Companies Developing COVID-19 Therapies

Bausch Health Initiates VIRAZOLE® (Ribavirin for Inhalation Solution, USP) Clinical Study in Patients with COVID-19 - a clinical trial program in Canada evaluating an investigational use of VIRAZOLE® (Ribavirin for Inhalation Solution, USP) in combination with standard of care therapy to treat hospitalized adult patients with respiratory distress due to COVID-19. Because ribavirin is a synthetic nucleoside that works to stop viral replication, VIRAZOLE may be effective in reducing the severity of COVID-19 infection. VIRAZOLE is currently approved in several countries around the world, including the United States and Canada, for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV).

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19

BioCryst Pharmaceuticals is developing its drug galidesivir as a potential treatment for more than 20 RNA viruses. But SARS-CoV-2, the virus that causes COVID-19, will no longer be one of them. 

The Durham company has reported early stage clinical trial results showing that treatment with the experimental antiviral offered COVID-19 patients no benefit compared to a placebo. The study wasn’t designed to demonstrate clinical efficacy, and small Phase 1 clinical trials typically enroll healthy volunteers to assess a drug’s safety before testing the drug on sick patients. Galidesivir achieved the safety measure with no serious problems associated with the drug. 

Nevertheless, the BioCryst study, funded by the National Institute of Allergy and Infectious Diseases (NIAID), failed to provide signs that the drug could treat COVID-19 infection. 

Galidesivir is an investigational broad-spectrum antiviral drug that was safe and well tolerated in previously reported Phase 1 trials in healthy subjects. Galidesivir has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS.

Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine - The collaboration aims to accelerate development of BioNTech’s potential first-in-class COVID-19 mRNA vaccine program, BNT162, which is expected to enter clinical testing by the end of April 2020. 

CanSinoBIO’s Investigational Vaccine Against COVID-19 Approved for Phase 1 Clinical Trial in China - The vaccine candidate is built upon CanSinoBIO’s adenovirus-based viral vector vaccine technology platform. Results from preclinical animal studies of “Ad5-nCoV” show that the vaccine candidate can induce strong immune response in animal models. The preclinical animal safety studies demonstrated a good safety profile.

A Phase I Clinical Trial in 18-60 Adults

Celularity Announces FDA Clearance of IND Application for CYNK-001 in Coronavirus, First in Cellular Therapy - Celularity Inc., a clinical-stage company developing allogeneic cellular therapies from human placentas, has announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for the use of its proprietary CYNK-001 in adults with COVID-19. With this, Celularity will commence a Phase I/II clinical study including up to 86 patients with COVID-19. 

Other companies mentioned: Sorrento Therapeutics, United Therapeutics/Lung Biotechnology

MediciNova Announces Plans to Initiate a Clinical Trial of MN-166 (ibudilast) for COVID-19 Acute Respiratory Distress Syndrome (ARDS) - MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. The lead Principal Investigator (PI) for this trial is Dr. Geoffrey Chupp, Professor of Medicine (Pulmonology), Director of the Yale Center for Asthma and Airway Disease and Director of the Pulmonary Function Laboratory at Yale-New Haven Hospital.  

MediciNova Announces Plans to Develop MN-166 (ibudilast) for Severe Pneumonia and Acute Respiratory Distress Syndrome (ARDS) - MediciNova’s decision to pursue development of this indication was based on positive results of a recent preclinical study in an animal model of ARDS (Med Sci Monit, 2020; 26: e922281). Results of this preclinical study showed that ibudilast treatment reversed histological changes observed in the ARDS mouse model including inflammation, hemor­rhage, alveolar congestion, and alveolar wall edema.

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Currently, MediciNova is not accepting requests from patients or their advocates (including treating physicians) under the Expanded Access/Compassionate Use Program because of its focus on planned Phase 3 trials to evaluate MN-166 (ibudilast). 

Moderna Confirms Discussions with the Ministry of Health, Labour and Welfare to Supply Japan with 40 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - Moderna confirmed that the Company is engaged in discussions with the Ministry of Health, Labour and Welfare of Japan (MHLW) to potentially purchase 40 million or more doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support Japan’s aim of providing vaccines to the public as soon as possible. Under the terms of this arrangement, the vaccine would be supplied by Moderna, Inc. and distributed in Japan by Takeda Pharmaceutical Co., Ltd. (NYSE: TAK) beginning in the first half of 2021, if the vaccine receives regulatory approval. Kato Katsunobu, Minister of MHLW, announced the discussions in a meeting with media today in Japan.

