NanoViricides™ is on the
cutting-edge of nanobiotechnology, with a rapidly developing portfolio of
indications designed to treat some of the most daunting viruses known to man
and do so in a wholly new and compelling fashion, to which said viruses may never
be able to effectively adapt. The company’s core technology exploits the very
mechanism and features of a virus which allow it to bind to a cell. By focusing
on the receptor binding molecules on the surface of a virion itself, which are
chemically similar even among viruses of varied protein signature and which
rarely change as a virus mutates, the company’s nanoviricides actually cover up
and block a virus’ multiple binding sites.
By using virus-binding ligands
that are derived from the virion’s own cell surface receptor binding sites,
which are covalently attached to nanomicelle polymers as a backbone carrier (an
aggregation of surface tension lowering molecules with polymer strands that can
unfold and encompass a virion, potentially also carrying active
pharmaceuticals), the company’s nanoviricides provide an unrivaled versatility
when it comes to how they work and how they can be administered. Nanoviricide
technology represents a real breakthrough in how we handle viral infections and
because the technology may be capable of optionally attacking the viral genome
itself and eradicating the virus, as well as smuggling active pharmaceutical
ingredients in, right up to the surface of the virus, there is considerable
upper limit potential here as well.
This platform technology is
being developed along two distinct vectors. Firstly, for providing solutions to
highly targeted and virus-specific applications, as is suitable for treating
HIV, Influenza and Avian (bird) Flu, like the A(H5N1) and A(H7N9) strains that
have crossed over into humans. Secondly, for providing broad-spectrum
nanoviricidal indications which could prove extremely effective at combating
some of the most rapidly changing tropical diseases, such as Ebola. The
company’s virus-specific nanoviricides function in such a targeted manner that
the non-specific (side) effects which are typically experienced with most
anti-viral agents on the market today, impacting both the virus and healthy
host cells, are essentially eliminated. The PEG-based (polyethylene glycol)
polymer used also means an optimum safety threshold with very limited immune
reactions and foreseeably easy clearance via the FDA.
The company’s broad-spectrum
nanoviricides have the potential to address up to 95% of known viruses, providing
the same kind of shotgun approach that allows various classes of antibiotic to
treat multiple forms of bacteria, because they exploit a feature that is common
to all bacteria. Furthermore, the company’s proprietary Accurate-Drug-In-Field™
(or ADIF) technology could quickly become the go-to field solution for
containing outbreaks, giving healthcare providers the ability to dynamically
respond to outbreaks around the world, using stockpiled nanomicelles as their
primary weapon. This key technological advantage offers healthcare providers
the ability to have the first dosages of a treatment drug up and running in as
little as three weeks, with a window as short as three months possible for
being able to roll out enough of the drug in order to treat people external to
the outbreak zone and really contain the virus.
The capacity of ADIF technology
to generate a drug targeted at a specific virus, without having to understand
its molecular biology or even have a specific identification, has enormous
biodefense potential, and represents a true frontline solution for combating
novel viruses, in addition to its obvious ability to help put handles on an
outbreak of a known virus. The capacity to rapidly develop a field solution
that can simply and completely gum up the ability of virtually any virus to
bind to host cells could mean one of the only universally effective ways to
head off a future biological catastrophe at the pass. And because the mechanism
of action in a nanoviricide is wholly different than that of typical vaccines,
which rely on stimulating the host’s immune system, nanoviricidal indications
could prove to be highly successful even in patients with compromised or
weakened immune systems.
This novel mechanism of action
not only future-proofs the company’s technology due to its ability to fool
practically any virus that emerges, effectively coating the virus in
nanoviricide and eventually destabilizing/dismantling it without the help of
the host’s immune system, it is also backed up by considerable IP, given that
all of the company’s candidates are based on the highly-tailorable TheraCour®
polymeric micelle technology created by Anil R. Diwan, PhD, NNVC’s President
and founder. The biomimetic capabilities of such nanoviricides, which mimic
existing biochemical processes, take full advantage of such properties as
addressing and encapsulation, as well as lipid fusion, not just blocking a few
sites, but engulfing the virus particle in its entirety and initiating its
decomposition. With exclusive worldwide license to this technology and two
broad international patent applications covering everything from manufacture to
materials, as well as the methods and fields of use, NNVC is in a very strong
IP position and intends to file patent applications on each separate drug as
they go along.
