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Company: Gilead Sciences

Description:
Developed by Gilead Sciences to treat the Ebola virus. Provided to physicians and entered clinical trials based on success against other coronavirus infections. According to Bloomberg, the FDA began to move at “lightning speed” to approve remdesivir for treatment after successful trial results. On May 1, the FDA approved the drug for emergency treatment of hospitalized COVID-19 patients. Japan approved remdesivir for treatment of severe COVID-19 patients on May 7.

After previous April claims of drug efficacy, the National Institute of Allergy and Infectious Diseases released a study on May 22 including evidence that remdesivir shortened recovery time from 15 days to 11 days in hospitalized patients.

Remdesivir has not yet received formal approval by the FDA (the May emergency clearance does not count as formal approval).

Gilead also posted an informational tool to help interested people keep track of the company’s COVID-19 clinical trials program.

Research/Studies:

Trials: 

US Patent Applications Related to Remedesivir (Contact sales for Patent Challenge Risk):

US Patent Application #

US2018346504

US2019083525

US2017071964

US2016122356

US2018311263

Below are the patents directly related to Remdesivir and the ISO’s patent strength number. This number represents the difference between this patent’s ability to succeed in the event of a patent challenge and the average success across all patents.

US Patent No.

Relative Strength

         US9949994

                +1.8

         US9724360

       +1.4

Company: Fujifilm Toyama Chemical

Description: Flu antiviral that has shown promising results for shortening patient recovery time during trials in China. The White House has pushed the FDA to approve Avignan for emergency use against coronavirus. Japan’s Prime Minister Shinzo Abe touted the drug’s effectiveness ”in alleviating symptoms of the novel coronavirus” at an April conference. Fujifilm began phase 2 trials of the drug in Massachusetts the same month. However, there have been reported concerns with the drug such as potential fetal deaths and deformities, and transmission via semen.

In late May, reports came from Japanese media that interim results of Avignan’s clinical trials have not shown evidence of efficacy against the coronavirus. Despite these negative reports, Japanese trials are expected to continue with final results expected in July. U.S. trials are targeting a December-completion.

Status: Phase 1/Phase 2

Research/Studies:

Trials:

US Patent Applications Related to Favipiravir (Contact Sales For Patent Challenge Risk):

US Patent # 

US2012107274

US2004235761

US2013331404

US2015196578

US2012046238

US2011201665

US2011028510

US2012190637

US2012156259

US2009312406

US2015315228

US2011230432

US2015266832

US2015266831

US2013274472

Below are the patents directly related to Favipiravir and the ISO’s patent strength number. This number represents the difference between this patent’s ability to succeed in the event of a patent challenge and the average success across all patents.

US Patent No.

Relative Strength

US6800629

+0.2

US6787544

+8.3

US8901302

+3.1

USRE43748

-2.1

US9181203

-5.4

US8168789

+0.5

US8513261

-6.6

US8759354

+4.7

US9090571

-7.5

Company: Sanofi

Description: Anti-malaria drug undergoing national trials to test its prevention of disease in people exposed to coronavirus. The FDA issued an emergency authorization of Plaquenil for treatment of COVID-19. Later, on April 24, the FDA cautioned against use of the drug “outside of the hospital setting or a clinical trial due to risk of heart rhythm problems.” On May 7, the New England Journal of Medicine published a study (funded by the National Institutes of Health, or NIH) that found the drug did not prove beneficial to patients hospitalized with COVID-19. Though widely used initially, hospitals in New York City have reportedly halted use of the drug to combat COVID-19. The NIH announced on May 14, the start of clinical trials combining Hydroxychloroquine with the antibiotic azithromycin to treat those infected by COVID-19.

Research/Studies:

Trials:

Below are the patents directly related to Hydroxychloroquine and the ISO’s patent strength number. This number represents the difference between this patent’s ability to succeed in the event of a patent challenge and the average success across all patents.

US Patent No.

