Unprecedented Global Turmoil Underlines Need for Effective Diagnostics
- FinancialBuzz.com News Commentary
NEW YORK, Sept. 28, 2020 /PRNewswire/ -- The pandemic continues to take a toll on the world's economy, and as a result, effective and cheap mass testing is needed to properly implement preventive measures. Since the pandemic has begun, antigen tests have been widely used. 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 were approved to be sold directly to consumers. A report by the USA Today indicates that "the United States needs 30 million tests a week to adequately track the virus and protect vulnerable residents, according to the Rockefeller Foundation. Labs have worked round the clock to gradually bring more tests to Americans over the past six months. Still, the nation reached 1 million daily tests for the first time last week, about one quarter of Rockefeller's goal of more than 4 million tests each day, according to the COVID Tracking Project." Todos Medical Ltd. (OTCQB: TOMDF), Vir Biotechnology, Inc. (NASDAQ: VIR), Gilead Sciences, Inc. (NASDAQ: GILD), Amgen Inc. (NASDAQ: AMGN), BioNTech SE (NASDAQ: BNTX)
Overall, testing continues to be uneven, as some states have managed to provide higher rates of testing than others. In the meantime, 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. In addition, back in April, Rutgers University researchers had received U.S. government clearance for the first saliva test to help diagnose the virus, which is a new approach that could help expand testing options and reduce the risks of infection for healthcare workers. According to a report by the Associated Press, Andrew Brooks, who directs the Rutgers lab that developed the test, explained that the test "prevents health care professionals from having to actually be in the face of somebody that is symptomatic."
Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news last week that, "it has entered into an implementation and equipment financing partnership with AID Genomics, a multi-national genomic R&D company and solution provider focusing on precision medicines for cancers and infectious diseases. AID Genomics recently completed a contract with the Ministry of Health in Israel to build and scale-up 6 HMO laboratories in Israel. In addition, AID Genomics has entered into a worldwide partnership with Tecan Group for delivery of liquid handler machines. AID has sent key staff from Israel to the United States to assist Todos in its current US implementation projects.
'We are excited to enter the US market in partnership with Todos Medical,' said Snir Zano, CEO of AID Genomics. 'We have developed a proven, scalable solution that can now be implemented via Todos Medical in the US. Now that Todos has reached the level of scale with its clients that justifies a formal relationship, we believe that we can leverage this partnership through Todos' sales channels and drive significant uptake of our integration solutions and dramatically increase PCR testing capacity for the US.'
Under the terms of the agreement, AID Genomics will finance the purchase of the equipment necessary to allow Todos' clients to scale to meet their capacity requirements and will assist Todos in the implementation of best practices to speed time to scale and optimize sample accessioning and data reporting software. In return, AID Genomics will participate in the net profit of each contract. Additionally, AID Genomics will assist Todos with validating and commercializing its proprietary tests in Israel.
'We are very pleased to formally enter into this partnership with AID Genomics that gives us access to proven implementation know-how and stable access to key automation technology that will allow our clients to reach their desired testing capacity,' said Gerald Commissiong, President & CEO of Todos Medical. 'We now intend to aggressively pursue new laboratory equipment and reagent supply agreements with access to non-dilutive funding that the AID Genomics relationship brings us so that we can meet the significant testing needs emerging in the US.'
For information related to Todos Medical's COVID-19 testing capabilities, please visit www.todoscovid19.com "
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Vir Biotechnology, Inc. (NASDAQ: VIR) and GlaxoSmithKline plc reported last month that the first patient was dosed last week in a Phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization. The aim of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study, which will enroll approximately 1,300 patients worldwide who have early symptomatic infection, is to assess whether VIR-7831, as a single- dose monoclonal antibody, can prevent hospitalization due to COVID-19. Initial results may be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021. Last week's initiation of the study follows the signing of a collaboration between the two companies in April 2020 to research and develop solutions for coronaviruses.
Gilead Sciences, Inc. (NASDAQ: GILD) announced on August 28th, the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) enabling use of the investigational antiviral Veklury® (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19. The expanded EUA is based on results from the Phase 3 SIMPLE trial evaluating Veklury in hospitalized patients with moderate COVID-19 pneumonia, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range of disease severity. "With the growing understanding of the utility of Veklury to help improve outcomes for a range of patients with COVID-19, we welcome the FDA's decision to expand emergency use authorization," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease. Today's action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury."
Amgen Inc. (NASDAQ: AMGN), AbbVie, Inc. and Takeda Pharmaceutical Co., members of the COVID R&D Alliance AbbVie, Inc., on August 3rd, announced the first patients enrolled in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) clinical trial. The I-SPY COVID Trial will evaluate the efficacy of cenicriviroc, a chemokine (CCR2 and CCR5) dual-receptor antagonist, Otezla® (apremilast), a PDE4 inhibitor, and Firazyr® (icatibant injection), a bradykinin B2 receptor antagonist in severely ill, hospitalized COVID-19 patients who require high-flow oxygen. "Collaborative research efforts leveraging adaptive platform trials enable faster and more complete learning about what works for patients, and they are especially critical for addressing urgent public health threats like COVID-19," said Dr. Mark McClellan, director of the Robert J. Margolis, Center for Health Policy at Duke University and former commissioner of the U.S. FDA and administrator of the Centers for Medicare and Medicaid Services. "Platform trials bring down the cost and increase the ease of executing well-powered, high quality studies, especially when multiple, potential therapies need to be evaluated quickly. The I-SPY COVID Trial is expanding a timely and effective platform trial strategy to evaluate promising treatments while maintaining an appropriate level of safety and statistical rigor necessary for regulatory evaluation."
BioNTech SE (NASDAQ: BNTX) reported last month additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. The newly released manuscript describes key safety and immunogenicity data from the U.S. Phase 1 trial for the BNT162b2 vaccine candidate, which at 30ug recorded 7 days after the second dose elicited SARS-CoV-2-neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults. Further, across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants. "The totality of the clinical and preclinical data informed Pfizer and BioNTech's decision to select BNT162b2 as the lead candidate to advance into pivotal trials. We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "We are especially pleased to offer these early data showing our vaccine candidate's promising safety and immunogenicity profile from the U.S. trial and we look forward to sharing T cell immune response data from the German trial in the near future."
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