Taiwan Bio Therapeutics Co., Ltd.

TAIPEI, Taiwan & CHICAGO--( BUSINESS WIRE )--Taiwan Bio Therapeutics, Inc. and TRACT Therapeutics, Inc. are pleased to announce the successful transfer of TRACT Therapeutics’ innovative regulatory T cell (TregCel TM ) platform technology to Taiwan Bio’s state-of-the-art GMP cell manufacturing facility. This critical milestone is a significant step forward as the companies prepare for the initiation of a global Phase 2 clinical trial in living donor kidney transplant patients and is an exciting development for SOT patients seeking new therapeutic options to improve their quality of life. Cyrus Yang, CEO of Taiwan Bio Therapeutics, stated, “We are extremely excited about the successful transfer of TRACT Therapeutics’ Treg cellular product to our facility. This achievement underscores our commitment to advancing cutting-edge cellular therapies and highlights our capabilities in high-quality cell therapy manufacturing. We look forward to supporting the upcoming Phase 2 clinical trial and the global manufacturing needs of this innovative cellular therapy. We are optimistic about the potential impact of this therapy on patients undergoing kidney transplants.” Dr. Joseph Leventhal, Scientific Founder of TRACT Therapeutics, added, “This successful technology transfer represents a crucial step in our journey to bring our regulatory T cell therapy to patients in need. The collaboration with Taiwan Bio has been exceptional, and their manufacturing excellence aligns perfectly with our mission to develop transformative therapies. We are excited to continue our work towards improving outcomes and quality of life for transplant patients.” The companies announced their strategic partnership in December 2023 to leverage Taiwan Bio’s expertise in cellular therapy manufacturing and TRACT Therapeutics’ pioneering immune-modulating regulatory T cell therapy platform, called TregCel TM . The technology transfer was completed by a dedicated and collaborative team led by Carrie Wu, PhD from Taiwan Bio and Cheryl Stratton, MS from TRACT Therapeutics. Their expertise and teamwork were instrumental in achieving this important milestone. The upcoming Phase 2 clinical trial, running concurrently at sites in Taiwan and the US, builds on the promising results from a Phase 1 study, which demonstrated an excellent safety profile and encouraging efficacy indicators with TRACT’s autologous Treg product and has the potential to change the treatment paradigm for transplant patients by reducing the reliance on immunosuppressant drugs. Further updates on the trial’s progress will be shared in the coming months. About Taiwan Bio Taiwan Bio Therapeutics, Inc. is a one-stop, total solution cell therapy CDMO focusing on accelerating the translation of early-stage cell therapies to clinical products. Its cell engineering and cGMP manufacturing technology platforms streamline “vein-to-vein” process design and allow thorough product characterization. Taiwan Bio is where cutting-edge science meets world-class manufacturing, helping innovators to convert their bench side discoveries into bed side therapies in record time. Discover more at: https://twbio-thera.com/language/en/about-us/ About TRACT Therapeutics TRACT Therapeutics, Inc. is a clinical stage biotechnology company developing a novel therapeutic approach to restoring immune balance in organ transplantation and autoimmune disease. Its proprietary platform technology, using autologous polyclonal expanded regulatory T cells, was developed at Northwestern University by pioneer, Joseph R Leventhal, MD, PhD, Fowler McCormick Professor of Surgery at Northwestern University, and his research colleagues. For additional information, visit our website at www.tracttherapeutics.com . This press release contains forward-looking statements that express the belief, potential anticipation, or expectation, as well as other statements which are not historical fact, and statements related to clinical trials and their results, design, FDA product approvals or other marketing approvals, features, functionality, and performance. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements.

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

CHICAGO & TAIPEI, Taiwan--( BUSINESS WIRE )--TRACT Therapeutics and Taiwan Bio Therapeutics are pleased to announce a poster presentation at the 2024 annual meeting of the American Transplant Congress (ATC) taking place June 1-5, 2024, in Philadelphia, PA. TRACT Therapeutics, a clinical-stage biotechnology company, and Taiwan Bio Therapeutics, a world-class expert in cell therapy manufacturing, formed a strategic partnership in Nov 2023 to advance a novel regulatory T cell (Treg) therapy approach to preventing rejection in solid organ transplants. Together, the companies will launch a Phase 2 clinical trial investigating the ability of Treg therapy to reduce the use of immunosuppressant drugs in living donor kidney transplant recipients. Research centers will be located in the United States and Taiwan. Joseph R Leventhal, MD, PhD, Fowler McCormick Professor of Surgery at Northwestern University and Scientific Founder of TRACT Therapeutics stated, “Developing more effective treatments for patients facing an organ transplant is a pressing need and the ATC provides a dynamic platform for professionals to exchange insights on their work and experiences in the field of transplantation medicine. TRACT’s regulatory T cell therapy has the potential to make a significant impact on treatment paradigms, improving patient outcomes and quality of life, and we look forward to sharing our Phase 2 trial design and methods at the conference.” Details of the poster presentation are as follows: Abstract Title: “A Phase 2 Study of Regulatory T Cell Therapy to Achieve Immunosuppression (IS) Reduction in Living Donor Kidney Transplant (LDKTx) Recipients: The RETIRE Trial” Authors: J Leventhal, C Stratton, J Mathew, C Yang, S Murray Category: Clinical Trials About TRACT Therapeutics TRACT Therapeutics, Inc. is a clinical stage biotechnology company developing a novel therapeutic approach to restoring immune balance in organ transplantation and autoimmune disease. Its proprietary platform technology, using autologous polyclonal expanded regulatory T cells, was developed at Northwestern University by pioneer, Joseph R Leventhal, MD, PhD, Fowler McCormick Professor of Surgery at Northwestern University, and his research colleagues. For additional information, visit our website at www.tracttherapeutics.com . About Taiwan Bio Therapeutics Taiwan Bio Therapeutics Co., Ltd. is a one-stop, total solution cell therapy CDMO focusing on accelerating the translation of early-stage cell therapies to clinical products. Its cell engineering and cGMP manufacturing technology platforms streamline “vein-to-vein” process design and allow thorough product characterization. Taiwan Bio is where cutting-edge science meets world-class manufacturing, helping innovators to convert their bench side discoveries into bed side therapies in record time. Discover more at: https://twbio-thera.com/language/en/about-us/ . This press release contains forward-looking statements that express the belief, potential anticipation, or expectation, as well as other statements which are not historical fact, and statements related to clinical trials and their results, design, FDA product approvals or other marketing approvals, features, functionality, and performance. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements.