Fractures, Ununited

MAX BioPharma is Pursuing Strategic Partnerships and Series A Financing LOS ANGELES, Oct. 24, 2024 /PRNewswire/ -- MAX BioPharma, Inc. ( ) recently published an article demonstrating the anti-atherosclerotic, anti-inflammatory, and cholesterol-lowering effects of its orally bioavailable oxysterol lead compound, Oxy210, in the peer-reviewed journal, Cells. Oxy210 is derived from the Company's Oxysterol Therapeutics® platform of proprietary small molecule oxysterols that has enabled discovery of diverse oxysterol-based drug candidates in different therapeutic areas, such as bone regeneration, viral and bacterial infection, cancer, pathologic fibrosis, and chronic inflammation. Oxy210 displays unique mechanisms of action that mediate its anti-inflammatory and anti-fibrotic effects based on multipronged targeting of not just one, but multiple cellular signaling pathways. When dysregulated, these vital signals are known to drive the progression of complex diseases such as metabolic dysfunction-associated steatohepatitis (MASH) and its comorbidity, atherosclerosis, which is the leading cause of death in people with MASH. Continue Reading During previous research conducted at the David Geffen School of Medicine at the University of California, Los Angeles and directed by Principal Investigator Dr. Jake Lusis, Professor of Medicine, and Dr. Simon Hui, Project Scientist, Oxy210 was found to significantly inhibit the development of fibrosis in a humanized mouse model of MASH that involves progressive inflammation, fat deposition, and fibrosis in the livers of these mice. The inhibition of fibrosis by Oxy210 was associated with reduced hepatic lipid deposition and the inhibited expression of pro-fibrotic and pro-inflammatory factors including transforming growth factor beta (TGF-β), NLRP3 inflammasome, interleukin-6 (IL-6), tumor necrosis alpha (TNF-α), interleukin-1 beta (IL-1β) and monocyte chemotactic protein 1 (MCP-1). Moreover, Oxy210 inhibited adipose tissue inflammation, suggesting its anti-inflammatory potential that reaches beyond the liver. In their recently published article, the investigators report on significant inhibition of atherosclerosis, a chronic inflammatory disease, in addition to parallel inhibition of MASH. Treatment with Oxy210 was associated with lowering circulating cholesterol levels and reducing macrophage proliferation and content in the artery wall. Together with the in vitro findings of the anti-inflammatory effects of Oxy210 in aortic endothelial cells and macrophages, it appears that Oxy210 could be a promising drug candidate for targeting MASH, atherosclerosis, and perhaps other chronic inflammatory diseases associated with metabolic dysfunction. An anti-inflammatory, anti-fibrotic, cholesterol-lowering oxysterol drug candidate targeting MASH and atherosclerosis Post this "There is an urgent need for therapies to treat fatty liver disease and its more advanced form, MASH, and I find the results of our studies with MAX BioPharma quite exciting" states Dr. Lusis. "Our humanized hyperlipidemic mouse model of MASH reflects the natural history of metabolic dysfunction-associated steatotic liver disease (MASLD) progression in humans and reproduces the salient features of human MASH. Attenuation of hepatic fibrosis and inflammation, as well as anti-atherosclerotic effects suggest that Oxy210 should be further explored as a therapeutic candidate for targeting both conditions " explains Dr. Hui." Dr. Frank Stappenbeck, Director of Chemistry at MAX BioPharma, comments: "Oxysterol-based molecules have been our treasure-trove, driving the Company's drug discovery efforts across several therapeutic indications", adding that "Surprisingly, Oxy210 acts a bit like a Swiss-army knife by combining anti-inflammatory, anti-fibrotic, and lipid-lowering effects, a rare combination of helpful properties". Additional pre-clinical studies required by the FDA for clinical development of Oxy210 are currently underway at MAX BioPharma and the Company is seeking strategic partnerships with biotechnology and pharmaceutical companies with the expertise and resources to further the development of oxysterol-based molecules towards FDA approval and commercialization. In addition, MAX BioPharma is in the process of raising a series A tranche financing round to support the advancement of its therapeutic development programs. "We are very excited and hopeful that our efforts will result in an effective and safe therapy for MASH, a condition with currently only one FDA-approved treatment, indicated for non-cirrhotic MASH and apparently effective in less than 30% of patients. Nevertheless, with dozens of failed clinical drug candidate in this field, this first ever FDA-approved drug reintroduced some degree of hope for people suffering with this condition, once considered untreatable" says Dr. Farhad Parhami, Founder, President and CEO of