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Coronavirus treatment: Vaccines/drugs in the pipeline for COVID-19 (16/04/2020) | Praveen Duddu @ArenaClinical

Chloroquine approved for emergency use by US FDA
Favilavir, the first approved coronavirus drug in China

Pharmaceutical companies involved in developing coronavirus drugs/vaccines
[Novel coronavirus vaccines]
Fusogenix DNA vaccine by Entos Pharmaceuticals
… Fusogenix drug delivery platform is a proteo-lipid vehicle that introduces genetic payload directly into the cells. …
ChAdOx1 nCoV-19 by University of Oxford
…an adenovirus vaccine vector developed by the university’s Jenner Institute. …
Gimsilumab by Roivant Sciences
…a clinical-stage, human monoclonal antibody. The drug targets granulocyte-macrophage colony stimulating factor (GM-CSF), which is a pro-inflammatory cytokine found in high levels…
AdCOVID by Altimmune
…to develop a single dose intranasal vaccine for COVID-19 named AdCOVID. The company is currently carrying out immunogenicity studies after, which phase one clinical trial material will be developed. Altimmune and UAB will work with researchers to conduct preclinical animal studies and phase one clinical trial in the third quarter of 2020.
TJM2 by I-Mab Biopharma
…a neutralising antibody, as a treatment for cytokine storm in patients suffering from a severe case of coronavirus infection. The drug targets the human granulocyte-macrophage colony-stimulating factor (GM-CSF), which is responsible for acute and chronic inflammation.
Coronavirus vaccine by Medicago
…after having produced Virus-Like Particles (VLP)… …a collaboration with Laval University’s Infectious Disease Research Centre…
AT-100 by Airway Therapeutics
…novel human recombinant protein named AT-100 (rhSP-D)… AT-100 has shown efficacy in preclinical studies in reducing inflammation and infection in the lungs, while also generating an immune response against various respiratory diseases.
TZLS-501 by Tiziana Life Sciences
…monoclonal antibody named TZLS-501… …a human anti-interleukin-6 receptor (IL-6R), which helps in preventing lung damage and elevated levels of IL-6. …reducing chronic lung inflammation.
OYA1 by OyaGen
BPI-002 by BeyondSpring
…a small molecule agent indicated for treating various infections… …to activate CD4+ helper T cells and CD8+ cytotoxic T cells and generating an immune response in the body. If combined with another COVID-19 vaccine, the drug has the ability to generate long-term protection against viral infections. …
Altimmune’s intranasal coronavirus vaccine
…being developed based on a vaccine technology platform that is similar to NasoVAX, an influenza vaccine developed by Altimmune.
INO-4800 by Inovio Pharmaceuticals and Beijing Advaccine Biotechnology
NP-120 (Ifenprodil) by Algernon Pharmaceuticals
…an N-methyl-d-aspartate (NDMA) receptor glutamate receptor antagonist sold under the brand name Cerocal. …
APN01 by University of British Columbia and APEIRON Biologics
…ACE2 protein was the main receptor for the SARS virus. …
mRNA-1273 vaccine by Moderna and Vaccine Research Center
…targets the Spike (S) protein… …shipped to NIAID for phase one human clinical trial. …
Avian Coronavirus Infectious Bronchitis Virus (IBV) vaccine by MIGAL Research Institute
…efficacy in pre-clinical trials conducted by the Volcani Institute. …in the oral form. …
TNX-1800 by Tonix Pharmaceuticals
…a modified horsepox virus developed using Tonix’s proprietary horsepox vaccine platform. … Southern Research will be responsible for evaluating the efficacy of the vaccine, under the partnership.
Brilacidin by Innovation Pharmaceuticals
…a defensin mimetic drug candidate, as a potential treatment… …has shown antibacterial, anti-inflammatory and immunomodulatory properties in several clinical trials. …already investigating the drug for inflammatory bowel disease and oral mucositis in cancer patients. …has signed two material transfer agreements with a university in the US and 12 biocontainment labs in the US for evaluation…
Recombinant subunit vaccine by Clover Biopharmaceuticals
…a recombinant subunit vaccine using its patented Trimer-Tag© technology. …binding with the host cell and causing a viral infection. …successfully produced the subunit vaccine in a mammalian cell-culture based expression system… …antigen-specific antibody in the serum of fully recovered patients who were previously infected by the virus. …equipped with in-house cGMP biomanufacturing capabilities…
Vaxart’s coronavirus vaccine
…in tablet formulation using its proprietary oral vaccine platform, VAAST. …for mucosal and systemic immune responses.
CytoDyn-leronlimab
…(PRO 140), a CCR5 antagonist, as a potential coronavirus drug. …being investigated in phase two clinical trials as a treatment for HIV and has been awarded fast-track approval status…
Linear DNA Vaccine by Applied DNA Sciences and Takis Biotech
…will use Polymerase Chain Reaction (PCR)-based DNA manufacturing technology… …high purity, increased production speed, and absence of antibiotics and bacterial contaminants. …can be effective without being inserted into the patient’s genome. …based on the entire spike gene of the coronavirus, while…based on the antigenic portions of the protein.
BXT-25 by BIOXYTRAN to treat late-stage acute respiratory distress syndrome (ARDS)
…in late-stage patients infected with the coronavirus. The diffusion of oxygen to the blood is comprised in patients suffering from ARDS leading to fluid build-up in the lungs. …designed to be 5,000 times smaller than blood cells and efficiently transport oxygen through the body for a period of nine hours before being processed by the liver. The drug can help in supplying oxygen to the vital organs and enable the patient to recover and survive.
Novavax’s MERS coronavirus vaccine candidate
…designed to primarily bind to the major surface S-protein and developed using the company’s recombinant nanoparticle vaccine technology. Tested along with the Novavax’s proprietary adjuvant Matrix-M™, it inhibited infection by inducing immune responses in the laboratory studies.
Inovio Pharma’s INO-4700
…being developed by Inovio in partnership with GeneOne Life Science. It is delivered as vaccine intramuscularly, using the Cellectra® delivery device.

