FinancialBuzz.com News Commentary
NEW YORK, April 13, 2020 /PRNewswire/ -- The consequences of the current pandemic are vast and complex for business stakeholders and customers alike, as international and local supply chains are under unparalleled economic pressure. Numerous major industries, such as tourism, airline, dining, film and others are now in system paralysis. In the meantime, several biotechs, as well as medical device companies, have made announcements that vaccines are being developed or testing kits are in production. For example, a Phase 1 clinical trial evaluating an investigational vaccine designed to protect against the viral infection 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 has opened the emergency use authorization (EUA) process to high-complexity CLIA labs on Feb. 28th, creating a new pathway for regulated assay development. Algernon Pharmaceuticals Inc. (OTC: AGNPF) (CSE: AGN), Vir Biotechnology, Inc. (NASDAQ: VIR), Novavax, Inc. (NASDAQ: NVAX), Co-Diagnostics, Inc. (NASDAQ: CODX), Moderna, Inc. (NASDAQ: MRNA).
As of April 9th, the outbreak has caused more than 93,000 deaths around the world and more than a million and a half people have been infected with the virus, according to a dashboard created by Johns Hopkins University's Whiting School of Engineering, which reports the numbers in near real time. Dr. Anthony Fauci, one of America's leading experts on infectious diseases and a key member of the White House's coronavirus task force, revealed that antibody tests have been developed and will be available "very soon." In addition, Dr. Fauci explained that "the number of deaths and the cases that we're seeing right now are really validating what we said, that this is going to be a very bad week, on the one hand… On the other hand, as you can see there are some glimmers of hope, particularly when you look at the situation in New York — where the number of hospitalizations, requirements for intensive care and intubation over the last few days have actually stabilized and [are] starting to come down."
Algernon Pharmaceuticals Inc. (OTCQB: AGNPF) (CSE: AGN) is also listed on the Canadian Securities Exchange under the ticker (CSE: AGN). Last week, the Company announced breaking news that, "a regulatory submission has been made to the Ministry of Food and Drug Safety in South Korea for an investigator-led Phase 2 COVID-19 study of its re-purposed drug NP-120 (Ifenprodil).
The 40-patient trial is designed to test the effect of Ifenprodil in COVID-19 infected patients with severe pneumonia. The primary endpoint will be the rate at which their lung function improves by measuring oxygen levels in the blood (Pa02/Fi02). Secondary endpoints will include mortality, rate of mechanical ventilation, and patient reported effects on cough and breathlessness (dyspnea).
Once the trial has been approved, the Company, along with its lead Asia-Pacific CRO Novotech and the physician-investigators, will work to enrol patients and begin the study as soon as possible.
The Company believes that Ifenprodil is a drug that could reduce both the severity and duration of a COVID-19 infection, potentially limiting the progression of patients to ventilation and intubation.
About NP-120 (Ifenprodil): NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NDMA) receptor glutamate receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil also exhibits agonist activity for the Sigma-1 receptor, a chaperone protein up-regulated during endoplasmic reticulum stress. Although the anti-fibrotic activity of Ifenprodil in IPF is not known, recent studies have suggested a link between both receptors and pathways associated with fibrosis.
About Algernon Pharmaceuticals Inc.: Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing."
Algernon has filed new intellectual property rights globally for NP-120 (Ifenprodil) for the treatment of respiratory diseases and is working to develop a proprietary injectable and slow release formulation.
The Company cautions that it is in the early stages of clinical research and development and is not making any express or implied claims that NP-120 (Ifenprodil) is an effective treatment for the COVID-19 virus at this time."
Vir Biotechnology, Inc. (NASDAQ: VIR) and GlaxoSmithKline plc announced last week that they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will use Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.
Novavax, Inc. (NASDAQ: NVAX) announced last week that it has identified a coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using Novavax' proprietary nanoparticle technology, and will initiate a first-in-human trial in mid-May. Novavax' proprietary Matrix-M™ adjuvant will be incorporated with NVX-CoV2373 in order to enhance immune responses and stimulate high levels of neutralizing antibodies. NVX-CoV2373 was shown to be highly immunogenic in animal models measuring spike protein-specific antibodies, antibodies that block the binding of the spike protein to the receptor and wild-type virus neutralizing antibodies. High levels of spike protein-specific antibodies with ACE-2 human receptor binding domain blocking activity and SARS-CoV-2 wild-type virus neutralizing antibodies were observed after a single immunization. In addition, the already high microneutralization titers seen after one dose increased eight fold with a second dose. High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.
Co-Diagnostics, Inc. (NASDAQ: CODX) announced last week that its Logix Smart™ Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2. The Company's test can be used by clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) to detect the presence of the virus that causes COVID-19, and is available for purchase from the Company's Utah-based ISO-13485:2016 certified facility. Co-Diagnostics began offering its COVID-19 test to some U.S. CLIA labs in March 2020 as a result of the FDA's policy for diagnostic tests for COVID-19 during the current public health emergency. Previously, the Company had initiated sales of its CE-IVD test to the European Community, and to other global markets that accept a CE marking as valid regulatory approval following routine local product registration.
Moderna, Inc. (NASDAQ: MRNA) announced last month 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."
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