MAX BioPharma, adding "we hope to continue the advancement of MASH therapeutics with our novel drug candidate". About MAX BioPharma, Inc. MAX BioPharma is a privately held preclinical stage California-based biopharmaceutical company developing novel small molecule lipids as drug candidates for intervention in debilitating and fatal human diseases. The company will be a leader in a new field of Oxysterol Therapeutics® by leveraging a robust and growing intellectual property portfolio that will lead to treatments for numerous indications. MAX BioPharma's first success based on small molecule lipids has contributed to the discovery of novel osteogenic oxysterol compounds that target multipotent mesenchymal cells, including mesenchymal stem cells, to induce the formation of bone-forming osteoblasts and bone. The company is translating this technology into the next generation of therapeutic agents for stimulation of bone formation, locally and systemically, in indications such as spinal fusion, non-union fractures, and osteoporosis. MAX BioPharma is also pursuing the development of small molecule oxysterols that function as anti-tumorigenic Hedgehog and TGF-b pathway antagonists that will be more effective than currently known antagonists in treating a variety of cancers, including lung and pancreatic cancer, and hematologic malignancies, as well as fibrotic diseases of liver, lung, and kidney among others. For more information, please visit us at Media Contact: Farhad Parhami [email protected] SOURCE MAX BioPharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

At six months post-grafting surgery with NVDX3, x-rays demonstrate that 90% of patients have reached, or are steadily progressing towards, complete bone healing Derived from Novadip’s 3M 3 stem cell platform, NVDX3, a unique ‘off-the-shelf allogeneic matrix product to cure common but challenging orthopedic conditions, has potential to replace existing allogeneic bone substitutes to heal fractures MONT SAINT-GUIBERT, Belgium I October 17, 2024 I Novadip Biosciences, a clinical stage biotechnology company specializing in regenerative medicine, today announces positive interim results from its first-in-human clinical trial, NVDX3-CLN01, assessing the safety and efficacy of NVDX3 to heal distal radius fractures in adults. Originating from Novadip’s 3M 3 platform, NVDX3 is an allogeneic bone grafting material created from human osteogenic adipose tissue-derived mesenchymal stem cells (ASCs). It is formulated as a lyophilized powder intended to be used as an ‘off-the-shelf’ implant to induce bone formation between two bone segments in both orthotopic and heterotopic environments. NVDX3 is a new class of regenerative tissue products that accelerates bone healing in a single treatment for patients at high risk of nonunion due to co-morbidities (ageing, diabetes, obesity, smoking and other conditions) and medication use. NVDX3-CLN01 (NCT05987033) is a single-arm, open-label clinical trial designed to assess the safety and preliminary efficacy of NVDX3 in adults with distal radius fractures, involving the wrist joint with multiple bone fragments. Ten participants, aged 28 to 84 years old, were treated. Radiologically, 90% of patients have achieved, or are on-track to achieve, complete bone healing. All but one are progressing as expected clinically. There is no apparent impact of age or sex on the efficacy of NVDX3, despite the complexity of fractures treated. There have also been no safety concerns arising from this study. “The interim results of this first clinical trial mirror the safety and efficacy of NVDX3 demonstrated in our nonclinical program. NVDX3 is the first and only bone graft product following a Biologics License Application (BLA) pathway.Based on these preliminary data, NVDX3 has the potential to address the high unmet needs of patients with bone defects who, due to co-morbidity factors, experience delayed bone formation or nonunion,” said Denis Dufrane, MD, PhD, CEO of Novadip Biosciences. “We will share the results of this trauma study with the US FDA as part of our IND submission to support the further clinical development of NVDX3 as we explore its potential for the treatment of complex cervical spine fusion.” “We need more options to improve outcomes in bone healing, particularly for patients with co-morbidities like advanced age, diabetes and smoking,” said Philipp Leucht, MD, PhD, Vice Chair of Research, Department of Orthopedic Surgery at NYU Grossman School of Medicine. “These interim results suggest that NVDX3 may have the potential to address this unmet need.” The 12-month results of NVDX3-CLN01 are expected at the end of 2024. In parallel to NVDX3-CLN01, Novadip is investigating the safety and preliminary efficacy of NVDX3 as a bone graft to achieve spine fusion in the lumbar spine in trial NVDX3-CL02 (NCT05961956). One-year results from this trial are expected in March 