NanoViricides to Present at the Biotech Showcase in San Fransisco
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Insights
The announcement by NanoViricides regarding the successful Phase 1 clinical trials of NV-CoV-2 Oral Syrup and Oral Gummies drug products is a promising development in the field of antiviral therapies. The company's novel approach, which utilizes a nanomedicine technology to mimic cell-side receptor molecules, could potentially address the issue of viral resistance that is a common hurdle in antiviral drug development. The broad-spectrum activity of NV-387 across multiple virus families, including coronaviruses and RSV, positions it as a versatile candidate in a market that is in need of effective, broad-spectrum antiviral drugs.
From a research perspective, the 'Re-Infection Blocker' mechanism of NV-387 is particularly intriguing. It represents a significant departure from traditional antiviral approaches, which often target specific viral proteins that can mutate and render drugs ineffective. By mimicking sulfated proteoglycans (S-PG), NV-387 has the potential to maintain efficacy even as viruses evolve. This could be a game-changer in treating not only current viral threats but also emerging ones, as the mechanism suggests a reduced likelihood of resistance development.
Furthermore, the ability of NV-387 to encapsulate and deliver other drugs orally enhances its therapeutic potential and could lead to improved patient compliance compared to intravenous administration. The oral delivery of traditionally difficult-to-administer active pharmaceutical ingredients (APIs) could also open new avenues for drug development within the industry.
Given the reported market size for RSV therapeutics at $1.8 billion in 2022, with an expected compound annual growth rate (CAGR) of 18.9%, reaching $8.73 billion by 2031, the successful development of NV-387 could tap into a significant and rapidly expanding market. The ongoing challenges posed by SARS-CoV-2 variants and the potential threat of other coronaviruses, such as MERS-CoV, underline the importance of developing drugs like NV-387 that can be administered to all patient populations due to their strong safety profiles.
Additionally, the comparison of NV-387 to antibiotics in terms of its potential impact on antiviral treatment is noteworthy. Should NV-387 prove to be as broadly effective as suggested, it could indeed revolutionize the treatment of viral infections and capture a substantial share of the multi-billion-dollar antiviral drug market. This could have significant implications for NanoViricides' valuation and attractiveness to investors, especially considering the company's broad pipeline of antiviral drugs targeting various viruses.
The emphasis on NV-387's potential role in biodefense is critical, particularly in the context of smallpox and its 'cousin' Mpox. The mention of NV-387's efficacy compared to the approved drug tecovirimat (TPOXX®) in a mouse model highlights its potential as an alternative or complementary option to current biodefense strategies. In the scenario of bioterrorism, where engineered viruses could be a threat, the ability to rapidly deploy effective therapeutics is paramount.
The development of broad-spectrum antivirals like NV-387 is essential for preparedness against bioterrorism threats. The ability of NV-387 to act against a wide range of viruses, including potential bioengineered variants, could make it a valuable asset in national stockpiles and international biodefense strategies. This aspect of NV-387's development may also attract government interest and funding, which could further support NanoViricides' research and development efforts and potentially lead to strategic partnerships or contracts.
SHELTON, CT / ACCESSWIRE / January 4, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, announced today that it is presenting at Biotech Showcase™ 2024.
Event Information:
| Event | NanoViricides Presentation at the Biotech Showcase, San Fransisco |
| Day & Date | Tuesday, January 9, 2024 |
| Time, Track & Room | 3:30pm PT, Yosemite C (Ballroom Level) |
| Location | Hilton San Fransisco - Union Square |
This year, registered attendees can view NanoViricides' presentation live, and also access a recorded version after the event. With 24x7 on-demand access, attendees can view recorded presentations at their convenience when scheduling does not allow viewing during the main event week.
Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year in San Francisco during the course of one of the industry's largest gatherings and busiest weeks.
"We are delighted that NanoViricides will be joining us in San Francisco and presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is a prime opportunity for life science entrepreneurs and investors to come together to discover the potential of innovative technologies that will drive the future of drug discovery."
Anil R. Diwan, PhD, President and Executive Chairman of the Company will provide an update including the successful Phase 1 clinical trials of NV-CoV-2 Oral Syrup and Oral Gummies drug products that contain the novel ultra-broad-spectrum antiviral nanomachine active ingredient NV-387.
"Resistance is Futile"
Viruses escape antibodies and vaccines readily as they evolve in the field, requiring expensive new development and deployment of vaccines in continuing cycles. NV-387 overcomes this issue. A virus is highly unlikely to escape NV-387 because NV-387 has an extremely wide spectrum of activity, reminiscent of antibiotics.
We develop nanoviricide drugs to mimic the cell-side receptor molecule that the virus binds to in order to cause infection. Even as the virus evolves, it continues to bind to the same receptors in the same fashion. Thus, the nanoviricide technology enables development of drugs that viruses cannot escape.
NV-387 Has Shown Broad-Spectrum Antiviral Activity Across Multiple Virus Families:
Coronaviruses, an Important and Large Market:
NV-387 is possibly the only anti-coronavirus drug that has such a strong safety profile that it can be given to all patient populations. While the most severe part of the SARS-CoV-2 pandemic is likely to be past, its variants continue to pose challenges across the world, as seen most recently from the JN.1 variant. Additionally, MERS-CoV is so deadly that it has not been able to spread in humans yet, and the threat of novel variants of pandemic-potential coronaviruses remains.
