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Treat severe cases of infection at COV with XAV-19

Periodic Reporting for period 1 - BRIGHT (Treat severe cases of infection at COV with XAV-19)

Reporting period: 2020-08-01 to 2021-07-31

The issue addressed in BRIGHT by XENOTHERA is the treatment of coronavirus disease 2019 (COVID-19). The goal is to reduce progression of mild to severe disease. Passive antibody therapies with convalescent plasma or monoclonal antibodies have demonstrated efficacy but also limitations, such as variant resistance and high cost. To circumvent these limitations, XENOTHERA is using its glyco-humanized polyclonal antibody platform to generate XAV-19, a highly efficient, broadly neutralizing and cost-effective antibody. According to a SEIR compartmental epidemiological model, efficiently treating all susceptible patients with XAV-19 could strongly impact a country like France where up to 45,000 lives might have been spared. The overall objective of BRIGHT is to provide a clinical proof of concept that this goal can be reached with XAV-19.
In this first part of BRIGHT, the company XENOTHERA has gone through all steps to clinic. The exceptional speed of the development of XAV-19, its glyco-humanized anti-SARS-CoV-2 polyclonal antibody, has been made possible by the support of EU.
The company was able to demonstrate the strong interest of XAV-19 as potential candidate for treatment of COVID-19 in moderate patients. First of all, several samples of the product were obtained by immunizing donor animals for antibody production in our Belgian facility. The activity of XAV-19 as inhibitor of the different forms of virus, including variants of concern, was demonstrated. In parallel, in vivo activity was shown in mice in collaboration with the excellent team of Pasteur Institute in Hong Kong, China.
Once the preclinical proof of concept was established the company was able to produce batches compliant with the pharmaceutical good manufacturing practices, demonstrate preclinical safety and initiating a clinical trial offering hope to patients suffering from moderate COVID-19. The clinical trial EUROXAV is currently recruiting in Greece, Romania and Bulgaria, and Spain.
XENOTHERA is a biotech based in Nantes, France, and has recruited more than 10 people in less than one year. The visibility of the company in France and Europe has been boosted by the interest of its technology and the capacity of the management team to accelerate in the COVID context.
The EU support has allowed the SME XENOTHERA to publish 4 original scientific papers on COVID-19 and to raise 20M€ in equity since last August 2020.