With 25% of all exosome publications released in the past year and exosome companies flooding into the marketplace, we are witnessing an exosome explosion.
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. Specifically, they transfer DNA, RNA, and proteins to other cells, thereby altering the function of the targeted cells.
Exosomes are commonly found in blood, urine, and saliva, among other fluids. Exosomes are also present in other body fluids, such as synovial fluid, amniotic fluid, semen, vaginal fluid, breast milk, and more.
It has been long known that stem cells have the potential to exert therapeutic effects, but it has only been recently recognized that exosomes play an important role how stem cells exert their cellular functions.
When Did Exosomes Become All the Rage?
Ten years ago in 2006, there were only 76 articles published about exosomes (PubMed.gov: Date Range: Jan 1, 2006 to Dec 31, 2006). Five years ago in 2001, there were 271 articles published about exosomes (PubMed.gov: Date Range: Jan 1, 2006 to Dec 31, 2006).
Today, there are more than 4,400 articles published about exosomes. Importantly, 1,088 of the articles (~25%) were released in the 2016 calendar year.
With a quarter of all exosome publications being released in the past 12-months, we are witnessing an exosome explosion.
See a full graph of exosome publications here.
Exosome Companies Flood Into the Marketplace
In addition to exponential increases in exosome publications over the past 10 years, exosome companies have been flooding into the marketplace.
Yesterday, Creative Medical Technology Holdings (OTCQB:CELZ) announced that it had filed a U.S. patent application (#62/400557) titled “Treatment of Stroke by Amniotic Fluid Derived Stem Cell Conditioned Media and Products Derived Thereof.” As stated in the company’s press release, the patent application “covers the use of the Company’s newly licensed AmnioStem stem cell as a production means for generation of nanoparticles termed exosomes, which regenerate damaged brain tissue after stroke. The AmnioStem stem cell is subject to issued US patent #7,569,385 and was licensed exclusively from University of California San Diego (“UCSD”).”
Furthermore, exosome company Kimera Labs announced last week the creation of a 6,000 sq ft, ISO:9001 certified exosome production facility in Florida. As an FDA registered tissue facility, Kimera Labs Miramar will produce tissue specific mesenchymal stem cell derived exosomes, as well as it Amnio2x amniotic fluid-derived product for orthopedic, cosmetic and regenerative medicine applications.
As stated in the company press release by Duncan Ross, Ph.D., President of Kimera Labs, “In many cell-based therapeutic applications, long distance paracrine signaling via microvesicles is emerging as the primary mode of action for tissue regeneration. With over 300 growth factors and thousands of nucleic acids, the KM300 series of exosomes is a frozen, off the shelf solution to inflammatory disease and tissue dysfunction.”
On December 8th, Exosome Diagnostics broke news that it is launching the first instrument for exosomal protein (exoProtein) capture and analysis directly from any biofluid. As stated by Dr. Johan Skog, CSO of Exosome Diagnostics, “Exosomes carry membrane associated proteins that are not normally released in blood. This new platform uniquely enables detection of low abundant membrane proteins, even in the background of complex plasma proteins. exoProteins are important biomarkers for drug development, disease monitoring and the rapidly expanding field of immuno-oncology.”
It is also significant that ReNeuron, a clinical stage biotechnology company headquartered in the UK, is developing exosomes derived from its CTX neural stem cell line. The company states that its “exosome platform is yielding encouraging early pre-clinical data across a range of potential indications which are being investigated further.”
Capricor Therapeutics, a biotechnology company based in Beverly Hills, California, is competing in the exosome arena too. In May 2014, Capricor entered into an exclusive worldwide license agreement with Cedars-Sinai Medical Center for intellectual property (IP) related to the development of exosomes originating from cardiosphere-derived cells (CDCs) for regenerative medicine applications.
Finally, the strongest indicator of major investment flowing into the exosome space comes in the form of Codiak Biosciences. Found in late 2015 and located in Woburn, Massachusetts, the company tagline is “Realizing the Potential of Exosome Biology.” Codiak states that it is “taking advantage of the natural propensity of exosomes to transmit macromolecule payloads between cells,” with its research covering two areas, therapeutics and diagnostics.
More importantly, however, if the massive funding that the company has attracted. In November 2015, Codiak Biosciences launched with $80M in investor funding, making it the largest venture-backed exosome company in existence.
Shortly thereafter in January 2016, Codiak BioSciences secured an additional $61 million Series B round, bringing its total investment to $92 million.
The investment rounds were led by: ARCH Venture Partners and Flagship Ventures, with participation by the Alaska Permanent Fund, Alexandria Venture Investments and Fidelity Management and Research Company. To quote Douglas E. Williams, Codiak’s President and CEO, “This financing is a strong indication of the promise of exosomes to improve human health.” With $92M to support this statement, I would have to agree.
The Future of Exosome Companies
Clearly, exosomes are gaining momentum as a novel strategy for accessing the therapeutic effects of stem cells without the risks and difficulties of directly administering the cells to patients. Exosome companies are also multiplying in number, with new market entrants popping up rapidly.
To learn more about this exploding field of study, view our recent article “The Exosome Revolution is Here.”