Brexogen Co., Ltd.

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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First entry to clinical trial of exosome for atopic dermatitis The first exosome-based therapeutics in US clinical trial among Korean companies SEOUL, South Korea, Nov. 2, 2022 /PRNewswire/ -- The US FDA granted the initiation of the phase 1 clinical trial of 'BRE-AD01', an exosome- based therapy for atopic dermatitis. 'BRE-AD01' is being developed by Brexogen with its own exosome-platform technology. It is the first phase 1 clinical trial of therapeutic exosome for atopic dermatitis in major countries. This IND clearance is very meaningful in that patients with atopic dermatitis can benefit from receiving better treatment with 'BRE-AD01', which is armed with multiple mode of action. 'BRE-AD01' is produced from stem cells (named 'BxC') stimulated with a specified, well-defined clinical available compound, which comprised the backbone of Brexogen's technology. In various preclinical models, superior therapeutic effects were demonstrated by BRE-AD01 compared to competing drugs (Dupixent, JAK inhibitors, steroids). Recently, serious side effects have been reported by patients that received JAK inhibitor, which was approved as an innovative drug for the atopic dermatitis. In contrast, no side effect was observed in BRE-AD0-received atopic dermatitis animals, with better therapeutic efficacy. BRE-AD01 has multiple MOAs (such as repressing type 2 immune reaction, regulating IL-31R, and promoting skin barrier recovery, contributing to enhanced atopic dermatitis symptoms. According to Brexogen Inc. on October 27, the Center for Biologics Evaluation and Research (CBER), US FDA, completed the review of phase 1 clinical trial for BRE-AD01 and confirmed the starting of the phase 1 clinical trial. In this clinical trial, patients with severe atopic dermatitis will receive BRE-AD01, and the safety and therapeutic efficacy of IGA, EASI, and SCORAD will be evaluated as well. Dr. Soo Kim, the CEO and co-founder of Brexogen Inc. said, "I am very happy to hear our Phase 1 clinical trial was accepted by the US FDA. Conducting the first clinical study on an exosome therapeutics developed from South Korea has an important meaning in that the potential of exosome technology, which is currently at the research level, can be greatly improved to a level that can be commercialized as a reliable option. We will use our stem cell priming strategy to accelerate the development of next pipeline using the results from this clinical trial. After successful completion Phase 1 trial, we will conduct follow-up clinical trials with the patients. However, exosome therapy is still facing difficulties in development, but can be commercialized at a global level once we overcome these issues (such as quality control and manufacturing process). We will continue to provide a therapeutic exosome for several indications." Dr. Kim said, "We are making efforts to commercialize not only pharmaceuticals but also various products using exosomes with different ingredients developed through the Brexogen exosome platform technology. Starting from this clinical trial, we will continue developing exosome products." [Introduction] Brexogen is a company established in 2019 by CEO Soo Kim, who has expertise in stem cells and exosomes for more than 20 years. She established the BG-Platform technology for developing exosome therapeutics to overcome the limitations of current exosome therapeutics in quality control and mass production. BG-Platform technology utilizes the therapeutic cargo-controlled exosome optimized for various diseases such as atopic dermatitis (BRE-AD01), myocardial infarction (BRE-MI01), and non-alcoholic fatty hepatitis (BRE-NA01). SOURCE Brexogen