Novadip Biosciences SA

1st 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 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 Logo: Media & Investors Inquiries Denis Dufrane Direct: +32 10 77 92 20 Mobile: +32 477 42 00 34 [email protected] SOURCE Novadip

Second patient scheduled for implantation with NVD-003 in June 2023 Pivotal trial is expected to begin in the second half of 2024* MONT SAINT-GUIBERT, Belgium--(BUSINESS WIRE)-- 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 patient has been implanted with its investigational tissue regeneration product, NVD-003, in its Phase 1b/2a clinical trial treating four patients with Congenital Pseudarthrosis of Tibia (CPT). Novadip is developing NVD-003, an autologous therapy derived from adipose stem cells (ASC), as a potential single treatment to save limbs and restore mobility​ in patients with CPT, a rare pediatric bone condition. The patient was treated at the Saint-Luc University Hospital in Brussels by Dr. Pierre-Louis Docquier, EU principal investigator for this study. Dr. Docquier has considerable clinical experience using ASC-based therapies generated from Novadip’s 3M3 tissue regeneration platform in clinical and compassionate use settings. "The potential for this approach to accelerate healthy bone formation, restore mobility and avoid the need for amputation in patients with CPT is tremendous,” said Professor Pierre-Louis Docquier, MD, PhD, a specialist in pediatric surgery at the University Hospital Saint-Luc in Brussels. “I think patients will benefit from this therapy as it does not require invasive iliac crest bone grafting which not only can be very painful for patients but is also associated with co-morbidities such as infection, bleeding and large scar formation.” And as already observed in previous compassionate uses in 4 children. The Phase 1b/2a trial will enroll four CPT patients between two and eight years of age in the US and EU. The primary endpoint of the study is short-term safety of NVD-003 up to 12 months following grafting surgery (GS). Secondary endpoints include evaluation of long-term safety, tibial length, bone formation, bone remodeling and bone union at 3-, 6-, 12- and 24-month time intervals following GS. “We are excited by the progress in patient recruitment and treatment to date and look forward to assessing clinical and patient outcomes at near- and longer-time intervals post implantation,” said Denis Dufrane, MD, PhD, CEO, and founder of Novadip Biosciences. “With our growing research partnerships with the clinical investigators and their peer network in the EU and US, we are confident that we will be able to identify and enroll the CPT patients we will need for our planned pivotal trial, which we expect will begin in 2024,” added Judy Ashworth, MD, Novadip Biosciences’ Chief Medical Officer. NVD-003 Provides Clinical Proof of Concept for Future Development Programs The company previously announced positive data from a Phase 1/2 clinical trial evaluating the safety and clinical activity of NVD-003 in patients with severe bone non-union (BNU) of the lower limb following trauma. The results demonstrate NVD-003’s ability to reverse severe bone deterioration and to achieve accelerated ossification, and derisk the development of the Company’s allogeneic “off-the-shelf” therapeutic, NVD-X3, to provide accelerated, durable bone union in common orthopedic conditions such as spinal fusion and non-healing fractures. Both investigational products are derived from Novadip’s 3M³ platform, a 3-dimensional, extracellular matrix that utilizes adipose-derived stem cells to deliver highly specific growth factors and miRNAs to mimic the physiology of natural tissue healing. About CPT Congenital pseudarthrosis of the tibia, or CPT, is a devastating diagnosis. Impacting patients in just .5-3.5 in 150,0001,2,3 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. 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 for more information. *A pivitol trial is typically a Phase 3 study which presents the data that the FDA uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. 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

