Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced initiation of PREVENT-19, its pivotal
Phase 3 study in the United States and Mexico to evaluate the
efficacy, safety and immunogenicity of NVX-CoV2373, the Company’s
COVID-19 vaccine candidate. The trial builds on research from Phase
1/2 studies demonstrating that the vaccine provoked a robust immune
response, generated highly neutralizing antibodies against the
virus and was generally well-tolerated.
“With the COVID-19 pandemic raging around the
globe, this trial is a critical step in building the global
portfolio of safe and effective vaccines to protect the world’s
population,” said Stanley C. Erck, president and chief executive
officer, Novavax. “We thank our colleagues and partners who
continue to work with us to urgently advance our commercial-scale
manufacturing processes, and we are grateful for the hard work and
assistance from Operation Warp Speed, the U.S. FDA and the
government of Mexico on this program.”
NVX-CoV2373 contains a full-length, prefusion
spike protein made using Novavax’ recombinant nanoparticle
technology and the company’s proprietary saponin-based Matrix-M™
adjuvant. The purified protein is encoded by the genetic sequence
of the SARS-CoV-2 spike (S) protein and is produced in insect
cells. It can neither cause COVID-19 nor can it replicate, is
stable at 2°C to 8°C and is shipped in a ready-to-use liquid
formulation that permits distribution using standard vaccine supply
chain channels.
PREVENT-19 is being conducted with support from
Operation Warp Speed partners, including the Department of Defense
and the National Institute of Allergy and Infectious Diseases
(NIAID), part of the National Institutes of Health (NIH), and the
Biomedical Advanced Research and Development Authority (BARDA),
part of the U.S. Department of Health and Human Services (HHS)
Office of the Assistant Secretary for Preparedness and Response.
BARDA is also providing up to $1.6 billion under a Department of
Defense agreement (identifier MCDC OTA agreement number
W15QKN-16-9-1002).
The company is also currently conducting a large
pivotal Phase 3 clinical study in the United Kingdom (U.K.), a
Phase 2b safety and efficacy study in South Africa, and an ongoing
Phase1/2 trial in the U.S. and Australia. Data from these trials
are expected as soon as early first quarter 2021, although timing
depends on transmission rates in the regions.
About the PREVENT-19 Phase 3
Study
PREVENT-19 (the PRE-fusion
protein subunit Vaccine Efficacy
Novavax Trial |
COVID-19) is a randomized, placebo-controlled,
observer-blinded study to evaluate the efficacy, safety and
immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000
subjects 18 years of age and older compared with placebo. The trial
design has been harmonized to align with other Phase 3 trials
conducted under the auspices of Operation Warp Speed, including the
use of a single external independent Data and Safety Monitoring
Board to evaluate safety and conduct an unblinded review when
predetermined interim analysis events are reached.
The trial’s primary endpoint is the prevention
of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint
is the prevention of PCR-confirmed, symptomatic moderate or severe
COVID-19. Both endpoints will be assessed at least seven days after
the second study vaccination in volunteers who have not been
previously infected with SARS-CoV-2.
Two thirds of the participants will be assigned
to randomly receive two intramuscular injections of the vaccine,
administered 21 days apart, while one third of the trial
participants will receive placebo. Trial sites were selected in
locations where transmission rates are currently high, to
accelerate the accumulation of positive cases that could show
efficacy.
The primary efficacy analysis is event-driven,
based on the number of participants with symptomatic mild, moderate
or severe COVID-19 disease. Participants will be followed for 24
months following the second injection.
Enrollment and Study
Population
Information about the trial and how to enroll in
PREVENT-19 is available on clinicaltrials.gov under trial
identifier NCT04611802 and www.Novavax.com/PREVENT-19.
Novavax plans to recruit, enroll, and study a
diverse population with an emphasis on communities and demographic
groups most impacted by the disease as well as to maximize
participation of older adults and those living with co-morbid
conditions (e.g., obesity, hypertension and diabetes) that place
them at higher risk of complications from COVID-19. Enrollment
goals are:
- ≥ 25
percent of the study population is intended to be in the 65 years
of age or older group
- ≥ 15
percent black/African American
- 10-20
percent LatinX
-
1-2 percent American Indian
“We are encouraged by the data generated to-date
on NVX-CoV2373 and are optimistic about our ability to positively
build on the body of evidence with this trial,” said Gregory M.
