Exosomes are small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. They transfer DNA, RNA, and proteins to other cells, thereby altering the function of the targeted cells.
In recent years, exosomes have become gained attention as a strategy for accessing the therapeutic effects of cells without the risks and difficulties of administering the cells to patients. With at least 12,431 scientific articles published about exosomes and 128 clinical trials underway, these small vesicles have intriguing potential to be used within a range of therapeutic applications.
The term “exosomes” has become an increasingly common Search Term on Google over the past 10 years, as shown in the graph below:
Despite this flurry of activity, exosomes are coming under increasing scrutiny, with a Public Safety Notification on Exosome Products released December 6, 2019, by the U.S. FDA stating:
“Certain clinics across the country, including some that manufacture or market violative ‘stem cell’ products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions… As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements.”
Currently, there are no FDA-approved exosome products and exosomes are clearly regulated such that each product requires a specific IND for each clinical condition.
Exosome Company Spotlights
Today, a rapidly growing number of companies are developing exosome-based products. The list below presents all known exosome companies worldwide and the innovative technologies they are developing. While many of these companies are working alongside regulatory agencies, such as the U.S. FDA, all too many of them are not.
Aegle Therapeutics Corp. is a first in class, Phase 1/2a ready, biotechnology company isolating extracellular vesicles (“EVs”) from allogeneic bone marrow derived mesenchymal stem cells (BM-MSCs) to treat severe dermatological conditions, including burns and epidermolysis bullosa, a rare pediatric connective tissue disorder, and to prevent scarring. Aegle’s isolation process allows for the production of therapeutic-grade extracellular vesicles from bone marrow derived MSCs. In April of 2018, the U.S. Food and Drug Administration (FDA) cleared the company’s first Investigational New Drug (IND) application to begin clinical trials in burn patients.
Aethlon Medical, Inc.
Aethlon Medical (NASDAQ: AEMD) is an American company focused on addressing unmet needs in global health and biodefense. It initiated its tumor-derived exosome research at a time when the medical community believed exosomes were cellular debris. Today, a therapeutic to address tumor-derived exosomes represents a significant unmet need in cancer care. Aethlon has demonstrated that the affinity mechanism of the Hemopurifier® can capture tumor-derived exosomes underlying several forms of cancer, including breast, ovarian and metastatic melanoma.
Anjarium Biosciences AG
Hybridosomes® are nanoparticle shells of about 100 nm. Anjarium Bioscience’s Hybridosome® platform excels in conjunction with such optimized RNA modalities, providing an avenue to employ the potential of exosomes in RNA-based applications such as RNAi, mRNA replacement and gene editing. Coupled with the targeting technology and proprietary manufacturing methods, Anjarium’s Hybridosome® platform is a promising technology to overcome the delivery hurdles today’s most powerful RNA therapeutic candidates face.
ArunA Bio is harnessing the natural abilities of neural exosomes to cross the blood brain barrier and enhance the body’s anti-inflammatory, self-repair and protective mechanisms to treat neurodegenerative disorders. Its proprietary neural exosomes inherently cross the blood-brain barrier and enable drugs and drug-combinations to naturally target cells and treat patients neurological disorders.
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of biological therapeutics for the treatment of rare disorders. Its CAP-2003 product is comprised of exosomes isolated from the company’s proprietary cardiosphere-derived cells (CDCs). It is being developed as a next-generation therapeutic platform in regenerative medicine and as a vehicle to deliver therapies to cells in the human body.
Clara Biotech is focused on providing the tools researchers need to harness the full potential of exosomes, including therapeutic, diagnostic and clinical applications. The company is developing a high-throughput lab tool (ExoSS) that aims to automate exosome prootcols, making its world-class exosome isolation service possible in your own lab at rates up to 100 samples/hour.
Codiak BioSciences is pioneering exosome research and development to create an entirely new class of medicines, exosome therapeutics. Its proprietary engEx™ technology platform for exosome engineering and manufacturing represents a transformative step in the treatment of disease, enabling the development of therapies for diseases that are currently considered intractable. Using this breakthrough platform, it can produce exosomes that have precise and intentionally chosen properties and make them at industrial quality and scale.
Creative Medical Technology Holdings
Creative Medical Technology Holdings is a commercial stage biotechnology company committed to improving patient lives in the areas of Urology, Neurology and Orthopedics. It has a patent application that covers the use of the company’s AmnioStem product as a production tool for the generation of exosomes to regenerate damaged brain tissue after a stroke.
