Biotech Companies Concentrate on Vaccine Formulation and Distribution

NEW YORK, March 19, 2020 /PRNewswire/ -- COVID-19 has drastically changed the world's social and economic landscape since the virus was first identified in China in January. Countries have shut down schools and businesses, restricted travel, are in the midst of canceling entertainment and sporting events, as well as encouraging the public to stay at home as much as possible. Earlier last week, the World Health Organization (WHO) proclaimed the COVID-19 outbreak a global pandemic. According to WHO Director-General's opening remarks at the media briefing on COVID-19 on March 11th, 2020: the number of cases, the number of deaths and the number of affected countries is expected to climb even higher in the days ahead. As of Monday, more than 5,000 people have tested positive for the new COVID-19 disease in the U.S. and at least 71 have died. Worldwide, more than 194,000 people confirmed to have the virus. And while about half have already recovered, the death toll was just over 7,800 at the time of writing. In an effort to slow the spread of the coronavirus pandemic, the Centers for Disease Control (CDC) announced on Sunday that it recommends organizers (whether groups or individuals) cancel or postpone in-person events that consist of 50 people or more throughout the United States for the next 8 weeks. Todos Medical Ltd. (OTC: TOMDF), BioNTech SE (NASDAQ: BNTX), Moderna, Inc. (NASDAQ: MRNA), Vir Biotechnology, Inc. (NASDAQ: VIR), Aytu BioScience, Inc. (NASDAQ: AYTU)

Several biotechs, as well as medical device companies, have made announcements that vaccines are being developed or testing kits are in production. In the meantime, a Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. According to the National Institutes of Health (NIH), "The study is evaluating different doses of the experimental vaccine for safety and its ability to induce an immune response in participants. This is the first of multiple steps in the clinical trial process for evaluating the potential benefit of the vaccine." As for testing, labs and healthcare facilities are facing supply shortages, a lack of instrument access, as well as increased staffing needs. In response, the FDA opened the emergency use authorization (EUA) process to high-complexity CLIA labs on Feb. 28th, creating a new pathway for regulated assay development. According to the FDA's announcement from last week, it has issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit. "This action today shows our agency's dedication to working around the clock to review and authorize diagnostics during this public health emergency," said FDA Commissioner Stephen M. Hahn, M.D. "We have been engaging with test developers and encouraging them to come to the FDA and work with us. Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process."

Todos Medical Ltd. (OTCQB: TOMDF) just announced breaking news today that, "announced it has entered into an exclusive distribution agreement for the United States and Israel (the "Distribution Agreement") with Gibraltar Brothers & Associates, LLC, a U.S.-based subsidiary of Shanghai Liangrun Biomedicine Technology Co. ("Shanghai"), for its proprietary colloidal gold immunochromatography test ("Colloidal Gold").

Colloidal Gold has been approved as a diagnostic test for the novel coronavirus (COVID-19) in China by the NMPA (formerly the China FDA) and in Europe under a CE Mark. Todos will be responsible for obtaining U.S. Food and Drug Administration (FDA) approval and plans to do so under the Emergency Use Authorization Program.

Shanghai has shipped test kits for validation by Todos. During the four-week validation process, Todos intends to place its first purchase order based upon the market demand identified. Shanghai currently has 500,000 Colloidal Gold test kits in stock, and has indicated to Todos that it can manufacture up to 300,000 test kits per day to help meet the demand in the U.S., given that demand for test kits in China has begun to decline.

COLLOIDAL GOLD NOVEL CORONAVIRUS (COVID-19) TEST KIT VIDEO INSTRUCTIONS

VIDEO LINK: https://www.youtube.com/watch?v=bqkqUkZljFs&feature=youtu.be

The Colloidal Gold point-of-care (POC) test kit uses a drop of blood from a finger prick to test for antibodies to COVID-19.  The test kit contains a detection kit, a lancet, a disinfectant wipe, a micropipette, a cotton ball and the reagent.  The kit comes in a sealed plastic bag and includes instructions; the only thing not included is a timer.  This is a rapid test that takes between two and 10 minutes to obtain results, compared with the nasal swab test currently in widespread use that takes two to three days for results.

