Novavax Initiates Phase 2 Portion of Phase 1/2 Clinical Trial of COVID-19 Vaccine
August 24 2020 - 9:00AM
Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced that the first volunteers have been
enrolled in the Phase 2 portion of its ongoing clinical trial to
evaluate the immunogenicity and safety of NVX-CoV2373, Novavax’
COVID-19 vaccine candidate. The Phase 2 clinical trial expands on
the age range of the Phase 1 portion by including older adults
60-84 years of age as approximately 50 percent of the trial’s
population. NVX‑CoV2373 is a stable, prefusion protein made using
Novavax’ nanoparticle technology and includes Novavax’ proprietary
Matrix‑M™ adjuvant.
“We expect this Phase 2 portion of the trial to
expand on the encouraging Phase 1 safety and immunogenicity data
for NVX-CoV2373, and we will now look for robust immune responses
in older adults,” said Gregory M. Glenn, M.D., President, Research
and Development at Novavax. “Our Phase 3 trial of NanoFlu, which we
reported in March of 2020, provided us with a deep understanding of
the unique needs of older adults, who are particularly vulnerable
to COVID-19. We know that the world is closely watching all of
these trials, and we anticipate interim data from this trial in the
fourth quarter of this year.”
The Phase 2 portion of the ongoing Phase 1/2
clinical trial is a randomized, placebo-controlled,
observer-blinded study to evaluate the safety and immunogenicity of
NVX-CoV2373 with Matrix-M in subjects aged 18 to 84 years. The
clinical trial will assess two dose sizes (5 and 25 µg), each with
50 µg of Matrix‑M. Although the trial was designed to confirm
immunogenicity and safety in adults, secondary objectives include
preliminary evaluation of efficacy. The study is targeting
enrollment of up to 1,500 healthy volunteers, with approximately 50
percent of participants ≥60 years of age, at up to 40 sites in the
U.S. and Australia
The trial is supported by funding from the
Coalition for Epidemic Preparedness Innovations (CEPI).
In the Phase 1 portion of the Phase 1/2 clinical
trial, conducted in Australia, NVX-CoV2373 was generally
well-tolerated and elicited robust antibody responses numerically
superior to that seen in human convalescent sera. These data have
been submitted for peer-review to a scientific journal and are
posted online at the preprint server medRxiv.org.
For further information, including media-ready
images, b-roll, downloadable resources and more, click here.
About NVX-CoV2373
NVX‑CoV2373 is a 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 and contains Novavax’
patented saponin-based Matrix-M™ adjuvant to enhance the immune
response and stimulate high levels of neutralizing antibodies. In
preclinical trials, NVX‑CoV2373 demonstrated indication of
antibodies that block binding of spike protein to receptors
targeted by the virus, a critical aspect for effective vaccine
protection. In its Phase 1 data of the Phase 1/2 clinical trial,
NVX‑CoV2373 was generally well-tolerated and elicited robust
antibody responses numerically superior to that seen in human
convalescent sera. Phase 2 clinical trials began in August. Novavax
has secured $2 billion in funding for its global coronavirus
vaccine program, including up to $388 million in funding from the
Coalition for Epidemic Preparedness Innovations (CEPI).
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. Novavax
is undergoing clinical trials for NVX-CoV2373, its vaccine
candidate against SARS-CoV-2, the virus that causes COVID-19.
NVX‑CoV2373 was generally well-tolerated and elicited robust
antibody responses numerically superior to that seen in human
convalescent sera in its Phase 1 data of the Phase 1/2 clinical
trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine,
met all primary objectives in its pivotal Phase 3 clinical trial in
older adults. Both vaccine candidates incorporate Novavax’
proprietary saponin-based Matrix-M™ adjuvant in order to enhance
the immune response and stimulate high levels of neutralizing
antibodies. Novavax is a leading innovator of recombinant vaccines;
its proprietary recombinant technology platform combines the power
and speed of genetic engineering to efficiently produce highly
immunogenic nanoparticles in order to address urgent global health
needs.
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
8-K for the period ended June 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:
Novavax
Investors and mediaSilvia Taylor and Erika
Trahanir@novavax.com240-268-2022
MediaBrandzone/KOGS CommunicationEdna
Kaplankaplan@kogspr.com617-974-8659
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