DGAP-News: NanoViricides, Inc. / Key word(s): Miscellaneous
NanoViricides, Inc.: Broad-Spectrum Direct Antiviral Nanomedicine Should Remain Effective Against COVID-19 Virus
Variants, Says NanoViricides, Inc.'s President, Dr. Anil Diwan
2021-01-27 / 12:15
The issuer is solely responsible for the content of this announcement.
Broad-Spectrum Direct Antiviral Nanomedicine Should Remain Effective Against COVID-19 Virus Variants, Says
NanoViricides, Inc.'s President, Dr. Anil Diwan
SHELTON, CT / ACCESSWIRE / January 27, 2021 / NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a global leader
in the development of highly effective broad-spectrum antiviral therapies based on a novel nanomedicines platform,
today discusses the current developments in the COVID-19 pandemic and the Company's exciting accomplishments related to
"We welcome the strong engagement of President Biden and his new administration's commitment to combat this
once-in-a-century pandemic with new approaches and fresh ideas," said Anil R. Diwan, PhD, President of the Company.
We would like to note that the scientific community at large and regulatory efforts to date have remained focused on
(a) vaccines, (b) antibodies, and (c) re-development of pre-existing drugs. Even as alarm bells were raised by renowned
scientists regarding the likelihood of escape mutations and the limitations of any vaccines and antibody therapies in
combating a rapidly evolving global viral pandemic, there has been an effort to downplay these risks at all levels.
This has left the world now grappling with a situation where vaccines are being rolled out even as virus variants that
are highly likely to be resistant to current vaccines and antibody drugs have already been found to be spreading
rapidly. Current vaccines are now assumed to require constant updates and re-inoculation campaigns to keep up with
ongoing changes in the virus. Attention needs to be focused instead on broad-spectrum antiviral therapeutics that
minimize the possibility of virus variants escaping the drug, thereby making the costly ongoing development of vaccine
updates, their deployment and re-inoculation campaigns unnecessary.
NanoViricides believes it is very likely the only company with a platform technology that enables development of drugs
that viruses would not escape. In fact, we have successfully screened our COVID-19 drug candidates to be able to
protect cells against infection by distinctly different coronaviruses. This broad-spectrum drug development approach
was adopted to ensure that our drug candidates should remain effective even as future variants of SARS-CoV-2 evolve in
the field, as was already anticipated by us at that time.
Additionally, NanoViricides is the only company that, to the best of our knowledge, is developing antiviral treatments
designed to (a) directly attack the virus and disable it from infecting human cells, and (b) simultaneously block the
reproduction of the virus that has already gone inside a cell. Together, this strategy of a two-pronged attack against
the virus, both inside the cell and outside the cell, can be expected to result in a cure for coronaviruses and other
viruses that do not become latent.
The Company's nanoviricides(R) platform technology is based on biomimetic engineering that copies the features of the
human cellular receptor of the virus. No matter how much the virus mutates, all virus variants bind to the same
receptor in the same fashion. It appears that the later variants of SARS-CoV-2 may have evolved to bind to the human
cellular receptor ACE2 more strongly, in general, based on published datasets. Thus, if these features of the cellular
receptor are appropriately copied, the resulting nanoviricide drug would remain effective against current and future
variants of the virus.
Our current drug candidates to combat the COVID-19 pandemic are designed to attack not only SARS-CoV-2 and its current
and future variants, but also many other coronaviruses, and will be useful even after the pandemic is over, because
several coronaviruses are endemic in human populations.
Our COVID-19 drug candidates successfully entered core safety pharmacology studies required prior to any human clinical
trials around October/November, 2019. These studies have now been completed and we are anticipating the report from the
external CRO shortly. We are now working on preparing a pre-IND application for filing with the US FDA as soon as
possible. Additionally, we are actively seeking opportunities to engage appropriate sites for human clinical trials,
and we are engaged in the preparation of clinical trial protocols and other activities that would be necessary for
filing of an IND with the US FDA.
