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.
