Aegle Therapeutics Corp.

Exosomes are emerging as key tools in personalized and regenerative medicine, offering precise, targeted therapy with low immune risk. Their potential spans cancer, chronic disease, and regenerative applications, driven by biopharma's investment in biologics and gene therapies. Stem cell-derived exosomes further enhance tissue repair and immune modulation, positioning exosomes as transformative in next-gen therapeutics. LAS VEGAS, Nov. 4, 2024 /PRNewswire/ -- DelveInsight's ' Exosomes Pipeline Insight 2024 ' report provides comprehensive global coverage of available, marketed, and pipeline exosomes-based therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the exosomes-based therapies pipeline domain. Key Takeaways from the Exosomes-based Therapies Pipeline Report DelveInsight's exosomes pipeline report depicts a robust space with 70+ active players working to develop 80+ pipeline therapies for various indications. Key exosomes-based therapies companies such as Capricor Therapeutics, Regeneus, Aegle Therapeutics, Innovex Therapeutics, Coya Therapeutics, EV Therapeutics, StemXO Therapeutics, Brexogen, ILIAS Biologics, Organicell Regenerative Medicine, Codiak BioSciences, Direct Biologics, Exostemtech, Brexogen, OmniSpirant, ShiftBio Inc., and others are evaluating new exosomes-based therapies to improve the treatment landscape. Promising exosomes-based therapies in the pipeline in various stages of development include CAP-1002, Progenza, AGLE 102, ExoCoVac, COYA 201, EV-101, StemXO Endosome Therapy, BRE AD01, ILB 202, Zofin, exoSTING, ExoFlo, CARTISOME, BRE MI01, OS006, SBI-407, and others. In July 2024, Aruna Bio announced the issuance of a US Patent for the composition of matter for neural exosomes used to deliver therapeutics to the brain. The company is on a rack to initiate Phase Ib/IIa clinical trial of AB126 in acute ischemic stroke in the second half of 2024. In July 2024, ILIAS Biologics announced that it had received the final clinical study report (CSR) for ILB-202, a Phase I clinical trial completed in Australia in November last year. In April 2024, Biological Dynamics joined the growing list of customers adopting the ExoVerita Pro instrument, a cost-efficient, automated exosomal enrichment platform. In April 2024, EXO Biologics secures up to EUR 16 million in Series A funding for exosome therapeutic development and clinical supply. In April 2024, ExoXpert entered a strategic partnership with Neucore Bio to leverage ExoXpert's platform for the evaluation of advanced exosome loading. In April 2024, INOVIQ and Promega signed a global supply and distribution agreement for EXO-NET. Last year's company entered into a Co-Marketing agreement. In March 2024, VivaZome Therapeutics and La Trobe University collaborated to explore the therapeutic potential of extracellular vesicles in models of stroke in the laboratory of Professor Chris Sobey. In January 2024, Aegle Therapeutics announced positive 12-week data for the first patient enrolled in Phase I/IIa clinical trial of AGLE-102 for the treatment of severe second-degree burns. Request a sample and discover the recent advances in exosomes-based therapies @ Exosomes Pipeline Outlook The exosomes-based therapies pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage exosomes-based therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the exosomes-based therapies pipeline landscape. Exosomes Overview Exosomes are small extracellular vesicles, typically ranging from 30 to 150 nanometers in diameter, that are secreted by various cell types. They play a crucial role in intercellular communication by facilitating the transfer of proteins, lipids, and RNA between cells. This process can influence various physiological and pathological conditions, including immune responses, cancer progression, and neurodegenerative diseases. By carrying bioactive molecules, exosomes can modulate the behavior of recipient cells, contributing to processes such as tissue repair, immune regulation, and the spread of cancer cells. Their ability to transport molecular cargo makes them a subject of extensive research, particularly in the context of disease mechanisms and therapeutic applications. In recent years, exosomes have garnered significant interest in the field of biomedicine as potential biomarkers for disease diagnosis and as vehicles for targeted drug delivery. Researchers are exploring their use in therapeutic strategies, such as the delivery of RNA-based therapies and proteins, due to their natural ability to evade the immune system and penetrate cellular membranes. Additionally, exosomes derived from stem cells or engineered for specific therapeutic purposes hold promise for regenerative medicine, offering a novel approach to enhance tissue regeneration and repair. The ongoing investigation into the biology of exosomes continues to reveal their multifaceted roles in health and disease, paving the way for innovative applications in diagnostics and therapeutics. Find out more about exosomes-based therapies @ Exosomes-based Therapies in Development A snapshot of the Exosomes-based Therapies Pipeline Drugs mentioned in the report: Learn more about the emerging Exosomes-based therapies @ Exosomes-based Therapies Clinical Trials Exosomes-based Therapies Therapeutics Assessment The exosome-based therapies pipeline report proffers an integral view of the emerging exosome-based therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Exosomes-based Therapies Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Cell replacements, Inflammation mediator