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 194,000 people worldwide and killed at least 7,800. There are no Food and Drug Administration-approved vaccines or therapies for the disease.
Read more of MarketWatch’s coverage of COVID-19.
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:
Companies: BioNTech SE and Pfizer Inc.
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. BioNTech plans to put the vaccine candidate into clinical trials in late April, in Germany and the U.S. It is testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group Co. Ltd. in China. Pfizer and BioNTech for several years have said they would partner to develop mRNA-based influenza vaccines.
Year-to-date stock performances: Shares of BioNTech have soared 104%; Pfizer’s stock is down 20%.
Company: Gilead Sciences Inc.
Stage: Phase 3 clinical trials
Background: Gilead is a longtime drug 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 13.43%.
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 23.46%.
Company: Heat Biologics Inc.
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. It disclosed March 17 in a financial filing that its COVID-19 vaccine candidate had been added to the World Health Organization’s “draft landscape” of 41 candidate vaccines. The company also recently joined the Alliance for Biosecurity, which may help it “secure government funding to support its rapid development, production, and distribution” of its COVID-19 vaccine, according to Maxim Group analysts.
Year-to-date stock performance: Heat’s stock has gained 19%.
Company: Inovio Pharmaceuticals Inc.
Type: DNA-based vaccine
Background: Another CEPI grantee, awarded $9 million, 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. Inovio on March 12 announced a $5 million grant from the Bill & Melinda Gates Foundation to test a delivery device for its vaccine candidate. RBC analyst Gregory Renza recently downgraded the stock to sector perform from outperform on valuation grounds and said he believed in the technology.
Year-to-date stock performance: Shares of Inovio have soared 124.64%.
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. On March 13, J&J said it started preclinical testing on multiple candidates in collaboration with Beth Israel Deaconess Medical Center in Boston, and it aims to have a vaccine candidate by the end of the month. J&J also said in February that it partnered 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 7.49%.
Company: Moderna Inc.
Type: RNA-based vaccine
Stage: Phase 1
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.
Clinical trials: The first patient in the Phase 1 trial received a dose of the vaccine candidate on March 16. The study is expected to enroll 45 healthy adult patients, between the ages of 18 and 55 years old, in an open-label Phase I clinical trial to test mRNA-1273 as a vaccine for COVID-19. It’s 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. CEPI funded the manufacturing of the investigational vaccine for the first phase of the trial, which is evaluating different doses for safety and immune response.
Year-to-date stock performance: Moderna’s shares have gained 51.35%.
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 29.77%.
Companies: Regeneron Pharmaceuticals and Sanofi
Stage: Phase 2/3 clinical trial
Background: The FDA previously approved Kevzara, a treatment developed by Regeneron and Sanofi, as a therapy for rheumatoid arthritis in 2017.
Clinical trial: On March 16, the companies said they had started a Phase 2/3 trial testing Kevzara as a treatment for patients who have been hospitalized with severe COVID-19 infections. This randomized, double-blind, placebo-controlled trial is expected to enroll up to 400 patients and will take place at 16 sites in the U.S. The aim is to evaluate if the drug lessens patient fevers and their need for supplemental oxygen. The Phase 3 trial will evaluate if Kevzara prevents deaths and reduces need for mechanical ventilation, supplemental oxygen, or hospitalization. Early results from a small 21-person trial in China and that have not been peer-viewed found that COVID-19 patients reported reductions in fever and 7% of them had a reduced need for supplemental oxygen within days of starting treatment.
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 14.4%.
Company: Takeda Pharmaceutical Company Ltd.
Background: 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 29.01%.
Company: Vir Biotechnology Inc.
and Biogen 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. It later announced a partnership with Biogen to help develop and manufacture its monoclonal antibodies as a potential treatment for COVID-19. Biogen will handle clinical manufacturing of Vir’s antibodies, the company said.
Year-to-date stock performance: Vir shares have jumped 324.94%; Biogen’s stock is up 4.95%.