SHELTON, CT / ACCESSWIRE / May 4, 2020 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, announced that it has signed a Confidential Disclosure Agreement ("CDA") with a leading pharmaceutical company in the Asian region to explore collaborating on the Company's COVID-19 program.
NanoViricides previously disclosed that it has already identified certain drug candidates that are active against multiple coronaviruses in cell culture studies. The Company intends to perform testing against SARS-CoV-2 (the virus that causes COVID-19 disease) and is in advanced discussions with at least two sites that have such capability. This testing is expected to enable the Company to declare a clinical drug candidate for COVID-19 based on viral load reduction.
The pharmaceutical company with whom the CDA was executed has experience in drug development of novel technology platform-based drug candidates. It has both marketing and R&D presence in multiple countries within the Asian region. In addition, the pharmaceutical company has several collaborative drug development programs, both in-licensed from smaller biopharma companies and out-licensed to global Big Pharma companies, in a range of disease indications.
NanoViricides is developing what currently may be one of the very few novel antiviral drug candidates specifically targeting the coronavirus SARS-CoV-2, with broad-spectrum activity against other coronaviruses. The Company believes the broad-spectrum activity of its drug candidates substantiates that the drugs may continue to work even as the virus mutates in the field. Such viral mutations are already demonstrated with SARS-CoV-2 and it is widely thought that vaccines and antibodies could be rendered ineffective in the next iteration of the virus's outbreak due to such mutations.
NanoViricides' approach goes beyond antibodies. An antibody binds the virus at only two points of attack, and tens of antibodies would be needed to disable a single virus. In contrast, the Company's nanoviricides bind with copious numbers of binding points, all designed to occlude the receptor-binding-domain of the S-protein of the coronavirus, thus disabling the virus's ability to infect human cells. In addition, the attack of a nanoviricide micelle on the virus particle is expected to result in encapsulation of the virus particle, with potential uprooting of the S-protein tail from the virus lipid membrane, thereby neutralizing the virus particle. NanoViricides has previously demonstrated that such effects, driven by the well-known biophysical mechanism of lipid-lipid-fusion, can occur with at least some viruses.
Thus, in the current pandemic scenario, the Company believes its drug development is a highly promising approach. At the same time, as a novel drug candidate, it is necessary to execute on an accelerated path for human applications without compromising safety. The NanoViricides platform has been shown to be safe as injectable in preliminary, non-GLP animal studies directed at other diseases. The Company intends to perform similar animal studies for the clinical SARS-CoV-2 nanoviricide drug candidate for developing information for entering into first-in-human studies under the US FDA or other regulatory agencies.
The CDA allows the two companies to discuss publicly undisclosed information about NanoViricides' drug development against SARS-CoV-2 to treat COVID-19 that is currently a worldwide pandemic. Further discussions may lead to additional collaborative development agreements. As with any such exploratory discussions, there is no guarantee of such additional agreements at this time.
"We are pleased with the global interest in our drug development programs," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "We believe a collaboration with a leading pharmaceutical company with expertise in rapid drug development of novel technologies would help us accelerate the time to human clinical trials for our SARS-CoV-2 drug candidate in development."
Even in late stages of the COVID-19 disease, the viral load in the patient remains high, unlike in the case of some other viral diseases such as influenza. Thus, a nanoviricide drug that is designed to directly attack the virus and destroy it, thereby minimizing the viral load, is expected to have high effectiveness in controlling the disease and enabling recovery of the patient.
About NanoViricides
NanoViricides, Inc. (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. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. 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. 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 does not currently have a license to the coronavirus field, however, TheraCour has not denied any licenses to the Company. The Company typically begins the licensing process only after demonstrating effectiveness of some candidates in optimization stage.
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.
As with any drug development efforts, there can be no assurance that any of these candidates would show sufficient effectiveness and safety for human clinical development at this time. There can be no assurance that the Company will be successful in establishing the necessary collaborations, although the Company has been successful at establishing necessary collaborations for its drug programs in the past. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. CMC refers to "Chemistry, Manufacture, and Controls".
