Lyon, France, July 16, 2020 – Fab’entech, a Lyon-based biopharmaceutical laboratory specializing in emergency immunotherapy, announces today the launch of a program to develop an immunotherapy treatment against COVID-19. This treatment will be used for severely ill patients requiring respiratory assistance. Human clinical trials should start in early 2021.
In order to meet new public health challenges, Fab’entech has created a development and production platform based on a polyclonal immunotherapy technology which enables targeted recognition of a virus or toxin and its specific neutralization. Fab’entech has already demonstrated the effectiveness and safety of this approach while developing its own products. This new COVID-19 program stems from the R&D and industrial platform developed by Fab’entech over the last decade, which draws on technology proven in the treatment of infectious diseases.
In January 2020 Fab’entech raised €8.5 million ($9.6M) from the Definvest fund of the Ministry of the Armed Forces, managed by Bpifrance, also from Institut Mérieux and from its historic shareholders. These funds helped Fab’entech move forward with a new industrial site that meets the requirements of both the EMA (European Medicines Agency) and the FDA (Food and Drug Administration). Located near Lyon, this new unit will ensure the production of immunotherapy treatments against COVID-19 in France and will quickly ramp up to increase its production capacities and provide treatments to cover other markets.
“Fab’entech will play an important role in the fight against and control of the COVID-19 pandemic,” said Dr. Bertrand Lépine, founder of Fab’entech. “We are convinced that this treatment will contribute toward reducing the use of critical care units and will mean many patients can be successfully treated, whilst also freeing up the healthcare system.”
Unlike monoclonal antibodies, polyclonal antibodies make it possible to target different parts of the antigen of interest. Polyclonal antibodies are therefore more suited to the modifications that the antigens may undergo, such as those resulting from virus mutations. Using an antigen derived from SARS-CoV-2, the company was able to launch a program to develop F(ab’)2 polyclonal antibodies, which will be administered to patients by injection with the aim of establishing passive immunity.
The polyclonal antibodies neutralize the virus and therefore slow down its progression in the organism, giving the patient’s immune system time to produce its own antibodies. Furthermore, these have a synergistic effect with other existing therapies, which Fab’entech was able to demonstrate in animals with H5N1 influenza by co-administering its anti-H5N1 product with oseltamivir. The study also showed a reduction in the nasal viral load, which is directly related to the level of contagiousness of the virus.
The process used by Fab’entech makes it possible to keep only the active part of the F(ab’)2 fragments and removes the Fc fragments from the antibodies. This prevents an excessive immune response by the patient, which could lead to a ‘cytokine storm’. Based on a strategy similar to convalescent plasma therapy, this approach is a standardized, safer, more reproducible and easily scalable solution.
Since its creation in 2009, Fab’entech, an innovative biopharmaceutical laboratory, has specialized in the development of immunotherapy products, in particular to treat emerging infectious diseases and to offer medical countermeasures in the face of bioterrorist threats. To meet these public health emergencies, Fab’entech worked on a technological development and production platform which provides a solution, based on the administration to the patient of fragments – F(ab’)2 – of highly purified immunoglobulins of equine origin. These specific F(ab’)2 fragments immediately neutralize the antigen contracted by the patient and slow down the infection. This technology arose from a process initially developed by Sanofi Pasteur and licensed to Fab’entech. Using this flexible, robust solution, Fab’entech has the ability to respond quickly to health emergencies. To date, Fab’entech has developed Fabenflu®, a first treatment against avian influenza (H5N1). While remaining in the area of emergency medicine, the company plans to develop other pharmaceutical products, such as antidotes to drug intoxication and treatments against nosocomial infectious diseases.