Relative Strength

6127111

+4.1

5314894

-7.7

8987302

-3.6

8506973

-0.9

5453431

+0.2

8871228

-9.2

8680132

+9.5

    8629141

              +2.2

 

Company: Sanofi/Regeneron

Description: A monoclonal antibody that inhibits the interleukin-6 (IL-6) receptor. “Investigators hypothesize that IL-6 may drive the inflammatory response within the lungs of patients who are critically ill with COVID-19.”  (ContagionLive)

The drug is undergoing a Phase II/III study for its effectiveness against COVID-19. After mixed results from the Phase II portion were released on April 27, the company decided to narrow the Phase III portion to test the drug’s effectiveness with only severe patients. Prior to the release of Phase II study results, Sanofi CEO Paul Hudson called Kevzara a “long-shot” for COVID-19 treatment.

Status: Phase II/Phase III

Research/Studies:

Trials: 

Company: AbbVie

Description: AbbVie has stated that early reports from China of Lopinavir-Ritonavir’s effects against coronavirus are unconfirmed. The drug did not prove effective “at improving clinical symptoms, extending lifespan or cutting viral shedding in patients hospitalized with severe COVID-19” in a 199-patient study published by The New England Journal of Medicine. The Centre for Evidence-Based Medicine also published a report with the verdict that “is currently no strong evidence for the efficacy of lopinavir/ritonavir in the treatment of COVID-19. Overall, the limited studies identified were subject to methodological flaws..” Though in a May 5 letter to the Journal’s editor, three Professors from Columbia University advocated for lopinavir-ritonavir to remain in the therapeutic guidelines for treatment of COVID-19.

Research/Studies:

Trials:

Company: Genentech (subsidiary of Roche)

Description: Arthritis drug undergoing tests for effectiveness at treating adults with severe COVID-19 and specifically pneumonia caused by the virus. The U.S. Biomedical Advanced Research and Development Authority, or BARDA, has committed $25 million in back for the drug’s development. Genentech began phase 3 trials of the drug on March 19. Tocilizumab has shown promising results in trials and in the case of one COVID-19 patient on a ventilator, use of the drug led to a response within 72 hours and allowed the patient to transition off the ventilator after five days.

Research/Studies:

Trials:

Company: Regeneron

Description: Antibody cocktail therapy based on the same platform as Regeneron’s Ebola candidate REGN-EB3. The FDA accepted the drug for Priority Review on April 16. Regeneron is targeting a June start date for human trials. 

According to Regneron, “All coronaviruses have a single glycoprotein on the virus surface called the spike protein, which is the protein on the virus cell surface that binds to the host cell and is required for infectivity. Regeneron’s SARS-CoV-2 antibodies will target the spike protein in order to block its interaction with the host cell, and thus neutralize the virus.” (Regeneron)

Regeneron will utilize its VelociSuite technologies to develop antibody medicines for the COVID crisis.

Research/Studies:

Below are the patents directly related to REGN3 and the ISO’s patent strength number. This number represents the difference between this patent’s ability to succeed in the event of a patent challenge and the average success across all patents.

US Patent No.

Relative Strength

9771414-8.1

Company: Johnson & Johnson

Description: Drug undergoing tests for treatment of pneumonia caused by COVID-19. Johnson & Johnson has stated there is no evidence that the Prezista has any effect on SARS-CoV-2. Spain has also rolled out a combination of chloroquine and Prezista to curb transmission from asymptomatic carriers. A preprint study released in April found that Prezista displayed no antiviral activity against the COVID-19 virus.

Research/Studies:

Trials:

Company: CytoDyn, working with Novant Health clinics

Description: Leronlimab is a CCR5 antagonist from late-stage biotechnology company CytoDyn. The drug is planned for therapy for patients with COVID-caused respiratory complications. The hope is that leronlimab can prevent cytokine storm which “inflames and fatally damages the lungs and other organs of many COVID-19 patients” (Albert Einstein College of Medicine). In early results, the drug has shown positive signs of COVID patient improvement.

Leronlimab announced on May 7 that enrollment had been initiated for the company’s Phase 2b/3 trial of leronlimab treatment with severely and critically ill COVID-19 patients. The FDA granted Emergency Investigational New Drug authorizations for leronlimab, first for 54 patients and then in this larger 2b/3 for 390 patients.

Trials:

Company: Takeda Pharmaceuticals

Description: Therapy based on immunoglobulins extracted from the blood of recovered COVID-19 patients and transfusing to sick patients to trigger the immune systems.