Moderna to Present New Interim Clinical Data About mRNA Vaccine Against COVID-19 (mRNA-1273) at Advisory Committee on Immunization Practices (ACIP) Meeting - Moderna announced its presentation at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) August Meeting. The live presentation can be viewed online here.This presentation includes new interim safety and immunogenicity data from the cohorts of older adults in the NIH-led Phase 1 study of mRNA-1273, Moderna’s vaccine candidate against COVID-19. The ACIP presentation slides will be available under “Events and Presentations” in the Investors section of the Moderna website.

Moderna Confirms Advanced Discussions with European Commission to Supply Europe with 80 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - Moderna has concluded advanced exploratory talks with the European Commission to supply 80 million doses of mRNA-1273 as part of the European Commission’s goal to secure early access to safe and effective COVID-19 vaccines for Europe.The potential purchase agreement with the European Commission of 80 million doses provides for an option for Member States to purchase an additional 80 million doses for a total of up to 160 million doses. The discussions are intended to ensure that Member States have access to Moderna’s vaccine. The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000 participants is on track to complete in September. 

Moderna Announces Supply Agreement with U.S. Government for Initial 100 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - The U.S. government has secured 100 million doses of mRNA-1273 as part of the U.S. government’s goal of securing early access to safe and effective COVID-19 vaccines for the American people. The award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, this announcement brings the U.S. government commitments for early access to mRNA-1273 to up to $2.48 billion. 

Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus - Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Each participant will be assigned to receive placebo, a 50 μg or a 250 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.

see also: https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19 - This page summarizes key milestones  to advance mRNA-1273, Moderna's vaccine candidate against the novel coronavirus.

Read more about developing therapeutics and vaccines for coronaviruses 

NIAID has also supported the clinical testing of two promising antibody-based therapeutics, which prevent the virus from infecting and entering cells.  NIAID conducted a phase 1 clinical trial of  SAB-301, an experimental MERS treatment developed from cattle that make human antibodies.  This was shown to be safe and well tolerated in healthy adults. More recently, NIAID supported a Phase I clinical trial of a combination of two monoclonal antibodies, REGN3048 and REGN 3051, and demonstrated this combination was also safe and well tolerated.  Planning for follow on Phase 2/3 efficacy studies using SAB-301 is currently ongoing with partners where MERS is endemic, including the Kingdom of Saudi Arabia.

NIH clinical trial of investigational vaccine for COVID-19 begins

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Developing Therapeutics and Vaccines for Coronaviruses

https://www.niaid.nih.gov/diseases-conditions/coronaviruses-therapeutics-vaccines

NIAID has also supported the clinical testing of two promising antibody-based therapeutics, which prevent the virus from infecting and entering cells.  NIAID conducted a phase 1 clinical trial of  SAB-301, an experimental MERS treatment developed from cattle that make human antibodies.  This was shown to be safe and well tolerated in healthy adults. More recently, NIAID supported a Phase I clinical trial of a combination of two monoclonal antibodies, REGN3048 and REGN 3051, and demonstrated this combination was also safe and well tolerated.  Planning for follow on Phase 2/3 efficacy studies using SAB-301 is currently ongoing with partners where MERS is endemic, including the Kingdom of Saudi Arabia.

NIH clinical trial of investigational vaccine for COVID-19 begins

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins

Novavax Awarded Funding from CEPI for COVID-19 Vaccine Development - Novavax has produced and is currently assessing multiple recombinant nanoparticle vaccine candidates in animal models prior to advancing to clinical trials. Initiation of Phase1 clinical testing is expected in late spring of 2020. Novavax’ COVID-19 vaccine candidates were created with its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein. Novavax recently entered into an agreement with Emergent BioSolutions, Inc. (Emergent) to provide contract development and manufacturing services, supplying Novavax with vaccine product for preclinical testing and for use in its Phase 1 clinical trial. 

Ridgeback Biotherapeutics Announces MHRA Clearance to Begin Human Testing of EIDD-2801 in the UK for COVID-19 and the Start of Phase 1 - This action by the MHRA allowed Ridgeback to commence Phase 1 in the UK on Friday April 10^th. EIDD-2801 is a direct acting anti-viral nucleoside analogue.  Essentially, EIDD-2801 tricks RNA viruses into including the wrong building blocks as it tries to reproduce itself.  This leads to dramatically reduced levels of virus in animals infected with a wide variety of RNA viruses when treated with EIDD-2801.  EIDD-2801 has been shown to treat MERS and SARS (two severe coronavirus infections) in animals when given after an infection has been established.  When given prophylactically EIDD-2801 is able to prevent significant manifestations of disease in animals challenged with MERS and SARS.    