[Coronavirus drugs]
Remdesivir (GS-5734) by Gilead Sciences
Actemra by Roche to treat coronavirus-related complications
China approved the use of Roche’s Actemra for the treatment of severe complications… …the ability to prevent cytokine storms or overreaction of the immune system, which is considered as the main reason behind organ failure…
Biocryst Pharma’s Galidesivir, a potential antiviral for coronavirus treatment
…(BCX4430) has shown broad-spectrum activity against a wide range of pathogens… …a nucleoside RNA polymerase inhibitor that disrupts the process of viral replication. …has already shown survival benefits in patients against deadly viruses such as Ebola, Zika, Marburg, and Yellow fever. …to combat multiple potential viral threats including coronaviruses, flaviviruses filoviruses, paramyxoviruses, togaviruses, bunyaviruses, and arenaviruses.
Regeneron’s REGN3048-3051 and Kevzara
…the combination of neutralising monoclonal antibodies REGN3048 and REGN3051… Both the antibodies bind to S-protein of MERS coronavirus. …in the mouse model of MERS resulted in the high-level neutralisation of the MERS coronavirus in circulating blood with reduced viral loads in the lungs. … Kevzara is approved for the treatment of rheumatoid arthritis and is known to block the interleukin-6 (IL-6) pathway, which causes an overactive inflammatory response…
SNG001 by Synairgen Research
…an inhaled drug, is planned to be tested by the University of Southampton to treat asthma, chronic obstructive pulmonary disease and lower respiratory tract illnesses… …a formulation of naturally occurring Interferon-β, which is administered through a nebuliser and is delivered directly to the lungs to reduce the severity…
AmnioBoost by Lattice Biologics
…exploring the efficacy of its amniotic fluid concentrate, AmnioBoost, in treating acute respiratory distress syndrome (ARDS)… …for chronic adult inflammatory conditions such as osteoarthritis. …reduces the production of pro-inflammatory cytokines while boosting the production of anti-inflammatory cytokines.

