XENOTHERA announces the signature of a contract to reserve 30,000 unit doses of XAV-19 with the French Ministry of Health and Solidarity. XAV-19 is the polyclonal anti-SARS-CoV-2 antibody developed in France by the Nantes-based biotech, based on its glyco-humanized antibody technology. This treatment is intended for patients suffering from moderate COVID, to avoid aggravation of the disease and a transfer to intensive care.
The contract covers the supply of the drug to Santé publique France in order to make it available to French patients at the end of the summer. This agreement allows XENOTHERA to start the industrial production of the first batches in anticipation of the results of the French POLYCOR clinical trial expected this summer and the authorization by the French National Agency for the Safety of Medicines and Health Products (ANSM). The polyclonal nature of XAV-19 makes it a particularly effective drug candidate, especially in view of its neutralising activity against circulating variants, and meets medical needs that are not currently covered. This point differentiates it in particular from monoclonals of American origin currently delivered to early-stage patients suffering from comorbidities.
The development of XAV-19 has been supported by the public authorities since May 2020. After a French Tech Bridge, the POLYCOR clinical trial promoted by the Nantes University Hospital,
labelled a National Research Priority by CAPNET in December 2020, was co-financed by the General Secretariat for Investment as part of a PSPC. More recently, the industrial investment projects presented by XENOTHERA and LFB for the production of XAV-19 were awarded a Capacity Building subvention from the French Ministry of Industry. In total, the XAV-19 programme has benefited from more than 15 million euros non-dilutive financing, split between XENOTHERA, the Nantes University Hospital, the University of Nantes and LFB.
“This signature illustrates the commitment of the French government to guarantee our sanitary independence in the COVID-19 epidemic. I am delighted that the Ministry of Health has responded favourably to our proposal to reserve the first production of our treatment for French patients, which seemed logical considering the support we had received since the beginning. This contract also demonstrates that entrepreneurship is possible in France! The story is not over, we now need to obtain authorisations from the ANSM, and we will continue to commit all our forces to the fight against this virus, and to meeting the needs of patients in the other therapeutic areas where XENOTHERA is involved. “comments Odile Duvaux, President of XENOTHERA.
On April 21, XENOTHERA and the Nantes University Hospital announced the end of the POLYCOR clinical trial; the mobilisation of 35 French hospitals made it possible to reach the inclusion objective in less than three months. A EUROXAV clinical trial of XAV-19 treatment has also started in Europe with the recruitment of the first patients in Greece.
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About the XAV-19:
XENOTHERA’s drug candidate XAV-19 is a protective anti-SARS-CoV-2 polyclonal antibody that mimics the natural human response. Based on a unique and patented proprietary technology, it acts through multiple mechanisms of action, including neutralisation of the virus and reduction of inflammation, thereby limiting the risk of a cytokine storm.
In April 2021, the University Hospital of Nantes, XENOTHERA, and the team of Professor Vincent Calvez at the Pitié Salpêtrière Hospital signed two major publications demonstrating the efficacy of XAV-19 on the variants (VanhoveB. et al.BioRxiv, 2021) and the first clinical results from phase IIa (Gaborit B. et al.MedRxiv, 2021). XAV-19 is currently one of the most promising anti-COVID treatments in development.
About XENOTHERA:
Founded in 2014, XENOTHERA is a Nantes-based biotech company that develops polyclonal “glycohumanised” antibodies. Its technological platform is built on a dual expertise in genetics and immunology. The company has a complete portfolio of products, the first of which, LIS1, an immunosuppressant in transplantation, has been in the clinic since 2019. XENOTHERA has also been developing its treatment for coronavirus infections for several years. XAV-19 is XENOTHERA’s treatment for patients in the early stages of hospitalisation and is based on a unique patented antibody production technology that has been developed and proven for several years by the biotech.
XENOTHERA, a member of the Atlanpole Biotherapies competitiveness cluster, is part of the scientific and medical environment of the Pays de la Loire. The company has been supported since its creation by private investors, by the Pays de la Loire Region and by BPI France. Since its creation, the company has raised more than 23 million euros to finance all of its products.
More info at: www.xenothera.com