About NanoViricides

NanoViricides, Inc., a clinical stage nano-biopharmaceutical company, specializes in the discovery, development, and commercialization of drugs to combat viral infections using its unique and novel nanomedicines technology. The company’s first drug in Phase 1a/1b clinical trial and several additional drug candidates in various stages of pre-clinical development, including IND-filing stage and late stage Investigational New Drug (IND)-enabling non-clinical studies. The company’s novel nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles, on the same sites that they use to bind to cells and dismantle them. The company’s unique biomimetic approach promises that a virus cannot escape its nanoviricide drugs due to mutations, if the virus-binding ligands perform as designed. The Nanoviricides Platform provides for modalities that can result in potentially cures for viruses that do not establish latent virus infection in humans. NV-CoV-2, First Nanoviricide Drug NV-CoV-2, the drug the company developed in response to the COVID-19 pandemic, has entered Phase 1a/1b human clinical trials sponsored by its licensee and collaborator, Karveer Meditech Private Limited (Karveer), in India, around June 19, 2023. Nanoviricides Platform Has Enabled Industry-Leading Orally Available Nanomedicines and Multiple Routes of Administration The company found that unlike almost all other nanomedicine platforms, its nanoviricide NV-387, the active pharmaceutical ingredient (API) of NV-CoV-2, demonstrated strong antiviral activity when administered orally in multiple animal models. The company developed two different oral formulations of NV-387, namely ‘NV-CoV-2 Oral Syrup’, and ‘NV-CoV-2 Oral Gummies’. The latter is a semi-solid fixed-dose form. The oral syrup enables body-weight-based dose titration as is required for pediatric cases. Both of these are in the Phase 1a/1b human clinical trial. The oral dosage forms are expected to provide wide-spread adoption across the entire population from children to senior citizens, and special cases, such as immune-compromised patients outside the hospital. The Oral Gummies fixed dosage form has the advantage that it is suitable even for patients that cannot swallow the usual hard tablets or capsules, because it slowly dissolves in the mouth as it is absorbed. The company has also developed a NV-387 formulation called ‘NV-CoV-2 Solution for Injection, Infusion and Inhalation’. The company engages in the application of nanomedicine technologies to the complex issues of viral diseases. It is developing a class of drugs, that it calls nanoviricides, using a platform technology. This approach enables rapid development of highly effective and safe new drugs against a number of different viruses. The company’s nanoviricide technology relies on copying the human cell-surface receptor to which the virus binds, and making small chemicals that are called ‘ligands’ that will bind to the virus in the same fashion as the attachment receptor or the cognate receptor (see below). These ligands are chemically attached to the base polymer or ‘nanomicelle’, to create a nanoviricide. The company’s antiviral drug candidate NV-HHV-1 is based on mimicking the cognate receptor HVEM (herpesvirus entry mediator). It has shown strong activity against VZV (Varicella Zoster Virus). VZV causes chickenpox in children and immune-compromised persons, and its reactivation causes Shingles in adults. NV-HHV-1 has completed pre-clinical IND-enabling studies for VZV. NV-HHV-1 was also effective against HSV-1 and HSV-2. The company plans on exploring its activity against other herpesviruses, such as CMV and EBV as well. Further, the company has developed drug candidates in the HIVCide Program that mimic the cellular CD4 binding site used by HIV to gain cell entry. Another important HIV cognate receptor is CCR5. The Nanoviricides Platform enables using mimics of one or more cellular receptors attached into a single nanoviricide drug. Thus this platform has the capability of mimicking both the CD4 binding site and the CCR5 binding site of HIV on one nanoviricide, which is expected to enable the most effective drug against HIV. The only countable number of patients that have been ‘cured’ of HIV were recipients of stem cells that possess a modified CCR5 lacking its HIV-binding region, attesting to the importance of mimicking both CD4 and CCR5 simultaneously. The company strives hard to develop virus-binding small chemical ligands that mimic the cognate cellular receptor of the virus, using rational design and molecular modeling strategies and its internal, accumulated expertise. Some viruses use more than one receptor. The nanoviricide platform technology allows use of different ligands on the same nanoviricide drug to be able to attack such difficult viruses. NV-CoV-2-R, the company’s other drug in the development for the treatment of coronaviruses contains the API NV-387-R. This API is made up of remdesivir encapsulated within the belly of the polymeric micelles of NV-387. While NV-387 is designed to directly attack the virus outside the cell, the remdesivir