Other companies developing coronavirus vaccines/drugs
Enanta Pharmaceuticals
…plans to develop antiviral drug candidates…
Predictive Oncology
…an AI Platform for the discovery and development of vaccines… …has signed an agreement with InventaBioTech to acquire Soluble Therapeutics, which provides it with access to the HSCTM Technology.
Emergent BioSolutions
…developing two plasma-derived product candidates or hyperimmunes using its hyperimmune platforms… …including vaccines for smallpox, botulism, and anthrax. … The hyperimmunes are polyclonal antibodies derived from plasma, which are capable of generating an immune response and protecting against infection. …with a severe case…
Integral Molecular
…has launched a vaccine programme using its two technology platforms including Shotgun Mutagenesis Epitope Mapping and the Membrane Proteome Array. …isolate the cellular receptors that enable the virus to spread quickly. …while the Membrane Proteome Array technology is capable of identifying the receptors through which viruses infect cells.
CEL-SCI
…using its proprietary LEAPS peptide technology, which utilises conserved areas of the coronavirus proteins to generate T-cell responses and reduce viral load. …to develop immunotherapeutic peptides with both antiviral and anti-inflammatory properties. …in reducing tissue damage from inflammation caused due to lung infection, which is a major cause of mortality in elderly patients.
AJ Vaccines
…will use the latest technology to develop antigens that can mimic the native structures of the virus. …
Takeda Pharmaceutical Company
… The anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) therapy will be designed to treat high-risk patients. The H-IG therapy includes concentrated pathogen-specific antibodies derived from plasma of recovered patients. …
Heat Biologics
…using its proprietary gp96 vaccine platform. …reprogramming live cells to produce antigens that can bind to the gp96 protein and generate an immune response against those antigens.
Pfizer
…antiviral compounds…
Mateon Therapeutics
…an antiviral response programme to develop coronavirus treatments using its therapeutic and artificial intelligence (AI) platforms. …
Hong Kong University of Science and Technology
…have identified B-cell and T-cell epitopes, which are capable of generating an immune response against the SARS virus and a similar response…
Vaccine by Generex
…following a contract from a Chinese consortium comprising of China Technology Exchange, Beijing Zhonghua Investment Fund Management, Biology Institute of Shandong Academy of Sciences and Sinotek-Advocates International Industry Development. The company will utilise its Ii-Key immune system activation technology to produce a COVID-19 peptide for human clinical trials.
Coronavirus drugs by Columbia University
Vaccine by Tulane University
Coronavirus vaccine by ImmunoPrecise Antibodies
…will use its B Cell Select™ and DeepDisplay™ discovery platforms to therapeutic compounds… …will be using the PolyTope mAb TherapyTM and EVQLV’s artificial intelligence platforms develop a COVID-19 therapy.
Serum Institute of India
…collaborating with Codagenix, a US-based biopharmaceutical company, to develop a cure for coronavirus using a vaccine strain similar to the original virus. …
Southwest Research Institute
…virtual screening called Rhodium…
Zydus Cadila
…two novel approaches. The first approach includes the development of a DNA vaccine against the viral membrane protein of the virus, while a live attenuated recombinant measles virus (rMV) vectored vaccine will be developed in the second approach. The rMV-based vaccine works by inducing specific neutralising antibodies…
NanoViricides
…developing a treatment for nCoV-2019 using its nanoviricide® technology. …used to develop ligands that can bind to the virus in the same way as a cognate receptor and attack various points of the virus.
Vir Biotechnology
…a clinical-stage immunology company… has identified two monoclonal antibodies that can bind to the virus… The antibodies target the spike (S) protein of the virus by entering through the cellular receptor ACE2. …a partnership with WuXi Biologics… …also partnered with Alnylam Pharmaceuticals to identify siRNA candidates… …another partnership with Biogen for cell line and process development and manufacturing…
HIV drugs for coronavirus treatment
Abbvie’s HIV protease inhibitor, lopinavir is being studied along with ritonavir for the treatment of MERS and SARS coronaviruses. …HIV infection under the trade name Kaletra®. … Lopinavir is believed to act on the intracellular processes of coronavirus replication and demonstrated reduced mortality in the non-human primates (NHP) model of the MERS. Lopinavir/ritonavir in combination with ribavirin showed reduced fatality rate and milder disease course during an open clinical trial in patients in the 2003 SARS outbreak. Cipla is also reportedly planning to repurpose its HIV drug LOPIMUNE, which is a combination of protease inhibitors Lopinavir and Ritonavir…
Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, donated its PREZCOBIX® HIV medication (darunavir/cobicistat)… Darunavir is a protease inhibitor… …as potentially having antiviral activity… …has no in vitro or clinical data… …has partnered with the Biomedical Advanced Research and Development Authority (BARDA)…

