Algenex SL, a biotech company backed by Cleon Capital and Columbus Ventures delivering disruptive technologies for recombinant biologics production, and FATRO S.p.A, a leader in the field of veterinary pharmaceutical products, today announce that the European Commission (EC) and the UK Veterinary Medicine Directorate (VMD), have granted marketing authorization for their CrisBio®-based vaccine for Rabbit Haemorrhagic Disease (RHD) for marketing authorization in the European Union and United Kingdom, respectively.
The product, FATROVAX RHD, is a recombinant subunit RHDV1 and RHDV2 vaccine for rabbits developed and manufactured using CrisBio®, Algenex’ proprietary and patent protected Baculovirus vector-mediated expression platform that harnesses the power of insects to act as natural single-use bioreactors. CrisBio® represents a new paradigm in biologics production, offering a quick, linearly scalable solution to meet the global demand for recombinant protein production without significant capex investment.
The EC approval follows a positive recommendation for approval from the Committee for Medical Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) received in June 2021.
Rabbit Haemorrhagic Disease Virus, with its variants RHDV and RHDV2, is endemic in most parts of the world, and causes a highly contagious, acute and fatal disease. The virus does not replicate in vitro and the production of protective antigens by recombinant baculovirus avoids the need to use live rabbits in the manufacture of RHD vaccines.
The CrisBio® platform offers a number of benefits that include reduced production costs and increased productivity reaching gram per litre yields, significantly outperforming alternative baculovirus vector approaches. The CrisBio® platform is rapidly scalable, with Algenex’ capacity currently geared for commercial scale production. Algenex anticipates that its facilities will be fully GMP compliant by the end of the year.
Claudia Jiménez, CEO of Algenex said: “Marketing authorization from the European Commission and UK VMD for a CrisBio®-developed product is further validation of the platform following the positive opinion offered by the EMA’s CVMP earlier in June this year, and gives further momentum to Algenex as we continue to expand our use of the platform into an extensive range of applications in both human and animal health.”
Dr. Francesco Meliota, vice president responsible for IVMPs at FATRO said: “This is an innovative new addition to our portfolio of vaccines for veterinary use. CrisBio® offers a highly practical and effective means of manufacturing recombinant vaccines and can support innovative product development. We are already collaborating with Algenex on additional products and look forward to further exciting developments.”
The marketing authorizations will be valid in all EU Member States, in the United Kingdom as well as in the European Economic Area (EEA) countries (Iceland, Liechtenstein and Norway).