Aegle Therapeutics Corp.

DUBLIN, March 29, 2024 /PRNewswire/ -- The "Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) - Advances & Applications, 2023" report has been added to ResearchAndMarkets.com's offering. MSCs appear to be an exceptionally promising tool for cell therapy, because of their unusual advantages, which include availability, expandability, transplantability, and ethical implications. Interest in therapeutic applications of human MSCs arises from their diverse ability to impact human health, as well as their ability to migrate to sites of tissue injury/inflammation or tumor growth. MSCs are essential raw materials for many regenerative medicine products, including cell-based therapies, engineered tissues, exosome products, cosmeceuticals, and cultured meat production. MSCs are also well-suited for use in the exponential growth field of 3D printing and numerous companies are working on manufacturing technologies to support the commercial-scale production of MSCs. Today, numerous market competitors are also exploring commercialization strategies for MSC-derived extracellular vesicles (EVs) and exosomes, because these extracellular "packages" represent a novel strategy for accessing the therapeutic effects of MSCs without the risks of administering whole cells to patients. Gene editing of MSCs for overexpressing antitumor genes or therapeutic factors is broadening their application as well. Despite the challenges associated with commercializing MSC-based therapeutics, there are more than 100,000 scientific publications published about MSCs and over 1,100 MSC-based clinical trials underway worldwide. Clinical trials involving MSC therapeutics have risen in recent years, in part due to trials related to COVID-19. Current "hotspots" for MSC clinical trials include the U.S., E.U., China, Middle East, and South Korea. While many early-stage MSC trials have demonstrated safety and efficacy, only a small number of MSC products have reached commercialization, indicating that the therapeutic market for MSCs remains early-stage. The first MSC-based cell therapy product was approved in 2010 in South Korea. To date, ten MSC-based cell therapy products have gained approval, as well as 19 MSC-based bone matrices. While therapeutic success has been challenging, the demand for MSC-based research products has surged in recent years, with most large research product suppliers now offering a variety of MSC-based products, services, kits, and manufacturing tools. Major players involved in the market for MSC-based research products include Lonza, Thermo Fisher Scientific, Sigma Aldrich, VWR, Sartorius, ATCC, EMD Millipore, and others. Smaller and mid-sized players are also competing in this promising market, including but not limited to Axol Bioscience, StemBioSys, PromoCell, and iXCell Biotechnologies. To date, the company to establish itself with the greatest domain knowledge in the area of MSC-based products and manufacturing technologies is RoosterBio, headquartered in Frederick, Maryland, USA. Cynata Therapeutics is also working diligently on technologies to enable large-scale production of MSC-based therapeutics, although it is exclusively focused on MSC-based therapeutics and is using its CymerusT platform technology to produce nearly infinite numbers of iPSC-derived MSCs. It is concurrently pursuing several clinical trials worldwide. In the coming years, an increasing number of research products and therapeutic products will continue to be developed around MSCs and their differentiated cell types. Within this rapidly changing landscape, having a thorough understanding of the competition is essential. Therefore, this global strategic report details the activities of 113 leading MSC companies, including their core technologies and products under development. It presents detailed market size figures for the global MSC market, segmented by Geography and Business Segment, and accompanied by future forecasts through 2030. This global strategic report includes: Market size determination for the global MSC market, segmented by Geography and Business Segment Future forecasts for the Global MSC Market through 2030 Major diseases addressed by MSCs in the ongoing clinical trials Cost of manufacturing autologous and allogeneic MSCs Rates, quantities, geographic locations, and types of MSC clinical trials Types and sources of MSC industry funding Detailed MSC patent analysis, including rates and geographic breakdown of MSC patents The top