Global Pandemic Reiterates the Need for Infectious Disease Therapeutics

FinancialBuzz.com News Commentary

NEW YORK, March 16, 2020 /PRNewswire/ -- The COVID-19 pandemic continues to aggressively spread around the world and cases are now confirmed in more than 120 countries with senior members of governments around the world among those affected. While more than half of the approximately 128,000 confirmed cases worldwide have already recuperated, the consequences are devastating. The toll in human lives and dollars is expected to get worse still, before it gets better. As of Friday, more than 4,700 people have died, including 42 in the U.S. According to a report by CBSNews, economists warn the world could be headed for a recession and global stock markets have already bled about USD 16 Trillion in value since the high on February 19th. In response to the pandemic, President Trump is to declare a national emergency, a move that would give the President authority to use USD 40 Billion of funds allocated by Congress for disaster relief to address the outbreak crisis. In the meantime, the Center for Disease Control (CDC) indicates that more cases are expected to be detected across the United States as testing capacity in the U.S. increases. And while information so far suggests that most COVID-19 illnesses are mild, a report out of China suggests serious illness occurs in 16% of cases. NanoViricides, Inc. (NYSE: NNVC), Johnson & Johnson (NYSE: JNJ), Quest Diagnostics, Inc. (NYSE: DGX), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), INOVIO Pharmaceuticals, Inc. (NASDAQ: INO)

COVID-19 is an infectious disease, a type of disease caused by pathogenic microorganisms such as bacteria, viruses, fungi and parasites. Infections can be transmitted by direct or indirect contact. Globally, infectious diseases such as malaria, HIV, tuberculosis, influenza, hepatitis A, hepatitis C and recently the COVID-19 put major strains on public health. However, infectious disease therapeutics are used to constrain the growth of these diseases, as these drugs can act through the host's natural defense system and directly target the malicious pathogen. Overall, the growth of this market is influenced by various major factors, such as the increasing occurrence of infectious diseases, the growing use of direct-acting anti-viral, growing healthcare awareness, increasing government funding in developing countries, as well as a growing geriatric population. Overall, the infectious disease therapeutics market was worth USD 105.13 Billion in 2018 and estimated to reach USD 154.18 Billion by the end of 2023 and at a CAGR of 7.96 %, according to data provided by QY Research.

NanoViricides, Inc. (NYSE: NNVC) announced breaking news on, "its efforts towards drug development for the current novel coronavirus SARS-CoV-2 that causes COVID-19.

The Company has completed the synthesis of a number of nanoviricide drug candidates for testing in just a few weeks after identification of virus-binding ligands. This was possible because the Company is boot-strapping its efforts on the basis of its inventory of novel custom chemicals in hand. Additionally, the polymer backbone was previously manufactured in multi-kilogram quantities. However, there can be no assurance that any of these candidates would show sufficient effectiveness and safety for human clinical development at this time.

The Company has acquired and expanded two different, low-threat circulating coronaviruses in its own BSL2 lab, and has already expanded them to enable testing of drug candidates. One of these coronaviruses, namely NL63, uses the same ACE2 receptor on human cells as SARS-CoV-2, although it does not cause a similar severe disease in humans.

If the Company's test candidates are effective against these cell culture studies against coronaviruses, then that would provide a strong rationale that they may be expected to be effective against the current SARS-CoV-2. Presently, the Company does not have any collaboration established for further testing of its drug candidates against SARS-CoV-2. The Company is working to establish such collaborations, however, there can be no assurance that we will be successful in establishing the necessary collaborations or that our drug candidates will succeed in further testing. In the past, the Company has established and worked on collaborations with the U.S. Center for Diseases Control and Prevention (CDC), as well as the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).

The Company has already successfully developed antiviral drug testing assays based on cell culture infection of certain low-threat coronaviruses viruses in our own BSL2 certified virology lab. Development of an assay to test the effectiveness of a drug candidate is an important milestone in the drug development process. We have been able to complete this milestone in just a few weeks because of the extensive experience and expertise in medium throughput drug testing antiviral assays development of our Senior Virologist.

