Periodic Reporting for period 2 - BRIGHT (Treat severe cases of infection at COV with XAV-19)
Berichtszeitraum: 2021-08-01 bis 2022-12-31
The issue addressed in BRIGHT by XENOTHERA is the treatment of coronavirus disease 2019 (COVID19). 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 XAV19, a highly efficient, broadly neutralizing and cost-effective antibody. According to a SEIR compartmental epidemiological model, efficiently treating all susceptible patients with XAV19 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 XAV19. XENOTHERA has effectively launched a phase 2/3 clinical trial in 6 countries in order to evaluate the efficacy of its treatment in reducing the probability of worsening in patients with moderate to severe COVID19. Due to insufficient enrollment the clinical trial was interrupted in November 2022. Encouraging results were obtained in early patients at mild to moderate stage of the disease. Thanks to its engagement and achievements, XENOTHERA was awarded "Start up of the year" by EY in 2021.
In this first part of BRIGHT, the company XENOTHERA has gone through all steps to clinic. The exceptional speed of the development of XAV19, 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 XAV19 as potential candidate for treatment of COVID19 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 XAV19 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 COVID19. The clinical trial EUROXAV is currently recruiting in Greece, Romania and Bulgaria, and Spain.
During the project, XENOTHERA was successful in:
1/ providing hyperimmune sera of anti-SARS-CoV-2 antibodies;
2/ purifying these immunoglobulins and bringing them to GMP status as XAV19;
3/ running toxicology and preclinical experiments proving the safety of XAV19 in preclinic;
4/ obtaining clinical trial authorization in 6 different countries;
5/ recruiting 287 patients in the afore mentioned clinical trial named EUROXAV.
Unfortunatley due to high slowering of the patients enrollment in the clinical trial, the company was not able to finalize its clinical trial recruitment plan. After 20 months of recruitment it was decided to interrupt the clinical trial in November 2022.
Interim encouraging results were obtained from the trial, but not statistically significant therefore preventing the company from demonstrating the clinical benefit of XAV19.
The company was able to demonstrate the strong interest of XAV19 as potential candidate for treatment of COVID19 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 XAV19 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 COVID19. The clinical trial EUROXAV is currently recruiting in Greece, Romania and Bulgaria, and Spain.
During the project, XENOTHERA was successful in:
1/ providing hyperimmune sera of anti-SARS-CoV-2 antibodies;
2/ purifying these immunoglobulins and bringing them to GMP status as XAV19;
3/ running toxicology and preclinical experiments proving the safety of XAV19 in preclinic;
4/ obtaining clinical trial authorization in 6 different countries;
5/ recruiting 287 patients in the afore mentioned clinical trial named EUROXAV.
Unfortunatley due to high slowering of the patients enrollment in the clinical trial, the company was not able to finalize its clinical trial recruitment plan. After 20 months of recruitment it was decided to interrupt the clinical trial in November 2022.
Interim encouraging results were obtained from the trial, but not statistically significant therefore preventing the company from demonstrating the clinical benefit of XAV19.
XENOTHERA is a biotech based in Nantes, France, and has recruited 15 people during the project. 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 5 original scientific papers on COVID19 and to raise 21M€ in equity since last August 2020.
Several press releases were consequently emitted by the company. This brought a very positive visibility to the company and its technology.
The company teams were also able to participate in several congresses in France, Europe and US.
One additional patent protecting the XAV19 and other anti-viral antibodies possibly released by the company was filed in 2022.
Several jobs were created indirectly in subcontractors (>20).
Finally BRIGHT brought a very positive focus on the company and on the innovative capabilities of biotechs in Europe. XENOTHERA has participated in several pitch sessions organised by EIC.
The EU support has allowed the SME XENOTHERA to publish 5 original scientific papers on COVID19 and to raise 21M€ in equity since last August 2020.
Several press releases were consequently emitted by the company. This brought a very positive visibility to the company and its technology.
The company teams were also able to participate in several congresses in France, Europe and US.
One additional patent protecting the XAV19 and other anti-viral antibodies possibly released by the company was filed in 2022.
Several jobs were created indirectly in subcontractors (>20).
Finally BRIGHT brought a very positive focus on the company and on the innovative capabilities of biotechs in Europe. XENOTHERA has participated in several pitch sessions organised by EIC.