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NanoViricides Bolsters Partnership Efforts - Engages Aagami Inc.

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NanoViricides has engaged Aagami Inc. to seek licensing and partnering opportunities for its key asset, NV-387, and platform technology in India and Japan. NV-387, a broad-spectrum antiviral nanomedicine, has completed Phase I clinical trials in healthy subjects with no adverse effects reported. It is now ready for Phase II trials.

NV-387, designed to mimic host-side virus-binding features, targets a wide range of viruses, including COVID-19, RSV, Influenza, and Smallpox. The drug's mechanism of action prevents viruses from escaping, even as they mutate.

NV-387 is available in oral syrup, gummy, and injectable forms, addressing various patient needs. The collaboration with Aagami is expected to enhance NanoViricides' business development and licensing efforts while allowing the company to focus on advancing its clinical trials.

Positive
  • NanoViricides engages Aagami Inc. for business development, focusing on India and Japan.
  • NV-387 has successfully completed Phase I clinical trials with no adverse effects.
  • NV-387 targets multiple viruses including COVID-19, RSV, Influenza, and Smallpox.
  • NV-387 is available in multiple formulations: oral syrup, gummy, and injectable.
  • Ultra-broad-spectrum antiviral action, making it effective against a wide range of viruses.
  • The collaboration with Aagami is expected to enhance licensing and partnering efforts.
  • No mutagenic, genotoxic, immunogenic, or allergenic effects observed in non-clinical data.
  • Mechanism of action prevents viruses from escaping, even during mutations.
Negative
  • No assurance that NV-387 will be effective in Phase II clinical trials.
  • Drug development is a lengthy and capital-intensive process, posing financial risks.
  • Dependence on external collaborators and consultants delays drug development timelines.
  • Potential risks associated with licensing agreements and business development efforts.

Engaging with Aagami for business development points towards NanoViricides' strategic effort to enhance its licensing and partnering pursuits in India and Japan. Such moves are critical as they help the company access broader markets and potentially generate revenue streams from licensing deals, which could be important for a clinical-stage company without commercialized products.

The completion of Phase I clinical trials for NV-387 with no adverse events is a positive indicator of its safety profile, a green light for moving to Phase II trials. Nevertheless, it's essential to note that clinical trials are highly regulated and expensive, impacting the company's cash flow and necessitating further capital.

Engaging a specialized firm like Aagami, which has deep knowledge and experience in the respective regions, could streamline their efforts in these markets. However, the ultimate success of these initiatives relies heavily on how well NV-387 performs in the subsequent clinical phases.

The data from the Phase I trials of NV-387 showing no adverse events is particularly promising. Phase I trials primarily focus on safety and the absence of adverse effects even at the highest dose levels indicates a strong potential for NV-387 to be well-tolerated by patients.

The unique mechanism of NV-387, a host-mimetic and direct-acting antiviral, presents a novel approach in antiviral therapy. Traditional antivirals often face resistance as viruses mutate, but NV-387’s method of targeting host-side features utilized by the virus for infection is a significant departure from conventional methods. This can make it a potentially more robust treatment against evolving viral strains.

The focus on multiple delivery methods, including oral syrup and gummies, also highlights the drug's versatility and patient-centric design, which can improve compliance, especially among patients with swallowing difficulties.

Identifying the engagement with Aagami highlights NanoViricides' intent to leverage external expertise for market penetration in India and Japan, key regions with significant patient populations and unmet medical needs in antiviral treatments. This could open up substantial business opportunities if NV-387 progresses successfully through clinical development.

The broader implications of a successful Phase II trial could be massive. If NV-387 demonstrates efficacy across its multiple indications, it could transform the landscape of antiviral therapeutics. The mention of treating multiple viruses, including SARS-CoV-2, RSV and Influenza, positions NV-387 as a potential game-changer.

However, the market's reaction will hinge on tangible progress in clinical trials and the execution of licensing deals. Investors should watch closely for updates on Phase II trial outcomes and any announced partnerships facilitated by Aagami.

SHELTON, CT / ACCESSWIRE / May 23, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, reports that it has engaged Aagami, Inc. for business development, specifically to seek licensing and partnering opportunities for our assets and platform technology.

The Company is currently seeking licensing and partnering opportunities for its key asset, NV-387, and its key nanoviricides™ platform technology. The Company has engaged Aagami, a small boutique firm, to help with these efforts for the regions of India and Japan, noting the firm's strength and specialty in these regions for licensing and partnering endeavors.

NV-387 has successfully completed a Phase I human clinical trial in healthy subjects in India.
No adverse events were reported even at the highest dose levels tested in the single-ascending dose or the multiple-ascending dose cohorts in the clinical trial. Two oral formulations of NV-387, (i) Oral Syrup, and (ii) Oral Gummies were tested in this clinical trial, which has been described in more details in prior press releases.

NV-387 is now ready for Phase II clinical trials in any of its multiple indications.

NV-387 is a unique host-mimetic, direct-acting, ultra-broad-spectrum antiviral nanomedicine based on our nanoviricides platform technology. NV-387 is a first-in-class drug that acts by a novel mechanism of action.