2025. In addition to its allogeneic program with NVDX3, the clinical development of the company’s lead autologous program, NVD003, will soon be entering phase 3 for the treatment of congenital pseudarthrosis of the tibia, a rare pediatric disease that often leads to amputation. Planning for a pivotal phase 3 trial and BLA submission is underway. About Novadip’s 3M 3 platform The 3M 3 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 bone grafting procedures and solid tumors. The platform consists of a 3-dimensional, scaffold-free, extracellular matrix (ECM) utilizing differentiated adipose-derived stem cells (ASCs), to generate highly specific growth factors and miRNAs to restore the physiology of natural healing. The components of the 3M 3 include a matrix with ASCs to deliver growth factors/miRNA, the mature implant mimicking the physiology of natural healing. About Novadip Biosciences Novadip is a Belgium-based clinical stage biotech company aiming at advancing the standard of care in bone and tissue regenerative medicine. Based on the scientific discoveries of founder Prof. Dr. Denis Dufrane, MD, PhD, the company is developing its unique 3M³ tissue regeneration technology platform, which has the potential to generate an array of candidates that utilize adipose-derived stem cells to mimic the physiology of natural tissue healing, and hard and soft tissue reconstruction, for patients with limited or no treatment options. Novadip is a spin-off company from the Université Catholique de Louvain (UCLouvain) and St. Luc University Hospital. www.novadip.com SOURCE: Novadip Biosciences

KING OF PRUSSIA, Pa.--( BUSINESS WIRE )-- Camber Spine , a leading innovator in spine and medical technologies, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SPIRA-A Integrated technology. Part of the SPIRA product platform, the SPIRA-A Integrated Fixation System is an anterior lumbar interbody fusion device that has an open matrix design to permit packing with autogenous and/or allogenous graft material to facilitate fusion, as well as additional fixation options to secure the implant in the disc space. “The FDA’s 510(k) clearance of our SPIRA-A Integrated technology ushers in the next evolution in our innovative SPIRA platform and marks another major step forward in our company’s development,” said Camber Spine CEO Brooks McAdam. “It also helps bring more innovation-based solutions and options to the surgical community and a solution for surgeons engaging or wanting to engage in the ALIF market. We believe SPIRA Technology, which encompasses the structure, surface, and science behind our 3D-printing process, is the archetypal design for modern spine implants and exemplifies the true benefits of additive manufacturing.” SPIRA-A Integrated offers a complete solution to the ALIF procedure, with integrated fixation deployed in a traditional ALIF cage and approach, as well as a windswept cage geometry for accessing L5-S1 with difficult vascular anatomy, and each implant offers up to 40 points of endplate contact. The superior and inferior surfaces of the SPIRA-A Integrated device have a rough surface to help prevent movement of the device while fusion takes place, and structural arches to help distribute load across the joint space. The device contains three holes to insert bone screws or anchors for integrated fixation, as well as blocking screws to prevent fixation back-out. SPIRA-A’s screws and anchors have been designed to complement the performance of the cage, increase fixation in the cortical endplate, and provide first-of-their-kind 3D-printed anchors with a SPIRA Surface, designed to increase potential for osseointegration and resist pull-out. The robust inserter attachment, multiple technique possibilities, and a wide variety of screw prep options are designed to facilitate clear visualization of, and easy access to, the surgical site once the approach is complete. The FDA’s action means that SPIRA-A Integrated is now indicated for use at one or more levels, from L1-S1 as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy) spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis and failed previous fusion (pseudarthrosis). Camber’s SPIRA implants are 3D printed. This specialized manufacturing technology allows Camber to create unique patented structures featuring open arched matrices and proprietary surfaces designed to enhance fusion and promote bone growth. All of Camber Spine’s products are developed and manufactured in the United States. Innovative spine and medical technology company Camber Spine Technologies is dedicated to creating surgeon-designed solutions in MIS and minimally disruptive access for the treatment of complex spinal pathology. Incorporating state-of-the-art manufacturing, 3-D printing, and an acute sensitivity to patient anatomy, Camber Spine is making quantum leaps in the spinal fusion market. Learn more at CamberMedtech.com .