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 750,000 people worldwide and killed at least 45,000. 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.
In the U.S., many of 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 also received funding from Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo that has provided millions of dollars in funding to vaccine makers. 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: CytoDyn Inc.
Stage: Phase 2 clinical trial
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. The investigational therapy has not been approved for any indications; for COVID-19, it’s being proposed as a treatment for mild-to-moderate respiratory complications that occur in patients with the disease. The randomized, double-blind, placebo-controlled study will test the efficacy and safety of leronlimab in 75 patients. CytoDyn had been studying the experimental therapy as a treatment for people with HIV and a form of metastatic breast cancer.
Year-to-date stock performance: CytoDyn’s stock has soared 189%.
Company: Dynavax Technologies Corp.
Type: Adjuvant platform for vaccines
Background: Dynavax said in March that it’s making its adjuvant technology available to companies developing COVID-19 vaccines through a partnership with CEPI. Dynavax’s adjuvant technology can help provide an increased immune response to a vaccine; the biopharmaceutical company is also working with the University of Queensland, Australia, on vaccine development through a CEPI deal.
Year-to-date stock performance: Its stock is down 38%.
Company: Gilead Sciences Inc.
Stage: Phase 3 clinical trials
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. 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. Gilead in late March halted individual compassionate use requests for remdesivir as outbreaks worsened in the U.S., having provided the investigational therapy to 1,000 patients. “The system cannot support and process the overwhelming number of applications we have seen with COVID-19,” Gilead CEO Daniel O’Day said March 28. “We are transitioning to what should be a more streamlined, sustainable approach with ‘expanded access’ programs.”
1. On Feb. 21, the National Institute of Allergy and Infectious Diseases started enrolling patients in a randomized, double-blind, placebo-controlled Phase 2 trial evaluating 394 hospitalized patients with COVID-19 at up to 50 sites worldwide, including at three sites in Singapore and South Korea. However, the majority of the study locations are in the U.S. 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 start enrolling patients in March, with results to come in May. The clinical trial listing states the study is taking place in Hong Kong, Singapore, South Korea and the U.S.
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 starts enrolling patients in March, with results expected in May. The clinical trial listing states the study is taking place in Hong Kong, Singapore, South Korea and the U.S.
Year-to-date stock performance: Shares of Gilead are up 13.4%.
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 its 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 23.5%.
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 says 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 doses 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. In late March, Inovio said that Ology Bioservices Inc., a contract development and manufacturing organization, had received a $11.9 million contract from the Department of Defense to support future potential manufacturing of Inovio’s vaccine candidate for military personnel.
Year-to-date stock performance: Shares of Inovio have soared 124.6%.
Company: Johnson & Johnson
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. 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 by March 30 it had identified a lead vaccine candidate. The company said it is scaling up its vaccine manufacturing capabilities in the U.S. and abroad as part of its commitment to bring “an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.” J&J also said in February that it had 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 put its lead vaccine candidate in a Phase 1 clinical trial in September, the company said March 30, and it may have investigational doses of the vaccine available by early 2021 for emergency use.
Year-to-date stock performance: Shares of J&J are down 7.5%.
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. “It’s pretty important that we do this in a placebo-controlled scientifically sound design so that once those trials readout we actually conclusively know and can demonstrate both the efficacy and overall safety profile of this vaccine,” Moderna chief medical officer Tal Zaks said during a March 30 call with investors.
Year-to-date stock performance: Moderna’s shares have gained 51.4%.
Company: Novavax Inc.
Background: Novavax, a preclinical biotechnology company, announced Feb. 26
it had several vaccine candidates in preclinical animal studies, and
that it plans to initiate a Phase I clinical study by June. In March the
company it had received $4 million from CEPI to develop a COVID-19
vaccine and that Emergent BioSolutions Inc.
Year-to-date stock performance: Its stock has gained 165.6%.
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 29.8%.
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 trials:The companies said March 16 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. New York’s Mount Sinai Hospital, the first site, has started enrolling patients, according to a company spokesperson. 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 that have not been peer-reviewed 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. On March 30, the companies said the first patient in their global trial had been treated. The patient is not located in the U.S., though the Phase 2/3 trial is being conducted in seven countries, including the U.S
Company: Roche Holding AG
Stage: Phase 3
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. Roche expects to begin enrolling around 330 patients in early April, in the U.S. and elsewhere in the world. The company plans to examine patient mortality and need for mechanical ventilation or an intensive care unit stay among other primary and secondary endpoints. The trial is in partnership with BARDA.
Year-to-date stock performance: Roche’s stock is down 12%.
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.
Sanofi announced a separate program with Translate Bio Inc.
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 29.0%.
Company: Vaxart Inc.
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. “We believe an oral vaccine administered using a room temperature-stable tablet may offer enormous logistical advantages in the rollout of a large vaccination campaign,” Vaxart CEO Wouter Latour said in a March 18 news release. The company plans to start a Phase 1 clinical trial in the U.S. in the second half of 2020, a company executive said. As of March 31, it has five vaccine candidates for preclinical testing.
Year-to-date stock performance: Vaxart’s stock is up 516.3%.
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. Vir later announced a research agreement with Generation Bio as part of its COVID-19 antibody development program.
Year-to-date stock performance: Vir shares have jumped 324.9%; Biogen’s stock is up 4.9%.