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 100,000 people worldwide and killed at least 3,400. There are no Food and Drug Administration-approved vaccines or therapies for the disease.
In the U.S., the companies that are initiating development have received funding from two organizations: the Biomedical Advanced Research and Development Authority (BARDA), which is a division of the Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. Some companies have received funding from Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo. Other companies are funding trials by themselves or through partnerships with other life sciences companies.
Here are some of the companies developing treatments or vaccines in the U.S. for COVID-19:
Company: Gilead Sciences Inc.
Stage: Phase 3 clinical trials
Background: Gilead is a longtime vaccine maker that is 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. The company has experience developing and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP), its preventive HIV medicine. Along with U.S. trials, Gilead is conducting a randomized, controlled clinical trial in Wuhan, testing remdesivir as a treatment for mild to moderate forms of pneumonia in people with the virus. The trial was given the go-ahead by China’s Food and Drug Administration in February.
1. On Feb. 21, the National Institute of Allergy and Infectious Diseases started enrolling patients in a randomized, double-blind, placebo-controlled Phase 3 trial evaluating 394 hospitalized patients with COVID-19 at up to 50 sites worldwide. The trial is expected to conclude April 1, 2023. Sites include the National Institutes of Health in Bethesda, Md., (not recruiting), the University of Nebraska Medical Center in Omaha (recruiting), the University of Texas Medical Branch in Galveston (not recruiting), and Providence Sacred Heart Medical Center in Spokane (recruiting).
2. On March 3, Gilead said a randomized, open-label Phase 3 trial will evaluate remdesivir in 600 patients with moderate COVID-19. The trial is expected to start enrolling patients in March, with results to come in May.
3. On March 3, Gilead said a randomized, open-label Phase 3 trial will evaluate remdesivir in 400 patients with severe COVID-19. The trial is expected to start enrolling patients in March, with results in May.
Year-to-date stock performance: Shares of Gilead are up 17.6%.
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. On Feb. 3, it said the CEPI-funded University of Queensland will have access to the British drugmaker’s vaccine adjuvant platform technology, which is believed to both strengthen the response of a vaccine and limit the amount of vaccine needed per dose. On Feb. 24, GSK said that Clover Biopharmaceuticals Inc., a Chinese biotechnology company, is also using adjuvant technology in combination with its vaccine candidate, COVID-19 S-Trimer, in preclinical studies. Dr. Thomas Breuer, chief medical officer for GSK Vaccines, is leading work on vaccines and the adjuvant platform.
Year-to-date stock performance: Shares of GSK have tumbled 12.8%.
Company: Inovio Pharmaceuticals Inc.
Type: DNA-based vaccine
Background: Another CEPI grantee, Inovio has said it already began preclinical testing and small-scale manufacturing.
Timeline: Inovio develops immunotherapies and vaccines but hasn’t yet had a product approved for treatment. For INO-4800, preclinical testing was performed between Jan. 23 and Feb. 29. The company plans to begin clinical trials in the U.S. with 30 participants in April. It also plans to launch human trials in China and South Korea that same month, and that it has a total of 3,000 doses prepared for the trials in the three countries. Inovio said it expects to have the first results from the trial in the fall and to have 1 million does of the vaccine ready for additional clinical trials or emergency use by the end of the year.
Year-to-date stock performance: Shares of Inovio have soared 278.2%.
Company: Johnson & Johnson
Name: TBD (“We are still in the process of identifying a vaccine candidate, so no there is no name at this time,” a spokesman said March 4.)
Background: On Feb. 11, J&J said it is working with BARDA to test its vaccine candidate, with both organizations providing funding for research and development and the public-health organization funding the Phase 1 trials. Similar to GSK, J&J’s AdVac and PER. C6 technologies are used to improve the development process for a vaccine and were also used to develop J&J’s experimental Ebola vaccine. “We are also in discussions with other partners, that if we have a vaccine candidate with potential, we aim to make it accessible to China and other parts of the world,” Dr. Paul Stoffels, J&J’s chief scientific officer, said in a statement. J&J also said Feb. 18 that it is partnering with BARDA on a project that aims to screen existing antiviral medications, including experimental or approved therapies, that may be effective against COVID-19.
Timeline: The company aims to start a Phase 1 clinical trial by the end of 2020, “compared to the typical five to seven years it takes for this milestone in vaccine development,” Stoffels said on Dr. Paul Stoffels, J&J’s chief scientific officer and leader of J&J’s global COVID-19 response, said March 2.
Year-to-date stock performance: Shares of J&J are down 4.8%.
Company: Moderna Inc.
Type: RNA-based vaccine candidate
Background: On Jan. 23, Moderna received funding from CEPI 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.
Clinical trials: On Feb. 21, the NIAID said it would begin enrolling 45 healthy adult patients in an open-label Phase I clinical trial at one location to test mRNA-1273 as a vaccine for COVID-19 on March 19. The trial is expected to conclude June 1, 2021. Participants will be followed for one year. The trial will be conducted at Kaiser Permanente Washington Health Research Institute in Seattle.
Year-to-date stock performance: Moderna’s shares have gained 45.7%.
Company: Regeneron Pharmaceuticals Inc.
Name: No name yet
Background: On Feb. 4, Regeneron announced it is working on developing monoclonal antibodies as treatments for COVID-19. The company’s VelocImmune platform uses genetically-engineered mice with humanized immune systems in preclinical testing. “We are aiming to have hundreds of thousands of prophylactic doses ready for human testing by end of August,” a spokesperson said. Christos Kyratsous, VP of infectious disease R&D and viral vector technology, is running the project.
Year-to-date stock performance: Regeneron’s shares are up 27.8%.
Name: No name yet
Background: Starting Feb. 18, Sanofi is working with BARDA to test a preclinical vaccine candidate for severe acute respiratory syndrome (SARS) for COVID-19 using its recombinant DNA platform. It has a long history of producing vaccines in its Sanofi Pasteur business and acquired this candidate through its 2017 acquisition of Protein Sciences for $750 million. The French drugmaker previously worked with the organization on flu vaccines. Scientists in Meriden, Ct., are working on the vaccine; David Loew, Sanofi Pasteur’s EVP, is leading the project.
Timeline: A spokesperson said Sanofi aims to put a vaccine into a Phase 1 clinical trial between March 2021 and August 2021.
Year-to-date stock performance: Shares of Sanofi are down 4.3%.
Company: Takeda Pharmaceutical Company Ltd.
Background: Takeda is one of the most recent entrants to the race to develop a treatment for COVID-19. The Japanese drugmaker said March 4 it plans to test hyperimmune globulins for people who are at high risk for infection. As part of its research, which will be performed in Georgia, Takeda said it would need access to plasma from people who have recovered from COVID-19 or those who have received a vaccine if one is developed. Dr. Rajeev Venkayya, president of Takeda’s vaccine business, is the co-lead of the company’s COVID-19 response team. Like J&J, Takeda plans to examine whether other therapies, both experimental or with regulatory approval, may have treatment potential.
Year-to-date stock performance: Shares of Takeda are down 8.7%.
Company: Vir Biotechnology Inc.
Background: Vir said Feb. 25 it is collaborating with Shanghai-based WuXi Biologics to test monoclonal antibodies as a treatment for COVID-19. If the treatment is approved, WuXi will commercialize it in China, while Vir will have marketing rights for the rest of the world. The preclinical company is run by George Scangos, the former CEO of Biogen.
Year-to-date stock performance: Vir shares have jumped 279%.