Novadip Biosciences Raises Funds to Support Regenerative Tissue Products

Novadip Biosciences raised an additional €40 million (~USD $40 million) in a Series B equity round and non-dilutive funding. This brings the company’s total funding to €88 million, to date.

Proceeds will accelerate the clinical development of two investigational adipose stem cell (ASC)-derived tissue regeneration products: NVD-X3, an allogeneic therapeutic that can provide accelerated, durable bone union in spinal fusion procedures and non-healing fractures, and NVD-003, an autologous bone graft product designed to provide a single treatment cure for patients with critical size bone defects such as congenital pseudoarthrosis of the tibia.

Novadip’s 3M³ platform is a 3-dimensional, extracellular matrix that employs adipose-derived stem cells to deliver growth factors and miRNAs to mimic the physiology of natural tissue healing. The platform supports three therapeutic programs:

• 3MAUTO: autologous ASC products that provide one-time curative treatment to achieve long-term union and stability of critical size bone defects
• 3MALLO: “off-the-shelf” allogeneic matrix products to provide accelerated, stable bone union in 90% of bone graft procedures
• 3MEXO: allogeneic exosome products that can repair tissue following surgical resection of solid tumors, such as osteosarcoma, melanoma, glioblastoma

Novadip’s lead allogeneic product, NVD-X3, employs a matrix containing multiple bioactive factors that induce accelerated tissue healing​. Designed as an “off-the-shelf” product, NVD-X3 can be shipped and stored at room temperature. Preclinical studies demonstrate that NVD-X3 offers superior bioactivity without the undesirable bone formation/resorption and inflammation observed with currently marketed bone engraftment products​. Novadip plans to initiate a Phase I/II clinical trial for NVD-X3 in spine fusion and bone non-union procedures in Europe by the end of 2022.

Further, Novadip is developing NVD-003, an autologous therapy derived from ASCs as a potential single treatment to save limbs and restore mobility​ in patients with congenital pseudoarthrosis of the tibia. The favorable safety profile and potential clinical utility of NVD-003 for promoting healthy and durable bone formation is supported by clinical data from more than 50 adult and pediatric patients with non-healing fractures of the lower limb, bone non-union (BNU), obtained in Phase Ib/IIa clinical trials and compassionate use.

“This financing milestone is a recognition by our committed group of existing investors of the clinical benefits and broad market opportunities provided by our 3M³ tissue regeneration technology platform,” said Denis Dufrane, M.D., Ph.D., CEO and Co-founder of Novadip Biosciences. “With this funding we will advance a new class of therapeutics that offer curative hope for patients suffering from large bone defects and enable accelerated healing of common orthopedic conditions such as radius fracture, spinal fusion.”

Source: Novadip Biosciences