NanoViricides
Announces COVID-19 Clinical Drug Candidate NV-CoV-2 was Effective
Against SARS-CoV-2, Further Demonstrating Its Broad-Spectrum
Pan-Coronavirus Activity
Shelton,
Connecticut -- (October 11, 2021) -- InvestorsHub NewsWire
-- NanoViricides,
Inc. (NYSE
American:
NNVC) (the
"Company"), a leader in the development of highly effective
antiviral therapies based on a novel nanomedicines
technology, announced
today that its Pan-Coronavirus COVID-19 Drug Candidate
NV-CoV-2
was found to be effective against SARS-CoV-2 in a standard cell
culture pseudovirion assay, demonstrating that the drug indeed has
broad-spectrum pan-coronavirus activity. This pan-coronavirus
activity implies that the drug NV-CoV-2 should remain active in
spite of evolution of variants of
SARS-CoV-2
in the field, a highly sought-after characteristic to combat the
current global pandemic.
In this
assay, both the drug candidate NV-CoV-2 and a positive control
antibody specific to the Spike antigen S1 of the SARS-CoV-2 virus
suppressed the infection by the SARS-CoV-2-pseudovirions in cell
culture studies to virtually the same baseline levels.
We have
now demonstrated that NV-CoV-2 is highly effective in cell cultures
against SARS-CoV-2, human coronavirus NL-63, and human coronavirus
229E, all very different human coronaviruses. These results imply
that the drug will remain active in spite of novel variants of
SARS-CoV-2 evolution in the field, and indeed demonstrate the
pan-coronavirus activity of our clinical drug candidate
NV-CoV-2.
Additionally, the
pseudovirion study also showed that NV-CoV-2 neutralizes the virus
particles themselves, outside of the cells, validating our design
mechanism.
"We are
now preparing submission documents to enable initiation of human
clinical trials," commented Dr. Anil Diwan, Chairman and President
of the Company, adding, "We believe that NV-CoV-2 may help end the
pandemic if it is shown to be effective in human clinical
trials."
A strong
SARS-CoV-2 infection inhibition activity of NV-CoV-2 was observed
in this pseudovirion study. Pseudovirion assay is a standard method
for evaluating virus entry-inhibitors in BSL2 laboratories and is
primarily used for viruses that would otherwise require high
security BSL3 or BSL4 laboratories.
In this
study, SARS-CoV-2-pseudovirion virus particles were made that carry
a green fluorescent protein (GFP) producer mRNA inside, and use the
SARS-CoV-2 S1 protein on their surface to bind to ACE2 receptor
protein on cells. They were incubated with NV-CoV-2 (test article),
or a known neutralizing antibody (positive control), or just the
vehicle buffer (negative control). Then these solutions were
separately used to infect ACE2 positive cells and the cultures were
incubated. Only the infected cells produced GFP and were visualized
by green fluorescence in microscopy. In this well-known assay,
NV-CoV-2 was as effective as the neutralizing antibody in reducing
the virus infection. This study demonstrates that NV-CoV-2 attacks
the SARS-CoV-2 pseudovirion particles and renders them incapable of
binding to the ACE2 positive cells.
A
"pseudovirion" is a virus particle made of a BSL-2 virus shell, but
with its original cell-binding protein replaced by the cell binding
protein of a BSL3 or BSL4 virus, in this case, the S1 antigen
of
SARS-CoV-2.
Additionally,
the pseudovirion particle contains an mRNA that is packaged like
the original virus, except that the mRNA is edited and redesigned
so that it cannot produce infectious virus particles. In our study,
this mRNA allowed expression and production of the green
fluorescent protein (GFP) enabling visual detection of the infected
cells (green) in microscopy.
About
NanoViricides
NanoViricides,
Inc. (the "Company") (http://www.nanoviricides.com)
is a development stage company that is creating special purpose
nanomaterials for antiviral therapy. The Company's novel
nanoviricide® class of drug candidates are designed to specifically
attack enveloped virus particles and to dismantle them. We are
developing clinical candidates for the treatment of COVID-19
disease caused by SARS-CoV-2 coronavirus. Our other lead drug
candidate is NV-HHV-101 with its first indication as dermal topical
cream for the treatment of shingles rash. In addition, the Company
has several antiviral programs in various pre-clinical
stages.