Testing of our drug candidates against these BSL2 coronavirus strains is expected to begin shortly in our BSL2 virology lab.

As of March 11th, SARS-CoV-2 has caused at least 800 confirmed cases in more than 30 states, and the virus has led to more than 26 deaths in the U.S., with area lockdowns, quarantines, and state of emergency being declared in several states. The entire country of Italy is under quarantine. Japan is also experiencing a severe outbreak. This COVID-19 outbreak has caused cases in at least 99 countries, with confirmed cases totaling over 110,000, of which 62,000 have already recovered, with deaths of over 3,800 patients, according to CBS news (https://www.cbsnews.com/live-updates/coronavirus-outbreak-death-toll-us-infections-latest-news-updates-2020-03-09/). The health risks associated with the virus rise significantly with age and many younger, otherwise healthy people who contract it might show only mild symptoms, if any. It appears that the outbreaks in China and in South Korea are now showing signs of being controlled, with new cases having decreased significantly.

The U.S. Government has approved $8.3 Billion for COVID-19 response that includes development of drugs as well as vaccines, patient care, containment, and education, in a holistic approach.

Although vaccine development has started very quickly against the SARS-CoV-2, an effective vaccine may take at least 12-18 months before it can be used to treat patients.

Viruses are known to escape antibody drugs and vaccines via mutations. In contrast, the NanoViricides platform technology enables development of a drug that a virus is unlikely to escape by mutation. This is because we develop biomimetics that are designed to interfere with the virus binding to its cognate cellular receptor, and are further capable of disabling the virus from binding to cells. Coronaviruses mutate less rapidly than other RNA viruses such as influenza and HIV.

One of the coronaviruses we are using for testing of our drug candidates uses the same ACE2 receptor as the current SARS-CoV-2 virus (aka nCoV-2019). However, this coronavirus does not cause similar, severe disease in humans. Another coronavirus we are testing against uses a different but somewhat related receptor (in terms of biophysics). Investigating against both of these strains would allow us to examine which of the test candidates have more broad-spectrum effectiveness. However, there can be no assurance that successful results against these forms of coronavirus will lead to similar results against nCoV-2019 aka SARS-CoV-2. Moreover, the path to typical or standard drug development of any pharmaceutical product is extremely lenghty and requires substantial capital. However, regulatory agencies in China created expedited processes to enable rapid clinical testing of exploratory drug candidates. Accelerated pathways were also developed for enabling anti-Ebola clinical drug candidates in the 2017-18 epidemic in DRC. Nevertheless, there can be no assurance that even successful results against SARS-CoV-2 will lead to successful clinical trials or a successful pharmaceutical product, which is true of every drug development effort against SARS-CoV-2 at present.

Previously, on January 30th, the Company confirmed that it is working on a drug to treat the SARS-Cov-2 virus infections. The Company said that it had successfully completed the important milestone of finding potential virus-binding ligands that mimic the ACE2 interaction with SARS-CoV (2002) using molecular modeling. The current coronavirus strain, namely SARS-CoV-2 is closely related to the 2002 SARS-CoV, and uses the same human cellular receptor. We have now completed the next two milestones, namely synthesis of test candidates, and development of anti-CoV assays for testing them.

About NanoViricides: NanoViricides, Inc. (www.nanoviricides.com) is a development 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-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. The Company is also 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. 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 does not currently have a license to the coronavirus field, however, TheraCour has not denied any licenses to the Company. The Company typically begins the licensing process only after demonstrating effectiveness of some candidates in optimization stage. 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. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. CMC refers to "Chemistry, Manufacture, and Controls".  

