December 23, 2020
01:00
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The Walloon government has granted Novadip two recoverable advances to support the development of a treatment for pseudarthrosis of the tibia, a rare pediatric disease.
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Repairing a young patient’s shin by implanting a bone graft is the treatment developed by Novadip Biosciences. Last September, this spin-off of UCLouvain and the Saint-Luc University Clinics presented in a world premiere the placement of a 3D tissue implant of more than 18 cm3 on a 5 year old boy suffering from congenital nonunion of the tibia.
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To support the next development phases of its NVD-003 treatment, Novadip has just been granted by the Walloon government aid in the form of a recoverable advance of 5.7 million euros. NVD-003 is an experimental autologous cell therapy (using stem cells drawn from the patient himself) for congenital nonunion of the tibia. This rare and debilitating disease, characterized by a broken tibia that does not heal, mainly affects children.
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The endorsement of the FDA
“This aid will be dedicated to development of protocols for a clinical study to be carried out mainly in the United States. We could also open one or two clinical study centers in Belgium, under the cover of the American FDA, ”explains Denis Dufrane, CEO of Novadip.
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“This assistance will be dedicated to the development of protocols for a clinical study to be carried out mainly in the United States.”
Denis Dufrane
CEO of Novadip Biosciences
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The company obtained in September from the American regulator the status of rare pediatric disease and the designation of orphan disease for NVD-003 concerning the treatment of congenital pseudarthrosis of the tibia. “This disease has always been among the most difficult for orthopedic specialists to treat. Even after several surgical treatments aimed at fusing the fractured bone, the restoration of healthy bone tissue is hampered and the likelihood of a fracture recurring. is high “, emphasizes Denis Dufrane.
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Allogeneic treatment
With this financial support, Novadip hopes to expand its product family and consider early market access for congenital tibial pseudarthrosis before tackling other indications.
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That’s not all. The Walloon government has also released another recoverable advance of 3.7 million euros to help Novadip develop a new product, NVD-X3, a cell-free matrix which is a direct derivative of NVD-003. This allogeneic powder, in other words taken from healthy donors whose cells are “reprogrammed” in the laboratory, can be produced on a large scale and therefore offered as a first-line treatment in a large population of patients. The objective of the program is to allow the clinical development of this product within 2 years.
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