Viruses would not be able to escape NV-387 even as new variants develop in the field, because any new variant continues to use the same host-side features for infection that NV-387 presents, we believe. In contrast, viruses escape vaccines, antibodies and small chemical drugs readily as they change in the field.

NV-387 is a nanomachine designed to complete the task of dismantling the virus particle without requiring the host immune system involvement. This is important because the host immune system is dysregulated by any virus that causes significant pathology. In contrast, vaccines and antibodies require a functioning immune system.

NV-387 is active when given orally. The oral gummy formulation, in particular, overcomes the problem of swallowing issues present in many adults and children with severe respiratory diseases, as it dissolves in the mouth slowly.

Additionally, we have developed a formulation, Solution for Injection, Infusion, and Inhalation, for the treatment of severe, hospitalized cases.

NV-387 is inherently designed to be safe, and the non-clinical data support its safety. NV-387 is non-mutagenic, non-genotoxic, non-immunogenic, and there were no signs of any allergenicity. The recently completed Phase I clinical trial evaluating its safety in humans corrobaorates our non-clinical findings; there were no adverse effects reported in this clinical trial.

NV-387 could be a single drug to treat all of the "tripledemic" viruses, a "holy grail" of development of antiviral therapeutics. Its observed antiviral spectrum in cell culture and animal studies includes the Coronavirus family, including SARS-CoV-2 (COVID, Long COVID), RSV, Influenza A (potentially including H5N1 "Bird Flu"), as well as Smallpox/Mpox.

This ultra-broad-spectrum of NV-387 is, we believe, the result of its host-mimcry. NV-387 is designed to mimic the key virus-binding features of sulfated proteoglycans. A large pool of human pathogenic viruses may be susceptible to NV-387 because more than 90% of human pathogenic viruses are known to use one or more of the sulfated proteoglycans as attachment receptors.

Moreover, even novel viruses, whether from natural sources or bio-engineered, are expected to be susceptible to NV-387 if they employ a sulfated proteoglycan for gaining access to human cells to infect and cause disease.

NV-387 mechanism is designed to attack the virus particle by mimicking the host-side attachment receptor(s) used by the virus particle, followed by engulfing the virus particle via the lipid-lipid-fusion with the virus surface, thereby rendering the virus incapable of infecting cells.

We believe that NV-387 is a revolutionary ultra-broad-spectrum antiviral drug with a strong potential to transform treatment of viral infections just as the broad-spectrum antibiotic, penicillin, transformed the treatment of bacterial diseases.

"Engaging Aagami gives a significant boost to our licensing and partnering efforts, while at the same time substantially freeing up our executives and staff to focus more strongly on further development of our multiple drugs and the nanoviricides platform through clinical trials," said Anil R. Diwan, PhD, President and Executive Chairman of the Company.

About Aagami

Aagami, Inc. is a life sciences consulting firm based in the suburbs of Chicago which offers, Strategic Consulting Services, Business Development support in regions where the client is unable to reach out due to bandwidth, Technology Licensing Services, and Business Research & Market Intelligence Services.

For Global companies in Pharma, Biotech, Medical Devices & Technology, Consumer Healthcare, CROs, CDMOs, & Academia; Aagami brings: Deep Experience of overcoming business and socio-cultural differences of various countries; Extensive ‘C' level network nurtured for 21+ years; Global Deal making skills, honed for decades; Partners having combined experience of 250+ years; Supplementing the client's bandwidth to save time, effort & cost. Aagami has served 110+ clients in 180+ Assignments globally.

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 are designed to specifically attack enveloped virus particles and to dismantle them. Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs.

Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection.

Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 "cold sores" and HSV-2 "genital ulcers". 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 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 poxviruses and/or enteroviruses if the initial research is successful. 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'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.

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". API means active pharmaceutical ingredient.

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

FAQ

What is the focus of NanoViricides' recent collaboration with Aagami?

NanoViricides has engaged Aagami Inc. to seek licensing and partnering opportunities for its key asset, NV-387, and platform technology in India and Japan.

What is NV-387?

NV-387 is a first-in-class, ultra-broad-spectrum antiviral nanomedicine developed by NanoViricides.

What phase are NV-387’s clinical trials currently at?

NV-387 has completed Phase I clinical trials and is now ready for Phase II trials.

What viruses does NV-387 target?

NV-387 targets a wide range of viruses including COVID-19, RSV, Influenza, and Smallpox.

Were there any adverse effects reported in NV-387's Phase I trial?

No adverse effects were reported during the Phase I clinical trials of NV-387.

What are the formulations of NV-387?

NV-387 is available in oral syrup, gummy, and injectable forms.

What regions is Aagami focusing on for NanoViricides?

Aagami is focusing on India and Japan for NanoViricides' licensing and partnering efforts.

What makes NV-387 different from vaccines and antibodies?

NV-387's mechanism prevents viruses from escaping, even as they mutate, unlike vaccines and antibodies that require a functioning immune system.

What are the potential risks associated with NanoViricides' business development efforts?

Potential risks include the lengthy and capital-intensive drug development process, dependence on external collaborators, and uncertainties in licensing agreements.

NanoViricides, Inc.

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