COVID-19 Top News – May 7, 2020

May 7, 2020

VIR-2703 / Vir Biotech, Alnylam
Vir and Alnylam identify RNAi therapeutic development candidate, VIR-2703 (ALN-COV), targeting SARS-CoV-2 for the treatment of Covid-19 (Alnylam Press Release) – May 4, 2020 – “Vir Biotechnology, Inc….and Alnylam Pharmaceuticals, Inc….today announced the selection of a development candidate (DC) for VIR-2703 (also referred to as ALN-COV)….The companies plan to soon meet with the U.S. Food and Drug Administration (FDA) and other regulatory authorities to discuss a potential accelerated path for filing an Investigational New Drug (IND) or IND equivalent application at or around year-end 2020….The companies plan to advance VIR-2703 as an inhalational formulation for the potential treatment and/or prevention of COVID-19….We will further accelerate our efforts and plan to begin studies in humans at or around year-end…”


PPP003 / Tetra Bio-Pharma
Tetra Bio-Pharma provides PPP003 inflammatory cytokine reduction drug program (Tetra Bio-Pharma Press Release) – May 6, 2020 – “Tetra Bio-Pharma Inc….is pleased to announce that it has now completed the modifications to the nonclinical safety program of PPP003 to ensure the launch of a Phase 1 trial in healthy volunteers later this year and subsequently be able to initiate a Phase 2 trial in patients with COVID-19 immediately after….The phase I study will enroll approximately 100 healthy volunteers….The study will include standard safety assessments, pharmacokinetics and cardiovascular evaluations. The phase II study will enroll approximately 100 covid-19 infected patients in several hospitals.”


GLS-1200 / GeneOne, University of Pennsylvania
GeneOne Life Science announces US FDA approval of a phase 2 study of GLS-1200 nasal spray for Covid-19 prevention (PRWeb) – May 4, 2020 – “GeneOne Life Science, Inc. announces today an Investigational New Drug (IND) approval by the U.S. Food and Drug Administration of a Phase 2 study of GLS-1200, its nasal spray for the prevention of COVID-19 infection. This study will recruit hospital personnel and other frontline healthcare workers who are at significantly higher risk for infection with COVID-19. In this study, GLS-1200 will be topically self-administered as a spray to the nose, the primary entry point for COVID-19 infection….This study of GLS-1200 will enroll a total of 225 participants into a randomized, double-blind, placebo-controlled clinical trial. The study will investigate whether three-times daily nasal administration of GLS-1200 over 4 weeks can prevent infection with COVID-19 while in use.”


llllllllll Organicell Announces FDA Approval of IND Application for the Treatment of SARS Due to COVID-19 (GlobeNewswire, ORGANICELL REGENERATIVE MEDICINE, INC) – May 5, 2020 – “Organicell Regenerative Medicine, Inc….announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Organicell Flow, for patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection. This trial will be the first randomized, double-blinded, placebo-controlled, phase I/II multi-center clinical trial investigating the safety and potential efficacy of amniotic fluid sourced components for COVID-19.”


Coronavirus Vaccine / AdaptVac, Bavarian Nordic
Bavarian Nordic Enters Agreement with AdaptVac to Advance COVID-19 Vaccine Program (GlobeNewswire, Bavarian Nordic A/S) – May 6, 2020 – “Bavarian Nordic A/S…today announced that it has entered into an exclusive head of terms agreement with AdaptVac…to license AdaptVac’s proprietary capsid virus like particle (VLP) based SARS-CoV-2 subunit vaccine. The parties seek to enter into the final license agreement within the next two months…. AdaptVac’s technology has the potential to mimic a virus to the body’s immune system, giving the optimal stimulus to generate a fast, long-lasting immune response that offers a highly efficacious protection….AdaptVac is working with AGC Biologics for the manufacture and scale-up of the vaccine. Bavarian Nordic will support the consortium to achieve clinical proof of concept and takes responsibility for clinical development and global commercialization of the vaccine. Current plan is to initiate a clinical study later this year.”


TerraCoV2 / Oragenics, National Institute of Allergy and Infectious Diseases
Oragenics acquires Noachis Terra Inc., to develop its TerraCoV2 NIH-generated SARS-CoV-2 (Covid19) vaccine candidate utilizing “Spike Protein” (Businesswire) – May 4, 2020 – “Oragenics, Inc….today announced its acquisition of Noachis Terra Inc., following its entry into a stock purchase agreement…to develop and commercialize TerraCoV2, a vaccine candidate which could provide specific immunity from the novel coronavirus….Noachis Terra Inc., holds a worldwide, nonexclusive license to the TerraCoV2 vaccine candidate from the National Institute of Allergy and Infectious Diseases (NIAID)…”


Jakafi oral (ruxolitinib) / Novartis, Incyte
Novartis, Incyte will take Jakafi into 2nd trial for Covid-19 patients on ventilators (Fierce Pharma) – May 5, 2020 – “Novartis and Incyte have already pitted their blockbuster JAK inhibitor Jakafi against COVID-19 as a possible treatment for a severe respiratory immune reaction….Partners will take Jakafi into a second late-stage trial. The partners plan to test Jakafi in a second phase 3 trial for COVID-19 patients with acute respiratory distress syndrome (ARDS)….The U.S. trial will evaluate Jakafi’s safety and efficacy over standard of care in ARDS patients who’ve needed ventilators….In the first quarter, Jakafi posted global revenues of $459 million, Incyte said.”


remdesivir (GS-5734) / Gilead
U.S. firm Gilead files for remdesivir approval in Japan (Japan Times) – May 5, 2020 – “Gilead Sciences Inc. is seeking Japanese regulatory approval for remdesivir, a drug that potentially can reduce the impact of the coronavirus in some patients, according to sources. The health ministry is expected to move quickly and approve remdesivir using a fast-track process that allows for substantially shortened screening procedures on condition that the drug has already been approved overseas.”


‘Cytokine storms’: Why doctors are exploring extreme inflammatory response in severe coronavirus patients (Cleveland) – May 6, 2020 – “Cleveland Clinic is researching how markers in the blood could indicate whether a patient is going to have a severe inflammatory response…..The Cleveland Clinic is exploring the use of rheumatology drugs to treat inflammation in COVID-19 patients. University Hospitals is hosting a clinical trial of a stem cell treatment for acute respiratory distress syndrome, linked to inflammation…..Goetz is partnering with McCall on research testing the effectiveness of different chemicals to prevent cytokine storms. The team received a $100,000 grant…for the study. Research will test five compounds that limit the activity of GSK-3 enzymes…”


Lilly and Junshi Biosciences to co-develop antibody therapies for the prevention and treatment of Covid-19 (Eli Lilly Press Release) – May 4, 2020 – “Junshi Biosciences…and Eli Lilly and Company…announced today they have entered into an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19….Multiple neutralizing antibodies have been engineered, with the lead asset poised to enter clinical testing in the second quarter….Lilly will receive an exclusive license to conduct clinical development, manufacturing and distribution of products outside of Greater China. Junshi Biosciences will maintain all rights in Greater China.” 

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