Direct Biologics is a biologics manufacturer of regenerative medical products including exosomes. Its ExoFlo exosomes are isolated from donated human mesenchymal stem cells (MSCs) and purified using proprietary processing. According to the company, the benefit to its exosomes is that they are stem cell-derived and bring a wide array of growth factors to stimulate and modulate many processes within the healing cascade.
Incorporated in September 2019, EverZom is a start-up based in France that is developing a GMP compliant extracellular vesicle manufacturing platform. As a CDMO for EVs, EVerZom aims to overcome the challenge of producing EVs at commercial scale with a breakthrough patented production method. This technology was developed in collaboration with the University of Paris and the CNRS. The process consists in applying a turbulence stimulation on cells resulting in a increase of the EV production yield by 100 times with minor impact on cell viability.
Evox Therapeutics is a platform technology company spearheading the development of exosome therapeutics for the treatment of life-threatening diseases. It is combining groundbreaking exosome technology from two renowned institutions in exosome research, Oxford University and the Karolinska Institutet. It has built a comprehensive IP portfolio encompassing key aspects of EV-based nucleic acid and protein delivery technology. Coupled with targeting technology and proprietary manufacturing and purification methods, the company is set to develop transformational therapeutics across a wide range of disease areas.
Headquartered in Seoul, South Korea, ExoCoBio is focusing on stem cell-derived exosomes, to develop innovative therapeutic as well as cosmetic products. The company is exploring the use of stem cell derived-exosomes to regenerate or activate/de-activate various tissues or cells.
Exopharm Pty Ltd
Exopharm is an Australian regenerative medicine biopharmaceutical company that is seeking to develop and commercialize exosomes as therapeutic agents – initially a product called Plexaris™ and later a product called Exomeres™. Exopharm’s LEAP Technology also provides a key step in the downstream manufacturing process to isolate and purify exosomes from adult stem cells and other sources. Its LEAP Manufacturing Process has been developed to address the existing limitations in exosome purification processes. It entered into a partnership with RoosterBio in August 2017.
Exosome Diagnostics is commercializing minimally invasive molecular diagnostics in blood and urine to enable doctors to select optimal therapies for cancer and other diseases. To do this, it utilizes exosomes, which are lipid bilayer covered microvesicles shed by solid tumors into body fluids, such as blood and urine. For example, its ExoDx™ Prostate Test is a simple, non-DRE, urine-based, liquid biopsy test used to diagnose and assess the risk of prostate cancer.
Exosome Plus is pioneering regenerative biotechnology with its exosome-based pharmaceutical platform (ExoThera™). It is focused on providing an “innovative proprietary regenerative pharmaceutical platform, ExoThera™, for irreversible diseases.”
Exosome Sciences is working in collaboration with its majority shareholder, Aethlon Medical (Nasdaq:AEMD), to discover exosome-based biomarkers to diagnose and monitor Alzheimer’s disease (AD), Chronic Traumatic Encephalopathy (CTE) and other neurological disorders. It is advancing a TauSome™ biomarker (also referred to as exosomal tau) as the basis for a candidate blood test to diagnose CTE in living individuals.
Exosomics S.p.A., an Italian start-up company developing exosome-based early-stage cancer screening and molecular diagnostic tests. Exosomics has unique IP related to the isolation and selective enrichment of tumor-originated extracellular vesicles (EVs)/exosomes from complex biofluids. Its mission is to develop and commercialize a new generation of tests for cancer screening and liquid biopsy based on analysis of circulating extracellular vesicles and exosomes. The company offers a wide range of proprietary reagents and kits for cancer screening and liquid biopsy, suitable for research use and clinical diagnostics. It also has a strategic partnership with Lonza, entered into in May 2017.
Invitrx’s EX-MSC is an exosome allograft derived from Wharton’s Jelly MSCs and is sourced from a proprietary blend of cells developed for growth and repair. Exosomes and other Extracellular Vesicles (EVs) are isolated from their parent cells and concentrated to produce the Exosomal Product.
Kimera Labs is a regenerative medicine focused biotechnology company specializing in exosome manufacturing. Its XoGlo™ product is an isolated, xeno-free, chemically defined, cell-free placental MSC derived exosome re-suspended in 0.9% normal saline. According to the company, this cosmetic product contains a multitude of growth factors, which are involved in skin repair, beautification and regeneration. The company also manufactures sterile, pharmaceutical-grade mesenchymal stem cell exosomes for future IRB-approved clinical research.
