News Commentary

New York, NY (12/17/2021) – The ongoing pandemic is causing renewed concerns as new variants are becoming more prominent. As an example, test positivity rates in New York City have doubled in just three days, Dr. Jay Varma, a top health advisor to Mayor Bill de Blasio, tweeted Thursday. According to data provided by the CDC on Wednesday, New York and New Jersey are the two states with the most rapid spread of the Omicron variant. To identify and track SARS-CoV-2 variants, CDC uses genomic surveillance. CDC’s national genomic surveillance system collects SARS-CoV-2 specimens for sequencing through the National SARS-CoV-2 Strain Surveillance (NS3) program, as well as SARS-CoV-2 sequences generated by commercial or academic laboratories contracted by CDC and state or local public health laboratories. In the meantime, restrictions for private businesses have become more strict. Todos Medical Ltd. (OTC: TOMDF), Pfizer Inc. (NYSE: PFE), Johnson & Johnson (NYSE: JNJ), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Vaxart, Inc. (NASDAQ: VXRT)

As a result of the most recent surge, schools like New York University and Cornell University have canceled in-person events and shifted finals online. On Tuesday, former White House senior pandemic advisor Andy Slavitt told CNN that businesses should mandate boosters before bringing people back into offices. Generally, the data shows that the Omicron variant infects the human body 70 times faster than previous coronavirus strains, though the infections appear to be less severe. Michael Chan Chi-Wai, the lead researcher on the study, noted that “It is also noted that, by infecting many more people, a very infectious virus may cause more severe disease and death even though the virus itself may be less pathogenic. Therefore, taken together with our recent studies showing that the Omicron variant can partially escape immunity from vaccines and past infection, the overall threat from Omicron variant is likely to be very significant,” according to The Hill.

Todos Medical Ltd. (OTCQB: TOMDF) reported yesterday breaking news that, “it will host a Key Opinion Leader (KOL) webinar entitled Tollovir™: a Potential Treatment for Covid-19 on December 22, 2021 at 12:00pm ET.

This webinar will feature presentations from KOLs Yossef Av-Gay, Ph.D., from the University of British Columbia, and David Greenberg, MD, Faculty Member of Health Sciences of the Ben-Gurion University of the Negev.

• Dr. Av-Gay will discuss the mechanics of SARS-CoV-2 viral replication, 3CL protease biology and the relevant benefits of targeting 3CL protease with respect to viral replication, NEMO cleavage inhibition and its role potentially downregulating innate immune response to infection.

• Dr. Greenberg will present a review of SARS-CoV-2 virus biology and what the relevant therapeutic targets are for antiviral intervention, which interventions are being evaluated, and what occurs in the state of hyper-inflammation and cytokine storm that occurs.

A presentation by Dr. Dorit Arad, NLC Pharma, JV partner with Todos Medical, will discuss 3CL protease inhibition and the various medicines targeting it. Todos will examine the competitive landscape referencing past studies as well discuss what is upcoming, including Todos Medical’s Tollovir™ 3CL protease inhibitor oral antiviral Phase II Covid-19 trial results in hospitalized patents, expected to be released to the public in December 2021, or early January 2022.

A question and answer session will follow. To register for the event, please click here.

David Greenberg, MD is an Associated Professor at the Faculty of Health Sciences of the Ben-Gurion University of the Negev. He is serving as the Chairman of the Israeli Clinical Pediatric Society. Dr. Greenberg is a member of the COVID vaccines advisory team for the Ministry of Health in Israel.

Dr. Greenberg obtained his MD from Ben-Gurion University of the Negev in Beer-Sheva, Israel in 1991, was boarded in Pediatrics in 1996, and did his fellowship in Pediatric Infectious Diseases at “The Children’s Hospital” in Vancouver from 1997 to 1999. He was boarded in Infectious Diseases in Israel in 2000. He joined the Department of Pediatrics and the Pediatric Infectious Disease Unit of Soroka University Medical Center as a pediatrician and a senior consultant in Pediatric Infectious Diseases in 1999. In collaboration with various researchers from several universities worldwide, Dr. Greenberg was a member World Health Organization Pneumonia Vaccine Trial Investigators’ Group and of the Pneumococcal Molecular Epidemiology Network (PMEN)…

Concurrent with this announcement, the Company, along with NLC Pharma, have agreed to extend the closing date for the formation of their new joint venture 3CL Sciences (60% owned by Todos / 40% owned by NLC Pharma) to December 31, 2021 in order to allow for the completion of legal due diligence by both companies.”

Pfizer Inc. (NYSE: PFE) announced yesterday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued advice on the use of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), stating that PAXLOVID can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease. The CHMP also recommend that PAXLOVID should be administered as soon as possible after diagnosis of COVID-19 and within five days of the start of symptoms. The EMA issued this advice under Article 5(3) of Regulation 726/2004 to support authorities of European Union (EU) Member States who may decide to allow the supply and use of PAXLOVID, for example in emergency use settings, prior to EU conditional marketing authorization. PAXLOVID is currently not authorized for use in the EU. “The CHMP’s advice signifies the strength of our data for PAXLOVID in the treatment of high-risk adults diagnosed with COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “COVID-19 continues to take lives at an unprecedented pace globally and exacts a devastating toll on health care systems. If authorized, PAXLOVID has the potential to help save lives and reduce hospitalizations. We look forward to working with the EMA and other regulatory agencies worldwide to bring this potential treatment to patients as quickly as possible.”

Johnson & Johnson (NYSE: JNJ) reported earlier this week 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.”

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.”

Vaxart, Inc. (NASDAQ: VXRT) explained yesterday 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.

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