Novadip Biosciences has raised an additional €40 million ($39.2 million) in a round of series B capital and non-dilutive financing.
The clinical-stage biopharmaceutical company is developing a new class of regenerative tissue products to accelerate the healing of large bone defects and injuries in a single treatment.
The funding will accelerate the clinical development of two of Novadip’s investigational adipose stem cell (ASC)-derived tissue regeneration products: NVD-X3, an allogeneic therapeutic that can provide accelerated and 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 critically sized bone defects, such as congenital nonunion of the tibia (CPT).
The financing consists of €24 million in new capital and €16 million in non-dilutive financing mainly from the Walloon Region. CR-CP Life Science Fund (China) joined existing investors including New Science Ventures (US), Fund+, SRIW Life Sciences, VIVES Louvain Technology Fund, InvestSud, family offices and private investors such as Pierre Drion and Olivier van der Rest, to support the equity round.
Advancing new therapies
“This financial milestone is recognition by our committed group of existing investors of the clinical benefits and broad market opportunities offered by our 3M³ tissue regeneration technology platform,” said Denis Dufrane, CEO and co-founder of Novadip Biosciences. .
“With this funding, we will advance a new class of therapies 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.”
Novadip’s 3M³ platform is a three-dimensional extracellular matrix that uses adipose-derived stem cells to deliver highly specific miRNAs and growth factors to mimic the physiology of natural tissue healing.
The platform supports three therapeutic programs: 3M AUTO, autologous ASC products that provide unique curative treatment to achieve long-term union and stability of critically sized bone defects; 3M ALLO, “ready-to-use” allogeneic matrix products to provide accelerated and stable bone union in 90% of bone graft procedures; and 3M EXO, allogeneic exosome products that can repair tissue after surgical resection of solid tumors, such as osteosarcoma, melanoma, glioblastoma.
“We appreciate the expanded support of our international investors, who appreciate the immense potential of the 3M³ technology platform to deliver best-in-class tissue regeneration products that disrupt the standard of care in the US, EU and Asia. Eric said. P. Pâques, Chairman of the Board of Directors of Novadip Biosciences.
“We have been extremely impressed with the progress the Novadip team has made in bringing the 3M AUTO and 3M ALLO programs into clinical studies. Looking ahead, it is
It is clear that Novadip’s therapeutic programs can be very important to patients, and we look forward to supporting these dedicated individuals as they work to cultivate the clinical promise of the 3M Technology Platform 3 in multiple high-opportunity markets.”
About the NVD-X3 for Spinal Fusion and Nonunion Applications
The risk of nonunion after fracture is greater than 50% for all bones due to fracture severity, comorbidities (diabetes, obesity, smoking, and other conditions), and medication use.
In addition, more than 600,000 spinal fusion procedures are performed annually. Together, these indications represent a maximum sales opportunity for Novadip of $2.2 billion. Novadip’s leading allogeneic product, NVD-X3, employs a matrix containing multiple bioactive factors that induce accelerated tissue healing.
Designed as an “out of the box” product, the NVD-X3 can be shipped and stored at room temperature and offers superior intra-operative handling characteristics. A favorable COGS profile supports wide distribution and increased patient access. Preclinical studies demonstrate that NVD-X3 offers superior bioactivity without the undesirable bone formation/resorption and inflammation seen with currently marketed bone graft products.
Novadip plans to start a phase 1/2 clinical trial for NDV-X3 in spinal fusion and nonunion procedures in Europe by the end of 2022.
About NVD-003 and CPT
Congenital nonunion of the tibia (CPT) is a rare pediatric bone condition that occurs in one in 150,000 births. Children with PTC carry a high disease burden, including frequent fractures, loss of mobility, and possible amputation.
The current standard of care, autologous bone graft surgery, is associated with poor long-term outcomes, including a high risk of chronic pain, infection, blood loss requiring transfusion, and persistent risk of amputation.
Novadip is developing NVD-003, an autologous ASC-derived therapy as a potential single treatment to save limbs and restore mobility in patients with PTC. The favorable safety profile and potential clinical utility of NVD-003 in promoting the formation of healthy and durable bone is supported by clinical data from more than 50 adult and pediatric patients with non-healing lower extremity fractures, non-healing nonunions (BNU ), obtained in phase 1b/2a clinical trials and compassionate use.
Active cells in the NVD-003 autologous graft helped achieve durable union in critically sized bone fractures with follow-up data of up to five years. These results de-risk the company’s clinical development program for CPT and support future discussions with drug regulatory agencies about designing late-stage pivotal trials to support eventual product registration.
Novadip will begin Phase 1b/2a clinical trials in PTC patients aged two to eight years in the US and EU in late 2022. NVD-003 has received orphan drug and rare pediatric disease designations for its accelerated approval from the US Food and Drug Administration (FDA). If NVD-003 is approved by the FDA, Novadip is eligible to receive a priority review voucher that could provide revenue of more than $100 million.