Other SARS-CoV-2 updates
News
FDA gives emergency OK to Lilly’s antibody treatment for Covid-19
CNN, November 9, 2020
Synairgen targets in-home patients for next phase of SNG001 trial
Proactive Investors, UK, July 20, 2020
Coronavirus: Protein treatment trial ‘a breakthrough’
BBC, UK, July 20, 2020
Hospitals see shortages of a cheap steroid that one study says helps Covid-19 patients
STAT, June 25, 2020
The hunt for COVID-19 treatment, vaccines
Yahoo News, June 18, 2020
WHO welcomes preliminary results about dexamethasone use in treating critically ill COVID-19 patients
WHO, June 16, 2020
Coronavirus: Dexamethasone proves first life-saving drug
BBC, June 16, 2020
Opinion: Gilead should ditch remdesivir and focus on its simpler and safer ancestor
STAT, May 14, 2020
Gilead strikes deal to make remdesivir coronavirus treatment for 127 countries
CNBC, May 12, 2020
Drug inspired by an old treatment could be the ‘next big thing for Covid-19’
CNN, May 6, 2020
Giving blood thinners to severely ill Covid-19 patients is gaining ground
STAT, May 6, 2020
Gilead CEO: We’re going to make sure that access is not an issue with remdesivir
STAT, April 29, 2020
Academia
GVN Centers
VeroScience, Erasmus, MC, Rotterdam, Netherlands, Marion Koopmans
Scientific advisor The WHO R&D Blueprint and GLOPID-R
- VeroScience has isolates and cell-line cultures
- COVID-19 Global reference database in zoonotic & emerging viruses and 800+ hospitals network. Samples from different human coronaviruses patients of previous years.
- COVID-19 animal infection experiments-pathogenesis and transmissibility
- Patient enrollment for clinical trials; Animal vaccine evaluation and therapeutic antibody studies.
https://www.biorxiv.org/content/10.1101/2020.03.17.995639v1
University of Buffalo, Buffalo, New York, Gene Morse
- Preliminary animal model studies-Lopinavir-ritonavir and Tocilizumab-Il-6 blocker
- Assays-Centers in Jamaica and Zimbabwe for screening approaches
- Collaborations: Pharma-antiviral INDs & NIAID: Remdesivir & IgM
- Develop regional early-warning strategies-Covid-19
- In-vitro antiviral testing, link observed activity of compounds with repurposing software at
- University of Buffalo that searches existing databases for similar structures
- Template phase | protocol for rapid transition from pre-clinical to clinical studies?
- mAB from recovering individuals be modeled to our current HIV-1-bNAb translational research protocols
http://medicine.buffalo.edu/covid-19.html
Global Biolife, Inc., David Ostrov, University of Southern Florida, USA
- Compounds to target ACE-2, spiked, protein, protease inhibitor. In Preliminary Studies and discussions with GVN: https://ostrovlab.pathology.ufl.edu/
Doherty Institute, Melbourne, Australia, Sharon Lewin and Damian Purcell
- Clinical work and sample collection. Studies in Pre-Clinical
- Drugs to establish IC50/Test repurposed drugs in-vitro, block receptor by spike
Target Protease inhibitor
- Hydroxychloroquine-lopinavir therapy
Florian Krammer-Mount Sinai, New York, NY
- Plasmapheresis-antibodies from recovered patients with COVID-19
- Collaborations: New York Blood Center and the New York State Department of Health’s Wadsworth Center laboratory in Albany and guidance from the U.S. Food and Drug Administration
- Challenge: identifying sufficient patients with antibodies; scale-up
Assay Development
- The assay is sensitive and specific, allowing for screening three days, post onset of symptoms.
- Use in plasmapheresis, the antibody test, using recombinant or manufactured antigens from the spike protein on the surface of the SARS-CoV-2.
