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MAbCo19, human monoclonal antibodies against SARS-CoV-2

MAbCo19, human monoclonal antibodies against SARS-CoV-2

Special Project – EU Malaria Fund

SARS-CoV-2, severe acute respiratory syndrome coronavirus 2, is a respiratory Coronavirus that has rapidly spread worldwide to pandemic levels becoming a Public Health Emergency of International Concern. On the 11th February 2020, the World Health Organization (WHO) announced that the respiratory disease caused by 2019-nCoV had been officially named Covid-19 (Corona Virus Disease 2019). Covid-19 infection has a high death toll especially, but not exclusively, amongst elderly patients with pre-existing comorbidities.

No vaccines, immune therapeutics or effective drugs are currently licensed against Covid-19. Even if a successful solution were found, it is expected that significant time will be needed for large-scale implementation of immunization programs.

Vaccines are a long-term solution against emerging infections. However, in an emergency situation such as the Covid-19 pandemic, monoclonal antibodies are a pivotal tool that can be used for immediate therapy of any patient testing positive for the virus, and to provide immediate protection from infection in high-risk individuals for a number of months.

Antibodies are proteins generated by the immune system. They are one of the host resistance mediators against infection. Antibodies can be used for the treatment of infectious diseases, cancer and autoimmune syndromes.

Monoclonal antibodies (mAbs) are derived from identical host immune cells that originate from a single progenitor B-lymphocyte that recognizes a single molecular structure. Monoclonal antibodies can be manufactured at commercial scale using the appropriate cell-based expression systems. These human-derived proteins are a valuable pharmaceutical remedy to cure and prevent disease.

mAbs are one of the most effective pharmaceutical remedies in modern medicine. Only few of about 100 currently licensed mAbs are for use in the treatment of infectious diseases. However, in the future mAbs are expected to play a key role in curing and preventing infectious diseases especially those caused by emerging pathogens and microbes that exhibit an increasing level of antibiotic resistance.

The MAbCo19 project aims to rapidly deliver a human neutralizing monoclonal antibody as prophylactic and therapeutic tool against Covid-19. Human antibodies have proven to be powerful solution for diseases like HIV, RSV and recently provided the first cure for Ebola.

The project will exploit cutting edge technology, where B-cells from Covid-19 convalescent patients are selected for their ability to produce high-affinity antibodies. The genes encoding these antibodies are cloned in appropriate expression (antibody-production) systems, followed by preclinical evaluation of their protective efficacy and further rational engineering to achieve maximum therapeutic efficiency. MAbCo19 is engineered to have a high virus-neutralizing potency and it will be easily administered via the intramuscular route.

Dr. Rino Rappuoli

This special project is funded by EU Malaria Fund and is conducted in cooperation with Dr. Rino Rappuoli’s “MadLab” based at the Toscana Life Sciences Foundation (TLS). This is the only AchilleS Vaccines, jointly with TLS, are coordinating highly experienced organizations such as Menarini Biotech S.r.l. and Istituto Biochimico Italiano Giovanni Lorenzini S.p.A  to ensure the rapid pharmaceutical development and manufacturing, according to the cGMP criteria, of the first clinical batch, thus completing an Italian consortium from the R&D laboratory to clinical studies. Subject to successful clinical trials, the project already includes a sound commercial manufacturing strategy.European project for the development of a monoclonal antibody against Covid-19. (Read more)

MAbCo19 mAb will be an invaluable remedy to protect the most vulnerable sections of the population (elderly individuals especially those with multiple comorbidities) where mortality from Covid-19 is highest; medical personnel who are at high risk of exposure, thus preserving the numerical integrity and effectiveness of health systems; immune-suppressed patients and those who may not respond to vaccination. Furthermore, mAbs will enable refined identification protective epitopes towards rational design of vaccines against Covid-19.