Vaccine Development Holdups Reinforce the Need for Interim Solutions

The number of new cases continues to rise, and new restrictions are being implemented. As the pandemic remains a major threat, the development of a new vaccine is imperative. Paul Mango, Deputy Chief of Staff for Policy for Health and Human Services Secretary Alex Azar, repeated the administration’s position: that all Americans who want to be vaccinated against the virus will be able to do so by early spring 2021. Yet, recent delays from vaccine manufacturers make it unclear how soon we can expect one. Just earlier this week, Pfizer reported that the first interim analysis in its Phase 3 clinical trial has not yet occurred. A report by STAT also indicates that AstraZeneca, which in June anticipated it could begin to supply up to 2 Billion doses of vaccine in September, instead saw its Phase 3 trials in several countries put on hold when a participant experienced neurological symptoms that chairman Pascal Soriot said were consistent with transverse myelitis. Johnson & Johnson, the only manufacturer among the major vaccine makers testing a one-dose Covid vaccine, also saw its Phase 3 trial paused for two weeks after a volunteer in his 20s suffered what the Washington Post stated to be a stroke. Todos Medical Ltd. (OTC: TOMDF), Pfizer Inc. (NYSE: PFE), Gilead Sciences, Inc. (NASDAQ: GILD), Vaxart, Inc. (NASDAQ: VXRT), Moderna, Inc. (NASDAQ: MRNA)

“While it’s unfortunate, I don’t find it surprising that the timeline is being moved back,” said Michael Osterholm, Director of the University of Minnesota’s Center for Infectious Diseases Research and Policy. “Clinical trials like this routinely have unexpected occurrences that delay planned timelines. It’s just not unexpected.” Therefore, in the meantime, to properly combat the virus and avoid further restrictions, effective mass scale testing is crucial. Overall, three companies gained authorization from the Food and Drug Administration (FDA) to sell antigen testing instruments to labs or clinics. Additionally, a fourth company, Abbott Laboratories, also won approval to market a specific USD 5 rapid test administered by a health care professional. Yet, there are no tests that have yet been approved to be sold directly to consumers. Overall, testing continues to be uneven, as some states have managed to provide higher rates of testing than others. In addition, various companies are racing to develop antibody tests, also called serological tests, that can confirm whether someone was infected even after their immune system has cleared the virus.

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news last week that, “it has selected the brand name “Tollovid™” for its proprietary, patent protected 3CL protease inhibitor, previously called NLC-001. Todos licensed the exclusive worldwide distribution rights for Tollovid, excluding Israel, from Israel-based joint venture partner NLC Pharma in September 2020. Tollovid is an orally administered proprietary blend of plant extracts that includes a powerful 3CL protease inhibitor that helps support and maintain healthy immune function. The 3CL protease plays a vital role in the intracellular replication of coronaviruses, and 3CL protease inhibition is being evaluated as a potential therapeutic target for COVID-19 by several groups, including Pfizer.

Concurrent with this announcement, the Company announced that it has entered into a private label and distribution agreement with The Alchemist’s Kitchen, based in the SoHo district of New York City with a significant online presence. The Alchemist’s Kitchen is New York’s leading botanical wellness destination, leveraging the power of plants to improve health while working closely with leading clinicians and medical doctors to educate patients on how to use natural remedies to improve their health in the face of illness or disease. The Alchemist’s Kitchen has been featured in several high-profile educational series, including Dr. Sanjay Gupta’s CBD and cannabis specials that were previously featured on CNN. The Alchemist’s Kitchen will sell Tollovid under its Plant Alchemy™ brand and will train its herbalists to help educate consumers on how adding Tollovid to their immune boosting strategy could potentially lead to improved outcomes in the face of circulating coronaviruses.

‘Tollovid certainly is a unique asset in the botanical wellness space, and we are very pleased to be the first to bring this product to market in the United States,’ said Lou Sagar, President & CEO of The Alchemist’s Kitchen. ‘It’s clear there has been a tremendous amount of science developed around Tollovid as it relates to 3CL inhibition, and we believe this could be an important mechanism during this critical time heading into the colder months of the year where people will congregate indoors more often. As a brand, The Alchemist’s Kitchen is always looking to be on the cutting edge of innovation in the botanical wellness space, and Tollovid certainly reinforces our market leading position.’