owners, inventors, and sponsors of MSC patents Recent business developments related to MSCs, including strategic collaborations and partnerships MSC-based products with marketing approval and the companies commercializing them Currently marketed MSC-based bone matrices Pricing comparison of MSC-based products with marketing approval The pipeline for MSC-based therapeutics Emerging applications for MSCs, including genetic modification, 3D bioprinting, clean meat production, and cosmeceuticals Company profiles for MSC market competitors, including their products, services, and technologies under development Dozens of charts, figures, and tables And so much more In summary, this global strategic report presents market size figures with forecasts through 2030, as well as rates of MSC clinical trials, scientific publications, patents, funding events, and strategic collaborations. It also presents the pipeline for MSC-based therapeutics, identifies leading market competitors, and explores future directions for the industry at large. With the competitive nature of this global market, you don't have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities. Key Topics Covered: 1. REPORT OVERVIEW 2. MESENCHYMAL STEM CELLS (MSCS): AN OVERVIEW 3. PUBLISHED SCIENTIFIC PAPERS ON MSCS 4. STEM CELLS PATENT LANDSCAPE: AN OVERVIEW 4.1 Geographical Distribution of Stem Cell Patent Filing 4.2 MSC Patents 5. MSCS: CLINICAL TRIAL LANDSCAPE 5.1 Analysis of Data from ClinicalTrials.gov 5.2 Administration of MSCs in Clinical Trials 5.3 MSC Clinical Trials by Disease Category 6. BIOENGINEERING SOLUTIONS TO BOOST MSC'S FUNCTIONS 6.1 Small-Molecule Priming 6.2 Particle Engineering 6.3 Genetic Engineering 6.4 Bioengineering Approaches to Improve MSC Administration 7. MANUFACTURING OF MSCS 7.1 Autologous and Allogeneic MSCs 7.2 Methods of Isolation of MSCs 7.3 Cell Expansion: Conventional Cultures to Bioreactors 7.4 Bioreactors in Current Use 7.5 Main Features of Commercial Bioreactors 7.6 Number of Cells per Batch by Technologies 7.7 Microcarriers for the Expansion of MSCs 7.8 Downstream Processing of MSCs 7.9 Autologous & Allogeneic MSC Manufacturing: A Comparison 7.10 Cost Breakdown in MSC Manufacturing 8. SMALL SCALE PROCESSING OF MSCS 8.1 Model Design 8.2 Culture Media 9. LARGE-SCALE MANUFACTURING OF MSCS 9.1 The Four Common Bioprocessing Strategies for Large-Scale Expansion of MSCs 9.2 Commonly Used Sources of MSCs for Large-Scale Expansion 9.3 Commonly used Culture Media for Large-Scale Expansion of MSCs 9.3.1 Expansion Ratios Achieved with Different Culture Media 9.4 Comparison between the Four Large-Scale MSC Expansion Strategies 10. CONTRACT MANUFACTURING FOR CELL & GENE THERAPIES 10.1 The Need for Staff with Expertise 10.2 Capacity Constraints 10.3 CDMO Platforms Showing Greatest Growth Potential 10.4 Outsourcing Trends for Cell & Gene Therapies (CGT) 10.5 CMOs/CDMOs 10.6 Global Bioprocessing Capacity 10.7 Top Global CDMOs in 2022 10.8 U.K.'s Domination in European Cell & Gene Therapy Contract Manufacturing 11. MAJOR DISEASES ADDRESSED BY MSCS 12. CURRENT STATUS OF MESENCHYMAL STEM CELL INDUSTRY 12.1 Brief Account of Modified MSCs 12.2 MSC-Based Products with Marketing Approval 12.3 Currently Marketed MSC-Based Bone Matrices 13. RECENT COLLABORATIONS IN MSC SECTOR 14. MARKET ANALYSIS 14.1 Price Tags of MSC-Based CT Treatment 14.2 Price Tags of MSC-Based Matrices 14.3 Market Size of MSC-Based Therapies 14.4 Global Market for MSC-Based Therapeutics 14.5 Global Demand for Mesenchymal Stem Cells (MSCs) 15. COMPANY PROFILES 101 Bio AGC Biologics AMS Biotechnology AQ Skin Solutions AbbVie Abzena Adipomics Advancells Advent Bio Aegle Therapeutics Aethlon Medical AgeX Therapeutics AlloSource Ambulero American CryoStem Corporation American Type Culture Collection (ATCC) Andelyn Biosciences Anemocyte Anterogen Arranta Bio Aruna Bio Avid Bioservices Bacthera Baylx, Inc. Bio-Techne BioCardia BioCentriq BioEden, Inc. BioRestorative Therapies Bioinova Bioscience Institute Blue Horizon International Boehringer Ingelheim BioXcellence Bonus Biogroup, Ltd. BrainStorm Cell Therapeutics CCRM CardioCell, LLC Caregen Nordic Catalent Pharma Solutions CellResearch Cellipont Bioservices Celltex Therapeutics Cellular Biomedicine Group Celprogen, Inc. Charles River Laboratories International, Inc. Citius Pharmaceuticals, Inc. Corestem, Inc. Creative Bioarray Cynata Therapeutics, Ltd. Cytovance Biologics Dendreon Direct Biologics EXOSOMEplus ElevateBio Exothera FUJIFILM Cellular Dynamics