FDA Clears the Way for Ridgeback Biotherapeutics to begin Human Testing of a Promising Potential Treatment for COVID-19 - The U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug application by Drug Innovation Ventures at Emory (DRIVE), LLC, wholly owned by Emory University, for an orally available antiviral compound, EIDD-2801, exclusively licensed to Ridgeback Biotherapeutics.  This action by the FDA allows Ridgeback to initiate human clinical testing of EIDD-2801 in the United States. EIDD-2801 prevents the replication of SARS-CoV-2, the virus that causes COVID-19, and has shown potent activity against SARS-CoV and MERS-CoV in animal models of infection. In addition to coronaviruses, EIDD-2801 has broad spectrum activity against a number of diseases of public health concern, including influenza, chikungunya, Ebola, and equine encephalitis (VEE and EEE). The antiviral is orally available and, in addition to COVID-19, is being developed for the treatment of seasonal and pandemic influenza under a contract awarded to Emory Institute for Drug Development by the National Institute of Allergy and Infectious Diseases (NIAID) and for Venezuelan and Eastern equine encephalitis virus (VEEV and EEEV) by the Defense Threat Reduction Agency (DTRA). 

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mAb114 is currently under study in the Democratic Republic of the Congo through an Expanded Access Protocol administered as part of the Monitored Emergency Use of Unregistered and Investigational Interventions for Ebola virus disease (MEURI).

Roivant Announces Development of Anti-GM-CSF Monoclonal Antibody to Prevent and Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with COVID-19

• Gimsilumab is a monoclonal antibody that targets GM-CSF, a pro-inflammatory cytokine found to be up-regulated in COVID-19 patients
• Emerging clinical evidence in COVID-19 patients suggests that GM-CSF contributes to immunopathology caused by SARS CoV-2 in patients with or at risk of developing ARDS
• ARDS is a serious complication of COVID-19 which necessitates hospitalization and mechanical ventilation or other life support measures
• A Phase 1 study of gimsilumab conducted by Roivant completed dosing last month following extensive non-clinical research; gimsilumab treatment has been associated with a favorable safety and tolerability profile to date

Vaxart to Test Cross-Reactivity of its COVID-19 Oral Tablet Vaccine Against Omicron - Vaxart plans to test the cross-reactivity of its oral tablet COVID-19 vaccine candidate against the Omicron SARS-CoV-2 variant in two different studies expected to begin January 2022.

In the first study, Vaxart will test the activity of its Phase II COVID-19 oral vaccine candidate against Omicron by analyzing mucosal and serum samples from subjects to whom the vaccine was administered in Vaxart’s current COVID-19 vaccine Phase II trials. In the second study, Vaxart will conduct an animal Omicron challenge study to assess how its current Phase II COVID-19 vaccine candidate performs in comparison to an Omicron-specific vaccine candidate that Vaxart is developing. 

Vaxart deliberately engineered its COVID-19 vaccine candidate to be cross-reactive against emerging variants based on Vaxart scientists’ early recognition of the risk of emerging variants of SARS-CoV-2. In May 2021, the Company announced Phase I clinical test results demonstrating that its vaccine candidate, VXA-CoV2-1, produced broad cross-reactive T cell and IgA responses against other, non-COVID coronaviruses.

Vaxart Announces Publication of Complete Data from Preclinical COVID-19 Oral Vaccine Hamster Challenge Study in Journal of Infectious Diseases - The Journal of Infectious Diseases has published complete data from Vaxart’s preclinical Hamster Challenge Study. The study shows Vaxart’s COVID-19 oral vaccine candidate’s potential efficacy in preventing SARS-CoV-2 infection.

Vaxart Provides Update on its Oral COVID-19 Vaccine Program - Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, has produced five COVID-19 vaccine candidates for testing in its preclinical models.  Each of the COVID-19 vaccine constructs is based on a different coronavirus antigen combination, and Vaxart expects to advance the best performing vaccine to manufacturing for clinical trials.