Nanoviricides as a tool have the
potential to effectively combat some of the most daunting viruses in existence
that have defied medical science for decades or more, like the constantly and
rapidly changing Influenza virus, better known as the common cold, for which
existing vaccination regimens have proven to be only marginally effective. With
the CDC’s own data openly acknowledging the widely ranging effectiveness of
vaccination against various strains of Influenza and with other daunting
viruses on the loose like dengue (fever), which was just recently the subject
of an epidemic declaration in Brazil by the country’s Health Minister, as well
as HIV, herpes, and even Ebola now spreading around the globe, the demand for a
wholly new and clinically effective approach is greater than ever before.
Currently, the company has six
commercially significant drug development programs in various stages, including
both an injectable and oral version of an Influenza drug, aptly named FluCide®.
Injectable FluCide™ saw a good safety report profile come out back in January
of this year, showing no direct adverse clinical effects observed after a
4,200mg/kg total intravenous dosage over 14 days in a GLP-like toxicology study
in rats, which was conducted by Bioanalytical Systems (NASDAQ: BASI). This
injectable version of FluCide is in IND-enabling studies at the moment and
represents the most advanced of all of the company’s pipeline candidates. With
this latest study confirming earlier results of a non-GLP toxicology study in
mice and also showing positive findings in different influenza A strains,
posting similarly high marks for safety and toxicology, FluCide is now clearly
ready to move on to the next step. Commissioning operations are currently in
the offing and are slated to take place at the company’s new state-of-the-art
cGMP-compliant manufacturing and R&D facility in Connecticut, which was
acquired in January this year.
The company’s strong
cash-in-hand position and $36.4 million in current assets plus restricted cash
reported at the close of 2014, on a burn rate in the neighborhood of $2 million
a quarter, NNVC feels very comfortable having grabbed this important 18k square
foot facility, which has all the lab, as well as cGMP-compliant raw materials
handling/dispensing and clean room suites needed, to make and package
clinical-scale quantities of the company’s nanomedicines. More importantly, the
acquisition is a much more economically sustainable option than leasing and the
company is confident that this facility, combined with their strong financial
position, will ably carry them into human clinical studies on at least one of
their promising candidates, and quite possibly allow for one other drug to
reach the IND development stage.
The company’s anti-HSV (herpes
simplex virus) drug candidates have demonstrated greater than 99.9% inhibition
in cell culture against two distinct, different strains of herpes. The
incredible effectiveness of the company’s anti-herpes drug candidates reported
in April this year – where it blew the current standard of care, acyclovir, out
of the water, with lethally infected HSV-1 H129c strain mice showing
substantially complete survival – is a clear indication of how promising these
anti-HSV candidates truly are. NanoViricides will seek rapid drug approval from
the FDA for its anti-herpes candidates and the company is especially confident
considering that acyclovir used at two times the concentration needed for
humans has only showed a less than a 58% survival rate. What’s more, the
anti-herpes candidates from NanoViricides demonstrated a significant reduction
in disease severity alongside the extremely high survival rate, potentially
making it a shoe in for FDA fast track. NNVC has also seen some powerful results
in EKC (epidemic kerato-conjunctivitis), or severe pink eye disease, with their
EKC-Cide™ candidate, and ongoing work in HIV/AIDS has also been quite
promising, with sustained viral load reduction in HIV-1 even after treatment
with HivCide™ was stopped, according to a recent mouse model study.
Also worth mentioning here is
how the company’s rapid design platform has led to several EbolaCide™
candidates being developed in recent months, with positive results from the
company’s collaborating BSL-4 facility in January showing broad-spectrum
efficacy against both Ebola and the closely related Filoviridae family
hemorrhagic fever virus, Marburg. Given the recent Ebola outbreak in West
Africa, the largest in the planet’s history according to CDC data, with two reported
cases having been officially imported to the U.S. during the outbreak, NNVC’s
EbolaCide candidates could be just the thing that the CDC and WHO have been
looking for in order to help stop the next outbreak before it happens.
Mimicking natural host cell
receptors and tricking a virus to bind to nanoviricidal nanomicelles,
effectively encapsulating the virus and making it non-infectious, is a
potentially disruptive, game-changing technology for the roughly $27.6 billion
global antiviral market, which is on track to hit upwards of $36.44 billion by
2019 according to recent analysis published by Mordor Intelligence. The space
is projected to grow at a CAGR of around 5.71% over the next several years
through 2019, and NanoViricides is positioned to capture significant market
share if their revolutionary nanomedicines pan out as hoped.
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MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html
