
A mix of legacy drugmakers and small startups have stepped forward with plans to develop vaccines or treatments that target the infection caused by the novel coronavirus.
COVID-19, which was first detected in December in Wuhan, China, has sickened more than 1.5 million people worldwide and killed more than 89,000. There are no Food and Drug Administration-approved vaccines or therapies for the disease although the regulator on March 29 granted an emergency use authorization to hydroxychloroquine sulfate and chloroquine phosphate to treat COVID-19 patients. The emergency rules require patients to receive doses of the drugs donated to the U.S. federal stockpile by drug manufacturers or through clinical trials.
Here are some of the companies developing treatments or vaccines in the U.S. for COVID-19:
- Companies:
- BioNTech SE and Pfizer Inc
- Type:
- Vaccine
- Stage:
- Phase 2
- Name:
- BNT162 2
- Background:
- On March 17, Pfizer announced that it would help develop and distribute BioNTech SE’s COVID-19 vaccine candidate, though the deal excludes China.
- Companies:
- Amgen Inc and Adaptive Biotechnologies Corp
- Type:
- Treatment
- Stage:
- Preclinical
- Background:
- The very early-stage collaboration seeks to discover and develop antibodies that can be used to prevent or treat COVID-19. Financial terms of the exclusive collaboration will be finalized “in the coming weeks,” the companies said April 2.
- Companies:
- CalciMedica Inc
- Type:
- Treatment
- Stage:
- Phase 2
- Name:
- CM4620-IE
- Background:
- The privately held clinical-stage company is testing an investigational drug in 60 patients with severe COVID-19 pneumonia and who are at risk for their disease to progress to acute respiratory distress syndrome (ARDS).
- Companies:
- CytoDyn Inc
- Type:
- Treatment
- Stage:
- Phase 2 clinical trial
- Name:
- Leronlimab
- Background:
- CytoDyn, a preclinical biotechnology company based in Vancouver, said March 31 that the FDA is allowing a mid-stage trial for its experimental drug Leronlimab in COVID-19 patients to move forward.
- Companies:
- Dynavax Technologies Corp
- Type:
- Adjuvant platform for vaccines
- Name:
- No name yet
- Background:
- Dynavax said in March that it’s making its adjuvant technology available to companies developing COVID-19 vaccines through a partnership with CEPI..
- Companies:
- Gilead Sciences Inc.
- Type:
- Treatment
- Stage:
- Phase 3 clinical trials
- Name:
- Remdesivir
- Background:
- Gilead is a longtime drugmaker best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease but also kicked off the national debate about drug pricing.
- Companies:
- GlaxoSmithKline
- Type:
- Pandemic adjuvant platform for vaccines
- Name:
- AS03 Adjuvant System
- Background:
- GSK is another leading vaccine maker, having brought to market vaccines for human papillomavirus (HPV) and the seasonal flu, among others.
- Companies:
- Heat Biologics Inc.
- Type:
- Vaccine
- Stage:
- Preclinical
- Name:
- No name yet
- Background:
- Heat Biologics has previously announced that it is developing a vaccine for the novel coronavirus with the University of Miami Miller School of Medicine
- Companies:
- Inovio Pharmaceuticals Inc.
- Type:
- DNA-based vaccine
- Stage:
- Phase 1 clinical trial
- Name:
- INO-4800
- Background:
- Another CEPI grantee, awarded $9 million, Inovio has begun testing its vaccine candidate in Phase 1 clinical trial at two sites in the U.S.: the Perelman School of Medicine at the University of Pennsylvania and the Center for Pharmaceutical Research in Kansas City.
- Companies:
- Johnson & Johnson
- Type:
- Vaccine
- Name:
- TBD
- Background:
- J&J announced Feb. 11 it was working with BARDA to test its vaccine candidate, with each organization providing $1 billion for research and development and the public-health organization funding the Phase 1 trials.
- Companies:
- Moderna Inc.
- Type:
- RNA-based vaccine
- Stage:
- Phase 1
- Name:
- mRNA-1273
- Background:
- Moderna received funding from CEPI in January to develop an mRNA vaccine against COVID-19. On Feb. 24, it said it had shipped the first batch of mRNA-1273 to the NIAID for a Phase 1 clinical trial in the U.S.
- Companies:
- Novavax Inc
- Type:
- Vaccine
- Stage:
- Phase 1 clinical trial
- Name:
- No name yet
- Background:
- Novavax, a preclinical biotechnology company, announced Feb. 26 it had several vaccine candidates in preclinical animal studies.
- Companies:
- Regeneron Pharmaceuticals Inc.
- Type:
- Treatment
- Stage:
- Preclinical
- Name:
- No name yet
- Background:
- On Feb. 4, Regeneron announced it is working on developing monoclonal antibodies as treatments for COVID-19.
- Companies:
- Regeneron Pharmaceuticals and Sanofi
- Type:
- Treatment
- Stage:
- Phase 2/3 clinical trial
- Name:
- Kevzara
- Background:
- The FDA previously approved Kevzara, a treatment developed by Regeneron and Sanofi, as a therapy for rheumatoid arthritis in 2017 as part of a recently concluded longstanding R&D partnership between the two companies.
- Companies:
- Roche Holding AG
- Type:
- Treatment
- Stage:
- Phase 3
- Name:
- Actemra
- Background:
- Roche’s Actemra was first approved in 2010 as a rheumatoid arthritis drug. The Swiss drugmaker has initiated a Phase 3 clinical trial evaluating Actemra as a treatment for patients with COVID-19 who have been hospitalized with severe pneumonia.
- Companies:
- Sanofi and Translate Bio Inc.
- Type:
- Vaccines
- Stage:
- Preclinical
- Name:
- No name yet
- Background:
- Starting Feb. 18, Sanofi is working with BARDA to test a preclinical vaccine candidate for the severe acute respiratory syndrome (SARS) for COVID-19 using its recombinant DNA platform.
- Companies:
- Takeda Pharmaceutical Company Ltd.
- Type:
- Treatment
- Stage:
- Preclinical
- Name:
- TAK-888
- Background:
- The Japanese drugmaker said March 4 it plans to test hyperimmune globulins for people who are at high risk for infection.
- Companies:
- Vaxart Inc.
- Type:
- Vaccine
- Stage:
- Preclinical
- Background:
- Vaxart was one of the first companies to announce plans to develop a vaccine when it did so Jan. 31. In March, the clinical-stage company announced that Emergent BioSolutions will help develop and manufacture its oral vaccine candidate.
- Companies:
- Vir Biotechnology Inc.
- Type:
- Treatment
- Stage:
- Preclinical
- Name:
- No name yet
- Background:
- The Japanese drugmaker said March 4 it plans to test hyperimmune globulins for people who are at high risk for infection.
- Companies:
- Vir Biotechnology Inc.
- Type:
- Treatment
- Stage:
- Preclinical
- Name:
- No name yet
- Background:
- In many ways, Vir has been one of the most prolific partners in the biotech field during the pandemic. The preclinical company is run by George Scangos, the former CEO of Biogen Inc.