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New Challenges Spur Greater Innovation in Diagnostic Testing Capabilities

NEW YORK, Sept. 17, 2020 /PRNewswire/ -- The diagnostics test manufacturing industry has been under immense pressure in recent times. The sudden global demand for accurate, high-quality testing is unlike anything the market has experienced before. The Food and Drug Administration (FDA) has also emphasized the importance of testing capabilities back in March and according to the FDA's announcement, it issued the fourth diagnostic related Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath Combo Kit. FDA Commissioner Stephen M. Hahn, M.D explained that "we have been engaging with test developers and encouraging them to come to the FDA and work with us. Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process." Numerous companies from a vast field of industries, including pharmaceuticals, medical device innovators and others have all made various declarations regarding products or services related to the pandemic, with testing kits at the center of attention. Todos Medical Ltd. (OTC: TOMDF), ADMA Biologics, Inc. (NASDAQ: ADMA), Cerus Corporation (NASDAQ: CERS), Altimmune, Inc. (NASDAQ: ALT), Vir Biotechnology, Inc. (NASDAQ: VIR)

While biotech companies work on vaccines and possible treatments and medical device companies progress on patient monitoring, many others have been working on improving testing options. For example, various companies are racing to develop antibody tests, also called serological tests, that can confirm whether someone was infected even after their immune system has cleared the virus. Experts warn, however, that vaccines are not going to be distributed quickly. According to a report by CNN, CDC Director Dr. Robert Redfield told a Senate Appropriations Subcommittee on Wednesday that, while a very limited supply of a vaccines might be ready in November or December, it will have to be prioritized. "It will be those first responders and those at greatest risk for death, and then eventually that will expand," he said. "If you're asking me when is it going to be generally available to the American public, so we can begin to take advantage of vaccine to get back to our regular life, I think we're probably looking at third, late second quarter, third quarter 2021."

Todos Medical Ltd. (OTCQB: TOMDF) just announced breaking news that, "NLC Pharma has added dietary supplement NLC-001 to its joint venture with Todos Medical. NLC-001 is composed of a proprietary blend of plant extracts that includes a powerful 3CL protease inhibitor. The 3CL protease plays a vital role in the intracellular replication of coronaviruses, and 3CL protease inhibition is believed to be a promising potential therapeutic target for coronaviruses, including SARS-CoV-2.

The US Food & Drug Administration granted a Certificate of Free Sale for NLC-001 to the Joint Venture's US contract manufacturer on August 28, 2020. NLC-001 has not received US FDA approval as an effective therapeutic candidate for the treatment of COVID-19.

'In looking at the landscape of COVID-19, it is becoming clear that despite the great number of therapeutical alternatives being used today, some of our best weapons are in fact oral compounds that help to boost immunity or reduce excessive inflammation,' said Jorge Leon, PhD, Chief Medical and Scientific Officer for Todos Medical. '3C protease inhibitors as a potential therapeutic for COVID-19 is based on sound science. The role of 3C protease is to inhibit the virus reproduction and allow the immune system to recognize the virus. Pfizer recently announced the development of 3C-L protease inhibitor as a potential drug for Covid 19. NLC Pharma had worked in parallel Agoutron (later acquired by Pfizer) for many years to identify 3C inhibitors for the HRV virus. We believe the NLC-001 inhibitor will be effective over various strains of the Corona virus as it is a mechanism based drug that does not change within the whole Corona virus family.'

Under the terms of the agreement, Todos has been granted exclusive worldwide distribution rights for the FDA-cleared formulation of NLC-001, excluding Israel, as well as a right of first refusal to develop a pharmaceutical drug based on the NLC technology. Todos is responsible for all commercial activities, including manufacturing, clinical testing in COVID-19 patients, marketing and distribution. The active ingredient in NLC's formulation of NLC-001 is a powerful 3CL protease inhibitor that we believe provides a viable target would enable immediate production of the supplement for prevention and/or shortening of the course of the disease.

'We started developing 3C protease inhibitors in the 1987 as anti HRV antiviral drug, early 2000 when the initial SARS pandemic surfaced, and have been diligently advancing both our diagnostic and therapeutic understand of the 3C protease as a theragnostic target,' said Dorit Arad, PhD, President & Chief Scientific Officer of NLC Pharma. 'At the time that everybody is running towards a vaccine we are targeting the reproduction mechanism of the Corona virus. Unlike vaccine targets, this mechanism does not change even when the Corona virus mutates. A safe and effective therapeutic that can quickly slow or stop viral replication, giving the body's immune system time to mount an appropriate response is the best route to re-open economies safely and achieve the desired herd immunity. For this strategy to be effective, screening and diagnostic technologies will become more important than ever, and because of this, we felt Todos was the right partner for this potentially game-changing dietary supplement.'