The need for the broad-spectrum nanoviricide SARS-CoV-2 drug cannot be overstated in the current circumstances and the
present status of the pandemic. To understanding this, we are providing a short review of the current state of the
Strong government support led to rapid emergency use approval, and later full approval, of an already known antiviral
drug now called Veklury (remdesivir, Gilead) early on. Strong fiscal support and regulatory enablements from the
government also led to the emergency use approval of two different antibody drugs, one from Regeneron (REGN-CoV-2, a
monoclonal antibody cocktail containing two different antibodies), and one from Eli Lilly (bamlanivimab, a single
antibody for restricted use) in the fastest ever drug development timeframe. All of these antibody drugs target the
viral Spike protein that binds to the human cellular receptor, ACE2.
Even stronger commitments and strong government support led to the fastest ever emergency use approval of two vaccines,
both employing nanotechnology; one by Pfizer-BioNTech, and one by Moderna, with additional vaccines in development. All
of these vaccines target the original 2019-nCoV-Wuhan variant, and all but a few target primarily its Spike protein.
Yet, as the vaccines are undergoing deployment, several new virus variants of tremendous concern have already emerged.
Additional virus variants will continue to emerge at an even faster rate because of the widespread dissemination of the
virus with many patient bodies serving as virus factories providing historically the biggest ever opportunities for the
virus to escape existing vaccines and antibody drugs. Failure of vaccines and antibody drugs is therefore certain; the
only question is how long will it be before the vaccines become substantially ineffective.
Replacing current vaccine with a new vaccine, as has been suggested, would be an endless game of chasing a rapidly
changing epidemic that would be costly and also would remain substantially non-responsive to the threat, since the
virus will continue to remain many steps ahead of the vaccine.
It is well known that viruses, particularly RNA viruses, mutate rapidly, and that such changes produce "variants" that
can escape from vaccines as well as from antibody drugs. SARS-CoV-2 has a repair mechanism that retains some fidelity
during reproduction, and therefore it changes less rapidly than Influenza A viruses or HIV. Nevertheless, given the
significant penetration of the virus into human population, and the very high viral loads achieved in severe cases of
the infection, the virus has a huge opportunity to change. Additional virus variants will undoubtedly continue to
emerge at an even faster rate because of the widespread dissemination of the virus through many patients, their bodies
effectively serving as "factories". This important concern, voiced by several eminent scientists, has not been regarded
with the seriousness it deserves by supporting and enabling rapid regulatory development of broad-spectrum
The world has already witnessed at least five important SARS-CoV-2 variants with significant impact, as a result of the
large number of persons becoming infected. The very first important variant, namely D614G, replaced the original Wuhan
strain completely and rapidly during the first wave of the pandemic itself. In the current second wave, we have seen
emergence of the lineage B.1.1.7 variant from United Kingdom (Kent and London), the N501Y-V.2 (also called lineage
B.1.351) from South Africa, and the P.1 variant (also called lineage B.1.1.248) from Brazil. California has seen
lineage B.1.429 /(CAL.20C) variant become dominant in Los Angeles county recently, with over 50% of the infections. It
appears to be replacing the earlier dominant CAL.20G variant. Several additional variants have been identified. New
variants continue to be identified at a rapid pace as viral genome sequencing efforts are accelerated.
Each of these five variants arose independently and in distinct geographic areas, and yet they share many common
features, including a number of mutations in the receptor-binding region of the coronavirus Spike protein. It appears
that the 501Y mutation in the spike protein leads to stronger binding to the human cellular receptor ACE2, allowing the
virus to infect more productively, and has become more common in later variants. It appears that the E484K mutation,
along with other mutations, present in the South African and Brazilian variants, may result in escape from vaccines and
A major concern is the fact that the variants that are now becoming dominant have an accumulation of multiple
mutations. This is predictive of such variants being more resistant to drugs and vaccines. They are likely to have been
selected against drug pressure or immune system pressure, and thus would likely have resistance to antibody drugs, as
well as other commonly used drugs, as suggested by eminent scientists. Further, it is now known that some of the new
variants can cause infection of a previously recovered coronavirus patient, and sometimes may lead to more severe
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January 27, 2021 06:15 ET (11:15 GMT)