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Reasons for hope: The drugs, tests and tactics that may conquer coronavirus(04/17/2020) | Christine Soares @reuters,@stltoday

DRUGS
Remdesivir (Gilead Sciences)
Antiviral drug, originally developed to combat RNA viruses including respiratory syncytial virus. …antivirals work best when patients are healthier…
Hydroxychloroquine and chloroquine
Malaria drug also believed to have antiviral activity. Blocked SARS-CoV-2 entry into cells in an in-vitro experiment. …
Actemra or tocilizumab (Roche)
Monoclonal antibody approved for rheumatoid arthritis and also for treating the “cytokine storm” immune overresponse in cancer patients. …
Kevzara or sarilumab (Sanofi, Regeneron Pharmaceuticals)
Monoclonal antibody approved for inflammatory arthritis, and in trials targeting the “cytokine storm” immune response in severely ill COVID-19 patients. …
Jakavi or ruxolitinib (Novartis, Incyte)
Developed to treat inflammatory and autoimmune diseases, and in late-stage development as a cream for atopic dermatitis. …
Kaletra or lopinavir-ritonavir (Abbvie)
Antiviral combination used to treat and prevent HIV infections. …
(rhACE2) APN01 (Apeiron Biologics)
A recombinant human angiotensin converting enzyme 2 (rhACE2) under Phase-2 clinical development in ALI (Acute Lung Injury) and PAH (Pulmonal arterial hypertension). …
Camostat Mesylate (University of Aarhus, Denmark)
Protease inhibitor licensed in Japan and South Korea to treat chronic pancreatitis. In vitro experiments found it blocks a mechanism SARS-Cov-2 uses to enter human cells. … The University of Tokyo also announced plans for a trial of camostat mesylate and a related drug, nafamostat mesylate, starting as early as April 2020.
IFX-1 (InflaRx)
Monoclonal antibody targeting complement activation product C5a. Designed to block a mechanism of inflammation…
Aspirin, clopidogrel, rivaroxaban, atorvastatin, omeprazole (Imperial College, London)
Trial of cardioprotective drugs to prevent direct damage to the heart muscle that appears to drive the severity of COVID-19…

VACCINES
MRNA 1273 (Moderna/NIAID)
RNA vaccine made with messenger-RNA (mRNA) encoding the spike protein of SARS-CoV-2 encapsulated in a lipid nanoparticle. …
NVX-COV2373 (Novavax)
…enhance immune responses. …
Lentiviral minigene vaccines (LV-SMENP) (Shenzhen Geno-Immune Medical Institute)
Engineered minigenes encoding viral antigens; lentiviral vector designed to infect dendritic and T cells to induce immunity. …
BCG tuberculosis vaccine (Murdoch Children’s Research Institute; UMC Utrecht)
Bacillus Calmette-Guérin tuberculosis vaccine that induces a broad innate immune-system response, which has been shown to protect against infection or severe illness with other respiratory pathogens. …
INO-4800 (Inovio Pharmaceuticals, Coalition for Epidemic Preparedness Innovations)
DNA plasmid vaccine delivered into the skin via a patch-style electroporation device. …
AD5-NCOV (Cansino Biological Inc. / Beijing Institute of Biotechnology)
Non-replicating viral vector. …
CHADOX1 (University of Oxford)
Non-replicating chimpanzee adenovirus vector. …