BIO-11006

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 23, 2020. News information is not all-inclusive. Please check back for updates. FDA Actions EUA for Remote Monitoring : The FDA issued a EUA for products (Philips Medizin Systeme Boeblingen GmbH’s IntelliVue Patient Monitors MX750/MX850, IntelliVue 4-Slot Module Rack FMX-4 and IntelliVue Active Displays AD75/AD85) intended to be used by healthcare professionals in a hospital environment for remote monitoring of patients having or suspected of having COVID-19. This is to help reduce healthcare exposure to COVID-19. Temporary Policy : The FDA issued guidance for a temporary policy for repackaging or combing FDA-approved propofol injectable emulsion, 10 mg/mL(propofol) products during the COVID-19 pandemic. Warning Letter : The FDA and FTC issued a warning letter to Copper Touch, LLC for selling fraudulent COVID-19 products. Diagnostics Update : The FDA has worked with more than 360 test developers who plan to submit EUA requests to detect COVID-19. Also, 43 individual EUAs have been issued. In addition, 17 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs). The FDA has been notified that more than 215 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. Testing Therapies, Antivirals and Vaccines On March 16, Moderna and the National Institute of Allergy and Infectious Disease (NIAID) began dosing patients with mRNA-1273, its vaccine candidate against COVID-19. The second round of dosing in healthy Seattle volunteers has now begun. Plurisitem Therapeutics’ PLX (Placental eXpanded) cells are showing promise as a therapy for patients with severe cases of COVID-19. Insmed Incorporated: Insmed announced it will provide funding and clinical drug supply for the STOP-COVID19 trial, an investigative study for brensocatib. The study includes 300 hospitalized patients with COVID-19 sponsored by the University of Dundee. Akers Biosciences and Premas Biotech completed the second milestone in their agreement, the successful expression of the three coronavirus antigens, Spike (S), Envelope (E), and Membrane (M) that were selected for their vaccine candidate. Valneva SE and Dynavax Technologies are teaming up to develop VLA2001, a COVID-19 vaccine based on Valneva’s already commercialized and validated Japanese encephalitis (JE) vaccine. This is only the second inactivated-virus vaccine strategy in development for the coronavirus. Dynavax is providing CpG 1018, the adjuvant contained in the FDA-approved HEPLISAV-B vaccine, to develop the inactivated, whole virus COVID-19 vaccine candidate. Valneva plans to use its manufacturing facilities to ramp up activities as quickly as possible and the goal is to initiate COVID trials before the end of 2020. Theravance Biopharma announced that the first healthy volunteer has been dosed in a Phase 1 study of TD-0903, Theravance’s lung-selective, nebulized Janus kinase inhibitor in development for the potential treatment of hospitalized patients with Acute Lung Injury caused by COVID-19. Theravance believes JAK inhibition may have the potential to obstruct the cytokine storm associated with acute lung injury and prevent progression to dangerous respiratory distress. Algernon Pharmaceuticals got the green light from South Korea to start its PH2 COVID-19 treatment trial for ifenprodil, an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B. Algernon has strong data to support its belief that this drug has a strong potential to reduce lung injury from COVID-19 and help people recover. Insmed Incorporated will provide funding and clinical drug supply for the STOP-COVID19 trial, an investigator-initiated study of brensocatib in up to 300 hospitalized patients with COVID-19. The trial is sponsored by the University of Dundee. The study is expected to begin enrollment in May 2020. Brensocatib is a novel oral, reversible inhibitor of dipeptidyl peptidase 1 currently being developed by Insmed for the treatment of bronchiectasis and other inflammatory diseases. Biomarck Pharmaceuticals, Ltd. announced positive results in its Phase IIa study of its anti-MARCKS technology for the treatment of Acute Respiratory Distress Syndrome. The study evaluated the safety and efficacy of aerosolized BIO-11006 Inhalation Solution in patients with moderate to severe ARDS due to sepsis where all patients received mechanical ventilation as the standard of care. Clinical results with BIO-11006 demonstrated a 43% reduction in all-cause mortality at 28 days. Faster improvement in oxygenation measures supported the decrease in mortality. Caladrius Biosciences announced the U.S. Food and Drug Administration authorized its Investigational New Drug Application for the study of CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung damage. The study will target patients with severe SARS-CoV-2 infection that required ventilatory support due to respiratory failure. Other Industry News Vaccine expert Rick Bright was terminated from his role as director of the Biomedical Advanced Research and Development Authority (BARDA) , over his opposition to the statements made by the White House regarding malaria drug hydroxychloroquine as a potential treatment for COVID-19. Earlier this month, Martin Shkreli made a public appeal in a published paper to be temporarily released from prison to work on a potential treatment for COVID-19. On Wednesday, his lawyers asked a federal judge for that release. There is no word on when a judicial decision will be made regarding a temporary halt to Shkreli’s seven-year sentence for fraud. Some scientists have an ambitious belief that a vaccine for the novel coronavirus could be in hand by the fall. That is a different expectation than most guidances in the U.S. have predicted, which is that it will be 2021 before the first vaccine candidates could be available. Leerink analyst Geoffrey Porges has tried to quell those expectations with a dose of reality. In a note to investors, Porges said a broadly used vaccine is likely to take two to three years in his “most optimistic” estimation.