Novadip Biosciences SA announces significant clinical milestones for both of its clinical-stage programs

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1^st US patient treated with an autologous cell-based product (NVD-003) in a rare pediatric disease

Full enrollment of patients on track for year-end completion in allogeneic cell-derived product (NVD-X3) trial in patients with a distal radius fracture following trauma

MONT SAINT-GUIBERT, Belgium, Dec. 5, 2023 /PRNewswire/ -- Novadip Biosciences SA ("Novadip" or "the Company"), a clinical-stage biopharmaceutical company developing a new class of regenerative tissue products to accelerate healing of large bone defects and injuries in a single treatment, today announced that the first US patient has been implanted with its investigational tissue regeneration product, NVD-003, in its Phase 1b/2a clinical trial in Congenital Pseudarthrosis of Tibia (CPT), a rare pediatric bone condition. An autologous therapy derived from a patient's own adipose stem cells (ASC), NVD-003 has the potential to accelerate healthy bone formation, restore mobility and avoid the need for amputation in children with CPT.

"This is an exciting moment to be able to treat one of our patients with NVD-003," said Philip K. McClure, MD, FAAOS, Director of the International Center for Limb Lengthening, Baltimore, Maryland and the principal investigator in the US on this trial. "Three months after we collected the patient's adipose tissue in here in Baltimore, the NVD-003 graft, which was then manufactured in Belgium, was sent to us for implantation. With NVD-003, there's hope that the standard use of invasive iliac crest bone grafting, which can be very painful and lead to complications such as infection, bleeding and large scar formation, can be avoided. This is particularly important for patients who have had previous surgeries on the pelvis, making graft harvest of higher risk." According to Novadip, this Phase 1b/2a trial has now reached full enrolment; 3 patients have been enrolled in Belgium, of whom 2 have already been grafted with NVD-003 by Professor Pierre-Louis Docquier, MD, PhD, a specialist in pediatric surgery at the University Hospital Saint-Luc in Brussels. The company is actively planning the pivotal trial to support NVD-003's approval by the US Food and Drug Administration (FDA).

Novadip also provided an update on NVD-X3, their allogeneic off the shelf matrix product, which entered clinical development this past summer with two parallel Phase 1b/2a EU clinical trials. Enrolment in the first trial, for the treatment of a distal radius fracture following trauma, is near completion with 9 of 10 patients already treated. In addition, the first patient has been treated in the second trial investigating NVD-X3 in spine fusion. "We are very pleased with the speed of recruitment in our first clinical trial with NVD-X3," said Judy Ashworth, MD, Novadip's CMO. "As we now begin to prepare our Investigational New Drug Application to submit to the FDA, we're anxious to advance NVD-X3 into an aggressive phase 2 program in the US with trials beginning in early 2025."

"We are excited by the progress of both of our programs in Europe and in US," said Denis Dufrane, MD, PhD, CEO, and founder of Novadip Biosciences. "We have demonstrated our capacity to manage multiple clinical trials in parallel as well as the robustness of our manufacturing platform for two different classes of cell-based and cell-derived products with the aim to deliver the best therapeutic agents to the patients. Novadip is now a clinical advanced company."

About NVD-003 and CPT

Congenital pseudarthrosis of the tibia, or CPT, is a devastating diagnosis. Impacting patients in just .5-3.5 in 150,000^[1][2][3] live births, the condition is very rare and debilitating. Treatment of CPT is difficult and once a fracture occurs, subsequent fractures are likely. Children with CPT can face impaired mobility, years of corrective surgeries to try to repair and stabilize the bone, it is not uncommon for patients to ultimately undergo amputation of the limb.

Novadip is developing NVD-003, an autologous therapy derived from adipose stem cells as a potential single treatment to save limbs and restore mobility in patients with congenital pseudoarthrosis of the tibia (CPT) and other rare pediatric bone disorders.

About NVD-X3 for Spinal Fusion and Bone Non-Union Applications

The risk of bone non-union following fracture is greater than 50% across all bones due to fracture severity, co-morbidities (diabetes, obesity, smoking and other conditions) and medication use^[1]. Additionally, more than 600,000 spine fusion procedures are performed annually. Together, these indications represent a peak sales opportunity for Novadip of $2.2 billion.

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 and offers superior intraoperative handling characteristics. A favorable COGS profile supports broad distribution and expanded patient access. Preclinical studies demonstrate that NVD-X3 offers superior bioactivity without the undesirable bone formation/resorption and inflammation observed with currently marketed bone engraftment products.

About Novadip Biosciences

Novadip Biosciences is a clinical stage biopharmaceutical company leveraging its proprietary tissue regeneration technology platform 3M³ to generate multiple product candidates to address tissue reconstruction for patients who have limited or no treatment options. The 3M³ platform involves use of 3-dimensional extracellular matrix and adipose-derived stem cells to deliver highly specific growth factors and miRNAs to mimic the physiology of natural healing to create a range of products that address specific challenges in tissue regeneration. Novadip's initial focus is on reconstruction of critical size bone defects. The company is also applying its 3M³ platform to develop truly novel off-the-shelf/allogeneic therapies addressing more prevalent tissue defects and miRNA/exosome products for broader indications. Visit www.novadip.com for more information.

^1. Khan T, Bone Joint J. 2013, PMID: 23908415
^2. Heikkinen ES, Acta Orthop Scand. 1999, PMID: 10429605
^3. Hefti F, J Pediatr Orthop B. 2000, PMID: 10647103

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SOURCE Novadip