Lonza (HansaBioMed Life Sciences Ltd)
In May 2017, Lonza acquired HansaBioMed Life Sciences based in Tallinn, Estonia, a start-up company dedicated to the research and development, manufacturing, and distribution of products for the exosomes research market. Now under the Lonza brand, HansaBioMed Life Sciences Ltd (HBM-LS) develops products in the field of exosome sciences and offers an advanced portfolio of products and services for EV research. (Lonza is also the leading and strategic investor in Exosomics Group, another exosome company.)
NanoView Biosciences was founded on a technology platform that uniquely identifies and characterizes exosomes. Its ExoView™ platform provides the ability to measure up to 4 markers on a single extracellular vesicle, with single binding event sensitivities.
Organicell™ describes itself as a fully integrated Exosome Therapeutics Company. Its Organicell™ Flow product contains approximately 400 billion exosomes per milliliter quantified in every batch by Nanosight technology. Exosomes are nanovesicles that contain protein and microRNA that can be transferred to other cells to support tissue repair and homeostasis.
Based in Scottsdale, Arizona, Regen Suppliers announced its exosome industry involvement with a January 16, 2020, announcement stating that the company offers ReBella and ReBellaXO, umbilical stem cell and exosome products used for regenerative aesthetic procedures involving hair, facial and sexual rejuvenation. According to the company, ReBellaXO is an MSC Derived Exosome Biologic that is a “minimally manipulated allograft derived from full term, post c-section umbilical cord tissue and Wharton’s Jelly.”
ReNeuron is a UK-based stem cell company developing therapies for unmet medical needs. ReNeuron has developed a technological process enabling it to produce exosomes from a cell line, such as its proprietary CTX neural stem cell line under different culture conditions, which can in turn be harvested at a commercially relevant scale.
In August 2017, RoosterBio Inc and Exopharm Pty Ltd announce an agreement under which they will work together on a Stem Cell Exomere Program, aimed at bringing high-grade therapeutic extracellular vesicles/exosomes derived from adult stem cells into clinical practice. According to the companies, they are working together to develop and implement a standardized, scalable, commercially-viable biomanufacturing process utilizing Exopharm’s Exomere technology in order to enable rapid clinical translation with a cGMP-compliant Exomere product into regenerative medicine (RM) applications.
Stemcell Medicine Ltd.
Announced January 2018, Stem Cell Medicine Ltd. (SCM) has licensed an innovative exosome-based technology for the treatment of neurodegenerative and neuropsychiatric indications, specifically, autism spectrum disorder (ASD). The treatment is based on vesicles, exosomes, derived from adult stem cells (MSC-exo) that are administered intranasally. The technology was developed by Professor Dani Offen, Sackler School of Medicine, Sagol School of Neurosciences Tel Aviv University and was licensed from Ramot, the Business Engagement Center at Tel Aviv University.
Tavec is developing the next-generation of potent anti-cancer gene therapies using the power of injectable, miRNA loaded exosomes. It has demonstrated an ability to deliver high levels of specific miRNA, including widely known cancer disruptive targets such as miR195, directly to cancer cells. Using in vivo models, its miRNA-loaded exosomes inhibit cancer growth and prolong lifespan. The company is focused on exploiting a cancer cells natural pre-disposition to taking up large quantities of certain types of exosomes to insert microRNAs that will disrupt the cancer growth instruction set.
The Cell-Factory BVBA (Esperite)
The Cell Factory, is a platform-based biotech company focused on innovative products development, clinical translation and commercialization. It is developing extracellular vesicles (EVs) and exosomes, in particular allogenic “off-the-shelf” MSC-derived EVs and exosomes to used as inhibitors of acute and chronic inflammation and immunosuppressants in the treatment of unmet medical needs. Its target diseases are Crohn’s disease, drug-resistant epilepsy, and others. It fully owns a patent family on broad applications of MSC-derived EVs and exosomes in treatment of various inflammatory diseases.
VivaZome Therapeutics Pty Ltd
VivaZome Therapeutics Pty Ltd is a privately-held Australian biotech company, based in Melbourne, Victoria. It was formed to develop and commercialise exosome-based therapies, with a focus on treatments for debilitating and/or life-threatening disorders which are not adequately managed by current therapies.
XOStem, Inc. was registered as a company in Delaware on May 9, 2018. While there is limited information available about the company, XOStem appears to be developing engineered exosomes for regenerative skin care, joint care, and other therapies.
Are there other exosome companies that should be added? Let us know in the comments and we’ll get them added right away.
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