Johnson & Johnson (NYSE: JNJ) announced last week that its Janssen Pharmaceutical Companies have entered a collaboration with the Beth Israel Deaconess Medical Center (BIDMC) to support the development of a preventive vaccine candidate for COVID-19. The parties have commenced preclinical testing of multiple vaccine prospects, with the aim to identify by the end of the month a COVID-19 vaccine candidate for clinical trials. Janssen is optimistic that, in collaboration with multiple global strategic partners, it can initiate a Phase 1 clinical study of a potential vaccine candidate by the end of the year. In parallel to these efforts, Janssen is preparing to upscale production and manufacturing capacities to levels required to meet global public health vaccination needs. "It is critical to work with the best scientific minds as we look to rapidly identify and develop solutions to the COVID-19 outbreak," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. "We are grateful for talented and experienced collaboration partners like Dan Barouch and his team at BIDMC. By mobilizing our collective resources, we believe we can leverage the top science and cutting-edge capabilities to respond to this pandemic." Janssen's vaccine program will use the Janssen AdVac® and PER.C6® technologies that provide the ability to rapidly upscale production of an optimal vaccine candidate. The company is leveraging its proven vaccine technology that it is also using to develop its investigational Ebola (which also utilizes its MVA-BN® technology), Zika, RSV and HIV vaccines. Research and collaboration on preclinical work for our Zika and HIV vaccine candidates at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center was foundational to developing these vaccines.

Quest Diagnostics, Inc. (NYSE: DGX) announced earlier this month that it will launch a coronavirus (COVID-19) test service. The new test service aids the presumptive detection of nucleic acid in respiratory specimens of patients meeting CDC's clinical criteria for COVID-19 testing.  Quest will be in position to receive specimens for testing, and begin to provide testing on Monday, March 9, 2020. With the new service, Quest Diagnostics will provide access to a COVID-19 test service for patients in the United States. The new test service will be provided as a laboratory developed test, pending review by the FDA under emergency use authorization (EUA) which the company will submit per FDA guidance within 15 days of clinical testing. The test is a molecular based assay which detects viral RNA in respiratory specimens. "In times of national health crises, quality laboratory testing is absolutely critical to mobilizing effective public health response," said Steve Rusckowski Chairman, CEO and President, Quest Diagnostics. "Quest's national scale, diagnostic expertise and innovation, and relationships with half the country's physicians and health systems is a vital complement to the efforts of the CDC and other public health labs to contend with a growing number of suspected COVID-19 cases in the United States. We applaud the FDA for providing the flexibility for innovative, quality lab developed tests to be brought to patients and providers quickly to advance effective response to the coronavirus outbreak."

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced back in February an expanded agreement with the U.S. Department of Health and Human Services (HHS) to develop new treatments combating the novel coronavirus, 2019-nCoV, which was recently declared a global public health emergency by the World Health Organization. Regeneron has a number of active collaborations with HHS's Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR), including a collaboration to advance Regeneron's investigational Ebola treatment REGN-EB3, which demonstrated positive clinical data in 2019. The HHS and Regeneron Other Transaction Agreement (OTA), originally established in 2017, is focused on discovery, research, development and manufacturing of a portfolio of antibodies targeting up to 10 pathogens that pose significant risk to public health, now including the Influenza virus and 2019-nCoV. This effort utilizes Regeneron's proprietary VelociSuite^® technologies – including the VelocImmune^® platform which uses a unique genetically-engineered mouse with a humanized immune system that can be challenged with all or parts of a virus of interest – to facilitate swift identification, preclinical validation and development of promising antibody candidates. Regeneron's rapid response VelociSuite® technologies are particularly well-suited for use in quickly-developing outbreak situations, as was done for Ebola.

INOVIO Pharmaceuticals, Inc. (NASDAQ: INO) announced last week that it has received a new $5 million grant from the Bill & Melinda Gates Foundation to accelerate the testing and scale up of CELLECTRA® 3PSP proprietary smart device for the intradermal delivery of INO-4800, a DNA vaccine for COVID-19. INO-4800 is in preclinical studies and is planned to advance into Phase 1 clinical trials in the U.S. in April with up to $9 million funding from CEPI. INOVIO plans to accelerate the testing and scale up of the CELLECTRA 3PSP devices to support large scale manufacturing of INO-4800 doses by the end of 2020. The next generation CELLECTRA 3PSP device is designed specifically for a COVID-19 type pandemic scenario. It is a small, portable, hand-held, user-friendly device that runs on readily available "AA" batteries. This allows for stockpiling of the device in quantity without maintenance. It is easy to use and is based on our current device with extensive history (over 6,000 administrations) which has received the CE mark and has an acceptable safety profile.

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