The China Mail - NanoViricides is in a Great Position to Fight Potential Bird Flu Pandemic with a Drug that the Mercurial H5N1 Influenza A Virus is Unlikely to Escape

"Despite all changes, the H5N1 Influenza A virus should remain susceptible to NV-387 because NV-387 mimics the very essential host-side feature that H5N1 continues to use even as it changes," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding "This drug puts us in a great position to be able to fight a bird flu pandemic should it happen."

WHO has stated "Available virus sequences from human cases [of H5 infection] have shown some genetic markers that may reduce susceptibility to neuraminidase inhibitors (antiviral medicines such as oseltamivir) [NAIs] or endonuclease inhibitors (such as baloxavir marboxil) [PBIs]" in their updated public health assessment of recent Influenza A H5 infections, dated December 20, 2024^[1].

NAIs and PBIs^[2] are the only classes of drugs that currently exist for influenza treatment, and as the virus evolves, they are very likely to be rendered ineffective in the field, since already strains with reduced susceptibility are circulating.

While the US Government has already sourced and stockpiled two different H5N1 vaccines, the Biden administration has currently no plans to authorize their use.

Influenza viruses change far more rapidly than SARS-CoV-2 ever did in the COVID-19 pandemic^[3]. At least one mutation in the H5 coat protein would be required for efficient infection of humans, and a few more changes that would still be required for rapid human-to-human transmission, in order for the H5N1 virus to turn into a pandemic virus; changes that have not happened yet.

Nevertheless, any currently designed H5N1 vaccines are unlikely to be of much use, or possibly very limited use, from public health perspective to protect from a potential pandemic strain of H5N1 that has not appeared yet.

In any case, vaccine against a rapidly changing virus is a game of chasing a rapidly moving target, as we have all learned from the experience during the COVID-19 pandemic^[4].

It is thus clear that a drug that the virus cannot escape is the only appropriate tool to fight a potential pandemic.

We have already developed such a drug. NV-387 is a broad-spectrum antiviral that mimics the very host-side features that the virus continues to require no matter how much it changes in the field. It is highly unlikely that a susceptible virus would escape such a drug.

The ultra-broad antiviral spectrum of NV-387, which encompasses a large number of diverse kinds of viruses including COVID, RSV, Influenza and even Orthopoxviruses (i.e. MPox, Smallpox), further substantiates that it is unlikely that a susceptible virus would escape this drug.

What is more, NV-387 has demonstrated substantially superior activity to existing influenza drugs in a lethal lung infection animal study, as we have previously reported (reproduced below):

In this animal study, we also found that NV-387 treatment led to significant lung protection in the infected animals: lung destroying immune cell infiltration was substantially reduced, and the amount of mucus in the lungs was also substantially reduced, indicating that NV-387 protected the lungs and the animal from advancing into pneumonia.

We believe that any H5N1 highly pathogenic virus is likely to be even more susceptible to NV-387 than the seasonal H3N2 influenza A virus. This is because all High-Path Avian Influenza A viruses are known to possess a poly-basic site that is much longer than the corresponding sequence in seasonal influenza viruses. The virus uses this poly-basic site to bind to sulfated proteoglycans prior to entry into cells. NV-387 displays a copious amount ligands that mimic this sulfated structure, which is how this drug (NV-387) entraps the virus. Thus a longer poly-basic site would be expected to cause a stronger interaction between the H5N1 High Path viruses and NV-387 in contrast to the interaction between NV-387 and seasonal influenza viruses.

NV-387 has completed a Phase I human clinical trial with no reported adverse events and no drop-outs, indicating excellent safety and tolerability. We are now preparing for a Phase II clinical trial for the treatment of MPox which is currently an epidemic in Central Africa. We are also working on a Phase II clinical trial of NV-387 for the treatment of respiratory virus infections (including Influenza viruses, Coronaviruses, and RSV, among others).

Thus we believe that we are in a strong position to combat a potential bird flu pandemic, being one of very few companies globally that is developing a broad-spectrum antiviral drug with the promise that viruses would be highly unlikely to escape the drug.

^[1] https://www.who.int/publications/m/item/updated-joint-fao-who-woah-assessment-of-recent-influenza-a(h5n1)-virus-events-in-animals-and-people_dec2024

^[2] NAIs = Neuraminidase inhibitors. These include Oseltamivir (Tamiflu®), Peramivir (Rapivab®), Zanamivir (Relenza®). They inhibit the exit of the virus particle from cell after the virus has already replicated into copious quantities inside the cell. PBIs = Viral Polymerase (B) inhibitors. Currently only Baloxavir (Xofluza) is licensed. They inhibit the production of new copies of viral genomic RNA. However, resistant virus to baloxavir was created in patients treated with baloxavir in its clinical trial itself. Further, the toxicity of this drug limits its use to a single dose.

^[3] Influenza viruses change very rapidly because they have many more tools to change themselves compared to other viruses. Firstly, an influenza virus is made up of eight separate segments of RNA, that it can simply swap with other influenza viruses (called "Re-assortment"). Secondly, segments of RNA can hop from one RNA to another (Called "Recombination"), and thirdly, single point mutations occur all the time across the entire RNA, because the virus lacks "proof-reading" capability (i.e. ability to ensure that the RNA is copied correctly).

^[4] The COVID vaccines did not protect the vaccinated from getting sick, and they did not even stop the vaccinated from transmitting the virus to others. The benefit of vaccination is thought to be in persons with other morbidities who would have been likely to contract severe disease from infection with hospitalization and possible death. However, the vaccines always lagged behind in time, developed against a strain that was already overtaken by a different one in the field even before rollout of the vaccine.

About NanoViricides

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. 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 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 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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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 which 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.

The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

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. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.

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SOURCE: NanoViricides, Inc.

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