Innovative Products Emerge to Mitigate Concerns Over the Pandemic's Longevity

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Jan 06, 2022, 09:00 ET

NEW YORK, Jan. 6, 2022 /PRNewswire/ -- The pandemic's longevity has renewed concerns as new variants are becoming more prominent around the globe. In fact, the currently spreading Omicron variant has proven to be a highly contagious continuation of the pandemic. As a result, the U.S. Food and Drug Administration (FDA) on Monday expanded the Emergency Use Authorization for Pfizer's vaccine boosters to children ages 12 to 15. Children in this age group represent about 5% of the total U.S. population. Furthermore, they account for about 4% of the fully vaccinated population in the U.S. with about 3% of those eligible to receive a booster shot, according to the latest CDC data. In the meantime, New York city has become the epicenter for the pandemic once again, as state officials confirmed 62,526 new cases across city on Sunday, the latest in a surge of cases following the holidays. Todos Medical Ltd. (OTC: TOMDF), Johnson & Johnson (NYSE: JNJ), Vaxart, Inc. (NASDAQ: VXRT), Hologic, Inc. (NASDAQ: HOLX), Merck & Co., Inc. (NYSE: MRK)

"Throughout the pandemic, as the virus that causes Covid-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind," FDA Acting Commissioner Dr. Janet Woodcock said in a statement, according to CNN. "With the current wave of the omicron variant, it's critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight Covid-19."

Todos Medical Ltd. (OTCQB: TOMDF) announced yesterday breaking news that, "its President & CEO Gerald Commissiong today issued a letter to shareholders outlining the Company progresses towards a national exchange listing expected in the first half of 2022.

Dear Valued Shareholder,

I would like to thank you for joining us in our journey here at Todos to transform the course of the COVID-19 pandemic and help patients with cancer and Alzheimer's get better access to diagnostic tools that could dramatically impact their health. I'm going to touch on the key themes of great interest to our shareholders and hopefully set out the key plans we have that we believe will drive shareholder value in the months ahead.

Acquisition of NLC Pharma Assets and Formation of 3CL Sciences

We continue to make good progress to complete the acquisition of NLC Pharma's assets, and have updated the timeline expected to close the transaction to this month January 2022. As a reminder, Todos and NLC Pharma are currently operating under our active joint venture with NLC Pharma called COVID Antigen Test Killer (CATK) established in Q2/2020 where Todos has been funding the development and commercialization of 3CL protease biology-related products that include Tollovid®, Tollovid Daily™, Tollovir™ and TolloTest™. As a reminder, Dr. Dorit Arad of NLC Pharma is a pioneer in the field of 3CL protease biology whose lab was the first to purify the 3C and 3CL proteases in the early 2000s and is slated to become the Chief Scientific Officer of 3CL Sciences.

Tollovid and Tollovid Daily are dietary supplements products that have received Certificates of Free Sale (CFS) from the US Food & Drug Administration (FDA) with 2 allowed claims:

1) Support and maintain healthy immune function

2) 3CL protease inhibitor (based on in vitro data)

These are important products available for purchase now on Amazon, Alibaba and our own website www.MyTollovid.com that empower people to make decisions now to support their immune system. We have seen record sales of Tollovid in the last month as increasing awareness of the significant benefit of 3CL protease inhibitors has gained international attention, and we believe we are uniquely positioned to meet that demand given that we have 3CL protease inhibitor products with authorized FDA claims on the market now in the United States and a partner in Europe via T Cell Protect Hellas that is preparing to distribute Tollovid Daily throughout Europe.

In parallel, we are developing botanical drug candidate Tollovir for the treatment of COVID-19 in hospitalized patients. Tollovir is a combination of herbal ingredients that have two specific compounds (NLC-EXT-1 and NLC-EXT-2) discovered by Dr. Arad through research under the joint venture that have 1) potent 3CL protease inhibition via sub nanomolar binding affinity activity and 2) anti-cytokine activity. We believe the dual mechanisms of Tollovir are critical in the hospitalized setting because they are synergistic in reducing the hyper-inflammation that likely drove the patient to the hospital and stopping the replication of the virus that likely created the hyper-inflammation in the first place.

The virus can maintain its activity at low levels for at least 3 months and research has shown it can persist for up to 8 months 1. Efforts aimed at reducing the hyper-inflammation and stopping the replication of the virus that created the inflammation feedback loop should be able to quell the cycle that causes hospitalized symptoms and death. It is very important to stabilize patients in order to get them out of the hospital faster so we can reduce the COVID burden on hospital systems. This time to stabilization is actually our primary endpoint in the current study. We believe we can produce in the tens of millions of treatment courses of Tollovir in 2022 to meet the demand for drug-grade 3CL protease inhibitors. We will be working with our European partners T-Cell Protect Hellas S. A. to gain Emergency Use Authorization (EUA) in Greece, and of course 3CL Sciences itself, as an Israel-based company, will be looking to advance EUA in Israel. We also expect we could receive EUA in other jurisdictions depending on the need in those jurisdictions. Given that we do not know which variant may emerge next, the variant-independent nature of the 3CL protease inhibitor products we are bringing forward will be a critical part of the fight against COVID-19 going forward.