None   Welcome to this week's (and last week's) Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  Galapagos sees 2 more C-suite members leave the island Galapagos Gilead Sciences-backed Galapagos went through a 2022 pipeline pivot without a chief scientific officer; now, it starts 2023 down two additional C-suite members. The company reported in late December that Chief Medical Officer Walid Abi-Saab, M.D., has decided to leave the company in addition to Chief Business Officer André Hoekema. Abi-Saab is staying on through May 2023 while the company finds a replacement.  The departure of Abi-Saab adds significant pressure to CEO Paul Stoeffels, who is rounding out his first year on the job, a bumpy tenure that’s been defined by new beginnings. Over the course of the year, the company essentially rebuilt its pipeline, ditching programs ranging from pulmonary fibrosis to inflammatory diseases for a suite of cell therapies sourced from acquisitions. It’s quite the change from the company that nabbed a $5 billion deal from Gilead to boost the larger pharma's inflammatory ambitions. As part of the clinical transition, Galapagos laid off more than 200 staffers.  With 2023 upon us, the company is hoping to build momentum on its newfound goals, specifically launching a differentiated CAR-T therapy every year for the next three years. Release  Moderna plucks another former Merck leader to spearhead commercial work Moderna  Almost nine months after Merck’s chief marketing officer Arpa Garay bolted to lead commercial work at Moderna, another top Merck leader is joining the Cambridge-based mRNA output. Moderna announced that Chantal Friebertshäuser would be joining to lead commercial efforts in Europe, Canada and the Middle East. She previously worked out of Merck & Co.’s Germany office as a human health senior vice president and managing director.  Friebertshäuser’s departure marks the end of a 10-year tenure at Merck & Co. that began in 2012 as a business director for primary care. She was promoted to managing director of Austria in 2015 before rising to global brand leader. Now at Moderna, her reach stretches beyond just one country’s borders.  Her arrival comes as Moderna is continuing to sell its COVID vaccine around the world, signing agreements with national governments while entering the private market in the U.S. But Moderna is also bracing to add additional products to its commercial portfolio, including an RSV vaccine slated to read out in the first quarter of 2023 and a cytomegalovirus vaccine that’s in a phase 3 study of its own. Fierce Pharma Zymeworks’ CMO heads for the exits amid management reconfiguration Zymeworks  Following “unprecedented” phase 2 results of the company’s biliary tract cancer med, zanidatamab, Zymeworks is rejigging its executive team to directly reflect its top-heavy priorities. As if its pipeline was a classroom with both honors and non-honors students, Zymeworks is splitting its management team in half, with one focusing on zanidatamab and the other focused on, well, everything else. As a part of the executive changes, chief medical officer Neil Josephson, M.D., is headed for the exits.  The changes reflect the weight that zanidatamab has on Zymeworks’ greater finances, after positive phase 2 data led Jazz Pharmaceuticals to pay $325 million to opt into rights for the drug in key markets including the U.S., Europe and Japan. Zymeworks has also handed rights of the med over to Beigene in key ex-Japan Asia markets, Australia and New Zealand. Leading up the zanidatamab wing of the organization is President and COO Neil Klompas. The head of the early-stage development arm will be newly appointed SVP of early development Jeffrey Smith.  The managerial overhaul comes after a tumultuous year for Zymeworks, which included a shareholder battle and layoffs. But CEO Kenneth Galbright has white-knuckled through the ups and downs, with the commercial promised land potentially on the horizon. Release Biogen separates R&D, seeks head of research Biogen The neurological disease biotech has decided it will separate its research and development into two distinct operations, both of which will report directly to CEO Christopher Viehbacher. As the company searches for a head of research, Priya Singhal, M.D., Biogen’s current head of global safety and regulatory sciences and interim head of R&D, will step into the new role of EVP and head of development.  