'We are extremely excited to have added NLC-001 to our joint venture with NLC Pharma due to its strong safety profile, as demonstrated by being granted a Certificate of Free Sale by the US Food & Drug Administration,' said Gerald Commissiong, President & CEO of Todos Medical. 'Selected dietary supplements currently represent some of the most accessible and close to market alternatives in the market to improve immune function. NLC is initiating clinical studies at hospitals in Israel to evaluate the efficacy of NLC-001 in the treatment of hospitalized COVID-19 patients. We believe NLC-001 certainly warrants to be commercialized immediately in the United States as a dietary supplement, without therapeutic claims. Going forward, we will be conducting robust studies in the United States to evaluate the efficacy of NLC-001 in a variety of clinical settings including hospitalized patients, symptomatic quarantined patients, asymptomatic patients, as well as a prophylactic intervention. Once the clinical development is completed, with data submitted and reviewed by FDA, we are hopeful NLC-001 will be granted therapeutic claims for COVID-19. We are now evaluating the best regulatory path for NLC-001.'

Key Scientific Publications related to potential of 3C Protease Inhibitors for COVID-19

Science Translational Medicine 3C-like protease inhibitors block coronavirus replication in vitro and improve survival in MERS-CoV–infected mice (https://stm.sciencemag.org/content/12/557/eabc5332)..."

For our latest "Buzz on the Street" Show featuring Todos Medical Ltd. recent corporate news, please head over to: https://www.youtube.com/watch?v=msW5MbyH5Bs

ADMA Biologics, Inc. (NASDAQ: ADMA) announced earlier this month the launch of COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma. ImmunoRank™ was developed in collaboration with Leinco Technologies, Inc. ImmunoRank is intended for use as an aid to identify individuals who produce an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV-2 neutralizing antibodies in human plasma of all immune globulin classes. ImmunoRank is designed to test up to 90 samples per test kit with 99.8% specificity. The assay procedure takes approximately 80 minutes. An Emergency Use Authorization (EUA) submission is currently being prepared for review and potential approval by the U.S. Food and Drug Administration. We will report on material regulatory and commercial developments as we progress.  ADMA has submitted patents for ImmunoRank in the U.S. and certain foreign markets. Both ADMA and Leinco are named as co-inventors on the patents.

Cerus Corporation (NASDAQ: CERS) reported back in July study results demonstrating that the INTERCEPT Blood System inactivates SARS-CoV-2, the causative agent for COVID-19, in plasma components intended for transfusion. These data are consistent with prior INTERCEPT studies showing complete inactivation, to below the limit of detection, of other coronaviruses associated with severe pulmonary disease: MERS-CoV1,2 (2018, 2019) and SARS-CoV-1 (2005). The in vitro study evaluated inactivation of SARS-CoV-2 in plasma components using both infection and molecular assays, as well as cell culture passaging experiments, allowing the confirmation of complete inactivation over time. Under the Principal Investigators Prof. Esam Ibraheem Azhar (Special Infectious Agents Unit - BSL3, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia) and Prof. Salwa Hindawi (Department of Hematology, Faculty of Medicine), the study was conducted at the Special Infectious Agents Unit - BSL3, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia, with a local clinical SARS-CoV-2 isolate. This center is known for its expertise in coronavirus research. A manuscript for publication is currently in preparation. The investigators are currently conducting a subsequent study to assess the ability of the INTERCEPT Blood System to inactivate SARS-CoV-2 in platelet components. These studies are funded by the Saudi Arabia Ministry of Health and supported by Cerus.

Altimmune, Inc. (NASDAQ: ALT) announced last month additional positive results from the preclinical studies of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. The studies were conducted as part of Altimmune's ongoing collaboration with the University of Alabama at Birmingham (UAB). The latest study showed potent stimulation of antigen-specific CD4+ and CD8+ T cells in the lungs of CD-1 mice as early as 10 days following a single intranasal vaccination, with responses strongly biased toward CD8+ T cells. The mucosal T cell response in the respiratory tract is believed to be dependent on the intranasal route of administration and we believe it has the potential to provide additional protection against COVID-19.  The induction of a mucosal T cell response in the lungs has not been shown, to date, with the intramuscularly administered COVID-19 vaccine candidates that are currently in the advanced stages of clinical development. Both CD4+ and CD8+ T cells displayed phenotypes consistent with the Th1 type immune response that is important for control of viral infections. CD8+ T cells, also known as killer T cells, can recognize and kill virally infected cells, and recent clinical reports in China and Europe have suggested the importance of T-cell responses in long-term protection from COVID-19.

Vir Biotechnology, Inc. (NASDAQ: VIR) and GlaxoSmithKline plc reported last month that the first patient was dosed last week in a Phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization. The aim of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study, which will enroll approximately 1,300 patients worldwide who have early symptomatic infection, is to assess whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalization due to COVID-19. Initial results may be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021. Last week's initiation of the study follows the signing of a collaboration between the two companies in April 2020 to research and develop solutions for coronaviruses.

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