LFB SIGNS AGREEMENT WITH XENOTHERA TO MANUFACTURE FIRST CLINICAL BATCH OF XENOTHERA’S XAV-19 FOR THE TREATMENT OF CORONAVIRUS INFECTIONS INCLUDING COVID-19
Les Ulis and Nantes, 15th April 2020: LFB and the Nantes biotech company XENOTHERA announced today the signing of an agreement for the production by LFB of the first clinical batch of a drug candidate, XAV-19, developed by XENOTHERA for the treatment of coronavirus infections including Covid-19. XAV-19 is a mixture of protective antibodies, similar to those produced naturally in humans, that neutralises the virus and prevents it from multiplying, while avoiding reactions in which antibodies rapidly aggravate the infection instead of treating it. XAV-19 is the result of research by XENOTHERA using a unique and patented technology to produce antibodies. This technology is already applied in clinical transplantations and R&D programmes in the prevention of hospital-acquired infections and in the field of cancer.
As part of this agreement, LFB’s bioproduction site located in Alès will mobilize its industrial capacities and expertise in the field of therapeutic protein production to manufacture the first clinical batch of XAV-19. This site, which was recently approved by the FDA, will prepare clinical batches of XAV-19 for clinical evaluation in the short term. Twenty-five LFB employees from the production, quality and logistics teams will be mobilised to meet this objective. A first clinical batch will be produced in May 2020. This first clinical batch will be essential for the launch of the clinical trial of XAV-19 that aims at treating several dozens of hospitalized patients by preventing respiratory decompensation which requires transferring the patients to an intensive care unit.
The Nantes-based biotech company believes that with its clinical experience and the support of public and private stakeholders such as LFB, it will be able to accelerate the production of XAV-19 and thus offer treatment in the coming months, subject to its validation in clinical trials.
According to Denis Delval, LFB’s Chairman and CEO: “In the context of the Covid-19 pandemic, it is our responsibility to do everything possible to foster research and development on a potential treatment. It was therefore logical that LFB, which is already engaged in other research projects in the fight against Covid-19, should respond positively to the request of XENOTHERA, whose technology is already applied in clinical programmes and in the prevention of hospital-acquired infections.”
Odile Duvaux, President of XENOTHERA added: “We are very pleased with this collaboration with LFB, a French pharmaceutical company well-versed in antibody technologies, that responded favourably to our request for urgent action in these times when the health emergency is the top priority. We have found in LFB a partner who knows our technology and is indeed very motivated to contribute to the fight against the epidemic. I have no doubt that this is a first step towards a longer-term partnership with a central player in the French health arena.”
XAV-19 is a preparation of hyperimmune polyclonal antibodies against the SARS-CoV-2 virus. It is composed of humanised glyco-optimised antibodies whose therapeutic activity is focused on three effects: neutralisation of the virus by blocking its entry into the patient’s cells, the absence of risk of ADE (antibody-dependent enhancement, a mechanism of aggravation of the pathology due to the patient’s antibodies) and reduction of the inflammatory response. XAV-19 results from the know-how of XENOTHERA that has been developing humanised polyclonal antibodies since 2015, and that already has a first product in clinical trial. XAV-19 will be administered to hospitalised patients to prevent aggravation of their condition and transition to the stage of acute respiratory distress syndrome which requires intensive care medical management.
LFB is a bio-pharmaceutical group that develops, manufactures and markets plasma derived products and recombinant proteins for the treatment of patients with serious and often rare diseases. LFB was founded in 1994 in France and is among the leading European bio-pharmaceutical companies providing healthcare professionals, with blood-derived therapeutics with the vision to provide treatment options to patients in three major areas: immunology, haemostasis, and intensive care.
LFB currently markets 15 products in more than 30 countries.
Please visit www.groupe-lfb.com for additional information.
Created in 2014, XENOTHERA is a Nantes-based biotech company which develops “humanized” polyclonal antibodies. Its technological platform is built on a dual expertise in animal genetics and immunology. The company has a complete portfolio of products, the first of which, LIS1, an immunosuppressant used for transplants, has been in clinical trials since 2019. XENOTHERA is part of the Nantes scientific, medical and academic environment and is supported by the Pays de la Loire region’s Atlanpole competitiveness cluster. Since its creation, the company has raised 6 million euros in equity and has received support from the BPI.
To find out more, please visit: www.xenothera.com
Didier Véron – Executive VP Corporate Affairs – LFB Group
Tel: +33 (0)18.104.22.168.97 or +33 (0)6.08.56.76.54