WHITEFISH, MT / June 26, 2014 / Probably the most explosive field in biotechnology right now is that of
immuno-oncology. The field is predicated on the concept that the body’s
immune system can be augmented or taught to modulate cancer without the
use of toxic chemotherapy agents and radiation, the standard of care
today worldwide. A few years ago, the immuno-oncology research was
relatively non-existent, but now it’s one of the hottest around with
some big pharmas making it a primary directive. Last year, Merck &
Co. (NYSE: MRK) brought back Roger Perlmutter, a man with an extensive
background in immunology, for a second tour with the company, this time
as EVP and President of Merck Research Laboratories, to shepherd a new
path for Merck focused on oncology at the research level with an
emphasis on immuno-oncology. Last week, Merck enlisted MorphoSys AG in a
partnership to develop therapeutic antibodies against immune
checkpoints. The antibody experts at MorphoSys are in high demand,
inking development agreements with Celgene (NASDAQ: CELG),
GlaxoSmithKline (NYSE: GSK), Novartis (NYSE: NVS) and more to develop
antibodies to support the human immune system against cancer.
Immuno-Oncology Partnering Frenzy Is On
Just a brief look at the recent slew of activity shows that most of the
biggest drugmakers in the world are heading down the immunology pathway
to develop novel drugs as the next frontier of cancer research. In
addition to working with MorphoSys, GlaxoSmithKine just cut a deal in
which it will spend $350 million to partner with U.K-based Adaptimmune
to study immuno-oncology candidates. Glaxo’s view of the future of
cancer – and possibly other indications – is evident given the fact that
in April they agreed to sell most of their cancer business to Novartis
for up to $16 billion, while spending $7.1 billion to acquire the
majority of Novartis’ vaccine business.
Pfizer’s failed $120-billion mega-offer to acquire AstraZeneca (NYSE:
AZN) was partly because of Pfizer’s desire to gain control of the
British company’s experimental drugs that help the body’s immune system
fight cancer. Bristol-Myers Squibb (NYSE: BMY) has made three recent
moves to strengthen its immuno-oncology pipeline, including a
$1.24-billion deal with CytomX. Incyte (NASDAQ: INCY) has been on the
move too, forging partnerships with AstraZeneca, Bristol-Myers and Roche
(OTCQX: RHHBY) in recent months to develop immunological therapies for
Cumulatively, AstraZeneca, Merck, Roche and Bristol-Myers Squibb have
initiated nearly 80 immune-based clinical studies, lending a great deal
of credence to Citigroup analyst Andrew Baum’s forecast that
immuno-oncology drugs will be generating $35 billion in annual sales in
the mid-term. Right now, immunotherapy drugs only comprise about 3
percent of cancer treatments globally, but Baum thinks that number will
surge to 60 percent by 2023.
To put this in perspective, if Baum is correct in his projection, cancer
immunotherapy drugs would become the biggest market in medicine,
topping even the peak sales of blockbuster drugs for high cholesterol.
The Emerging Importance of Exosomes
Within the immuno-oncology space, there is a tiny vesicle that virtually
every scientist had previously cast-off as nothing more than worthless
cellular debris that is starting to be the center of growing fanfare.
That particle is called an exosome and it’s something that Aethlon
Medical Inc. (OTCQB: AEMD) viewed as a potential key in oncology before
the rest of the world started to understand it and its importance.
Putting its money where its mouth is, Aethlon established a diagnostic
subsidiary, Exosome Sciences, Inc. and recruited Dr. Douglas Taylor as
Chief Scientific Officer of the company. Dr. Taylor, who is credited
with the discovery of tumor-secreted exosomes, is extensively published
on the topic and regarded as one of the world’s foremost experts on
exosomes. Think of this move as somewhat akin in relevance to Roger
Perlmutter bringing on oncology expert Dr. Roy Baynes as the head of
Merck’s new clinical development program.
Researchers are now widely realizing that tumor cells secrete exosomes
as a mechanism to suppress immune cells from doing their job of
destroying cancerous cells, which supports tumor proliferation.
Additional evidence suggests that exosomes have a hand in tumor
metastasis by playing a role in multi-drug resistance and serving as a
building block for tumors to created their own blood supply. It is also
now understood that there is a direct correlation between the number of
exosomes in the body and the stage of cancer progression. Simply, few
tumor-secreted exosomes suggest that cancer is in early stages and a
plethora of these exosomes indicates an advanced stage of the disease.
Further, studies have shown that exosomes transport a variety of cancer
targets, including PD-1 (programmed cell death 1) and its ligands, PD-L1
and PD-L2, probably the most talked about targets in cancer as they are
known to put the brakes on the immune system. Roche has been cast
into the spotlight with news last month that it won the vaunted FDA "Breakthrough Therapy" designation for its PD-L1 drug MPDL3280A.
Roche’s research arm Genentech presented promising data on the
experimental drug at this year’s American Society of Clinical Oncology
conference showing a 43% response rate and evidence of a durable effect
in patients with urothelial bladder cancer.
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The Future Research
At the root of all the aforementioned partnering activity is a
fascinating trend of biotechs to combine their immunotherapy with
another treatment to destroy cancer cells. This creates a particularly
compelling situation for Aethlon and its Hemopurifier extracorporeal
blood filtration device. Aethlon has demonstrated in clinical studies
that the Hemopurifier can rapidly and efficiently reduce or eliminate
viral loads in the treatment of HIV and hepatitis C infected patients.
Using different affinity agents in the process, the company has now
shown in the lab that the Hemopurifier can also capture and remove
tumor-secreted exosomes from the circulatory system.
With exosomes acting as a thumb on the immune system, allowing tumors to
run rampant, it seems logical that removing that thumb will allow
immune cells to attack and kill cancer cells and restore/maintain
homeostatic health. Aethlon will need to conduct clinical trials to
document the effectiveness of the Hemopurifier in reducing exosome load
and further delineate the clinical outcome of exosome depletion as it
relates to disease progression, but if it does so successfully it would
represent a major breakthrough in oncology. There are several catalysts
that can be derived from this clinical research, including Aethlon
likely becoming an attractive partner to increase the efficacy of either
a traditional small molecule drug or a biologic to treat cancer. It
just makes sense that in the quickly growing and competitive space of
immuno-oncology, companies looking to gain an edge could benefit from
marrying the Hemopurifier with their therapeutic to deliver the most
robust efficacy and improve speed in treatment.
Second, cancer is greatly lacking diagnostics, generally having to rely
upon biopsies that often do not happen until the disease has progressed,
or worse yet, metastasized. Because tumor-secreted exosomes are found
in all body fluids and are known to correlate to cancer progression,
there is the potential for a non-invasive blood (or even urine) test to
identify tumor presence at a much earlier stage.
At what could be considered a blistering pace, relative to typical drug
development, the oncology community seems to be approaching a major
breakthrough that will overcome the shortcomings of chemotherapy and
radiation treatments that are toxic with generally short-lived results.
Immuno-oncology regimens are showing themselves to hold a key to durable
response rates and it seems that combination therapies and new
diagnostic measures are positioning Aethlon and the Hemopurifier in the
thick of this transition to new and better ways to treat cancer.
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