Exosomes: Company Spotlights from “A” to “Z”

Exosome Companies

Today, a rapidly growing number of companies are developing exosome-based products. The list below presents all known companies worldwide that are developing exosome therapeutics or diagnostics. It also describes the innovative technologies they are developing. While many of these companies are working alongside regulatory agencies, such as the U.S. FDA, some of them are not.

AcouSort AB

AcouSort AB is a Swedish company that is pioneering acoustofluidic technology, as well as working on exosome-based diagnostics. In August 2022, the European Innovation Council (EIC) awarded AcouSort and its project partners SEK $26 million (approximately $2.5 million USD) to develop an acoustofluidic thin-film actuated chip for exosome separation from blood. Roughly half of that will go directly to AcouSort, while the rest of the funding is being provided to AcouSort’s partners Lund University, DTU, and Day One.

Aegle Theraeutics

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.

AGC Biologics

In April 2023, AGC Biologics entered a service agreement with Jikei University in Japan. Under the agreement, AGC Biologics will assume a technology transfer and feasibility study for a drug to treat idiopathic pulmonary fibrosis (IPF). Specifically, ACG scientists will focus on identifying the viability of developing a prototype for an exosome-based treatment of IPF derived from bronchial epithelial cells.

AGS Therapeutics

AGS Therapeutics is developing novel biomedicines utilizing extracellular vesicles from microalgae (MEV). This approach provides a safe, targeted, and highly versatile delivery system for therapeutic molecules and vaccines. MEVs can pass through the body’s natural barriers to carry biologics (such as mRNA, siRNA, DNA, peptides, and proteins) to specific tissues, while avoiding premature degradation or inactivation.

The company is involved with microalgae cell engineering and MEV exo-loading technologies, as well as MEV manufacturing at pre-industrial scale through AGS-M. AGS-M is a sister-company of AGS Therapeutics that is fully dedicated to the development of suitable processes for the bioproduction and purification of MEV, as well as the manufacturing of MEV batches for preclinical and clinical use.

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

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.

Biological Dynamics

Biological Dynamics has developed an early diagnostic detection test utlizing AC Electrokinetics (ACE) to isolate exosomes from blood, which studies show can identify pancreatic cancer as early as Stage 1.

Brexogen

Headquartered in South Korea, Brexogen is developing cell-free strategies to target incurable diseases using stem cell derived exosomes. In November 2022, the US FDA approved initiation of the company’s Phase 1 clinical trial of ‘BRE-AD01’, its exosome-based therapy for atopic dermatitis. This is the first clinical trial of an exosome therapeutic for atopic dermatitis and the first exosome trial being conducted in the United States by a Korean company.

Capricor Therapeutics

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.

Cellese Regenerative Therapeutics

Cellese Regenerative Therapeutics is an exosome-based skincare company, with a division called AnteAGE®. It is dedicated to creating innovative, safe, and effective products in it state of the art laboratory.

Cells for Cells

Cells for Cells (C4C) is a a clinical-stage biotech company that is developing XO-101, the company’s flagship exosome therapy derived from mesenchymal stem cells (MSC). In early 2022, C4C dosed the first-ever patient with an exosome-produced therapy for osteoarthritis. Due to this trial’s promising early results, C4C is forming a spin-off company with its exosome asset in the US and opening a Series A funding round with global investors.

Ciloa

Ciloa is a French biotech company, spin-off from the CNRS and the University of Montpellier, a pioneer in the development of vaccines and exosome-based therapies. Based in Montpellier, it was created in 2011 by Robert MAMOUN and Bernadette TRENTIN. Ciloa has an exclusive patented technology for the in vivo development of recombinant exosomes in therapeutic and preventive applications.

Clara Biotech

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

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.

ConvEyXO

ConvEyXO is a Belgian company founded in 2019, aspiring to release therapeutic full potential of engineered exosomes. They are developing unique and scalable technology platforms to make engineered exosomes affordable and available for therapeutics, combining cost-effective manufacturing and precise loading for targeted cargo delivery vehicle.

Creative Biostructure

Creative Biostructure has successfully developed exosome/microvesicle products derived from several different sources. Its range of products include exosomes isolated from cancer cell lines, exosomes isolated from stem cell lines, exosomes isolated from immune-related cell lines, exosomes isolated from general cell lines, exosomes isolated from body fluids, fluorescent exosomes/microvesicles, and lyophilized microvesicles.

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

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.

Dynacord

EriVan Bio

EriVan Bio is a biotech company that is developing products and services that leverage exosome technology for molecular, cell biology research, and therapeutic applications. EriVan Bio was founded to commercialize Dr. Thomas Schmittgen’s groundbreaking research on miRNA and exosomes, focusing on “noncoding RNAs, extracellular vesicles and cancer, with emphasis on the use of microRNAs as therapeutic or diagnostic agents.” Dr. Schmittgen’s lab won the 2018 University of Florida Big Idea Competition.