Fujifilm Diosynth Biotechnologies Future Cell Japan Co., Ltd. Genezen Hope Biosciences Invitrx Therapeutics JCR Pharmaceuticals Just-Evotec Biologics Kimera Labs LifeCell Longeveron Lonza Group, Ltd. Lorem Cytori USA, Inc. Lykan Bioscience Matica Biotechnology, Inc. Medipost, Co., Ltd. Mesoblast, Ltd. MilliporeSigma NecstGen Novus Biologicals NuVasive Orthofix Medical Personal Cell Sciences Personalized Stem Cells Pluristem Therapeutics Porton Advanced PromoCell Regeneus Reliance Life Sciences Rentschler Biopharma Resilience Richter-HELM RoosterBio, Inc. RoslinCT STEMCELL Technologies, Inc. Samsung Biologics Sentien Biotechnologies, Inc. Smith & Nephew plc Stemedica Cell Technologies, Inc. Stemmatters Stempeutics Research Pvt. Ltd. Symbiosis Pharmaceutical Syngene International Ltd. TaiwanBio Therapeutics Takeda Pharmaceutical Tempo Bioscience Thermo Fisher Scientific TranstoxBio VIVEbiotech Viralgen Waisman Biomanufacturing WuXi Biologics Yapan Bio Yposkesi Zimmer Biomet Holdings For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

TORONTO and HAIFA, Israel, March 01, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, is pleased to announce that Dr. Ina Sarel, the Head of CMC, Quality and Regulatory Affairs at NurExone, will be leading a workshop at the upcoming Exosome Characterization & Analytical Development Summit. Dr. Sarel will be sharing with her expert colleagues insight and information on the topic of "Regulatory Challenges in the Development of an Extracellular Vesicles (EVs) - Based Clinical Product." Dr. Sarel joins a prestigious lineup of speakers including representatives from leading exosome companies, e.g. AbbVie, RION Therapeutics, Aegle Therapeutics and universities, e.g. Harvard Medical school. With her experience in regulatory affairs and her deep understanding of the exosome field, Dr. Sarel is well-positioned to provide perspective on how to navigate the complex regulatory landscape and ensure the successful development of exosome-based therapeutics. Dr. Sarel who led the activities that resulted in the grant of Orphan Drug Designation for ExoPTEN, an exosome-therapy being developed by the Company, stated “NurExone is developing a platform for using exosomes to create wide range of nanodrugs including our first drug - ExoPTEN, for treating patients with acute spinal cord injury. We are proud to share our development outcomes together with our regulatory expertise and are committed to advancing the field of exosome therapeutics for clinical use.” The Exosome Characterization & Analytical Development Summit is a premier event that brings together experts from academia and industry to discuss the latest advancements in exosome characterization and analytical development. The summit will take place on April 23-25, 2024 in Boston, MA. To learn more about the summit and to register, please visit the Conference Website. About NurExone Biologic Inc. NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation bythe FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications. For additional information, please visit or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube. For more information, please contact: Dr. Lior Shaltiel Chief Executive Officer and Director Phone: +972-52-4803034 Email: info@nurexone.com Thesis Capital Inc. Investment Relation - Canada Phone: +1 905-347-5569 Email: IR@nurexone.com Dr. Eva Reuter Investment Relation - Germany Phone: +49-69-1532-5857 Email: e.reuter@dr-reuter.eu FORWARD-LOOKING STATEMENTS This press release contains certain forward-looking statements, including statements about the Company's future plans and intellectual property, the scientific and development and commercial activities to be carried out by the company, the efficient loading of exosomes, future potential manufacturing, clinical, licensing and marketing activities and the treatment of certain conditions. Wherever possible, words such as "may", "will", "should", "could", "expect", "plan", "intend", "anticipate", "believe", "estimate", "predict" or "potential" or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof. Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. Certain assumptions include the ability of the Company to commercialize its intellectual property internally and through licensing and that the Company has the appropriate team in order to realize commercialization. Risks and uncertainties include, but are not limited to, risks related to the Company's early stage of development, lack of revenues to date, government regulation, market acceptance for its products, rapid technological change, dependence on key personnel, protection of the Company's intellectual property and dependence on the Company's strategic partners. These factors should be considered carefully and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

