Whitefish, MT / April 30, 2014 / PD-1, or programmed death protein 1, is certainly a hot button in the
field of oncology, with the new immune checkpoint inhibitors pegged by
many as part of a wave of new therapies to meet areas of great unmet
medical need in cancer treatment. Merck & Co. (NYSE: MRK) has
received the coveted FDA "breakthrough" designation for its PD-1
inhibitor lambrolizumab, putting it in a position to vie for the lead
with Bristol-Myers Squibb's (NYSE: BMY) antibody nivolumab. Both
companies have reported impressive results on their drugs for several
cancer types, either as a monotherapy or in combination treatments,
including melanoma and non-small cell lung cancer.
The excitement around potentially paradigm-shifting new therapeutics was
also highlighted in a recent article in the publication Trends in Molecular Medicine, titled "Extracellular Vesicles: Emerging Targets for Cancer Therapy".
The article, authored by a team of researchers from Harvard Medical
School, Massachusetts General Hospital and University of Oxford, details
the importance of exosomes (also called "extracellular vesicles," "EVs" or "cell-derived vesicles") and the captivating role that they play in
cellular communication and homeostatic health. All nomenclature aside,
exosomes could be the next PD-1 inhibitors for cancer and other diseases
and conditions as part of the next generation of novel therapeutics.
Exosomes were thought of simply as cellular debris until recently, when
scientists started to understand that exosomes are essentially a coded
language established by the body's cells that carry critical genetic
information about cells of all types, including tumor cells. While more
human trials are required to validate the in vivo and in vitro lab
work, exosomes have been shown to play an active role in the
pathogenesis of cancer on many fronts, including the earliest stages of
signaling and angiogenesis, meaning that increased numbers of exosomes
could hold a vital key in early detection like never before.
In fact, earlier research indicates
that PD-1 itself is expressed and transported by dendritic cell-derived
exosomes. As you read through the discussion below, keep this in mind.
Exosome-based therapies may yet prove to intertwine with PD-1
inhibition. If this ends up being the case it could create a perfect
storm in the world of emerging cancer therapeutics.
Other realizations about the role of exosomes are groundbreaking. For example, as the article notes,
"One of the most striking features of tumour-derived EVs is their
potential to facilitate formation of the pre-metastatic niche, the
specialised microenvironment that forms at a distant organ site in
preparation for future tumour metastasis."
Vesicle shedding is also theorized to contribute to drug resistance and
immunosuppression as cells "fool" the body into believing they are
native, rather than dangerous. Breaking the cypher to understand how
cells are "speaking" to each other or recognizing where tumors plan to
metastasize before they do, in combination with other EV-inhibiting
therapies to interrupt the cell communication network, would
revolutionize how cancer is treated today.
These types of discoveries have opened the door to countless
applications related to exosomes, including diagnostics and treatment
for not only cancer but also bacterial and viral infections,
neurodegenerative diseases and many more. Moreover, because exosomes
are found in basically every bodily fluid (i.e. blood, lymph, urine,
saliva, etc.), there are strong implications that disease detection can
become vastly simplified by testing fluids, as opposed to invasive and
costly procedures such as biopsies.
Throughout the last decade or so, scientists, are starting to dial-in
the importance of exosomes and building on the pioneering work of
individuals like Dr. Douglas Taylor. Dr. Taylor, Chief Scientific
Officer of Exosome Sciences, Inc., a wholly-owned subsidiary of Aethlon
Medical Inc. (OTCBB: AEMD), published the first article describing
circulating tumor exosomes/microvesicles in 1979 and is widely
recognized as one of the world's foremost experts in exosomes and their
The Trends in Molecular Medicine publication specifically
mentions Aethlon's affinity plasmapheresis ADAPT(TM) platform, which
features a unique device called the Hemopurifier(R), for its potential to
capture specific exosomes during extracorporeal dialysis to improve
cancer therapies. More succinctly, the authors stated,
"For example, in human epidermal growth factor receptor-2 (HER-2)
overexpressing breast cancer, where HER-2-expressing EVs have been shown
to interfere with therapy and are associated with tumour
aggressiveness, anti-HER-2 antibodies could be used to remove
HER-2-expressing EVs from circulation with the aim of improving
therapeutic outcome. In principal, this approach could be tailored for
other tumour types, as long as the tumour cell-derived EVs are enriched
for tumour-specific proteins."
The old adage of "where there's smoke, there's fire," seems appropriate
in the case of exosomes, as elevated levels of the microvesicles say
that something is not right in the body. The Trends in Molecular Medicine
article makes the point very clear and adds to a growing library of
evidence about the relevance of exosomes in disease management. Major
pharma may be mostly looking over the fence at exosomes' diagnostic and
therapeutic uses at the moment, but it is highly probable that the trend
to utilize technologies targeting exosomes will start on a non-linear
path in the near future with additional clinical validation as the new
wave of therapies continues to roll in.
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