"I'm pleased to see Todos take on the task of bringing additional COVID-19 testing capacity into the United States, where we expect significant demand in the coming months as we grapple with the international pandemic," said Jorge Leon, Ph.D., Chief Medical Advisor to Todos. "The IgM antibody response to the SARS-CoV-2  virus appears at days 5-6 after infection showing recent exposure to the virus, and lasts for up to three weeks, therefore it is an important test to increase the window of diagnostic sensitivity of true positive cases since the molecular test (nucleic acid test), despite being the gold standard,  is not always positive in some patients during the early course of infection. The IgG antibody response peaks at day 21 and lasts for years, indicating the patient was infected with the virus. The Colloidal GolD IgM/IgG tests has become a very important test in the coronavirus testing paradigm, and we will be working to validate the assay here in the United States in the coming weeks in preparation for commercial launch under CLIA and parallel interactions with U.S. federal authorities to expedite its path to FDA approval using the recently enacted Emergency Use Authorization Program. Because Colloidal Gold tests for antibodies to the virus that causes COVID-19 (SARS-CoV-2), instead of testing for the virus itself, this test will be different and complementary to the nucleic acid test Todos will be validating in parallel. Validating and making available the Colloidal Gold and lab-based molecular testing together or in parallel has the potential to create a new paradigm in the screening for COVID-19 that we believe may allow for EUA from US FDA for Colloidal Gold POC test kit."

Todos and Provista Diagnostics, Inc. have agreed to use Provista's lab in Alpharetta, Georgia to conduct the validation required to launch the test in the U.S. under CLIA. Todos entered into an exclusive option to acquire Provista, and this transaction is expected to close in the second quarter of 2020. All COVID-19 testing inquiries should be directed via email to [email protected].

Rao Mulpuri, Ph.D., Chief Operating Officer of Provista, commented, "We are very pleased to help validate and ultimately offer this new, more comprehensive testing paradigm to meet the needs of our country during this COVID-19 crisis."

"In these extraordinary times, the value of widespread medical testing has become clearer than ever.  We are proud to use our business development expertise to identify multiple solutions that together have the potential to significantly increase testing accuracy and capacity in the U.S. by screening large numbers of patients in places where traditional lab testing methods may not be able to meet the demand," said Gerald Commissiong, President & CEO of Todos Medical.

"The concept behind a rapid test is to triage and quarantine the patient as quickly as possible after detection," he added.  "This test can be done at a doctor's officer or in a clinic by a nurse practitioner, but we are particularly focused on nursing homes and senior care centers.  These locations typically house seniors with underlying medical conditions that make them the most at-risk population due to lack of mobility.  Through testing we believe communities can quickly identify infections earlier and limit a group's overall exposure to COVID-19, which is particularly deadly in this demographic. There are more than 65 million Americans over the age of 65, and this is one of the most at-risk populations for whom we must ensure early detection. We also are looking to ensure solutions for various government organizations, self-insured employers, small businesses as well as other groups who need access to testing."

Clinical Results from Clinical Trial in Wuhan, China

All samples were tested using the Colloidal Gold diagnostic device, and the results were compared to RT-PCR or clinical diagnosis (including chest Computed Tomography and clinical signs and symptoms) of Novel Coronavirus. Colloidal Gold was evaluated with 188 blood samples obtained from clinically confirmed COVID-19 patients from multiple Chinese Hospitals and the Chinese CDC laboratories (positive), as well as 182 non-SARS-CoV-2 infected patients (negative). The results were:

• Sensitivity (positive): 90.43% (170/182)
• Specificity (negative): 100% (182/182)

About Novel Coronavirus (COVID-19) - Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses can be transmitted between animals and people and evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China, and additional cases have been found in a growing number of countries. COVID-19 is the disease caused SARS-CoV-2.

About Todos Medical Ltd. - Todos Medical Ltd. is an in-vitro diagnostic company engaged in the development of blood tests for the early detection of a variety of cancers, and also has initiated the development of blood tests for neurodegenerative disorders such as Alzheimer's disease through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. Todos has developed two cancer screening tests based on TBIA (Todos Biochemical Infrared Analyses), a method for cancer screening using peripheral blood analysis. The TBIA screening method is based on the cancer's influence on the immune system, which triggers biochemical changes in peripheral blood mononuclear cells and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing. The company's two cancer screening tests, TM-B1 and TM-B2, have received the CE mark. Todos owns 19.99% of Breakthrough Diagnostics, Inc., a joint venture with Amarantus Bioscience Holdings, Inc. (OTCPK: AMBS) that is developing the LymPro Test®, a blood test for diagnosing Alzheimer's disease. Todos has exercised its option to acquire Breakthrough and expects to close on that transaction in the first half of 2020. Todos has also entered into an exclusive option to acquire breast cancer blood testing company Provista Diagnostics, Inc. that is commercializing the Videssa® breast cancer blood test.

Todos has entered into a non-excusive distribution agreement with 3DMedicine Science & Technology Co (3DMed), a China-based cancer precision medicine company, for distribution in the US and Israel of 3DMed's ANDiS® SARS-CoV-2 Detection Kit (COVID), ANDiS® SARS-CoV-2  & Influenza A/B Detection Kit (COVID/Flu) and its proprietary ANDiS®350 3DMed Automated Solution countertop real-time PCR machine (3D Machine). 3DMed's COVID, COVID/Flu and 3D Machine have received a CE Mark in Europe. 3D Machine also has received approval from the Chinese FDA. 3DMed is currently engaged in discussions with the FDA regarding approval of its products.

