Abionyx Pharma has announced a strategic partnership with GTP Biologics (Fareva Group) and V-Nano (VBI Therapeutics Group), specialised in the production and formulation of biological nanomedicines.
CER-001, a complex engineered cell biology-based biomolecule with a diverse mechanism of action similar to natural HDL, has showed positive results in the treatment of an ultrarare kidney disease in a French patient, delaying the need for dialysis and diminishing corneal lipid deposits resulting in improved vision, as reported in a recently published case study.
Clinical development of CER-001 in renal disease continues in a Phase IIa study to prevent acute kidney injury in septic patients, currently underway in Italy. In view of these advances, Abionyx has decided to relaunch and reengineer the biomanufacturing of its recombinant bio-HDL mimetic.
GTP Biologics, based in Saint-Julien-en-Genevois, and V-Nano, based in Toulouse, reportedly have the necessary infrastructure and expertise to re-engineer and relaunch the biomanufacture of CER-001. GTP is a major site for biomanufacturing in Saint-Julien-en-Genevois. V-Nano is also a partner of CEA Tech Occitanie in the framework of a technology transfer in nano-characterisation for the opening of a joint laboratory which works in particular on the development of nano-formulations and will have a pilot unit upstream of the production site.
Alain Sainsot, CEO at GTP Biologics/Group Fareva and President of V-Nano/Group VBI Therapeutics said: “We are very pleased to make a strategic contribution to the development of Abionyx Pharma's CER-001 biomedical product, alongside Fareva. It is a major challenge for our industry to be able to produce the most advanced biomedicines in France, in addition to more mature products such as vaccines and monoclonal antibodies. In the case of Abionyx, the aim is to produce this new biomedicine as quickly as possible to meet the needs of patients without existing treatment and to extend the field of medical innovations that can be carried by this bio-HDL, both in the kidney and in ophthalmology.”
Cyrille Tupin, MD of Abionyx Pharma concludes: "We would like to thank Alain Sainsot, his team and shareholders for their strategic interest and support for the re-launch of the bioproduction of CER-001 in this next generation biomanufacturing facility in France. We are also delighted with the support of Fareva, through its strategic partnership with VBI Therapeutics in the context of the Saint-Julien-en-Genevois activities. The availability of new batches of bio-HDL is highly anticipated in the context of new ATUs in ultra-rare renal diseases or new indications in nephrology and ophthalmology, in order to improve the prognosis of rare and orphan diseases or other diseases for which there are currently no treatments".
