Researchers Race to Advance Viral Disease Identification as COVID-19 Spreads

FinancialBuzz.com News Commentary

NEW YORK, March 5, 2020 /PRNewswire/ -- The 2019 outbreak of a coronavirus (COVID-19), which used to be called the novel coronavirus (2019-nCoV), represents a new type of coronavirus. It causes respiratory illness and was first diagnosed in Wuhan, China. The COVID-19 can spread from person to person, and usually travels through respiratory droplets expelled by coughs or sneezes. There are several different types of coronaviruses that can infect humans, including the COVID-19, the Middle East respiratory syndrome (MERS) and the severe acute respiratory syndrome (SARS) coronaviruses. As of March 4th, the Centers for Disease Control and Prevention (CDC) reported at least 80 confirmed cases of COVID-19 in the U.S, along with nine deaths in Washington state. Furthermore, among the 13 states where the virus is found, California is now in the center of attention. According to a report by NPR, Los Angeles declared a health emergency due to the coronavirus on Wednesday, citing the need to address the possibility of community transmission of the disease that has caused more than 3,200 deaths globally. However, the CDC expects more cases to be detected across the country as the outbreak of COVID-19 continues to expand and testing capacity in the U.S. increases. And while information so far suggests that most COVID-19 illnesses are mild, a report out of China suggests serious illness occurs in 16% of cases. Specifically, older people and those with certain underlying health conditions like heart disease, lung disease and diabetes, for example, seem to be at greater risk of serious illness. Todos Medical Ltd. (OTC: TOMDF), Amarantus Bioscience Holdings, Inc. (OTC: AMBS), Vir Biotechnology, Inc. (NASDAQ: VIR), Co-Diagnostics, Inc. (NASDAQ: CODX), Inovio Pharmaceuticals, Inc. (NASDAQ: INO)

In response to the outbreak, governments around the world have focused their resources on curing COVID-19. Besides the research necessary to develop a vaccine, accelerated R&D also focuses on diagnostic techniques, specifically on the scope of blood testing services throughout the industry. For example, researchers around the world 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. According to a report published by American Association for the Advancement of Science (AAAS), disease trackers in Singapore have used an experimental antibody test for COVID-19 to confirm that a suspected patient was infected with the coronavirus. The patient was one of two people who together formed a missing link between two clusters of cases that each occurred in a Singaporean church. "The group that developed the test, at Duke-NUS Medical School in Singapore, is among the front-runners, although its assay has to be validated before it is taken into production and deployed widely. In blood samples from recovered patients, the team identified antibodies targeting the spike protein that proved able to block the virus from killing cells in laboratory tests. In parallel, they created synthetic viral proteins that can detect those antibodies in a blood sample without having to use the live virus," AAAS explains.

Todos Medical Ltd. (OTCQB: TOMDF) announced earlier this week the "publication of data from a human clinical study in the scientific journal Analytical Chemistry entitled 'Differential Diagnosis of the Etiologies of Bacterial and Viral Infections Using Infrared Microscopy of Peripheral Human Blood Samples and Multivariate Analysis'. The data demonstrate that the use of the Fourier-transform infrared (FTIR) spectroscopy technique on peripheral blood samples yields a differential diagnosis when seeking to make a clinical diagnosis between patients with viral infections, bacterial infections and healthy controls.

'With the recent explosion of novel coronavirus (2019-nCoV) worldwide, definitively diagnosing viral infections versus bacterial or other types of infections that present with similar symptoms has become paramount in order to appropriately triage patients and guide treatment decisions for healthcare professionals,' said Gerald Commissiong, President & CEO of Todos Medical. 'Todos' proprietary FTIR blood testing platform that focuses on the immune system's reaction to cancer has received CE Marks in Europe for the diagnosis of breast cancer and colon cancer, has recently achieved strong analytical performance results from our proprietary sample preparation methods, and is currently enrolling a pre-commercial breast cancer study in Romania with distribution partner Orot+ (a division of Orot Luces) ahead of an expected commercial launch in Romania later this year. Based on these recent successes and this publication from the Company's licensors at Ben Gurion University, we have now formally begun to evaluate the commercial feasibility of applying our technology towards the diagnosis of bacterial and viral infections, including coronavirus. Because we use AI to create the algorithms required to differentially diagnosis cancer, we believe the rate limiting step towards creating algorithms for viral and bacterial infections on our platform is access to sufficient viral and bacterial patient samples in order create those new algorithms. As such, we have begun outreach efforts to determine the potential of obtaining such samples from coronavirus-affected jurisdictions.'