component is known to block the virus replication inside the cell. By blocking both of these pathways, NV-387-R would result in a cure of the viral infection. Remdesivir is a broad-spectrum antiviral agent that has been approved for COVID and has shown strong pre-clinical activity against many RNA viruses. Its clinical activity is limited by its rapid metabolism in the bloodstream. NV-387 holds remdesivir like in a bottle and releases it slowly, thus limiting the metabolism and enhancing the pharmacokinetics and thereby the effectiveness of remdesivir. The company is developing NV-CoV-2-R on its own, independent of Gilead. The company has also developed other drugs based on this concept of curing the viral infection. One of these is NV-387-Rp, which contains a modified and improved form of Remdesivir. Another one is NV-387-Ribvp, which contains a prodrug of Ribavirin. Ribavirin is a highly toxic but highly effective antiviral drug. It is approved in the U.S.A. only for the treatment of RSV infection as a drug of last resort. However, it is used in the case of many viral infections for which no antivirals are known in severe hospitalized cases. NV-387-Ribvp is expected to enable cures for such viruses by combining the Re-Infection Inhibition activity of NV-387 with the Replication Inhibition activity of Ribavirin, while at the same time enabling lower doses of Ribavirin to stay well below its toxicity level. The company has several drugs in its pipeline, enabled by its strong and extensive nanoviricide technology platform. Of these, NV-CoV-2 is in Phase 1a/1b Clinical Trials for the COVID indication and is the farthest along in the regulatory pathway. The need for the broad-spectrum nanoviricide SARS-CoV-2 drug cannot be overstated in the circumstances and the status of the pandemic with continuous evolution of variants of the virus and a constant threat of the possibility that a substantially more pathogenic virus compared to the omicron variants may readily emerge. The set of tools available for combating the COVID-19 pandemic is not robust enough to allow a ‘Living with COVID’ attitude. Following completion of the Phase 1a/1b clinical trials of NV-CoV-2, the company plans on moving this drug into Phase 2 Efficacy Clinical Trials. The company has associated the treatment indication of COVID for this drug. The same API, NV-387, was also highly effective against a lethal infection of RSV in a mouse model. Thus, the company plans on entering this drug into Phase 2 Efficacy Clinical Trials for the RSV indication, in addition to COVID, depending upon its financial resources. The company plans on continuing additional exploratory studies to evaluate the effectiveness of NV-387 against other viruses that use S-PG class of attachment receptors. It has also completed pre-clinical development of a nanoviricide drug, namely NV-HHV-1. The company plans on undertaking Phase 1 and further clinical development of NV-HHV-1 as and when enabled by its financial resources. NV-HHV-1 is formulated as a Skin Cream for the treatment of Shingles. The company also has several additional pre-clinical drug development programs, including Herpes Simplex Viruses (HSV-1 that causes cold sores, and HSV-2 that causes genital ulcers), HIV/AIDS, Influenza, Dengue viruses, and Ebola/Marburg, that it plans to advance further towards clinical drug candidates as they progress further. Thus the company has a strong and broad pipeline that is expected to continue to result in highly effective drug candidates against a number of viral diseases. NV-387-Rp and NV-387-Ribvp have shown strong effectiveness against Coronaviruses and RSV in animal models respectively, and are expected to be highly active against a number of other viruses based on the known activities of the components. The company has developed in-house cell culture screening capability for developing drug candidates against human Coronaviruses (h-CoV), including SARS-CoV-2 pseudovirions, VZV, HSV-1 and HSV-2, Influenzas, HIV, RSV, Ectromelia Mousepox Virus (a model for MPox and Smallpox viruses), and pseudovirion technology for Ebola/Marburg viruses, among others. The company, in collaboration with Karveer, the Drug Sponsor in India, and PristynCR, a Clinical Research Organization (CRO) in India, completed medical writing of the IND-enabling studies, including Chemistry, Manufacture and Controls (CMC) and Pre-clinical Safety/Toxicology, Pharmacology, and Animal and Cell Culture Effectiveness Studies. The company, together with its collaborators, Karveer, and PristynCR, completed developing the full-fledged Clinical Protocols rapidly and thereafter a complete Clinical Trial Application was submitted by Karveer in India around November, 2022. n March 2023, the company consummated a License Agreement with Karveer pursuant to which it outlicensed to Karveer the two COVID drugs namely NV-CoV-2 and NV-CoV-2-R for further development and commercialization in India, as anticipated with the September 2021 engagement. Karveer has retained a local CRO, PristynCR Solutions, Pvt. Ltd., that developed the clinical trial protocols and clinical trial