SHELTON, CONNECTICUT -- Tuesday, June 9, 2020 -- NanoViricides, Inc. (NYSE Amer.: 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.