“Hyperimmune globulins are plasma derived-therapies that have previously been shown to be effective in the treatment of severe acute viral respiratory infections and may be a treatment option for COVID-19. As a leader in plasma-derived therapies with more than 75 years of experience in the development of plasma-derived products, Takeda has the expertise to research, develop, and manufacture a potential anti-SARS-CoV-2 polyclonal H-IG, which Takeda is referring to as TAK-888.” (Source)

Takeda announced the treatment’s development on March 4 and aims to make the medication available by the end of 2020.

On April 6, Takeda announced that Biotest, BPL, LFB, and Octapharma had joined the company’s alliance with CSL Behring to develop the anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine. The alliance announced on May 7 that a global study of the treatment is planned to begin this summer. 

Research/Studies:

Plasma Therapy Trials In/Past Recruiting Stage:

Company: BioCryst

Description: Nucleoside RNA polymerase inhibitor developed by North Carolina-based ByoCrist that the company calls “a broad-spectrum antiviral in advanced development for the treatment of viruses that pose a threat to health and national security, including SARS-CoV-2.” 

BioCryst began clinical trials funded by the National Institute of Allergy and Infectious Diseases, or NIAID, in April. The trial is a randomized, double-blind and placebo-controlled clinical trial.

Trials:

Research/Studies:

US Patent Applications Related to Galidesivir (Contact Sales For Patent Challenge Risk):

US Pat. # 

US2018346504

US2017137429

US2019054108

US2019083525

US2013331404

US2017143751

US2017128454

US2017042901

US2018311263

US2018360836

Below are the patents directly related to Galidesivir and their ISO’s patent strength numbers. This number represents the difference between this patent’s ability to succeed in the event of a patent challenge and the average success across all patents.

US Patent No.

Relative Strength

US9499554

-3.7

US9580428

EVEN w/Avg.

US9492452

-2.3

Company: Bioxytran

Description: Treatment option for late-stage COVID-19. Acute respiratory distress syndrome, or ARDS, has been shown to be a leading cause of death in patients with the novel coronavirus. According to the Mayo Clinic, ARDS “occurs when fluid builds up in the tiny, elastic air sacs (alveoli) in your lungs.” Bioxytran’s BXT-25 is a “glycol-polymer made of hybrid molecules of HEME chemical structure and a proprietary polymer chemical structure” that binds to oxygen molecules and helps carry oxygen to the body’s vital organs when blood flow is blocked. (Bioxytran) The treatment is designed to keep these organs alive until the body’s immune system can kill the virus.

Research/Studies:

Company: I-Mab Biopharma

Description: I-Mab announced in March that it would develop TDMJ to treat cytokine storm in severe COVID-19 patients. I-Mab describes the drug as “an I-Mab-discovered neutralizing antibody against human granulocyte-macrophage colony stimulating factor (GM-CSF), an important cytokine that plays a critical role in acute and chronic inflammation.”

I-Mab petitioned South Korea’s Ministry of Food and Drug Safety, or MFDS, for approval to conduct a clinical study in late-March The company announced on April 3 that the company received Investigational New Drug, or IND, application approval from the FDA to initiate clinical studies of the drug.

Status: Phase I/Phase II Trials

Research/Studies:

Trials:

Company: Algernon Pharmaceuticals

Description: Algernon describes NP-120 as “an N-methyl-d-aspartate (NDMA) receptor glutamate receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB).” (Algernon)

Algernon inked an agreement for Cascade Chemistry to manufacture NP-120’s active pharmaceutical ingredient.

Algernon has received clearance from Health Canada for Phase 2b/3 trials and in South Korea for Phase 2 trials of Ifenprodil’s efficacy in COVID-19 treatment.

Trials:


  Vaccines

 

Company: Moderna/NIAID/Vaccine Research Center

Description: “mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2.” (Pulmonary Fibrosis Foundation)

Moderna developed the mRNA vaccine candidate in collaboration with the NIAID Vaccine Research Center, or VRC. Phase 1 of the clinical trial was notified on Feb. 25 and according to the WHO, Moderna submitted an Investigational New Drug, or IND, request for Phase 2 trials. On May 7, the FDA approved the vaccine for Phase 2 trials.