RSV, a Multi-billion Dollar Market:
NV-387 was found to be as effective as ribavirin, the toxic last resort drug, against RSV infection in a lethal lung infection animal model, as reported previously. RSV is a virus particularly threatening to vulnerable infants, young children, older adults, and immunocompromised populations.
There is no approved drug for the treatment of RSV infection, except the toxic drug ribavirin which is only indicated for very severe cases due to its severe hemotoxicity.
In addition to the well-known strong and continuing market size for COVID drugs, GrowthPlus Reports, in June 2023, has said that the market size for RSV therapeutics was worth
Smallpox, an Important Biodefense Target, and its "cousin" Mpox that Causes Sporadic Epidemics:
Additionally, we recently reported that NV-387 was as effective as the approved drug tecovitrimat (TPOXX®, SIGA), in a lethal intra-digital infection by ectromelia virus in mice, a well-known model orthopoxvirus family drug development.
Smallpox poses a significant biodefense threat. It is important to develop additional smallpox therapeutics that work well with tecovirimat, an approved drug, and by themselves, since these viruses pose the threat of drug escape by mutation; further, in a bio-terrorism scenario, a human-engineered smallpox virus resistant to existing drugs could be a potential threat.
NV-387 Acts by a Novel Mechanism:
We developed NV-387 in response to the COVID pandemic as a broad-spectrum, pan-coronavirus antiviral. It is designed to "look like a cell" to the virus, displaying copious amounts of sites to which the virus binds on the surface of the nanoviricide nanomicelle, to trap and destroy the virus particle, rendering the virus incapable of infecting another cell.
We call this novel antiviral mechanism "Re-Infection Blocker".
NV-387 Could Revolutionize Antiviral Treatment Just As Antibiotics Did Against Bacteria:
NV-387 was designed to emulate an "attachment receptor family" called sulfated proteoglycans (S-PG), that over
NV-387 could usher in a new era in the treatment of antiviral infections, if it is found to be broadly effective against additional viruses that use S-PG, evoking a comparison to how antibiotics changed the treatment of bacterial infections.
NV-387 Addresses an Unmet Medical Need for Broad-Spectrum, Safe and Effective Antiviral Drug That Works Against Multiple Viral Threats:
There is a significant unmet medical need for a broad-spectrum antiviral drug that is effective and useable in all segments of the population. There are substantial limitations for all currently approved COVID drugs in terms of both the eligibility of a COVID patient, and the effectiveness of the drug.
We believe that the excellent safety and the distinctly different mechanism of NV-CoV-2 (NV-387) support the use of this drug across all patient populations. This is an important characteristic for a COVID drug as well as for a drug to treat RSV infection.
Nanoviricides Platform Technology Enables Oral Administration of Difficult API's:
NV-387 is also capable of encapsulating and delivering other drugs in a targeted manner, while at the same time improving the Pharmacokinetics/Pharmacodynamics of the guest drug by virtue of protecting it from the bodily metabolism. In fact, NV-387 encapsulated drugs can even be delivered orally and are effective with oral administration. This has already been demonstrated for Remdesivir, as well as prodrugs of Remdesivir and of Ribavirin to date.
NanoViricides Possesses a Broad Pipeline of Antiviral Drugs:
In addition to the clinical stage NV-387, we have developed nanoviricides effective against multiple herpes family viruses including the simplex viruses, HSV-1, HSV-2, as well as VZV that causes Shingles in adults and Chickenpox in children and susceptible (immune-compromised) adults. NV-HHV-1 has completed IND-enabling studies, developed as a skin cream to treat Shingles rash and possibly HSV-1 cold sores and HSV-2 genital ulcers. NV-HHV-1 mimics the HVEM, i.e. the well known HerpesVirus Entry Mediator on the surface of cells that these viruses use to infect a cell. Several additional nanoviricide drug candidates have shown activity against different viruses including HIV.
ABOUT BIOTECH SHOWCASE
Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place. Investors and biopharmaceutical executives from around the world gather at Biotech Showcase during this bellwether week which sets the tone for the coming year. Now in its 16th year, this well-established, highly respected conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings. Biotech Showcase is produced by Demy-Colton and EBD Group. Both organizations have a long history of producing high-quality programs that support the biotechnology and broader life sciences industry.
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 are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2, that contains the active pharmaceutical ingredient ("API") NV-387, for the treatment of COVID caused by SARS-CoV-2 coronavirus. NV-CoV-2 in Phase 1a/1b human clinical trials for evaluation of safety and tolerability in healthy volunteers and COVID patients, as well as initial indications of effectiveness in COVID patients.
The same API, NV-387, was recently demonstrated to be active against RSV as well as against ectromelia virus, a mouse model virus used for smallpox drug development.
Our other advanced candidate is NV-HHV-1 for the treatment of Shingles.
The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants.
The Company is currently focused on advancing NV-CoV-2 through Phase I/II clinical trials.
NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. 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 a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, Inc., which TheraCour licenses from AllExcel, Inc. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms 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 Coronaviruses. The Company intends to obtain a license for poxviruses, enteroviruses, RSV and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. 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.
Disclosure Statement
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 that are, in some cases, beyond the Company's control and that 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. In particular, 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 in human clinical trials to lead to a successful pharmaceutical product, including our coronavirus drug development program.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
View the original press release on accesswire.com
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