge for the humanity. To address this global challenge, this EIC Challenge will support the development of mAbs-based therapeutics against new variants of emerging pathogens of high concern, as a line of defence complementary to new vaccines.

Specific objectives:

In the era of pandemic preparedness and precision medicine, the overall goal of this EIC Challenge is to support the development of strategic approaches leading to broad spectrum mAbs-based therapeutics against new variants of emerging pathogens of high concern. Applicants to the Challenge can address:

• Broad-spectrum mAbs-based therapies
• More effective mAbs-based therapies (e.g., address the issue of inter-individual

variability)

• Clinical administration of broad spectrum mAbs-based therapeuticsto

outpatients with mild symptoms in overwhelmed hospitals or in dealing with

hypersensitivity to treatment

• Rapid production of mAbs-based therapies: technological innovations that

can allow for the production of a mAb, including test batches during the development phase, with minimal lead time, enabling rapid availability of a product in the event of an outbreak.

• Administration of mAbs-based therapeutics: new technologies that can simplify the administration of mAbs, thereby extending the half-life of the antibody or injecting mRNA coding for a mAb.

Expected outcomes and impacts:

This Challenge aims to enhance the EU’s response to future pandemics. It will provide solutions that can complement efforts to deliver rapid detection and analysis of virus variants, in coordination with relevant international systems and networks (such as the HERA incubator) and will ensure that the development of new antiviral treatments target the variants of highest concern. It will also help develop a platform of approaches that can ensure efficacy of future treatment in the event that new variants of high concern exhibit decreased susceptibility to current mAbs.

Budget: 50M€