Algenex SL, a VC-backed biotechnology company 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 Committee for Medical Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) has recommended FATRO’S CrisBio®-based vaccine for Rabbit Haemorrhagic Disease (RHD) for marketing authorization in the European Union. The final decision of the European Commission on the marketing authorisation of FATROVAX RHD is expected in the coming months.Klifovet advised the applicant in the regulatory submission.

The recombinant subunit RHDV1 and RHDV2 vaccine was developed and will be 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.

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 positive opinion of the EMA’s CVMP represents a significant regulatory validation for Algenex’s CrisBio® technology and a major milestone for the Company. The submission by FATRO was a first for our technology and its success further reinforces the potential of CrisBio® to provide a versatile and robust alternative to bioreactor-based expression technologies across multiple applications in human and animal health,” said Claudia Jiménez, CEO of Algenex.

“Today’s news signals a further expansion of our portfolio of vaccines for veterinary use,”stated Dr. Francesco Meliota, vice president responsible for IVMPs at FATRO.  “Our collaboration with Algenex has played an important part in enabling us to develop this new productand we have since worked with the Company on a second vaccine. We remain convinced that CrisBio® offers a highly practical and effective means of manufacturing recombinant vaccines and can support innovative product development.”