Diagnostics Remain Vital Despite a Growing Number of Vaccinated

NEW YORK, Jan. 11, 2022 /PRNewswire/ -- While the pandemic continues to be highly contagious, more so than before due to the Omicron variant, vaccines and testing on a regular basis remain crucial aspects in the fight against the spread. The number of new cases in New York in particular, which once again has become the epicenter of the pandemic in the U.S., has broken more records. According to data, the daily rate of new infections per 100,000 fully vaccinated New Yorkers grew by more than seven-fold over the course of December, from 29.8 new cases per 100,000 inoculated residents the first week of the month to 223.3 the final week, state data shows. Todos Medical Ltd. (OTC: TOMDF), Vaxart, Inc. (NASDAQ: VXRT), Novavax, Inc. (NASDAQ: NVAX), Pfizer Inc. (NYSE: PFE), Inovio Pharmaceuticals, Inc. (NASDAQ: INO)

Because tests are a necessary tool to understand the spread of the pandemic and also to predict its prognosis, COVID tests are now in short supply. According a report by ABC7, people desperate for at-home test kits are turning to resellers on Facebook and Craigslist. "It's unethical to price gouge in the face of panic and in the face of shortage, but it will go on. As for people buying them, what are they going to do? They can't find tests any other way. I cannot blame someone for wanting to protect their child, but you have to then remember the person who sells you something on the black market could sell you something that's not going to work," explained Arthur Caplan, a Professor of Bioethics at New York University's Grossman School of Medicine. Data published by Fortune Business Insights indicates that the global COVID-19 diagnostics market size is projected to reach USD 11.40 Billion by 2027 while exhibiting a CAGR of 7.9% during the forecast period.

Todos Medical Ltd. (OTCQB: TOMDF) announced yesterday breaking news that, "its President & CEO Gerald Commissiong will appear on Fox Business' The Claman Countdown on Tuesday, January 11 during the 3pm Eastern Time hour show to discuss COVID testing in the United States and how it relates to the pending availability of oral antiviral treatments such as the Company's Tollovir™ 3CL protease inhibitor oral antiviral treatment currently preparing to read out on Phase 2 clinical data in hospitalized patients. Mr. Commissiong is also presenting at the Biotech Showcase 2022 to be held virtually from January 10-12th, 2022. Concurrent with this announcement, Mr. Commissiong released a blog entitled "COVID Testing: What Needs to Happen Now to Turn the Corner in 2022" that discusses key points needed to improve the United States COVID testing infrastructure. The blog posting is available online at https://todosmedical.com/blog/covid-testing-what-needs-to-happen-now-to-turn-the-corner-in-2022.

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."

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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.

Novavax, Inc. (NASDAQ: NVAX) announced on December 20th, that the World Health Organization (WHO) has granted a second Emergency Use Listing (EUL) for NVX-CoV2373, Novavax' recombinant protein nanoparticle COVID-19 vaccine with Matrix-M™ adjuvant, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. Today's EUL pertains to vaccine to be marketed by Novavax as Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) in Europe and other markets. NVX-CoV2373 is also being manufactured and marketed in India and licensed territories by Serum Institute of India Pvt. Ltd. (SII), as Covovax™, which was granted EUL on December 17. Nuvaxovid and Covovax are based on the same Novavax recombinant protein technology and the EULs are based on a common pre-clinical, clinical and chemistry, manufacturing and controls (CMC) package.  "Today's Emergency Use Listing underscores the ongoing need and potential for Novavax to help significantly increase COVID-19 vaccine access across the globe through a protein-based option built on a well-understood platform," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank the World Health Organization for its thorough assessment and look forward to helping address major obstacles to controlling the pandemic, including practical barriers to access and vaccine hesitancy."

Pfizer Inc. (NYSE: PFE) announced last week that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The treatment includes nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer's laboratories, which was specifically designed to block the activity of the SARS-CoV-2 Mpro, an enzyme that the coronavirus needs to replicate. "Today's authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world. This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible."

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced last week updates on the Phase 3 program for VGX-3100 for HPV-associated cervical high-grade squamous intraepithelial lesions (HSIL), including a one-year follow-up of efficacy and safety data in participants from REVEAL1, completing enrollment in REVEAL2, and advancing its pre-treatment biomarker candidate for VGX-3100 to be further developed with QIAGEN. In addition, INOVIO's development partner within Greater China (mainland China, Hong Kong, Macao, Taiwan), ApolloBio Corp. ("ApolloBio"), dosed the first participant in a separate Phase 3 trial in China. Dr. J. Joseph Kim, President and CEO of INOVIO, said, "We are making strong progress in developing INOVIO's immunotherapies treating HPV-associated cervical HSIL. Left untreated, cervical HSIL may progress to cancer. VGX-3100 has the potential to be the first approved immunotherapy and non-surgical alternative for women with cervical HSIL and we look forward to advancing our efforts from our Phase 3 studies through commercialization."

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