SHELTON, CT / ACCESSWIRE / June 9, 2020 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, reported today that it has signed a Memorandum of Understanding ("MoU") with respect to anti-viral treatments for coronavirus derived human infections (the "Field") with TheraCour Pharma, Inc.
The MoU specifically provides a limited, exclusive license to all research and development in the Field for further research and development purposes towards human clinical trials. NanoViricides intends to retain an independent consultant for the evaluation of the assets in order to develop the full license agreement.
NanoViricides has been working on drug development to treat the SARS-CoV-2 infection in COVID-19 patients since January, 2020. Prior to this, the Company had engaged in limited research and development work for the treatment of MERS coronavirus during 2014 which allowed for rapid drug candidate identification against SARS-CoV-2. The MERS coronavirus program was set aside as the 2014 outbreak remained contained.
The Company has found that the broad-spectrum anti-coronavirus drug candidates that it is developing were several times more effective than favirpravir in cell culture assays against two different coronaviruses, namely hCoV-229E, and hCoV-NL63. These circulating coronaviruses use distinctly different, but related cellular receptors, namely APN for hCoV-229E and ACE2 for hCoV-NL63.
The Company believes the fact that these nanoviricides anti-coronavirus drug candidates are highly effective against two distinctly different coronaviruses that use different cellular receptors is very significant. Specifically, it provides a rational basis to scientists indicating that even if the SARS-CoV-2 coronavirus mutates, the nanoviricides can be expected to continue to remain effective.
The Company has also found that these drug candidates showed strong effectiveness in an animal model of human coronavirus disease, potentially superior to remdesivir in this particular model, although no firm conclusions to that effect can be drawn with the limited dataset at present. The Company employed hCoV-NL63 in this animal study, because hCoV-NL63 binds to the same cell receptor, namely ACE2, as does SARS-CoV-2 and the 2002-03 SARS-CoV. NL-63 causes clinical pathology in humans that is similar to SARS-CoV-2, but much milder. Thus this virus (NL-63) is expected to be a good surrogate for SARS-CoV-2.
The Company believes that it now has broad-spectrum anti-coronavirus drug candidates that are worthy of human clinical trials based on their effectiveness in cell culture and animal models.
Importantly, nanoviricides are designed to act by a novel mechanism of action, trapping the virus particle like the "Venus-fly-trap" flower does for insects. Antibodies, in contrast, only label the virus for other components of the immune system to take care of. It is well known that the immune system is not functioning properly at least in severe COVID-19 patients.
Prior to filing for human clinical trials, NanoViricides plans on conducting studies to further determine the effectiveness against SARS-CoV-2, perform drug development studies for safety/toxicology, and request a pre-IND Meeting with the US FDA for regulatory guidance.
Human coronavirus NL63 (hCoV-NL63) uses the same ACE2 receptor as the SARS-CoV-2 that causes CoVID-19. Both in terms of its clinical pathology, and its receptor usage, it is known to be very similar to SARS-CoV-2, except much milder. Therefore the Company believes hCoV-NL63 is a good surrogate model for therapeutics development against SARS-CoV-2. HCoV-NL63 can be studied in a BSL2 lab whereas SARS-CoV-2 currently requires a BSL3 or BSL4 facility.
TheraCour Pharma, Inc. is a privately owned company, controlled by Anil R. Diwan, PhD, the principal developer of the polymeric-micelle based nanomedicines technologies. Dr. Diwan is co-founder, President and Chairman of the Board for NanoViricides, Inc. TharaCour licenses its intellectual property from AllExcel, Inc., another company which is owned and controlled by Dr. Diwan. Dr. Diwan recused himself in the Board's discussions on the MoU, and recuses himself from the Company's discussions regarding the license agreements as well. McCarter & English, LLP advised the NanoViricides Board of Directors and DuaneMorris, LLP advised TheraCour on this MoU. These law firms are expected to continue as attorneys for the parties for the negotiation of the license predicated in the MoU.
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 has a limited license from TheraCour for the field of all human coronavirus infections under a Memorandum of Understanding ("MoU") to that effect, and is working on a full license which will replace the MoU.
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".
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