applications. PristynCR is performing the clinical trials at Mahatma Gandhi Mission Medical College and Hospital in Aurangabad, India (MGM). Karveer is managing the entire clinical trial process. Around March/April, 2023, the company completed cGMP-compliant manufacture of the clinical drug products at the company’s own facility and shipped them to Karveer. The clinical process documentation was prepared by the CRO in collaboration with Karveer and the clinical trial site, MGM. Subsequently, initial enrollment work began. On or about June 19, 2023, the first healthy volunteers were dosed in the clinical trial. The clinical trial has continued with interim data reviews and further enrollments as planned. On June 29, 2023, the company announced that the clinical trial of NV-CoV-2 Oral Syrup and Oral Gummies has started. The clinical trial is designed to assess the safety and tolerability of the two drug products in healthy volunteers, as well as in PCR +ve COVID patients. The Phase 1a part is a single-ascending dose (SAD) protocol study in healthy volunteer subjects and includes three cohorts for each of the drug products with six subjects per cohort. The Phase 1b part is a multiple ascending dose (MAD) protocol study. Phase 1b has two subparts. The healthy volunteers subpart of Phase 1b includes three cohorts for each of the drug products with six subjects per cohort. Additionally, the COVID patient subpart of Phase 1b includes three cohorts for each of the drug products with six subjects per cohort. Karveer intends to enroll PCR positive COVID patients with mild-to-moderate disease. All enrolled subjects will be sequestered in a hospital ward set aside for this purpose for the duration of the study in that subject. Clinical observations, Blood Chemistry, and Organ Function Tests are included at different time points and at a follow-up visit post-discharge. In addition, pharmacokinetics of the drug will be studied in the healthy volunteers cohorts. In the COVID cohorts, PCR tests will be conducted to determine when the virus clears. This part is designed to provide information on effectiveness of the drug and also to provide guidance on selection of dosing regimen for Phase II/III clinical trials. On August 21, 2023, the company reported interim communication that 26 out of the target of 36 healthy volunteers in the various cohorts in the Phase 1a Single-Ascending-Dose (SAD) have already completed the study. Additionally, 17 of the target of 36 healthy volunteers in the various cohorts in the Phase 1b Multiple-Ascending-Dose (MAD) part of the clinical trial had already completed the study by then. As of June 30, 2023, 26 out of 36 healthy volunteers in the various cohorts in the Phase 1b MAD study had completed the study, and an additional 10 healthy volunteers are expected to be recruited soon. Additionally, PristynCR has requested the Ethics Committee for permission to begin enrolling COVID patients. The company has previously developed NV-HHV-1 and formulated it as a skin cream for the treatment of Shingles rash, NV-HHV-1 has completed IND-enabling studies. The company plans on undertaking further development of NV-HHV-1 into human clinical trials once its NV-387 based drug candidates progress further in clinical trials. Licenses, Patents, Trademarks, Proprietary Rights: Intellectual Property Licenses from TheraCour The company’s drug development business model was formed in May 2005 with a license to the patents and intellectual property held by TheraCour Pharma, Inc. (TheraCour) that enabled creation of drugs engineered specifically to combat viral diseases in humans. This exclusive license from TheraCour serves as a foundation for the company’s intellectual property. The company has a worldwide exclusive license to this technology for several field of application verticals with specific targeting mechanisms for the treatment of a number of human viral diseases. The company’s drug candidates are licensed from TheraCour, and are developed by TheraCour for the company on the basis of several patents, patent applications, provisional patent applications, and other proprietary intellectual property know-how held by TheraCour. The company has exclusive licenses from TheraCour for drug candidates derived from and based on TheraCour’s technologies for several viruses. In 2005, the company obtained a license from TheraCour for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS) Influenza, including Asian Bird Flu Virus (INF), Herpes Simplex Virus (HSV-1 and HSV-2), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies. Thereafter, on February 15, 2010, the company entered into an Additional License Agreement with TheraCour granting the company the exclusive licenses for technologies developed by TheraCour for the additional virus types for Dengue viruses (DENV), Japanese Encephalitis (JEV), West Nile Virus (WNV), viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes Keratitis, and Ebola/Marburg viruses. While herpes simplex viruses were already specified as licensed previously, the term ‘ocular herpes keratitis’ was added to this additional license agreement