Novadip’s 3M3 platform drives multiple classes of product candidates with an initial focus on autologous cell therapies for critical size tissue reconstruction and allogeneic therapeutics in development for prevalent tissue defects. Additionally, we are applying our platform to investigate potential miRNA/exosome-based therapeutics for systemic tissue and other diseases.
AUTOLOGOUS CELL THERAPIES
For critical size tissue reconstruction
Active local delivery – Implantable
For smaller, prevalent tissue defects
Passive local delivery – Implantable
For systemic tissue and other diseases
Autologous cell therapies
Novadip’s clinical stage product candidates are highly bioactive, malleable materials comprised of differentiated stem cells within a complex extracellular matrix with the structural and functional characteristics to address critical size tissue reconstruction. The product candidates are easy for physicians to use and are readily integrated into current treatment paradigms, promising potentially better efficacy and tolerability than scaffold-based approaches as well as simplified manufacturing and lower regulatory barriers. They are individualised for each patient to maximise potential for efficacy and minimize safety concerns.
NVD-003 is a second-generation therapy for critical size bone reconstruction, which is comprised of differentiated stem cells within an extracellular matrix resulting in active local delivery of highly specific growth factors and miRNAs leading to biological activity necessary for tissue regeneration for large bone defects.
NVD-003 is a 3-dimensional, malleable product candidate that is capable of filling virtually any defect. It has been shown to promote osteogenesis and angiogenesis, with anti-osteoclastic and high mineralization properties, while maintaining the ability to function in a low oxygen environment.
The lead indication for NVD-003 is congenital pseudarthrosis of the tibia (or CPT), a rare pediatric orthopedic condition in which the tibia of a young child breaks due to bowing and does not heal, resulting in non-union. An initial clinical trial in North America is planned to begin in 2020.
A Phase 1/2a trial in adults with a large bone non-healing fractures (bone non-union) is ongoing1.
NVD-001 is a first-generation therapy for bone regeneration and is being tested in a controlled Phase 1/2a trial in single-level spinal fusion patients. The trial is fully enrolled2.
NVD-SKIN is an autologous cell therapy for critical size skin repair. It is designed to have the key attributes of angiogenesis and dermis tissue remodelling to restore deep-thickness skin integrity and be used for large skin grafts.
Novadip’s unique technology platform is also generating highly innovative allogeneic, ‘off-the-shelf’ product candidates with no viable cells to address prevalent indications in hard and soft tissue reconstruction.
The off-the-shelf products are made of ECMs to preserve passive delivery of highly specific growth factors and miRNAs necessary for tissue regeneration. The product candidates are lyophilized and sterilized for a long shelf life and simplified manufacturing. They are being specifically designed to treat smaller and more prevalent tissue defects.
NVD-AB1 (an allogeneic therapeutic derived from NVD-003) is in preclinical development for hard tissue reconstruction. Potential indications include single-level spine fusion and maxillofacial fractures.
NVD-AS1 (an allogeneic therapeutic derived from NVD-SKIN) is in preclinical development for soft tissue reconstruction. Potential indications include critical and chronic wounds and aesthetic dermatology.