Singhal joined Biogen in 2012 as VP of clinical trials and benefit-risk management before leaving in 2018 to head up R&D at Zafgen, then joined Biogen once again in 2020. Release > Texas-based Taysha Gene Therapies has appointed its chair Sean Nolan to lead as CEO following the resignation of RA Session II, who will continue to serve on the company’s board. Additionally, Sukumar (Suku) Nagendran, M.D., a director on the biotech’s board, has been appointed president and head of R&D. Release > Mohamed Zaki, M.D., Ph.D., has left his role as AbbVie’s VP and global head of oncology development to join ADC Therapeutics as its new CMO. Zaki succeeds Joseph Camardo, M.D., who is stepping down to pursue other opportunities. Release > Joseph Vittiglio has joined bluebird bio from Finch Therapeutics, stepping into the same roles of chief business and legal officer. Release > While announcing a phase 2 trial success, Renibus Therapeutics has also unveiled a double-dose of CEOs. Renibus used the readout to also reveal that Jeff Keyser, Ph.D., co-founder, president and current chief operating officer, will be joining Frank Stonebanks as co-CEO. Fierce Biotech > CRISPR Therapeutics has appointed Alex Harding, M.D., to serve as SVP and head of business development. Harding joins the gene editing company from Remix Therapeutics, and also helped start new biotechs—including Remix—when he previously worked at Atlas Venture. Release > Remix Therapeutics has tapped Agios’ Chris Bowden, M.D., to lead clinical development as chief medical officer. Before serving as Agios’ CMO and strategic adviser, Bowden has held roles at Roche’s Genentech, Bristol-Myers Squibb, Pharmacia Corp. and Janssen Pharmaceutical. Release > Zachary Roberts, M.D., Ph.D., who has previously held clinical leadership roles at Instil Bio and Kite Pharma, is joining Allogene’s team as EVP of R&D. Roberts will assume the responsibilities of Rafael Amado, M.D., who was Allogene’s EVP, head of R&D and chief medical officer for more than three years. Amado has headed to China and U.S.-based Zai Lab, where he has taken up the role of president and head of global oncology R&D. Release > Reset Pharmaceuticals is pressing restart, with a new CEO and president to kick off the new year. Innes Meldrum is taking over for Jan-Anders Karlsson, Ph.D., a founder of Reset Pharma. Meldrum most recently served as SVP and chief commercial officer for Otsuka Pharmaceuticals North America and has past work experience at Orexo and Novartis as well. Release > Pheast Therapeutics has ended its search for a permanent CEO, tapping Jacopo Leonardi to lead the oncology biotech. Since Pheast’s inception in 2020, Amira Barkal, M.D., Ph.D., principal founder and founding CEO, has led as interim CEO. Barkal will now serve as chief development officer while Leonardi takes the seat at the head of the table. The new CEO also serves as a venture adviser to Agent Capital and has held roles at Horizon Therapeutics, Baxalta, Baxter Healthcare, Eli Lilly and Johnson & Johnson. Release > Oncopeptides has appointed Monica Shaw to helm the Swedish biotech as CEO. She replaces Jakob Lindberg, who has been in charge since November 2021 and will assume his previous position as chief scientific officer. Before Oncopeptides, Shaw held leadership roles at GSK, LEO Pharma and Novartis. Release > At the top of the new year, Aerami Therapeutics welcomed Lisa Yañez as its new CEO upon Steve Thornton’s retirement. Yañez joined the company in 2022 as chief operating officer and has over 25 years of leadership experience across Merck, Genentech, GSK, United Therapeutics and Acceleron Pharma. Release > Harvard spinout Rejuvenate Bio has appointed Deborah Ascheim, M.D., to serve as the company’s first chief medical officer. Before Rejuvenate, Ascheim held the same position at StrideBio. She’s also the former president of d2a Ltd., former CMO for Capricor Therapeutics, and holds more than two decades of experience as a heart failure cardiologist and clinical trialist. Release > Otsuka Medical Devices’ ReCor Medical kicked off the New Year with the appointment of Lara Barghout as president and CEO. She’s taking the reins from Andrew Weiss, who has led ReCor since early 2013. Barghout joins ReCor from Siemens Healthineers, where she spent four years as SVP of the North American division of advanced therapies. Prior to Siemens, she was at Terumo Cardiovascular for nearly two decades. Fierce Biotech > Fulcrum Therapeutics CEO Bryan Stuart has left the clinical-stage company to pursue other opportunities. In his place steps Robert Gould, Ph.D., former president and founding CEO of Fulcrum, while the board seeks a permanent replacement. Release  > Novadip Biosciences has appointed Judy Ashworth, M.D., as chief medical officer. Ashworth is also currently SVP at Pinney Associates and the CMO for Harm Reduction Therapeutics. She will guide Novadip’s