COVID Cases Surge Once Again Amidst a Lack of Diagnostic Supplies

The pandemic remains a major concern around the world. According to recent data published by Johns Hopkins University's Center for Systems Science and Engineering, more than 5.6 million people have died from the disease worldwide, including over 872,000 Americans. As for vaccination statistics, data from the CDC indicates that about 63.5% of the population in the United States is fully vaccinated against COVID-19. Nevertheless, since Thanksgiving, there have been nearly 84,000 confirmed deaths. The Omicron variant, while less lethal than the previous variants, is still highly contagious and is estimated to account for 99.9% of all new cases in the U.S. as of January. 22nd. Yesterday, over 21 million new weekly cases were reported across the globe, the most recorded since the beginning of the pandemic, according to the World Health Organization. Todos Medical Ltd. (OTC: TOMDF), Pfizer Inc. (NYSE: PFE), Novavax, Inc. (NASDAQ: NVAX), BioNTech SE (NASDAQ: BNTX), Sorrento Therapeutics, Inc. (NASDAQ: SRNE)

As a result of the high numbers of new cases, 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) together with its 3CL protease theranostic joint venture partner NLC Pharma Ltd., announced yesterday breaking news regarding, "positive interim data for its Tollovir™ oral antiviral 3CL protease inhibitor Phase 2 clinical trial for the treatment of hospitalized (severe and critical) COVID-19 patients. Tollovir met its primary endpoint of reducing time to clinical improvement as measured by the National Emergency Warning System 2 (NEWS2) and met several key secondary clinical endpoints, including complete reduction in COVID-19 deaths. The Company has now formally closed the Phase 2 clinical trial due to positive interim efficacy data. Lead clinical site Shaare Zedek Medical Center now permits the use of Tollovir™ in hospitalized COVID-19 patients on a compassionate use basis.

The Company will host a conference call at 9:15am Eastern Time. 

The Company will also be presenting at Emerging Growth Conference at 3:00pm Eastern Time. 

'It is extremely exciting to see the validation of Tollovir in a placebo-controlled trial which now allows us to continue on the clinical and regulatory path towards Emergency Use Authorization for the treatment of COVID-19 patients,' said Dr. Dorit Arad, Founder & CTO of NLC Pharma, Todos Medical's 3CL science-based joint venture partner. 'The data produced in this study closely mirrors data we generated in an Observational Clinical study conducted in 2020. The recent emergence of the Omicron variant has been pushing healthcare systems to the brink of collapse. Tollovir could be an incredibly powerful tool to reduce death and stabilize patients faster, thereby reducing their recovery time from this debilitating disease. Tollovir will help flatten the curve by freeing up hospital capacity to see more patients and perform other more routine non-COVID related hospital treatments.'

'We are extremely pleased with the results from this clinical study in the hospital setting of our dual mechanism antiviral & anti-cytokine oral drug candidate Tollovir,' said Gerald E. Commissiong, President & CEO of Todos Medical. 'We have already begun preparing manufacturing for commercial quantities of Tollovir so that we will be able to deliver shipments in jurisdictions where we expect to be granted accelerated Emergency Use Authorization (EUA), and are in the process of fine tuning our proposed Phase 2/3 clinical study protocol for hospitalized COVID-19 patients. The new protocol is the key document that will enable our regulatory team to engage with regulatory bodies worldwide, including US FDA. Our goal is to immediately target EUA in jurisdictions that will require limited additional clinical data. We are also preparing for the development of Tollovir for the treatment of:

1) hospitalized pediatric COVID-19,

2) moderate to severe adult COVID-19 in the outpatient setting,

3) moderate to severe pediatric COVID-19 in the outpatient setting,

4) the treatment of Long COVID in adults and

5) the treatment of Long COVID in the pediatric setting.'…

About Dr. Dorit Arad - Dr. Dorit Arad is a D.C. in physical organic chemistry from the Technion who has more than 25 years of experience in the life science industry as an international researcher, executive and entrepreneur. Dr. Arad is a pioneer in the discovery and development of 3CL protease biology related products and product candidates. Dr. Dorit Arad is an interdisciplinary scientist with expertise in computer assisted drug design, biotechnology, mechanism-based drug design, diagnostics, infectious disease and cancer."

Pfizer Inc. (NYSE: PFE) reported on January 18th, results from multiple studies demonstrating that the in vitro efficacy of nirmatrelvir, the active main protease (Mpro) inhibitor of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), is maintained against the SARS-CoV-2 variant Omicron. Taken together, these in vitro studies suggest that PAXLOVID has the potential to maintain plasma concentrations many-fold times higher than the amount required to prevent Omicron from replicating in cells.  "We specifically designed PAXLOVID to retain its activity across coronaviruses, as well as current variants of concern with predominantly spike protein mutations. Following the clinical findings – showing PAXLOVID reduced risk of hospitalization or death by nearly 90% compared to placebo for high-risk patients when treated within five days of symptom onset – we are encouraged by these initial laboratory findings," said Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. "These data suggest that our oral COVID-19 therapy can be an important and effective tool in our continued battle against this devastating virus and current variants of concern, including the highly transmissible Omicron. We will continue to monitor the treatment's activity in real-world settings and believe that these in vitro findings will continue to be validated." 

Novavax, Inc. (NASDAQ: NVAX) announced on January 19th, that Australia's Therapeutic Goods Administration (TGA) has granted approval for provisional  registration of NVX-CoV2373, Novavax' COVID-19 vaccine (adjuvanted), for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine will be supplied to Australia under the brand name Nuvaxovid™.  "The grant of provisional registration of Nuvaxovid by the TGA reflects Novavax' increasing momentum around the globe and represents the first-protein based COVID-19 vaccine authorized for use in Australia," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "While the world continues to grapple with the ever-changing nature of the virus, we look forward to delivering our vaccine to the people of Australia. We would also like to extend our gratitude to the Australian clinical trial participants who contributed so significantly to the development of our vaccine."

BioNTech SE (NASDAQ: BNTX) and InstaDeep Ltd announced on January 11th, the development of a new computational method that analyses worldwide available sequencing data and predicts high-risk variants of SARS-CoV-2. The Early Warning System (EWS) developed in collaboration by BioNTech and InstaDeep is based on artificial intelligence (AI) calculated immune escape and fitness metrics.  "With the advanced computational methods we have been developing over the past months we can analyse sequence information of the Spike protein and rank new variants according to their predicted immune escape and ACE2 binding score," said Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "Early flagging of potential high-risk variants could be an effective tool to alert researchers, vaccine developers, health authorities and policy makers, thereby providing more time to respond to new variants of concern."

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) and Sorrento Mexico announced this week that COFEPRIS has given EUA approval to Sorrento Mexico to import, market and distribute COVISTIX tests directly in Mexico. COVISTIX is a sensitive platinum colloid-based lateral-flow rapid antigen test for the detection of SARS-CoV-2 infection, including Omicron and Delta variants of concern. Mexico passed 300,000 test-confirmed coronavirus deaths last week, however, so little testing is done in the country of 126 million that a government review of death certificates puts the real toll at almost 460,000. The virus infection spike was largely responsible for the cancelation of 260 flights between Jan. 6 and Jan. 10, as airline employees got infected and had to isolate, causing staff shortages. "The situation in Mexico is quite serious, and Sorrento and Sorrento Mexico are doing everything we can to increase testing capacity for the people of Mexico," said Dr. Henry Ji, President and CEO of Sorrento.

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