Glenn, M.D, president of research and development, Novavax. “We
recognize that volunteers considering our trial may have questions
about the potential impact on their ability to receive an
authorized vaccine when it becomes available to them. We wish to
reassure participants that we are working to ensure that their
involvement in our trial does not negatively impact their ability
to be vaccinated at the appropriate time.”
Many of the trial sites participating in
PREVENT-19 are part of the NIAID-supported COVID-19 Prevention
Network (CoVPN), which includes existing NIAID-supported clinical
research networks with infectious disease expertise and was
designed for rapid and thorough evaluation of vaccine candidates
and monoclonal antibodies for preventing COVID-19.
“This trial underscores the importance of private/public
partnerships in solving the need for globally available vaccines to
interrupt the ongoing COVID-19 epidemic,” said Larry Corey, M.D.,
virologist at the Fred Hutchinson Cancer Research Center and
co-leader of the CoVPN.
In the interest of transparency and scientific
exchange and to demonstrate the rigor with which the study is being
executed, Novavax has posted the Phase 3 trial protocol on its
website at novavax.com/resources.
For further information, including media-ready
images, b-roll, downloadable resources and more,
click here.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate
engineered from the genetic sequence of SARS-CoV-2, the virus that
causes COVID-19 disease. NVX-CoV2373 was created using Novavax’
recombinant nanoparticle technology to generate antigen derived
from the coronavirus spike (S) protein. It is adjuvanted with
Novavax’ patented saponin-based Matrix-M™ to enhance the immune
response and stimulate high levels of neutralizing antibodies.
NVX-CoV2373 contains purified protein antigen and can neither
replicate, nor can it cause COVID-19. In preclinical studies,
NVX-CoV2373 induced antibodies that block binding of spike protein
to cellular receptors and provided protection from infection and
disease. NVX-CoV2373 was generally well-tolerated and elicited
robust antibody responses numerically superior to that seen in
human convalescent sera in Phase 1/2 clinical testing.
About Matrix-M™
Novavax’ patented saponin-based Matrix-M™
adjuvant has demonstrated a potent and well-tolerated effect by
stimulating the entry of antigen-presenting cells into the
injection site and enhancing antigen presentation in local lymph
nodes, boosting immune response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a late-stage
biotechnology company that promotes improved health globally
through the discovery, development and commercialization of
innovative vaccines to prevent serious infectious diseases. The
Company’s proprietary recombinant technology platform combines the
power and speed of genetic engineering to efficiently produce
highly immunogenic nanoparticles designed to address urgent global
health needs. Novavax is conducting late-stage clinical trials for
NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus
that causes COVID-19. NanoFlu™, its quadrivalent influenza
nanoparticle vaccine, met all primary objectives in its pivotal
Phase 3 clinical trial in older adults and will be advanced for
regulatory submission. Both vaccine candidates incorporate Novavax’
proprietary saponin-based Matrix-M™ adjuvant to enhance the immune
response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com and
connect with us on Twitter and LinkedIn.
Novavax Forward Looking Statements
Statements herein relating to the future
of Novavax and the ongoing development of its vaccine and
adjuvant products are forward-looking
statements. Novavax cautions that these forward-looking
statements are subject to numerous risks and uncertainties, which
could cause actual results to differ materially from those
expressed or implied by such statements. These risks and
uncertainties include those identified under the heading “Risk
Factors” in the Novavax Annual Report on Form 10-K for the year
ended December 31, 2019, and Quarterly Report on
Form 10-Q for the period ended September 30, 2020,
as filed with the Securities and Exchange
Commission (SEC). We caution investors not to place
considerable reliance on forward-looking statements contained in
this press release. You are encouraged to read our filings with
the SEC, available at sec.gov, for a discussion of these
and other risks and uncertainties. The forward-looking statements
in this press release speak only as of the date of this document,
and we undertake no obligation to update or revise any of the
statements. Our business is subject to substantial risks and
uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration
to these risks and uncertainties.
Contacts:
Investors
Erika Trahan
ir@novavax.com
240-268-2022
Media
Edna Kaplan
media@novavax.com
617-974-8659
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