The
Company is now working on tasks for completing an IND application
for its COVID-19 drug candidates. The Company cannot project an
exact date for filing an IND for this drug because of its
dependence on a number of external collaborators and consultants.
The Company is currently pursuing two separate drug candidates for
the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide
drug candidate that does not encapsulate remdesivir. NV-CoV-2-R is
our other drug candidate that is made up of NV-CoV-2 with
remdesivir encapsulated in it. The Company believes that since
remdesivir is already US FDA approved, our drug candidate
encapsulating remdesivir is likely to be an approvable drug, if
safety is comparable. Remdesivir is developed by Gilead. The
Company has developed both of its own drug candidates NV-CoV-2 and
NV-CoV-2-R independently.
The
Company intends to re-engage into an IND application to the US FDA
for NV-HHV-101 drug candidate for the treatment of shingles once
its COVID-19 project moves into clinical trials, based on resources
availability. The NV-HHV-101 program was slowed down because of the
effects of recent COVID-19 restrictions, and re-prioritization for
COVID-19 drug development work.
The
Company is also developing drugs against a number of viral diseases
including oral and genital Herpes, viral diseases of the eye
including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu,
seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and
Ebola virus, among others. NanoViricides' platform technology and
programs are based on the TheraCour® nanomedicine technology of
TheraCour, which TheraCour licenses from AllExcel. NanoViricides
holds a worldwide exclusive perpetual license to this technology
for several drugs with specific targeting mechanisms in perpetuity
for the treatment of the following human viral diseases: human
Coronavirus infections, Human Immunodeficiency Virus (HIV/AIDS),
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes
Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV),
Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese
Encephalitis virus, West Nile Virus and Ebola/Marburg viruses. The
Company's technology is based on broad, exclusive, sub-licensable,
field licenses to drugs developed in these areas from TheraCour
Pharma, Inc.
The
Company's business model is based on licensing technology from
TheraCour Pharma Inc. for specific application verticals of
specific viruses, as established at its foundation in
2005.
As is
customary, the Company must state the risk factor that the path to
typical drug development of any pharmaceutical product is extremely
lengthy and requires substantial capital.
As with
any drug development efforts by any company, there can be no
assurance at this time that any of the Company's pharmaceutical
candidates would show sufficient effectiveness and safety for human
clinical development.
Further,
there can be no assurance at this time that successful results
against coronavirus in our lab will lead to successful clinical
trials or a successful pharmaceutical product.
This press
release contains forward-looking statements that reflect the
Company's current expectation regarding future events. Actual
events could differ materially and substantially from those
projected herein and depend on a number of factors. Certain
statements in this release, and other written or oral statements
made by NanoViricides, Inc. are "forward-looking statements" within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. You should not
place undue reliance on forward-looking statements since they
involve known and unknown risks, uncertainties and other factors
that are, in some cases, beyond the Company's control and which
could, and likely will, materially affect actual results, levels of
activity, performance or achievements. The Company assumes no
obligation to publicly update or revise these forward-looking
statements for any reason, or to update the reasons actual results
could differ materially from those anticipated in these
forward-looking statements, even if new information becomes
available in the future. Important factors that could cause actual
results to differ materially from the company's expectations
include, but are not limited to, those factors that are disclosed
under the heading "Risk Factors" and elsewhere in documents filed
by the company from time to time with the United States Securities
and Exchange Commission and other regulatory
authorities.
Although
it is not possible to predict or identify all such factors, they
may include the following: demonstration and proof of principle in
preclinical trials that a nanoviricide is safe and effective;
successful development of our product candidates; our ability to
seek and obtain regulatory approvals, including with respect to the
indications we are seeking; the successful commercialization of our
product candidates; and market acceptance of our
products.
FDA refers
to US Food and Drug Administration. IND application refers to
"Investigational New Drug" application. cGMP refers to current Good
Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and
Controls". CHMP refers to the Committee for Medicinal Products for
Human Use, which is the European Medicines Agency's (EMA) committee
responsible for human medicines.
Contact:
NanoViricides,
Inc.
info@nanoviricides.com
http://www.nanoviricides.com
Public
Relations Contact:
MJ
Clyburn
TraDigital
IR
clyburn@tradigitalir.com
Source:
NanoViricides, Inc.
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