Aggressive Infectious Diseases Prompt the Development of Powerful New Blood Tests

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NEW YORK, March 3, 2020 /PRNewswire/ -- Infectious diseases are caused by pathogenic microorganisms such as bacteria, viruses, fungi and parasites, and can be transmitted by direct or indirect contact. Globally, infectious diseases such as malaria, HIV, tuberculosis, influenza, hepatitis A, hepatitis C and recently the novel (new) coronavirus (named "COVID-19") put major strains on public health. Since the COVID-19 has become a major concern, scientists have begun to use a powerful new blood test to help identify people who have previously been exposed to the virus. Currently, this kind of test is still under development in the United States, but it has been cleared for use in Singapore and China. NPR's Science correspondent Richard Harris explains that the current lab test used in the United States doesn't reveal who had previously been infected. However, that's important information for understanding the unfolding epidemic. "That means the test can identify silent infections, as well as identifying people who were once sick but have recovered. If it turns out that many people got infected with the novel coronavirus but didn't get sick, that means the virus is less likely to be fatal than it now appears," according to NPR's report. In fact, blood testing and diagnosis is tremendously important for today's healthcare system. Additionally, the accelerated disease R&D, rising prevalence of chronic diseases and notable maturity in diagnostic techniques are anticipated to augment the scope of blood testing services throughout the industry. And, the global market for blood testing is expected to grow from nearly USD 53.8 Billion in 2018 to USD 60.5 Billion by 2023 with a CAGR of 2.4% during the period of 2018-2023, according to BCC Research. Todos Medical Ltd. (OTCQB: TOMDF), iBio, Inc. (NYSE: IBIO), Moderna, Inc. (NASDAQ: MRNA), Inovio pharmaceuticals, Inc. (NASDAQ: INO), Novavax, Inc. (NASDAQ: NVAX)

Coronaviruses are a large family of viruses that are common in many different species of animals, including camels, cattle, cats, and bats. However, it is only rarely that animal coronaviruses can infect people and subsequently spread throughout the population, but such a list includes MERS, SARS, and now the COVID-19. The sudden increase of cases in Italy, the Islamic Republic of Iran and the Republic of Korea have caused a worldwide panic, causing a major financial market sell-off last week. Now, new cases throughout the United States are also being reported. And as the virus continues to spread rapidly, world experts and funders set priorities for COVID-19 research. UN Humanitarian Chief Mark Lowcock just released USD 15 Million from the Central Emergency Response Fund (CERF) to help fund global efforts to contain the COVID-19 virus. In the meantime, the World Health Organization (WHO) has called for USD 675 Million to help fund the fight against the novel coronavirus. Tedros Adhanom Ghebreyesus, WHO Director-General, said: "The potential spread of the virus to countries with weaker health systems is one of our biggest concerns. These funds will help support these countries get ready for detecting and isolating cases, protecting their health workers, and treating patients with dignity and appropriate care. This will help us save lives and push back the virus."

Todos Medical Ltd. (OTCQB: TOMDF) announced yesterday that 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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iBio, Inc. (NYSE: IBIO) announces earlier last month their collaboration to develop and test a new 2019-nCoV vaccine to be manufactured using iBio's FastPharming System™. The companies are expediting work as predictions about spread of the disease continue to worsen.

The joint effort leverages twenty-five years of vaccine research and development experience – inclusive of work on the MERS-coronavirus – by Dr. Kevin Wang (Chairman and Chief Scientific Officer, CC-Pharming) along with the decades of experience that Dr. Sylvain Marcel (VP Upstream Bioprocessing, iBio) possesses in the rapid design of manufacturing processes for biopharmaceutical production in plant-based expression systems. If successful, the research will deliver product candidates which can then be quickly produced at iBio's FastPharming Manufacturing Facility. Dr. Wang commented, "This is an important collaboration to develop plant-derived vaccine strategies for the emerging coronavirus outbreak here in China, and around the world. iBio's capabilities will enhance our ability to rapidly scale-up vaccine candidate production in effort to combat the 2019-nCoV virus' threat to global health."

Moderna, Inc. (NASDAQ: MRNA) announced last week that it has released the first batch of mRNA-1273, the Company's vaccine against the novel coronavirus, for human use. Vials of mRNA-1273 have been shipped to the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH) to be used in the planned Phase 1 study in the U.S. mRNA-1273 is an mRNA vaccine against the novel coronavirus encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators at the NIAID Vaccine Research Center (VRC). Manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI). "I want to thank the entire Moderna team for their extraordinary effort in responding to this global health emergency with record speed. The collaboration across Moderna, with NIAID, and with CEPI has allowed us to deliver a clinical batch in 42 days from sequence identification," said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. "This would not have been possible without our Norwood manufacturing site, which uses leading-edge technology to enable flexible operations and ensure high quality standards are met for clinical-grade material."

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported on January 30th that it is collaborating with Beijing Advaccine Biotechnology Co. to advance the development in China of INO-4800, Inovio's vaccine against the recently emerged strain of coronavirus (2019-nCoV) that has killed numerous people and infected thousands more in China to date. Inovio recently announced that it is developing INO-4800 through Phase 1 human testing in the U.S. to evaluate safety and immunogenicity with the support of an initial grant up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

Novavax, Inc. (NASDAQ: NVAX) announced on February 26^th the progress in its efforts to develop a novel vaccine to protect against coronavirus disease COVID-19. Novavax has produced and is currently assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing, which is expected to begin by the end of spring 2020. Novavax created the COVID-19 vaccine candidates using its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein. Novavax expects to utilize its proprietary Matrix-M™ adjuvant with its COVID-19 vaccine candidate to enhance immune responses. "Our previous experience working with other corona  viruses, including both MERS and SARS, allowed us to mobilize quickly against COVID-19 and successfully complete the critical preliminary steps to engineer viable vaccine candidates," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Now that the protein has been expressed stably in our baculovirus system, we aim to identify the optimal candidate and scale up production of sufficient vaccine for preliminary clinical trials. We are now well-positioned to advance the COVID-19 vaccine candidate to Phase I clinical testing in May or June."

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