clinical programs, including an upcoming Type C meeting with the FDA regarding the next development step for NVD-003, an autologous therapy aimed to help save limbs and restore mobility​ in patients with a rare pediatric bone condition. Release > ADC biotech ImmunoGen has tapped Michael Vasconcelles, M.D., to serve as EVP of R&D and medical affairs. Most recently, Vasconcelles was senior advisor for life sciences at Frazier Healthcare Partners. He has also worked in a range of positions across Flatiron Health, Unum Therapeutics, Takeda/Millennium, Genzyme and Sanofi. Release > Venatorx Pharmaceuticals Chief Medical Officer Timothy Henkel, M.D., Ph.D., has announced his retirement from the infectious disease therapy company. Henkel had held the CMO position since 2015. Release > Marc Semigran, M.D., is joining Edgewise Therapeutics to serve as chief development officer. He most recently served as chief medical officer at Renovacor through its acquisition by Rocket Pharmaceuticals. Release > Francois Lebel, M.D., has stepped down from his spot as Spectrum Pharmaceuticals’ EVP and chief medical officer. The company’s clinical development operations is currently being led by Spectrum’s VP of clinical development Shanta Chawla. Release > Replimune Group is mixing up its leadership team, shifting Chief Commercial Officer Sushil Patel, Ph.D., to the newly created position of chief strategy officer and appointing Christopher Sarchi as chief operating officer. The incoming Sarchi brings along more than 28 years of oncology leadership experience, including head of commercial U.S. oncology at Sanofi positions at Boehringer Ingelheim, Roche’s Genentech and GSK. Release > Alentis Therapeutics has appointed Luigi Manenti, M.D., to serve as the Swiss biotech’s chief medical officer. Manenti most recently held the same position at HiFiBiO Therapeutics and has past experience at Novartis and Roche. Release > Massachusetts-based Apellis Pharmaceuticals has tapped Caroline Baumal, M.D., to serve as chief medical officer in place of current CMO Federico Grossi, M.D., Ph.D., who will remain at Apellis until Feb. 28 to help with the transition. Baumal is an ophthalmology professor at Tufts Medical Center in Boston and has been involved with research and clinical trials investigating new therapies for retinal diseases. Release > Abintus Bio, a genetic medicines biotech, has welcomed Lior Nissim, Ph.D., aboard. Nissim, who pioneered the first engineered gene circuit for precise targeting of cancer cells, will serve as Abintus’ head of synthetic biology. Release > Charm Therapeutics is expanding its team with the addition of five new leaders. Ross Pettit is joining from H3 Biomedicine and will serve as Charm’s chief operating officer, while Sarah Skerratt is joining from Merck Sharp & Dohme to take up the position as SVP and head of drug discovery. Daniel Rohle, joining from Biology at Ridgeline Discovery, will become VP and head of cancer biology, while Andrew Doré, who previously worked at Sosei Heptares, will serve as VP and head of structural sciences. Sergey Bartunov will serve as Charm’s director of AI, and joins after working on projects for Alphabet’s Deep Mind and being involved with several AI-driven startups. Release > BrainStorm Cell Therapeutics has promoted Stacy Lindborg, Ph.D., from her position as EVP and chief development officer to co-CEO. She will work alongside Chaim Lebovits, who will maintain his position as president and CEO. Before joining BrainStorm in 2020, Lindborg held senior leadership roles at Eli Lilly and Biogen. Additionally, Ralph Kern, M.D., is set to retire from his current role as president and chief medical officer. Release > Biotech innovation company Aditxt has formed a U.S.-based subsidiary called Adimune that will be helmed by Joachim-Friedrich Kapp, M.D., Ph.D. Kapp is the former president of the Therapeutics Business Unit at multinational pharmaceutical company Schering AG. Release > Eterna Therapeutics has tapped Matt Angel, Ph.D., to lead as CEO and president. Angel has served as the company’s interim CEO since May 2022 and also serves as Factor Bioscience’s co-founder, chair and CEO as well as co-founder and scientific advisory board chair for Exacis Biotherapeutics. Release > CRO Emmes has tapped Matt Honan to fill its newly created position of VP and global head of corporate development. Prior to Emmes, Honan most recently served as senior director of M&A and business development at Quest Diagnostics. Release