University Queensland, David Paterson
- Chloroquine & lopinavir/ritonavir. Studies in Pre-clinical
- 45 Patients Trial, awaiting more people for clinical trials by month’s end
IRTA-CReSA Institute of Agrifood Research and Technology and Department of Animal Health, Barcelona, Spain, Natalia Majo
- MERS-CoV strains from 3 different clades (A, B and C). Studies in Preliminary/Animal Models
- Reagents: samples from MERS-CoV-experimentally infected lamas/alpacas/dromedary camels/pigs (sera, nasal swabs, tissues)
- nCoV, SARS viruses and other reagents currently available.
- Sera, nasal swabs, tissues assays; also, in vitro/in vivo animal model vaccines and antivirals
- Sera from vaccinated dromedaries and llamas, and also from MERS-CoV positive control animals, assess the cross-reactivity against SARS-CoV and nCoV
AIDRC, St. Lucia, Queensland, Australia, Alexander Khromykh
- Fixed cell ELISA test using cells either infected with SARS-CoV-2 or cell stability expressing spike protein from Kunjin virus replicon.
- Serum ferratin blood test
- Corticosteroid Therapy
KU Leuven Riga Institute, Leuven, Belgium, Johan Neyts
- PLLAV vaccine technology used for YF, LVD, Rabies and applied to nCovid-19; Goal-develop pan-corona virus dugs. Studies in Animal Models.
- Has isolates; Antiviral assays up and running lends good CPE
- Molecular libraries, (Gates) begin testing 20,000 molecules based on viral replication
- Next, Animal Models: mice & hamster lines; massive replication in the lungs
- Poses possible transmission vi+C36:C43a feces
https://search.kuleuven.be/en/Pages/results.aspx?k=#k=covid-19%20and%20johan%20neyts
Lawrence Blatt, Global Head of Infectious Diseases, Janssen Pharmaceuticals, President and CEO Alios Biopharma, GVN Board Member, South San Francisco
- Alpha Interferon with fewer side-effects and corticosteroids. In Clinical trials
- Protease inhibitor experimentations
- Hand-held diagnostics device
See Other Immunomodulators/interferon and Blatt, L.:
https://www.elsevier.com/__data/assets/pdf_file/0007/988648/COVID-19-Drug-Therapy_Mar-2020.pdf
Raymond Schinazi, Director Laboratory Biochemistry and Pharmaceuticals, Emory University , Atlanta, Georgia
- Has the isolates
- Testing 5 Compounds affecting immunity and inflammation, use with nucleotide affect receptor, identify protease Inhibitors; scaling-up.
- Animal models-Remdesivir and anti-inflammatory in human studies with the VA.
https://www.nature.com/articles/s41422-020-0282-0
Wyss Institute at Harvard, Donald Ingber
- Engineered, SARS-CoV-2 pseudovirus. Collaborating with GVN (Number Centers/PIs)
- Covid-19 Human Lung Chip Model. Set-up Chip model in GVN Centers with technology purchase from Ingber’s company: emulate.bio.com. Proposes with BSL-4. Pseudovirus to study-capture agent FcMBL binds to Covid-19, efficiently; various other therapeutics. Testing to detect infection and viral entry-Airway Chips.
- Inhibition of viral entry (measured in this pseudovirus system) in Airway Chips, using multiple known and novel agents, including multiple FDA approved drugs were detected.
- Collaborate, Matthew Frieman, University of Maryland: installing Organ Chip instruments on his site, testing identified drugs and FcMBL capture technology.
Other Academic Updates
NIAID, Bethesda, Maryland and Rocky Mountain Labs
- Studies in Animal Models-Vaccine candidate-chimp adenovirus-vector
- Remdesivir and Lopinavir/ritovinir studies
Implications of antibody-dependent enhancement of infection for SARS-CoV-2 countermeasures
Nature, June 5, 2020
Classical drug digitoxin inhibits influenza cytokine storm, with implications for COVID-19 therapy
BioRxiv, April 13, 2020
Antibody Points to Possible Weak Spot on Novel Coronavirus
NIH Director’s Blog, April 14, 2020
Compassionate Use of Remdesivir for Patients with Severe Covid-19
NEJM, April 10, 2020
Crystal structure of SARS-CoV-2 main protease provides a basis for design of improved α-ketoamide inhibitors
Science, March 20, 2020
Soluble angiotensin-converting enzyme 2: a potential approach for coronavirus infection therapy?