Moderna announced on May 18 that the vaccine had positive interim date in Phase 1 trials with the NIAID. Because of these positive results, Moderna will adjust “to study two dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies.” The company’s interim phase announcement did not provide detailed data on the vaccine’s effect on the virus.

Status: Phase 2 (IND accepted) Phase 1

Research/Studies:

Trials:

Company: BioNTech/Pfizer/Fosun Pharma/NYU Grossman School of Medicine and the University of Maryland School of Medicine

Description: Potential vaccine developed through the partnership of Pfizer Inc. and Germany-based BioNTech, along with Fosun Pharma in China. The vaccine is a part of BioNTech’s “Project Lightspeed” implemented to defeat COVID-19. On April 22, the FDA approved phase 2 testing of the vaccine. On May 5, Pfizer and BioNTech announced the companies had begun dosing the trial’s first participants. The partners further stated that they intended to ramp “up manufacturing capabilities to further increase production capacity in 2020/2021.” NYU Grossman School of Medicine and the University of Maryland were the first centers to enroll patients.

Status: Phase 1/Phase 2

Trials:

Company: CanSino Biological Inc./Beijing Institute of Biotechnology

Description: Recombinant adenovirus type-5 vector developed by CanSino Biological and entered into Phase 1 clinical trial in China on March 17. Based on phase 1’s preliminary results, the company initiated a Phase 2 trial on April 9. This made Cansino and the partnering Academy of Military Medical Sciences the first COVID-19 vaccine developers to move to Phase 2 trials.

The National Research Council of Canada announced on May 12 that it would partner with CanSino to test the vaccine and to “advance bioprocessing and clinical development in Canada.”

A peer-reviewed study was published in the academic journal Lancet on May 22 that showed some positive results for the vaccine. The study showed that a single dose of the vaccine successfully produced virus-fighting antibodies and T cells. However some results were more mixed with about half of the volunteers having a dampened response.

Status: Phase 1/Phase 2

Trials:

Company: AstraZeneca/University of Oxford

Description: Vaccine candidate from the University of Oxford and British-Swedish pharmaceutical company AstraZeneca. The U.K. government has also pledged £20 million to support Oxford’s vaccine program and £22.5 million to fund Phase 2 testing. The vaccine “consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the genetic sequence of the SARS-CoV-2 Spike protein.” Human testing of the vaccine is expected to begin in June.

The U.S. Department of Health and Human Services has partnered with AstraZeneca to grant up to $1.2 billion for development of the vaccine. First doses of the vaccine are expected “as early as October.” (HHS)

In mid-May, a study was released that showed six rhesus macaques were protected from pneumonia caused by COVID-19.

Though there has been conflicting information regarding the likelihood, the UK government has stated that 30 million doses of the vaccine could be available by September if tests go well. The University of Oxford announced on May 22 that the vaccine was set to begin Phase II/III trials with human volunteers. 

Status: Beginning Phase II/III Trials

Research/Studies:

Trials:

Company: Sinovac Biotech

Description: Vaccine candidate from Chinese biopharmaceutical company Sinovac. According to a recent report from Sinovac, the vaccine showed success in neutralizing antibodies in mice, rats, and rhesus monkeys. On April 13, China’s National Medical Products Administration, or NMPA, approved the vaccine for “randomized, double-blinded, placebo-controlled phase I/II clinical trials.”

A joint Chinese research team published a study in Science that showed positive results for the vaccine’s ability to protect macaque monkeys from SARS-CoV-2. Researchers expect to begin testing with human vaccine candidates later this year.

Status: Phase 1/2

Research/Studies:

Trials:

Company: Novavax 

Description: Novavax’s NVX-CoV2373 vaccine is made using the company’s proprietary nanoparticle technology, Matrix-M (Precision Vaccinations). In contrast to Moderna and Pfizer’s vaccine candidates, Novavax’s candidate does not use mRNA to stimulate the creation of spike proteins. NVX is the established method of a subunit vaccine that sends copies of the COVID virus’ spike proteins directly into the body (Forbes).

The Coalition for Epidemic Preparedness Innovations, or CEPI, plans to invest a total of approximately $390 million of funding for the development of Novavax’s NVX-CoV2373. These funds will go to Phase I/II trials of the vaccine.

Phase I trials of the vaccine officially began on May 25. Novavax expects results from Phase I in July 2020.