ABSTRACT (https://pubs.acs.org/doi/10.1021/acs.analchem.8b00017)

Human viral and bacterial infections are responsible for a variety of diseases that are still the main causes of death and economic burden for society across the globe. Despite the different responses of the immune system to these infections, some of them have similar symptoms, such as fever, sneezing, inflammation, vomiting, diarrhea, and fatigue. Thus, physicians usually encounter difficulties in distinguishing between viral and bacterial infections on the basis of these symptoms. Rapid identification of the etiology of infection is highly important for effective treatment and can save lives in some cases. The current methods used for the identification of the nature of the infection are mainly based on growing the infective agent in culture, which is a time-consuming (over 24 h) and usually expensive process. The main objective of this study was to evaluate the potential of the mid-infrared spectroscopic method for rapid and reliable identification of bacterial and viral infections based on simple peripheral blood samples. For this purpose, white blood cells (WBCs) and plasma were isolated from the peripheral blood samples of patients with confirmed viral or bacterial infections. The obtained spectra were analyzed by multivariate analysis: principle component analysis (PCA) followed by linear discriminant analysis (LDA), to identify the infectious agent type as bacterial or viral in a time span of about 1 h after the collection of the blood sample. Our preliminary results showed that it is possible to determine the infectious agent with high success rates of 82% for sensitivity and 80% for specificity, based on the WBC data.

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."

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Amarantus Bioscience Holdings, Inc. (OTC: AMBS) 80.01%-owned subsidiary Breakthrough Diagnostics, Inc., currently a joint venture with Todos Medical, Ltd. has licensed intellectual property rights to the Alzheimer's blood diagnostic LymPro Test^® from Leipzig University that was originally developed by Dr. Thomas Arendt, as well as certain rights to multiple sclerosis diagnostic MSPrecise™ and Parkinson's diagnostic NuroPro. Amarantus entered into a joint venture agreement with Todos Medical, Ltd. (OTCQB: TOMDF) to advance the diagnostic assets, and Todos has exercised its exclusive option to acquire Amarantus' remaining ownership in Breakthrough in exchange for approximately 49% ownership of Todos. The transaction is expected to close in the first half of 2020. Amarantus also owns approximately 30% of the common shares of Avant Diagnostics, Inc, a tumor analysis company developing Theralink^®, the proprietary phosphoprotein tumor analysis platform run using reverse phase protein array (RPPA) platform.

Vir Biotechnology, Inc. (NASDAQ: VIR) announced earlier last week the development and manufacturing collaboration to advance and produce human monoclonal antibodies for the potential treatment of COVID-19 (Coronavirus Disease 2019), a disease caused by SARS-CoV-2. Under the terms of the agreement, the companies will work together on the clinical development, manufacturing, and commercialization of Vir's proprietary antibodies.  WuXi Biologics will conduct cell-line development, process and formulation development, and initial manufacturing for clinical development. If the antibodies receive regulatory approvals, WuXi Biologics has the rights to commercialize therapies in Greater China, and Vir has the rights to commercialize therapies in all other markets worldwide. "We are acutely aware of the importance of moving rapidly in response to COVID-19," said George A. Scangos, Ph.D., CEO of Vir Biotechnology. "In the event that we are in a position to develop an antibody therapy, our agreement with WuXi Biologics enables us to accelerate advancement against this global threat."

Co-Diagnostics, Inc. (NASDAQ: CODX) announced this week that following a recent change to the Food and Drug Administration's (FDA) policy towards the coronavirus outbreak, the Company's coronavirus test kits are available to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) for use according to the FDA guidelines.

The Company is in discussions with certain qualified CLIA laboratories who can use COVID-19 tests built on Co-Diagnostics' platform technology in their Emergency Use Authorization (EUA) submissions with the FDA. Once the labs have completed the process required for the EUA submission, it is expected that they would purchase the Company's reagents for use in their COVID-19 diagnostics, as permitted by the FDA. Dwight Egan, CEO of Co-Diagnostics, commented, "We believe this change will allow the diagnostics industry to respond to the developing situation much more rapidly and effectively, and we applaud the FDA for taking such aggressive action to address the coronavirus outbreak. Co-Diagnostics' patented CoPrimer™ technology has been vetted in numerous applications by some of the most highly-respected firms focusing on molecular technology, and we are pleased to make this platform available domestically immediately to support the FDA's mission to slow the spread of this disease and mitigate its impact."

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced this week an accelerated timeline for developing its DNA vaccine INO-4800 to address COVID-19, the respiratory infection the World Health Organization (WHO) has designated a Public Health Emergency of International Concern of the highest level. According to WHO, approximately 89,000 cases have been reported globally with more than 3,000 deaths. Dr. J. Joseph Kim, Inovio's President & CEO, shared this accelerated timeline at the U.S. Coronavirus Task Force meeting at the White House on March 2. Dr. Kim said, "Inovio is the leader in coronavirus vaccine development and the only company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS). Using our modern DNA medicines platform, we designed our DNA vaccine INO-4800 in three hours after the publication of the genetic sequence of the novel coronavirus that causes COVID-19." Dr. Kim continued, "We immediately began preclinical testing and small-scale manufacture and have already shared robust preclinical data with our public and private partners. We plan to begin human clinical trials in the U.S. in April and soon thereafter in China and South Korea, where the outbreak is impacting the most people. We plan on delivering one million doses by year end with existing resources and capacity. However, we will need additional resources to scale up to make enough doses to help protect Americans from COVID-19 as well as to lead global efforts to curtail this virus."

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