The Surge in New Cases Reinforces the Importance of a Healthy Lifestyle

- FinancialBuzz.com News Commentary

NEW YORK, Aug. 9, 2021 /PRNewswire/ -- While most of the economy has reopened, the number of new cases is once again on the rise. This time, two variants of COVID-19, the delta and lambda variants, are causing the numbers of newly inflected to rise. Delta is the most recent of four coronavirus mutations added to the World Health Organization's and Centers for Disease Control and Prevention's "variants of concern" lists. "[Delta is] mutating compared to other viruses incredibly quickly. I think a big part of that is because there is a significant percentage of people who are getting infected and are asymptomatic," Dr. Nevan Krogan, a University of California San Francisco, told KGO-TV according to ABC7. "The world is really a huge petri dish." Todos Medical Ltd. (OTC: TOMDF), Agenus Inc. (NASDAQ: AGEN), Hologic, Inc. (NASDAQ: HOLX), VBI Vaccines Inc. (NASDAQ: VBIV), iBio, Inc. (NYS: IBIO)

As a result, the highly transmissible delta variant now accounts for 83% of all positive samples

in New York City. As of last Friday, all five boroughs of the city have met the CDC guidelines to be considered "high transmission" areas where extra precautions should be taken. Even though vaccines are available and are being rolled out, testing remains a crucial factor. Experts say that people who exhibit symptoms consistent with the infection, such as cough, fever, congestion, fatigue, headache or loss of sense of smell should get tested even if they have been vaccinated or previously had been diagnosed with the virus. In addition, to reduce the severity of symptoms from the virus, a healthy immune system is the key. 

Todos Medical Ltd. (OTCQB: TOMDF) announced last week that, "it has received a notice of allowance from the US Patent & Trademark Office (USPTO) for a trademark for the Company's proprietary supplement Tollovid™. The Company received a Certificate of Free Sale (CFS) for the 5-day high dose regimen of Tollovid from the US Food & Drug Administration (US FDA) in April 2021.

This USPTO notice of allowance underscores the desire in the marketplace for Tollovid, especially given its high dose, 5-day formulation that helps to support and maintain healthy immune function. Tollovid is a potent botanical, delayed release, bioavailable 3CL protease inhibitor. The Company's lower dose, delayed release, daily-use formulation Tollovid Daily™ received a CFS from the US FDA in July 2021, including the critical 3CL protease inhibitor claim. Tollovid has high 3CL protease inhibitor activity than Tollovid Daily.

The Company is currently completing marketing plans for the US distribution of Tollovid™ (high dose, 5-day formulation) and Tollovid Daily™ (lower dose, daily use formulation), and has made Tollovid available to the market in the United States via www.MyTollovid.com and via The Alchemist Kitchen (https://www.thealchemistskitchen.com/products/tollovid), its SoHo, NYC based retail distribution partner that specializes in best of breed herbal supplements. The Company is working closely with the Alchemist Kitchen to implement best practices from a customer service perspective as it relates to the compliant use of botanical products to help support proper immune function.

'We are making diligent, regulatory compliant progress in terms of bringing our 3CL protease-related 'Tollo'-branded technologies to the marketplace,' said Gerald E. Commissiong, President & CEO of Todos Medical. 'It is clear that we have carved out a niche in the marketplace for 3CL protease inhibitor products, and that interest in these products is growing rapidly heading into the second half of 2021. We intend to remain fully regulatory compliant, and will seek to add additional data to the claims we ultimately intend to make for our various 'Tollo' branded products as we move forward in the second half of 2021 under the current uncertain market conditions. We intend to have both our Tollovid and Tollovid Daily products available on a first come first serve basis for their individual use cases in August 2021. We believe the second half of 2021 will be an extremely vibrant period for the development of 3CL protease inhibitors with significant human exposure data, and we firmly believe there is no other company in the world ahead of Todos Medical in this arena.'"

Agenus Inc. (NASDAQ: AGEN) announced on February 4th, positive preliminary results from its Phase 1 trial of iNKT cell therapy in patients with moderate to severe symptoms of COVID-19 through its subsidiary, AgenTus Therapeutics.  "We are heartened by these early results, which suggest that very sick patients who were admitted to intensive care units and intubated may benefit from a single administration of our iNKT cell therapy," said Dr. Garo Armen, Chairman and CEO of Agenus. "iNKT cells can be manufactured at scale and so far patients in this trial have tolerated the treatment well."

Hologic, Inc. (NASDAQ: HOLX) reported last week that it has obtained a CE Mark for the use of saliva samples with the Aptima® SARS-CoV-2 assay in Europe. The Aptima SARS-CoV-2 test is a molecular diagnostic assay that detects the genetic material of the pathogen causing COVID-19. The test runs on the fully automated Panther® system. "This new CE Mark demonstrates our commitment to providing European consumers and healthcare providers as many options as possible to manage the ongoing pandemic," said Jan Verstreken, Hologic's group president, International. "While vaccination is helping stem the tide of COVID-19, we envision that testing will continue to play an important role, particularly in screening programs needed to reopen society."

VBI Vaccines Inc. (NASDAQ: VBIV) announced back in June positive Phase 1 data from its Phase 1/2 trial of the first of its enveloped virus-like particle (eVLP) COVID-19 vaccine candidates, VBI-2902a, in healthy adults age 18-54 years of age. The 5µg dose of VBI-2902a, which expresses an optimized SARS-CoV-2 spike antigen and is adjuvanted with aluminum phosphate, was generally well-tolerated and elicited potent immune responses significantly higher than those seen in human convalescent sera. The data establish a robust human proof-of-concept, at a low dose without the use of a next-generation adjuvant, demonstrating the potency of the eVLP particulate delivery platform against COVID-19.

iBio, Inc. (NYS: IBIO) reported last month that preclinical studies of IBIO-202, its subunit vaccine candidate that targets the nucleocapsid protein ("N protein") of SARS-CoV-2, demonstrated a robust, antigen-specific, memory T-cell response.

Data on commercially available COVID-19 vaccines - all of which target the spike protein ("S protein") - suggests that neutralizing titers are effective, but likely to wane over time. In addition, the robustness of T-cell priming and cellular immunity achieved by S protein-directed vaccines may not be sufficient to create a durable immune response, especially in the context of emerging variant strains of the virus. In contrast, the N protein gene is more conserved and stable than the spike, with 90% amino acid homology and fewer mutations over time. Notably, the SARS-CoV-2 N protein shares substantial sequence conservation with the nucleocapsid of other coronaviruses.

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