EriVan Bio is located at the Sid Martin Biotechnology Incubator in Alachua, Florida, which is globally known for biotechnological innovation.

EV Therapeutics

EV Therapeutics is an exosome-based therapeutics company focusing on developing a novel immune modulator based on its proprietary tumor-derived extracellular vesicles (mTEVs) that enhance immunotherapy efficacy in advanced stage colorectal cancers (CRC) and other solid tumor cancers.

EverZom

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.

ExoProTher

ExoProTher is a preclinical stage company developing a novel oncology therapy based on delivery of a complex of tumor suppressor factors, including tumor protein p53 (p53), using extracellular vesicles as the delivery vehicle.

Its novel method of healthy p53 protein delivery into tumor cells is expected to assist in the treatment of more than 60% of human cancers, alone or in combination with other agents.

ExoQure

ExoQure stem cells and exosomes are the gold standard of UC-MSCs. The company offers high potency and purity, with stringent GMP FDA quality testing at every step of the process of isolation, expansion, harvest, and cryostorage.

Exosis

Exosome Diagnostics

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

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

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.

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.

Exostemtech

ExSURE

Evolutionary Biologics

Evolutionary Biologics manufactures EXO Series, an allogeneic Wharton’s Jelly MSC-derived exosome product. EXO Series is manufactured using the company’s proprietary isolation and purification technologies. It is produced at the company’s cGMP compliant FDA Certified labs using clean rooms and ISO 3 and ISO 7 technology.

Evora Biosciences

EVOGEX is Evora’s proprietary therapeutic discovery platform that leverages engineered exosomes. The purpose of EVOGEX is to enhance key properties of exosomes and to improve the efficacy of exosome-based therapeutic approaches. Evora is developing its EVOGEX-Digest based on world-class research in copolymer gels and exosomes from CNRS and Paris University laboratories. Its lead product, EVOGEX-Digest, aims to substantially improve patient outcomes in several GI-related indications.

GBI Bio has deep experience in the exosome space, operating in stealth mode until recently. The company offers CDMO support for companies who are developing and commercializing exosome products. Headquartered near Fort Lauderdale, Florida, it is a fully integrated cGMP Contract Manufacturing Organization with experience across a diverse range of advanced therapies, including exosomes as well as monoclonal antibodies, recombinant proteins, vaccines, Antibody Drug Conjugates (ADCs), and other bioconjugates.

Hilltop Biosciences

Located at the Mansfield BioIncubator in Massachusetts, Hilltop Bio is an innovative veterinary biotech company that develops exosome therapies to help reduce inflammation, accelerate healing, and normalize damaged tissue function in horses and companion animals. The company is leveraging its IP portfolio into a strong pipeline of off-the-shelf, room temperature biologic products. The company’s recent round of funding was led by Launchpad Venture Group.

Ilias Biologics Inc.

ILIAS developed a unique platform technology EXPLOR™ that makes it possible to load specific proteins into exosomes in a controllable way. Unlike the conventional methods employing passive loading of cargoes, EXPLOR™ allows active and reversible loading of target proteins into exosomes with high efficiency. ILIAS built a robust pipeline that covers inflammatory and metabolic diseases as well as cancers. Its therapeutic exosomes showed promising efficacy profiles in non-clinical studies and ILIAS is getting ready to start a clinical trial in 2021.

INOVIQ Ltd

INOVIQ Ltd (ASX:IIQ) is aggregating a set of diagnostic and exosome-based products for the earlier detection, diagnosis, prognosis and monitoring of cancer and other serious diseases. Specifically, INOVIQ’s EXO-NET^® product allows for “fast, accurate, and efficient capture and isolation of exosomes from any liquid biopsy sample.” The technology is scalable and compatible with existing automated testing systems, making it well-suited for high volume clinical lab applications.

Invitrx Inc.

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

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.)

MDimune Inc.

MDimune is a cell-derived vesicle (CDVs)-based therapeutics company that has developed a BioDrone® platform technology, which is a novel technology that uses cell-derived vesicles to achieve highly target-specific drug delivery. The BioDrone® platform technology is patented in the US, Europe, China, Japan, and Korea. MDimune’s current programs are focused on cancer, COPD and other rare diseases.

NanoView Biosciences

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.

Novaxomx

Novaxomx is a joint venture of curasan AG and Xlife Sciences that is researching and developing exosome based therapies to support musculoskeletal recovery.

NurExone Biologic

Oasis Diagnostics® Corporation

As a pioneer in the area of salivary diagnostics, Oasis Diagnostics® Corporation provides tools for the simple and immediate isolation of exosomes, cell free DNA, cell free RNA [miRNA, mRNA] from saliva specimens. As part of its long term goals in this area the Company is involved in the characterization of salivary exosomes, particularly looking at the nature of salivary exosomes, what they are, what role they play, how they can be employed as diagnostics to pinpoint specific diseases and whether there are unique differences between exosomes from normal, healthy individuals and those with targeted diseases.