[08-January-2024] First patient treated with AGLE-102 demonstrated 99% epithelialization in a deep second-degree burn within 7 days of receiving a single dose No evidence of burn wound conversion nor ischemia reperfusion injury as evidenced clinically and by laser doppler studies WOBURN, Mass. and MIAMI, Jan. 8, 2024 /PRNewswire/ -- Aegle Therapeutics Corp., a leader in the development of novel extracellular vesicle ("EV") therapies to treat rare and severe dermatological, including immuno-dermatological, conditions, today announced positive 12-week data for the first patient enrolled in a Phase 1/2a clinical trial of AGLE-102™ for the treatment of severe second-degree burns. The first patient was treated with a single topical dose of AGLE-102 within 48 hours of burn injury. The patient achieved 99% epithelialization of the burn wound and had a significant reduction in edema within seven days of treatment. Subsequent doses of AGLE-102 were not required. The patient had no evidence of ischemia reperfusion injury, as measured by Laser Doppler, one week post treatment, and no evidence of burn conversion was noted. Patient and Observer Scar Assessment Scale (POSAS) measurements showed significant improvement seven days post treatment and continued to improve over 12 weeks of follow-up. By day 90, the patient's POSAS score (which measures pain, itch, thickness, stiffness, color and irregularity) improved from a score of 40 at baseline to a score of 10 (6 being normal). No safety issues were reported. "We are very pleased with the first patient's results in this first-in-human trial of AGLE-102," said Shelley Hartman, Aegle's Chief Executive Officer. "This milestone highlights our commitment to advancing EV therapy as an important, novel, multi-faceted approach to treating rare and severe dermatological conditions." About AGLE-102TM AGLE-102 is an investigational product comprised of extracellular vesicles isolated from allogeneic stem cells using Aegle's proprietary and patented methods. The product is a composite of native EVs and their associated complex assemblies of biologic molecules such as proteins, peptides, ligands and nucleic acids that have the potential to induce a wide variety of effects in recipient cells, including reducing inflammation, modulating the immune system and promoting regenerative healing. About the Phase 1/2a Clinical Trial The phase I/2a trial, "A Pilot Safety Study of Mesenchymal Stem Cell Derived Extracellular Vesicles for the Treatment of Burn Wounds," is a prospective, single arm multi-center study designed to evaluate the safety and efficacy of applying AGLE-102 to deep second-degree burns. The program is being advanced for the discovery and development of allogeneic stem cell derived extracellular vesicle therapy that has the potential to offer patients reduced inflammation, accelerated regenerative healing (with minimal/no scarring) and prevention of burn conversion. More information on the phase 1/2a study (NCT05078385) is available at clinicaltrials.gov. About Aegle Therapeutics Corp. Aegle Therapeutics is a clinical-stage regenerative medicine biotechnology company developing novel EV therapies to treat rare and serious dermatological, including immuno-dermatological, disorders with significant unmet medical need. Aegle's proprietary platform technology safely isolates a broad composite of native EVs from stem cells. In addition to its phase 1/2a study in severe second-degree burns, Aegle's pipeline includes an anticipated launch of a phase 1/2a study in Q1 2024 evaluating AGLE-102 for the treatment of the rare disease epidermolysis bullosa and a preclinical program for graft vs. host disease. Aegle's EV therapy has the potential to treat a broad range of indications in multiple therapeutic areas in dermatology including inflammatory disorders, immune-based conditions and others. The anti-inflammatory and immune modulatory effects of Aegle's EV therapy also hold significant promise in the treatment of numerous other disorders in therapeutic areas outside of dermatology. For more information about Aegle Therapeutics, please visit . For More Information Contact: info@aegletherapeutics.com