Recruiting Clinical Trial: A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine

VBI Vaccines Announces New Preclinical Data and Initiation of VBI-2905 Clinical Study Targeting Broadened Immunity Against COVID-19 and Variants of Concern 

• New preclinical data demonstrate VBI-2905 induced robust neutralizing and antibody binding activity, as a 2-dose course and as a single booster dose, against COVID-19 and variants of concern including Beta and Delta
• Data also demonstrate trivalent VBI-2901 induced robust and consistent levels of immunity against the ancestral COVID-19 strain and a panel of variants including Beta, Delta, Kappa, and Lambda
• First subject dosed in Phase 1b portion of ongoing study to assess VBI-2905 as (i) a 1-dose booster in individuals previously immunized with an mRNA vaccine, and (ii) a primary 2-dose series in unvaccinated individuals
• Initial VBI-2905 data expected early Q1 2022, subject to speed of enrollment

VBI Vaccines Announces Initial Positive Phase 1 Data for its eVLP Vaccine Candidate Against COVID-19 - announcing positive Phase 1 data from its Phase 1/2 trial of the first of its enveloped virus-like particle (eVLP) COVID-19 vaccine candidates, VBI-2902a, in healthy adults age 18-54 years of age. The 5µg dose of VBI-2902a, which expresses an optimized SARS-CoV-2 spike antigen and is adjuvanted with aluminum phosphate, was generally well-tolerated and elicited potent immune responses significantly higher than those seen in human convalescent sera. The data establish a robust human proof-of-concept, at a low dose without the use of a next-generation adjuvant, demonstrating the potency of the eVLP particulate delivery platform against COVID-19.

VBI Vaccines Announces Initiation of Enrollment in Adaptive Phase 1/2 Study of Prophylactic COVID-19 Vaccine Candidate, VBI-2902 

Pan-Coronavirus Prophylaxis - VBI is applying its eVLP Platform in the development of a preventative pan-coronavirus vaccine candidate targeting COVID-19, severe acute respiratory syndrome (“SARS”), and Middle East respiratory syndrome (“MERS”). Enveloped virus-like particle (“eVLP”) vaccines closely mimic the structure of viruses found in nature, but without the viral genome, potentially yielding safer and more potent vaccine candidates.

Join Us In The Fight Against The Coronavirus! Vir Biotechnology is conducting a research study for COVID-19 patients who have recovered from this infection. Consider donating your blood to help researchers better understand this virus. Email at virus@vir.bio or visit https://www.vir.bio/virus/

GSK and Vir Submit Emergency Use Authorization Application to FDA for Intramuscular Administration of Sotrovimab for the Early Treatment of COVID-19 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced the submission of an application to the FDA requesting an amendment to the Emergency Use Authorization (EUA) for sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, to include intramuscular (IM) administration. The EUA for sotrovimab was granted by the FDA in May 2021 as an investigational single-dose intravenous (IV) (500 mg) infusion SARS-CoV-2 monoclonal antibody for the early treatment of COVID-19, and the companies are requesting an expansion to the EUA to also include IM administration (500 mg).

GSK and Vir Biotechnology Announce United States Government Agreement to Purchase Additional Supply of Sotrovimab, Authorized for the Early Treatment of COVID-19 - The US government will purchase an additional 600,000 doses of sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, enabling further nationwide access to sotrovimab for patients. The additional 600,000 doses will be delivered throughout the first quarter of 2022. This agreement is an amendment to earlier commitments announced with the US government in November 2021. Preclinical data generated through both pseudo-virus and live virus testing demonstrate sotrovimab retains activity against all tested SARS-CoV-2 variants of concern including Delta and Omicron.

Vir Biotechnology Announces New Research Describing the Structural Basis of SARS-CoV-2 Omicron Immune Evasion and Receptor Engagement - New preclinical research published to the preprint server bioRxiv, describing the structural basis and magnitude by which the new SARS-CoV-2 Omicron variant (B.1.1.529) evades antibody mediated immunity, as well as its enhanced ability to bind to the human ACE-2 receptor. Data define the specific Omicron mutations and their detrimental impact on the binding of the majority of tested monoclonal antibody (mAbs) therapies that target the receptor binding motif of the spike protein, a region that is more prone to mutate. Further, these data add to the growing body of evidence from recent pseudo- and live virus neutralization findings demonstrating that sotrovimab retains activity against the Omicron variant, as well as all tested variants of concern. This study was conducted in close collaboration with David Veesler, Ph.D., Associate Professor of Biochemistry, University of Washington & Investigator, Howard Hughes Medical Institute, and members of his laboratory. Sotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody developed in partnership with GlaxoSmithKline for the early treatment of COVID-19.

Vir and Alnylam Expand Collaboration to Advance Investigational RNAi Therapeutics Targeting Host Factors for the Treatment of COVID-19 - This expansion includes up to three additional targets focused on host factors for SARS-CoV-2, including ACE2 and TMPRSS2, both of which are considered critical for viral entry, with the potential for an additional host target to emerge from Vir’s functional genomics work.

GSK and Vir Biotechnology enter collaboration to find coronavirus solutions - Promising antibody candidates for SARS-CoV-2 to be accelerated into phase 2 clinical trials within the next three to five months

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