Status: Phase 1/Phase 2

Trials:

Company: Inovio Pharmaceuticals

Description: DNA vaccine candidate from Inovio Pharmaceuticals. It uses a hand-held smart device named CELLECTRA to deliver “optimized DNA into cells, where it is translated into proteins that activate an individual’s immune system to generate a robust targeted T cell and antibody response. CELLECTRA uses a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter. Once inside the cell, the plasmids begin replicating, thereby strengthening the body’s own natural response mechanisms.” (Precision Vaccinations) Citron Research has come after Inovio’s vaccine program, calling the company “the COVID-19 version of Theranos.”

On May 1, Inovio announced it had entered into a funding agreement with German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, including funding from the Coalition for Epidemic Preparedness Innovations, or CEPI. CEPI has contributed $17.2 million to the development of INO-4800. Inovio completed enrollment in Phase 1 trials by the end of April. 

A peer-reviewed study from Inovio scientists and other collaborators was published in Nature Communications that demonstrated “robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2” from the vaccine, according to the company.

Inovio expects preliminary safety and immune responses Phase I data results in June with the plan of starting Phase 2/3 efficacy trials by August.

Status: Phase 1

Research/Studies:

Trials:

Company: China National Pharmaceutical Group (Sinopharm)

Description: The third vaccine candidate granted Chinese approval for a second phase of clinical trials. The candidate was co-developed by the Wuhan Institute of Biological Products. The vaccine is an inactivated vaccine which “consists of virus particles, bacteria, or other pathogens that have been grown in culture and then lose disease-producing capacity. In contrast, live vaccines use pathogens that are still alive.” The National Medical Products Administration, or NMPA, fast-tracked the vaccine, approving it for both Phase 1 and Phase 2 trials on April 12.

Status: Phase 1/2

Company: China National Pharmaceutical Group (Sinopharm)

Description: Second inactivated vaccine candidate developed by Sinopharm’s vaccine and bioscience unit in combination with the Beijing Institute of Biological Products. An inactivated vaccine “consists of virus particles, bacteria, or other pathogens that have been grown in culture and then lose disease-producing capacity. In contrast, live vaccines use pathogens that are still alive.”

Status: Phase 1/2

Trials:

Company: Johnson & Johnson

Description: Johnson & Johnson announced its lead vaccine candidate on March 30. The company says it has been working on the vaccine since January. The candidate leverages the company’s AdVac® and PER.C6® technologies.

J&J plans to begin Phase I clinical trials of the candidate by September at the latest and says that “a vaccine could be ready for emergency use in early 2021.”

J&J penned a collaboration with Emergent BioSolutions to aid manufacturing of the vaccine, with the “goal to supply more than one billion vaccine doses globally.” On May 18, J&J entered into an agreement with Vibalogics, a GMP manufacturing & development company, for Vibalogics to produce additional clinical trial material for J&J’s vaccine candidate.

J&J further announced that in a partnership with Biomedical Advanced Research and Development Authority, or BARDA, the company would commit more than a billion dollars to COVID-19 vaccine research and development.

Company: GlaxoSmithKline/Sanofi

Description: Sanofi and GlaxoSmithKline, two top competitors in the biopharma sphere, announced on April 14 that the two would collaborate to create an adjuvanted vaccine for COVID-19. 

Sanofi is contributing its S-protein COVID-19 antigen. According to GSK, Sanofi’s recombinant DNA technology has “produced an exact genetic match to proteins found on the surface of the virus.” The COVID antigen’s DNA sequence was combined into “the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the US.” (GSK)

GSK CEO Emma Walmsley has said the company plans to build manufacturing capacity for a vaccine “at risk” with the intention of beginning human testing in the second half of 2020 and filing for approvals by the second half of 2021. (FiercePharma)

Company: Tonix Pharmaceuticals

Description: Vaccine construct modified from a horsepox virus vaccine that expresses a protein or protein fragment from the virus that causes COVID-19. TNX-1800 is the first vaccine in a research collaboration with Southern Research. (Tonix)

Contact

This is not a finished database but a living document. The goal is to compile as much information as possible on treatments and vaccines that respond to this crisis.

This is a free and open platform for the community to access information on how to solve the coronavirus. Any outside contributions will be a great help.

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