Portland Press, March 13, 2020
Drugs are possibly effective for 2019-nCoV include: remdesivir, lopinavir/ritonavir, lopinavir/ritonavir combined with interferon-β, convalescent plasma, and monoclonal antibodies
NCBI, March 12, 2020
Potential benefits of precise corticosteroids therapy for severe 2019-nCoV pneumonia
NCBI, February 21, 2020
Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro
Nature, February 4, 2020
Industry
Gilead
- Remdesivir
- Collaborator-University of Nebraska Medical Center and China-Japan Friendship Hospital and Chinese Academy of Medical Sciences
- late-stage clinical trials, beginning in March
- Novel, nucleotide analog
- In Phase-2 with NIAID: adaptive, Random, Controlled Trial
- Phase-3: Safety & Efficacy will receive FDA’s rapid acceptance of Gilead’s IND filing
- Gilead is suspending access of Remdesimir due to overwhelming demand. Remdesivir was established for limited access. To stem demand, Gilead will pivot from accepting compassionate-use requests to only providing treatment through expanded access programs.
https://www.gilead.com/purpose/advancing-global-health/covid-19
Fujifilm Toyama Chemical Company
- Favipiravir/antiviral treatment
- Potent inhibitor of influenza, virus RNA polymerase. Broad spectrum of activity against many viral pathogens.
- Approved in China for manufacture.
Quercegen Pharma
- Clinical trials-invited to China to conduct trials
- Research collaborations with the Institute of Montreal
- Quercetin is safe, natural, flavonoid, plant-based, anti-inflammatory: Quercegen has obtained a GRAS (Generally Recognized as Safe) notice from FDA in 2010. Specific vaccines against Wuhan Coronavirus will not be ready for a few months. Quercetin shows antiviral activities against HCV, Human Respiratory Syncytial Virus, Influenza (H1N1, H5N1…), Ebola, Zika, Dengue, Enterovirus 71…Quercetin inhibits the viral enzyme 3C-like protease that is vital to Coronavirus replication. Readily Available, potent and active against Ebola and Zika. Meets safety regulations, therefore, may profile-skip animal testing; Affordability-cost-$2/day compared $1,000/day
https://www.drwalt.com/blog/2020/03/23/what-about-covid-19-and-quercetin/
Regeneron Pharmaceuticals
- REGN3048 and 3051
- HHS/BARDA
- Currently, in-vitro, but no access to clinical trials data
- Public/Private sectors; Hydroxychloroquine more tolerable, meets safety profile and more potent than Chloroquine. Neutralizing monoclonal antibodies. Fully human mAbs binding the spike protein of MERS-CoV. VelocImmune Platform, part of the company’s VelociSuite technology. Produced by a single clone of cells or a cell-line with identical antibody molecules. The antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells. In Phase-1 clinical trials.
Regeneron w/ Sanofi
- Produce-Sarilumab-mAB blocks IL-6 receptor
- Phase 2/3 clinical trials, beginning immediately, and will start to enroll patients
Takeda
- Blood Plasma-derived Therapy
- Need right concentration or IgG titers from recovered patients
- Pre-clinical testing and small-scale manufacturing; have robust, shared pre-clinical data with public and private sectors
- Assistance required to scale-up for USA and globally
Vaxil
- SARS-CoV-2 vaccine candidate based on a single peptide domains technology on key proteins for targeted therapy. VaxHit uses a Bioinformatics mAB Platform
- Vaxil’s mAb platform directly recognizes the target protein expressed on malignant cells and recruits other elements of the immune system to lyse those cells.
- Phase-1 Approved by the FDA and Euro Medical Agencies
For a more complete listing of PhARMA/Biotech COVID-19 Treatment and Therapy:
https://www.clinicaltrialsarena.com/analysis/coronavirus-mers-cov-drugs/