at the specific request of the company for clarity only. In addition, the company completed the process of licensing the VZV (shingles, chicken pox virus) field from TheraCour in November 2019. The company further completed the process of licensing antivirals for the field of human coronavirus indications in September 2021 under the COVID agreement. As in the past, as and when advised by counsel, the company will seek additional licenses to verticals of antiviral fields from TheraCour. Out-Licensing to Karveer Meditech Private Limited, India On March 27, 2023, the company entered into a License Agreement with Karveer Meditech Private Limited (Karveer) wherein the company granted to Karveer a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the two clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID in patients in India. Karveer has engaged in further drug development in India, including sponsoring of drug candidates for human clinical trials in India and has acted as clinical trials manager for such clinical trials. Karveer shall provide NanoViricides with all reports of the clinical trials and the company can use such reports for further advancement of the drug candidates with regulatory authorities outside India. NanoViricides Drug Programs Drug Programs for Coronavirus Infections, including COVID The company is developing the following drug products for the treatment of COVID-19 disease: NV-CoV-2 Oral Syrup; NV-CoV-2 Oral Gummies, and NV-CoV-2 Solution for Injection, Infusion and Inhalation. It is also developing an additional drug product for the treatment of COVID-19 disease: NV-CoV-2-R Solution for Injection, Infusion and Inhalation. The FluCide Program The company intends to re-engage the FluCide program once the HerpeCide drug candidates enter human clinical trials, resource permitting. The company is developing an injectable drug candidate for the treatment of severely ill patients, and an oral drug candidate for the treatment of outpatients. DengueCide Program The company intends to reengage the DengueCide program if and when non-dilutive funding, such as research grants become available to it. HIVCide Program The company intends to re-engage the HIVCide program once the HerpeCide drug candidates enter human clinical trials, resource permitting. Adenoviral EKC The company is developing broad-spectrum eye drops that are expected to be effective against a majority of the viral infections of the external eye. Most of these viral infections are from adenoviruses or from herpes viruses. The company has shown excellent efficacy of its drug candidates against EKC (adenoviral epidemic keratoconjunctivitis) in an animal model. If feasible, the company is planning to merge the anti-EKC drug development program and the ocular Herpes Keratitis drug development program, to develop a single drug that is effective against both diseases, i.e. effective against both adenoviruses and herpes viruses. This work is in research stage. Other Drug Programs: ‘Disease X’, MPox, Smallpox, Acute Flaccid Myelitis (AFM, EV68), Polio, Pediatric Acute Adenoviral Hepatitis, Ebola/Marburg, Rabies and Others The company has research programs against Rabies virus, Ebola and Marburg viruses, and others. In addition to NV-387, the company has developed NV-387-Ribvp, a Nanoviricide Platform, for the treatment of RSV and potentially many other viral infections. NV-387-Ribvp is made up of NV-387 that encapsulates within the belly of the polymeric micelle, a pro-drug of Ribavirin which is a known active drug against many viruses. In response to the last year’s MPox virus (MPXV) epidemic, the company began a limited drug development program to treat MPXV patients. It intends to run the MPXV, EV68, and AD71 programs by initially evaluating the company’s existing drug candidate library for effectiveness. The company continues to add to its existing portfolio of products through its internal discovery and clinical development programs and also seeks to do so through an in-licensing strategy. Additionally, in response to the ongoing pediatric ‘acute flaccid myelitis’ (AFM, a disease that can lead to paralysis) cases that appear to be on an uptick, the company initiated a limited broad-spectrum drug development program for the treatment of Enterovirus D68 (EV68), the cause of AFM, and potentially other enteroviruses, including the poliovirus. The company intends to run the MPXV, EV68, and AD71 programs by initially evaluating the company’s existing drug candidate library for effectiveness. This year, the company has further focused its programs and prioritized them with the result that its first drug candidate NV-387 is in human clinical trials. Research and Development For the year ended June 30, 2023, the company’s research and development expenses were approximately $6,392,000. Government Regulation The Federal Food, Drug and Cosmetic Act and other federal and state statutes and regulations govern the testing, manufacture, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of the company’s products. History NanoViricides, Inc. was founded in 2005. The company was incorporated in 2005.