Diagnostics Remain Vital Despite a Slowdown in Infections

FinancialBuzz.com News Commentary

NEW YORK, Jan. 13, 2022 /PRNewswire/ -- Based on recent data of new Omicron cases, there is a sign of plateau in New York City, where the number of cases has been making records in recent weeks. Yet, in the rest of the state, cases are still on the rise. In addition, due to the high number of hospitalizations, there have been limits on certain procedures, causing major delays to often necessary services. "Looks like we may be cresting over that peak," New York Gov. Kathy Hochul said in a news briefing. "Cases are slowing down, the rate of increase is slowing down, but they are still high." As a result, the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization earlier this month 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. Todos Medical Ltd. (OTCQB: TOMDF), VBI Vaccines Inc. (NASDAQ: VBIV), Merck & Co., Inc. (NYSE: MRK), Hologic, Inc. (NASDAQ: HOLX), Novavax, Inc. (NASDAQ: NVAX)

Since December, and as a result of the new wave, COVID-19 testing kits are in short supply. According to Anthony S. Fauci, Chief Medical Adviser to President Biden, it is going to be very important "that we get a greater capability of testing, particularly when the demand for testing is so high, with the combination of the Omicron variant itself, as well as the holiday season, where people want to get that extra level of assuredness that they're protected, even if you are vaccinated and boosted."

Todos Medical Ltd. (OTCQB: TOMDF) announced yesterday breaking news that, "topline results from the Tollovir™ Phase 2 clinical trial for the treatment of hospitalized COVID-19 patients will be announced the morning of January 27th, 2022, with a conference call follow-up that will occur after market close. The Company will provide further details regarding the conference call during the week ending January 17, 2022 when it announces the data lock for the trial.

For more information, please visit www.todosmedical.com. For more information on the Company's CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com.

About Todos Medical Ltd. - Founded in Rehovot, Israel with offices in New York City, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. In 2021, Todos completed the acquisition of U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos' two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe. Todos is focused on the commercialization of Videssa and will bring the TBIA tests to market thereafter.

Todos has entered into a joint venture with NLC Pharma targeting diagnostic and testing solutions to address the COVID-19 pandemic. The Joint-Venture is pursuing the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target a fundamental reproductive mechanism of coronaviruses. The Company's proprietary therapeutic candidate Tollovir™ is currently in a Phase 2 clinical trial to treat hospitalized COVID-19 patients in Israel, and is preparing to initiate Phase 2/3 clinical trials for both hospitalized and non-hospitalized patients in Israel.

Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.

Todos is also distributing certain (COVID-19) testing materials and supplies to CLIA-certified labs in the United States. The products cover multiple suppliers of PCR testing kits, extraction kits, automation materials and supplies, as well as COVID-19 antibody and antigen testing kits."

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=0WaNkRiNS9U

VBI Vaccines Inc. (NASDAQ: VBIV) announced last year positive results from multiple preclinical studies against several COVID-19 variants of concern as well as the initiation of dosing in the Phase 1b portion of the ongoing clinical study of VBI's SARS-CoV-2 vaccine candidates in approximately 80 adults age 18-54. VBI's coronavirus pipeline, which includes multiple vaccine candidates developed using the Company's proprietary enveloped virus-like particle (eVLP) technology platform, is being developed with the objective to increase the breadth of protection against known and emerging variants of COVID-19. Bill Cameron, M.D., Medical Director of Clinical Research at the Ottawa Hospital Research Institute, Infectious Disease Specialist at The Ottawa Hospital, Professor at the University of Ottawa, and Principal Investigator of the ongoing Phase 1a/1b study, commented: "The significant number of COVID-19 infections on a global scale contributes to increasing numbers of mutations and thus emergence of new viral variants. Some are associated with increased transmissibility, like Alpha and Delta variants, and some with escape from natural or vaccine acquired immunity, like Beta, Mu, Lambda, and Kappa variants. These vaccine-escape variants have shown to be associated with decreased immunogenicity of licensed COVID-19 vaccines, which are based on expression of various forms of the S protein using the unmutated reference sequence from the ancestral strain. Development of an effective booster strategy or new vaccines that are able to broaden protection against more than one variant will be important for the public health management of COVID-19. In-line with that effort, we look forward to seeing the data from this next phase of VBI's clinical study."

Merck & Co., Inc. (NYSE: MRK) announced earlier last month that 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.

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.

Novavax, Inc. (NASDAQ: NVAX) reported yesterday that South Korea's Ministry of Food and Drug Safety (MFDS) has approved a Biologics License Application (BLA) from SK bioscience for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization in individuals 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2. Nuvaxovid™, Novavax' COVID-19 vaccine also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea and will be manufactured and marketed in the country by SK bioscience. "Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic as both the Delta and Omicron variants have taken hold," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank our partners at SK bioscience for their commitment to this public health challenge and the MFDS for its thorough assessment of our data as we look forward to helping address major obstacles to controlling the pandemic through the additional option of our protein-based vaccine."

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