modulators, Collagen type VII replacements, Immunosuppressants, NF-kappa B inhibitor Key Exosomes-based Therapies Companies: Capricor Therapeutics, Regeneus, Aegle Therapeutics, Innovex Therapeutics, Coya Therapeutics, EV Therapeutics, StemXO Therapeutics, Brexogen, ILIAS Biologics, Organicell Regenerative Medicine, Codiak BioSciences, Direct Biologics, Exostemtech, Brexogen, OmniSpirant, ShiftBio Inc., and others. Key Exosomes-based Therapies in Pipeline: CAP-1002, Progenza, AGLE 102, ExoCoVac, COYA 201, EV-101, StemXO Endosome Therapy, BRE AD01, ILB 202, Zofin, exoSTING, ExoFlo, CARTISOME, BRE MI01, OS006, SBI-407, and others. Dive deep into rich insights for exosomes-based therapies assessment, visit @ Exosomes-based Therapies Therapeutics Assessment Table of Contents For further information on the exosomes-based therapies pipeline therapeutics, reach out @ Exosomes-based Therapies Pipeline Landscape Related Reports Exosome Therapies Market Exosome Therapies Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key exosome therapies companies, including Direct Biologics, Capricor Therapeutics, Aegle Therapeutics, Vitti Labs, Rion, Aruna Bio, EXO Biologics, EV Therapeutics, ReNeuron, Coya Therapeutics, Evox Therapeutics , among others. 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Duchenne Muscular Dystrophy Pipeline Duchenne Muscular Dystrophy Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Duchenne muscular dystrophy companies, including Santhera Pharmaceuticals, Sarepta Therapeutics, Italfarmaco, Wave Life Sciences Ltd, FibroGen, Edgewise Therapeutics, Pfizer, Daiichi Sankyo, Sarepta Therapeutics, Inc., ENCell, Taiho Pharmaceutical, Solid Biosciences, Capricor, Nippon Shinyaku, Hansa Biopharma, Ultragenyx Pharmaceutical, Dyne Therapeutics, Entrada Therapeutics, AAVogen, PepGen, Antisense Therapeutics, BioMarin Pharmaceutical, Avidity Biosciences, Sarepta Therapeutics, Dyne Therapeutics, Solid Biosciences Inc, Regenxbio, Stealth BioTherapeutics, among others. Atopic Dermatitis Market Atopic Dermatitis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key atopic dermatitis companies, including Arcutis Biotherapeutics, Amgen, Kyowa Kirin, Dermavant Sciences, Cara Therapeutics, Pfizer, Arena Pharmaceuticals, BioMimetix, Eli Lilly and Company, Aldeyra Therapeutics, Inc., Hangzhou Yirui Pharmaceutical Technology Co., Ltd, LEO Pharma, Corvus Pharmaceuticals, Inc., Brexogen Inc., Sanofi, Shaperon, UCB Pharma, Q32 Bio Inc., Akeso, Apogee Therapeutics, Inc., Allakos Inc., Biosion, Inc. , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. 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AGLE-102 is a novel extracellular vesicle therapy being developed for the treatment of rare and immuno-dermatological disorders. WOBURN, MA, USA I August 14, 2024 I Aegle Therapeutics Corp., a clinical-stage biopharmaceutical company developing novel extracellular vesicle (“EV”) therapies to address immune and inflammatory-based dermatological disorders, today announced that the first patient has been dosed in a Phase 1/2a clinical study evaluating AGLE-102™ for the treatment of the rare pediatric skin blistering disease DEB. AGLE-102 is an investigational product comprised of extracellular vesicles isolated from allogeneic stem cells using Aegle’s proprietary methods. AGLE-102 is a native composite of cell-derived nanoparticles that contain active biomolecules including proteins and nucleic acids with anti-inflammatory, immunomodulating, and tissue regenerating properties. “We are thrilled to announce the initiation of this Phase 1/2a clinical trial for DEB, a complex disease characterized by chronic blistering and excessive inflammation. Aegle is committed to advancing new therapies to address the continued unmet medical need of this patient population,” said Shelley Hartman, Aegle’s Chief Executive Officer. Evangelos Badiavas, MD, PhD, Co-Founder and Chief Scientific Officer, said “AGLE-102 is designed to mimic the body’s healing mechanism by delivering proteins, including collagen 7, and other important biomolecules such as nucleic acids that act by reducing inflammation, modulating the immune system and inducing diseased cells to make their own collagen 7. AGLE-102 offers a unique, multifaceted approach to the treatment of DEB.” The phase I/2a trial, “A Safety Study of the Administration of Mesenchymal Stem Cell Extracellular Vesicles in the Treatment of Dystrophic Epidermolysis Bullosa Wounds”, is a prospective, non-randomized, multi-center study designed to evaluate the safety and efficacy of multiple doses of AGLE-102 in the treatment of chronic lesions. More information on the study (NCT04173650) is available at clinicaltrials.gov. About AGLE-102™ AGLE-102 is a native composite of nanoparticles called extracellular vesicles that are released by allogeneic mesenchymal stem cells. These EVs carry complex assemblies of active biomolecules that can induce a wide variety of effects in recipient cells. AGLE-102 is being evaluated in two phase 1/2a studies in DEB and severe burns. Compelling clinical results have been previously reported in burns ( https://www.prnewswire.aegle-therapeutics-302027568.html ). AGLE-102 is also in a preclinical program for GvHD. About Aegle Therapeutics Corp. Aegle Therapeutics is a clinical-stage biopharmaceutical company developing novel extracellular vesicle therapies for the treatment of immune and inflammatory-based dermatological disorders. For more information visit www.aegletherapeutics.com . SOURCE: Aegle Therapeutics

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