Rapid Advancements of Innovative Antiviral

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PALM BEACH,  Fla., Oct. 11, 2021 /PRNewswire/ — With the arrival of the COVID-19 virus, the antivirals market had all eyes watching the ongoing frenetic rush to find a cure or at least a therapy. That race has not yet abated… not at all! Substantial increase in number of patients suffering from viral infections and increasing R&D activities by major players for development of novel products are major factors expected to drive the growth of global antiviral drugs market. In US the proportion of outpatient visits for influenza-like illness increased. In fact, a report from Acumen Research and Consulting projected that the global antiviral drugs market is anticipated to grow at a CAGR of around 3.7% during the forecast period 2020 to 2027 and to reach around US$ 74.7 billion by 2027.  The report added: “Increase in pandemic effect across the globe and rise in mortality rate are pressurizing the government to take necessary steps for drug development. Major players are focused on conducting rapid clinical trials for development of new drug, along with early product approval from the government as a preventive measure for treatment of covid-19 patients are factors cumulatively expected to augment the market growth.”  Active Biotechs in the markets today include:  NanoViricides, Inc. (NYSE: NNVC), Pfizer Inc. (NYSE: PFE), Merck (NYSE: MRK), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), Eli Lilly and Company (NYSE: LLY).

Acumen Research article continued with:  “High investment by major players for new drug development and business development activities in order to enhance the business presence and increase the customer base is expected to boost the growth of antiviral drugs market… increasing investment by major players for cost effective drug development and supporting government regulations related to product approval and business establishment are factors expected to create new opportunities for players operating in the antiviral drugs market. In addition, increasing partnership and agreements between regional and international players is expected to support the revenue transaction of the target market. The market in North America is expected to account for major revenue share in the global drugs market due to rise in number of patients suffering from chronic diseases. In addition, availability of advanced infrastructure in the country, increasing R&D activities, and focus on introduction of innovative drugs are factors expected to impact the growth of antiviral drugs market.”

NanoViricides, Inc. (NYSE American: NNVC) Breaking News: NanoViricides Announces COVID-19 Clinical Drug Candidate NV-CoV-2 was Effective Against SARS-CoV-2, Further Demonstrating Its Broad-Spectrum Pan-Coronavirus Activity NanoViricides, a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, announced today that its Pan-Coronavirus COVID-19 Drug Candidate.

NV-CoV-2 was found to be effective against SARS-CoV-2 in a standard cell culture pseudovirion assay, demonstrating that the drug indeed has broad-spectrum pan-coronavirus activity. This pan-coronavirus activity implies that the drug NV-CoV-2 should remain active in spite of evolution of variants of

SARS-CoV-2 in the field, a highly sought-after characteristic to combat the current global pandemic. 

In this assay, both the drug candidate NV-CoV-2 and a positive control antibody specific to the Spike antigen S1 of the SARS-CoV-2 virus suppressed the infection by the SARS-CoV-2-pseudovirions in cell culture studies to virtually the same baseline levels.

We have now demonstrated that NV-CoV-2 is highly effective in cell cultures against SARS-CoV-2, human coronavirus NL-63, and human coronavirus 229E, all very different human coronaviruses. These results imply that the drug will remain active in spite of novel variants of SARS-CoV-2 evolution in the field, and indeed demonstrate the pan-coronavirus activity of our clinical drug candidate NV-CoV-2.

Additionally, the pseudovirion study also showed that NV-CoV-2 neutralizes the virus particles themselves, outside of the cells, validating our design mechanism.

“We are now preparing submission documents to enable initiation of human clinical trials,” commented Dr. Anil Diwan, Chairman and President of the Company, adding, “We believe that NV-CoV-2 may help end the pandemic if it is shown to be effective in human clinical trials.”

A strong SARS-CoV-2 infection inhibition activity of NV-CoV-2 was observed in this pseudovirion study. Pseudovirion assay is a standard method for evaluating virus entry-inhibitors in BSL2 laboratories and is primarily used for viruses that would otherwise require high security BSL3 or BSL4 laboratories.  In this study, SARS-CoV-2-pseudovirion virus particles were made that carry a green fluorescent protein (GFP) producer mRNA inside, and use the SARS-CoV-2 S1 protein on their surface to bind to ACE2 receptor protein on cells. They were incubated with NV-CoV-2 (test article), or a known neutralizing antibody (positive control), or just the vehicle buffer (negative control). Then these solutions were separately used to infect ACE2 positive cells and the cultures were incubated. Only the infected cells produced GFP and were visualized by green fluorescence in microscopy. In this well-known assay, NV-CoV-2 was as effective as the neutralizing antibody in reducing the virus infection. This study demonstrates that NV-CoV-2 attacks the SARS-CoV-2 pseudovirion particles and renders them incapable of binding to the ACE2 positive cells.

A “pseudovirion” is a virus particle made of a BSL-2 virus shell, but with its original cell-binding protein replaced by the cell binding protein of a BSL3 or BSL4 virus, in this case, the S1 antigen of SARS-CoV-2.  Additionally, the pseudovirion particle contains an mRNA that is packaged like the original virus, except that the mRNA is edited and redesigned so that it cannot produce infectious virus particles. In our study, this mRNA allowed expression and production of the green fluorescent protein (GFP) enabling visual detection of the infected cells (green) in microscopy.  Read the full press release by going to:  http://www.nanoviricides.com/companynews.html 

In other biotech news in the markets this week: 

Merck (NYSE: MRK) recently announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) recently announced they have submitted data to the U.S. Food and Drug Administration (FDA) from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to <12 years of age.

The Companies announced positive topline results from the pivotal trial on September 20, 2021. In the trial, which included 2,268 participants 5 to <12 years of age, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses. These results – the first from a pivotal trial of any COVID-19 vaccine in this age group – were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 μg doses. The 10 μg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to <12 years of age.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) recently announced that the New England Journal of Medicine (NEJM) published positive detailed results from a Phase 3 trial that assessed the ability of REGEN-COV™ (casirivimab and imdevimab) to treat COVID-19 in infected high-risk non-hospitalized patients (outpatients). The trial met its primary and all secondary endpoints and showed treatment with REGEN-COV significantly reduced the risk of hospitalization or death, with a safety profile consistent with previously reported data.

“Results from this NEJM publication show that REGEN-COV reduced the risk of hospitalization or death by 70% in high-risk non-hospitalized patients infected with COVID-19,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. “This peer-reviewed publication further supports the growing evidence on REGEN-COV’s critical role to improve outcomes for patients, and reduce the significant burden on their communities and healthcare systems during this COVID-19 pandemic.”

Eli Lilly and Company (NYSE: LLY) recently announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new indication for ERBITUX® (cetuximab injection) in combination with BRAFTOVI®(encorafenib), marketed by Pfizer, Inc., for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.1ERBITUX is the first and only anti-EGFR antibody approved, in combination with encorafenib, for this indication and is based on results from Pfizer’s BEACON CRC trial, the only Phase 3 trial to specifically study patients with previously treated metastatic CRC with a BRAF V600E mutation. With this approval, ERBITUX has now received seven FDA approvals to treat certain types of CRC and squamous cell carcinoma of the head and neck.

“The BEACON study showed that the combination of ERBITUX and encorafenib significantly improved overall survival in patients with metastatic colorectal cancer with a BRAF V600E mutation – a subtype that typically has worse outcomes compared to those without the mutation,” said David Hyman, M.D., chief medical officer, oncology at Lilly. “We are grateful to Pfizer for their collaboration as we’ve worked to bring this treatment regimen to patients.”

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