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 200,000 people worldwide and killed at least 8,500.
There are no Food and Drug Administration-approved vaccines or therapies
for the disease.
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. 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.
Type: Vaccine
Stage: Preclinical
Name: BNT162
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. GILD, +6.58%
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. 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.
Clinical trials:
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 start enrolling patients in March, with results 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 13.43%.
Company: 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. 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 23.46%.
Company: Heat Biologics Inc. HTBX, -6.43%
Type: Vaccine
Stage: Preclinical
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. INO, +1.36%
Type: DNA-based vaccine
Stage: Preclinical
Name: INO-4800
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 JNJ, -1.19%
Type: Vaccine
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. MRNA, +12.07%
US:MRNA US:MRNA 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.
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: Novavax Inc. NVAX, +12.11%
Type: vaccines
Phase: preclinical
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. EBS, -3.57% would support contract development and manufacturing for the experimental vaccine.
Year-to-date stock performance: Its stock has gained 165.62%.
Company: Regeneron Pharmaceuticals Inc. REGN, -1.36%
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.
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
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.
Clinical trials: 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. 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 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.
Company: Sanofi SNY, -4.49%
Type: Vaccine
Stage: Preclinical
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. TAK, -9.92%
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. 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: Vaxart Inc. VXRT, +21.24%
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. “We believe an
oral vaccine administered using a room temperature-stable tablet may
offer enormous logistical advantages in the roll-out 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.
Year-to-date stock performance: Vaxart’s stock is up 516.26%.
Company: Vir Biotechnology Inc. VIR, -2.51% and Biogen Inc. BIIB, -2.17%
Type: Treatment
Stage: Preclinical
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%.
https://www.marketwatch.com/story/guid/1e86a2bc-5f10-11ea-9eb1-848872f13637
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