Additionally, Todos has entered into an exclusive distribution agreement with Gibraltar Brothers & Associates, LLC, a U.S.-based subsidiary of Shanghai Liangrun Biomedicine Technology Co. ("Shanghai"), for its proprietary colloidal gold immunochromatography test ("Colloidal Gold") Rapid Test for the novel coronavirus that can deliver test results in two to 10 minutes at point of care. Colloidal Gold has been approved as a diagnostic test for COVID-19 in China by the NMPA (formerly the China FDA) and in Europe under a CE Mark. Todos will be responsible for obtaining U.S. Food and Drug Administration (FDA) approval. For more information, the content of which is not part of this press release, please visit http://www.todosmedical.com."

For our latest "Buzz on the Street" Show featuring Todos Medical Ltd. recent corporate news, please head over to: https://www.youtube.com/watch?v=-h0Le10feGc

BioNTech SE (NASDAQ: BNTX) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd announced yesterday a strategic development and commercialization collaboration to advance BioNTech's mRNA vaccine candidate BNT162 in China for the prevention of COVID-19 infections. Under the terms of the agreement, the two companies will work jointly on the development of BNT162 in China. The companies will collaborate to conduct clinical trials in China leveraging Fosun Pharma's extensive clinical development, regulatory, and commercial capabilities in the country. If approved, Fosun Pharma will commercialize the vaccine in China. BioNTech will supply the mRNA vaccine for clinical trials from GMP manufacturing facilities in Europe along with its partner Polymun. BioNTech will retain full rights to develop and commercialize the vaccine in the rest of the world. "We see this collaboration as an important step in our global effort to expedite the development of our mRNA vaccine to prevent COVID-19 infection. Fosun Pharma shares our commitment to move rapidly to address the COVID-19 outbreak and brings deep development experience and an extensive network in the pharmaceutical market in China," says Founder and CEO of BioNTech, Ugur Sahin, M.D.

Moderna, Inc. (NASDAQ: MRNA) announced this week that the first participant has been dosed in the Phase 1 study of the Company's mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2). This Phase 1 study is being conducted by the National Institutes of Health (NIH) under its own Investigational New Drug (IND) application. mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH. Manufacture of the first clinical batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI). "This study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2, and we expect it to provide important information about safety and immunogenicity. We are actively preparing for a potential Phase 2 study under our own IND," said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. "We are grateful to NIH for their ongoing collaboration and to CEPI for funding the initial manufacturing of mRNA-1273 and are proud to be included with the many companies, worldwide health agencies and NGOs working on a possible response to the novel coronavirus outbreak."

Vir Biotechnology, Inc. (NASDAQ: VIR) announced last week that it had signed a letter of intent with Biogen Inc. for the development and clinical manufacturing of human monoclonal antibodies for the potential treatment of COVID-19, the disease caused by the SARS-CoV-2 virus. Because of the urgency of the situation, the companies have begun work while a Clinical Development and Manufacturing Agreement is being negotiated. Subject to the completion of a definitive agreement, Biogen would continue cell line development, process development, and clinical manufacturing activities in order to advance the development of Vir's proprietary antibodies. "These exceptional circumstances presented by the threat of COVID-19 require that we work with great urgency in the interest of the public good," said George Scangos, Ph.D., CEO, Vir. "Biogen is one of the global leaders in cell line and process development for advanced biologics; tapping into their capabilities will provide us with a U.S. base for supply and manufacture of antibody therapies." Vir has identified a number of monoclonal antibodies that bind to SARS-CoV-2, which were isolated from individuals who had survived a SARS (Severe Acute Respiratory Syndrome) infection. The company is conducting research to determine if its antibodies, or additional antibodies that it may be able to identify, can be effective as treatment and/or prophylaxis against SARS-CoV-2.

Aytu BioScience, Inc. (NASDAQ: AYTU) announced yesterday that the company intends to expedite the U.S. launch of its recently licensed COVID-19 IgG/IgM Point-of-Care Rapid Test in light of the updated FDA policy on coronavirus diagnostic testing. On March 16th, 2020 the FDA announced, "as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29th on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today's updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests..." Further, the agency made recommendations specifically for test developers stating that "the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated" and other labeling conditions are satisfied. Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "While we are still working with FDA on making the COVID-19 Rapid Test available, we believe that this updated policy may enable near-term availability of our recently-licensed point-of-care test. During this public health emergency, we are working tirelessly to satisfy all requirements in order to make the test available to the professional medical community as soon as possible." Disbrow also commented that, "We have already gotten confirmation from the manufacturer that our initial supply is being shipped and is expected to arrive in the U.S. very soon."

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