‘We are excited to have selected the brand name Tollovid™ for NLC-001 and to be partnering with The Alchemist’s Kitchen to bring this important immune-boosting dietary supplement into the marketplace at this critical time in the United States,’ said Gerald E. Commissiong, President & CEO of Todos Medical. ‘Some of the most promising data in the scientific literature to date in combatting coronaviruses has been generated by dietary supplements that help reinforce the body’s ability to respond to potential challenges from a coronavirus infection. We are targeting Tollovid to be added to this immune-boosting paradigm, and believe Tollovid could be an important part of an immune boosting strategy to help support and maintain a healthy immune system during this upcoming period of significant concern about potential circulating viruses heading into the colder weather months ahead.’

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Pfizer Inc. (NYSE: PFE) announced on August 7th, a multi-year agreement with Gilead Sciences, Inc. to manufacture and supply Gilead’s investigational antiviral remdesivir, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19. Under the terms of the agreement, Pfizer will provide contract manufacturing services at Pfizer’s McPherson, Kansas facility to manufacture and supply remdesivir for Gilead.  In March, Pfizer launched a five-point plan, which called on all members of the innovation ecosystem – from large pharmaceutical companies to the smallest of biotech companies, from government agencies to academic institutions – to commit to work together in addressing the dire COVID-19 crisis.  “From the beginning it was clear that no one company or innovation would be able to bring an end to the COVID-19 crisis. Pfizer’s agreement with Gilead is an excellent example of members of the innovation ecosystem working together to deliver medical solutions,” said Albert Bourla, Chairman and Chief Executive Officer. “Together, we are more powerful than alone. As one of the largest manufacturers of vaccines, biologics and sterile injectables, it is a privilege to offer our expertise and infrastructure to help fight this pandemic. In that spirit, we are pleased that Gilead is using our manufacturing capacity to help facilitate supply of this medicine to patients as quickly as possible.”

Gilead Sciences, Inc. (NASDAQ: GILD) announced earlier last month that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury® (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Previously authorized by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the United States. The drug is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply. “The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources,” said Barry Zingman, MD, Professor of Medicine at the Albert Einstein College of Medicine and Montefiore Medical Center, New York. “The availability of a rigorously tested treatment that can significantly speed recovery and offers other benefits such as lower rates of progression to mechanical ventilation, provides hospitalized patients and their families important hope and offers healthcare providers a critical tool as they care for patients in need.”

Vaxart, Inc. (NASDAQ: VXRT) announced back in September that the U.S. Food and Drug Administration (FDA) has completed its review of the Company’s Investigational New Drug (IND) application for its Phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate. The Company also provided an update on its COVID-19 program. “Our goal is to deliver the best, most elegant solution for conferring mass protection against COVID-19. Our oral tablet vaccine offers a much more attractive mode of administration than injectables and may confer superior protection against COVID-19 due to activation of mucosal immunity. Importantly, our room-temperature stable tablet is significantly easier and cheaper to store and distribute to the farthest corners of the US and the globe, as it does not require the very costly and complex refrigerated cold chain needed for injectable vaccines.,” said Andrei Floroiu, chief executive officer of Vaxart. “The IND clearance and the initiation of our Phase 1 clinical trial moves us a step closer to proving the superiority of our convenient oral COVID-19 solution in the clinic. We are thus excited to start enrollment for our Phase 1 this month.”

Moderna, Inc. (NASDAQ: MRNA) confirmed last week that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., Ltd have agreed to purchase and distribute 50 million doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support Japan’s aim of providing vaccines to the Japanese public as soon as possible, subject to necessary regulatory approvals. Moderna is responsible for the manufacture and supply of Moderna’s vaccine candidate, and Takeda, with the support of the MHLW, the Japan Agency for Medical Research and Development (AMED) and Moderna, is responsible for all import, local regulatory, development and distribution activities in Japan to ensure timely access starting during the first half of 2021. “We thank the MHLW and Takeda for their support and for partnering with us to bring mRNA-1273, our vaccine candidate against COVID-19, to Japan. We appreciate the confidence of the MHLW in Moderna and mRNA-1273, which we hope will help address the pandemic, especially given the encouraging data we have recently published together with the NIH related to the clinical trial in the elderly and older adult population,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We look forward to our expected first review of our interim efficacy data, which is expected in November.”

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