OmniSpirant

OmniSpirant has a patent pending platform technology based on inhaled bioengineered stem cell exosomes, which are capable of efficient intracellular delivery of a variety of therapeutic cargoes to effectively treat respiratory diseases. Its engineered stem cell exosomes will initially be used to develop a first-in-class regenerative gene therapy for Cystic Fibrosis. The prorietatry mucus penetrating exosomes have similar transformative potential for treating many other respiratory diseases.

Organicell

Organicell™ describes itself as a fully integrated Exosome Therapeutics Company. Its Zofin™ 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.

Primoris Therapeutics

Primoris Therapeutics is an umbilical cord blood mesenchymal stem cell-released exosome (ExoPlus^TM)-based biomedicine development company and headquartered in Republic of Korea. ExoPlus^TM is a functionally reinforced-exosome with both enhanced inflammation inhibition and tissue regeneration effects through its own proprietary technologies. ExoPlus^TM has been manufactured at GMP facilities of Kangstem Biotech for clinical and commercial use. Preclinical studies have been completed and Phase I/II clinical trials for burn treatment will be conducted in late 2023.

Regenerelle

Regenerell is aggregating the world’s largest supply of high quality exosomes. Since coming to the market, the company has sold many trillions of Exosomes. It currently has 2,850 quintrillion exosomes in cryo-storage at its NY State Licensed tissue bank and is producing in excess of 750 trillion exosomes derived from umbilical cord Wharton’s jelly stem cells.

Regen Suppliers

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

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.

Rion

Rion is an exosome company based out of Rochester, Minnesota. The company was incorporated since 2017 and is now advancing various R&D and clinical programs. Rion has created a Purified Exosome Product^TM (PEP^TM), an biologic platform that leverages the therapeutic power of exosomes as a shelf-stable, allogeneic (donor-derived) product. PEP is Rion’s core technology that has the potential to support tissue regeneration across a diverse range of conditions, including wound healing, cardiovascular disease, knee osteoarthritis, and women’s health indications.

Rion has 3 active clinical trials, which include Wound Healing (NCT04664738), Acute Myocardial Infarction (NCT04327635), and Crohn’s Fistulizing Disease (IND 018436).

RoosterBio Inc.

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.

ShiftBio

SHIFBIO INC., based in Korea, is pioneering immunoregenerative Cell-Free Nanotherapy Platform Technologies using natural nanovesicles (exosomes) to create a new class of medicines. Their technologies empower nanovesicles by maximizing therapeutic protein expression, loading macromolecules, or enabling in vivo cell manipulation to tackle intractable and rare diseases. The lead program is based on Maxisome platform technology, which maximizes the expression of therapeutic proteins on the surface of nanovesicles for enhanced efficacy. The second platform technology, InProDel, enables intracellular delivery of previously “undruggable” macromolecules in a free-form state and efficiently delivers them to target cells. Lastly, its Fusosome platform technology enables a selective fusion of nanovesicles with target cell membranes and facilitates “in vivo manipulation” of the recipient cells. These technologies have the potential to revolutionize regenerative medicine.

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 Pharmaceuticals

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.

TheraXyte BioScience

TheraXyte BioScience is a biotech company focusing on extracellular vesicle (EV)-mediated drug delivery and EV-based novel therapeutics.  The company has developed an EV-based drug delivery platform (TAXY™) which could enable the mass production of modifiable EVs at GMP manufacturing level. It is being designed to facilitate payload packaging so that it can assist in targeting organs/cells of interest where payload drug molecules and active biological molecules could be released as therapeutics.

Unicyte AG

Headquartered in Oberdorf, Switzerland, Unicyte AG evolved from a fifteen year research collaboration with Prof Giovanni Camussi, a leading expert on extracellular vesicles and stem cells from the University of Turin and Fresenius Medical Care KGaA, the world’s largest provider of products and services for individuals with renal diseases. As a pioneer in liver stem cells and nano-extracellular vesicles, the company is dedicated to improving the lives of patients with kidney or liver disease, diabetes, and cancer. Unicyte was founded in 2015 as an independent affiliate of Fresenius Medical Care and is headquartered in Oberdorf NW, Switzerland.

Versatope

Headquartered in Lowell, Massachusetts, Versatope is using recombinant extracellular transport vesicles to deliver vaccines. Specifically, it is leveraging Recombinant Extracellular Transport Vesicles (RET-Vs) to deliver payloads that can modify a target cell’s activity.

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.

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.

Ready to learn more about this exciting market area? View the “The Global Exosome Market – Market Size, Forecast, Trials and Trends.”