We continue to believe that 3CL protease diagnostics could represent a sea-change in the COVID diagnostics market and TolloTest is uniquely positioned to meet that demand. On average, lateral flow antigen tests show evidence of disease 9 days after infection well after symptoms appear, but we expect our TolloTest to significantly cut that time and show evidence as early as 1 to 3 days before symptoms appear. The 3CL protease develops in the body 70 times faster than a virion, making detection easier. We have developed prototype models for mass screening systems for point-of-entry access to airports, schools, offices, sports arenas and other areas where large groups of people will interact indoors and will be building the prototype in the first half of 2022, and intend to partner the single use point of care intellectual property to a group currently in the market looking to differentiate their current nucleocapsid antigen testing kits by having an additional unique marker that could identify the virus earlier than currently available antigen tests.

COVID Testing

We have seen record demand for PCR testing at our CLIA/CAP lab Provista Diagnostics in recent weeks, and we are ramping up hiring to meet the substantial demand we expect will continue in the months ahead for COVID testing. With this demand increasing, we are seeing increasing sample flow from our reference lab clients and have received a number of new contracts to support new testing sites that are being established throughout the New York City area and the Atlanta area.

COVID testing at our client labs through our Corona Diagnostics subsidiary are also seeing increasing demand and we are looking at ways to more closely align with our labs to our mutual benefit so we can help them further scale to meet the demands of their local communities…"

Johnson & Johnson (NYSE: JNJ) reported earlier last month that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for use of the Company's COVID-19 vaccine as a booster for adults aged 18 and older at least two months after primary vaccination with a single-shot of the Johnson & Johnson COVID-19 vaccine, and as a 'mix and match' booster following primary vaccination with an approved two-shot mRNA COVID-19 vaccine regimen (known as heterologous boosting). "We are pleased with today's Positive Opinion from the CHMP supporting the use of our COVID-19 vaccine as a booster for eligible individuals in Europe," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "There is a growing body of data showing that the Johnson & Johnson COVID-19 vaccine induces broad and durable humoral and cellular immune responses, whether administered as a single shot for an efficient response to the pandemic, or as a booster shot after at least two months to strengthen protection against symptomatic COVID-19. Cellular immune responses are showing potential to be important for both breadth of protection and durability."

Vaxart, Inc. (NASDAQ: VXRT) explained last month that it plans to test the cross-reactivity of its oral tablet COVID-19 vaccine candidate against the Omicron SARS-CoV-2 variant in two different studies expected to begin next month. In the first study, Vaxart will test the activity of its Phase II COVID-19 oral vaccine candidate against Omicron by analyzing mucosal and serum samples from subjects to whom the vaccine was administered in Vaxart's current COVID-19 vaccine Phase II trials, Dr. Sean Tucker, Vaxart's Chief Scientific Officer and founder, said. In the second study, Vaxart will conduct an animal Omicron challenge study to assess how its current Phase II COVID-19 vaccine candidate performs in comparison to an Omicron-specific vaccine candidate that Vaxart is developing, Dr. Tucker said.

Hologic, Inc. (NASDAQ: HOLX) reported back in November that its three SARS-CoV-2 tests all detect the recently emerged Omicron variant of the coronavirus that causes COVID-19. Initially identified in South Africa and subsequently in a number of African, European and North American countries, the Omicron variant (B.1.1.529) contains approximately 30 mutations. Hologic conducted an analysis of genetic sequences from more than 175 Omicron-infected samples obtained through GISAID (Global Initiative On Sharing All Influenza Data, https://www.gisaid.org/) and determined that none of the new mutations occur within regions of the genome targeted by Hologic's Aptima® SARS-CoV-2 Assay, Aptima® SARS-CoV-2/Flu Assay or Panther Fusion® SARS-CoV-2 Assay. Hologic has also received data from clinical users in Europe indicating that the Aptima SARS-CoV-2 assay detected Omicron COVID-19 infections in samples from inbound air travelers.

Merck & Co., Inc. (NYSE: MRK) announced last month the New England Journal of Medicine has published findings from the Phase 3 MOVe-OUT trial evaluating molnupiravir, an investigational oral antiviral medicine, in non-hospitalized high risk adults with mild to moderate COVID-19. Data from MOVe-OUT demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. Molnupiravir is authorized in the United Kingdom as the first oral antiviral for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. The European Medicines Agency (EMA) issued a positive scientific opinion for molnupiravir under Article 5.3 Regulation 726/2004, which is intended to support national decision-making on the possible use of molnupiravir prior to marketing authorization. Regulatory applications are under review or are in the process of being submitted, including applications for Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) and Japan's Ministry of Health, Labor and Welfare.

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