Novavax Announces COVID-19 Vaccine Clinical Development Progress
30 November 2020 - 10:30PM
Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology
company developing next-generation vaccines for serious infectious
diseases, today provided an update on its COVID-19 vaccine program.
NVX‑CoV2373 is a stable, prefusion protein antigen derived from the
genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein
and adjuvanted with Novavax’ proprietary Matrix‑M™.
“Novavax is in a leading position to
significantly contribute to the need for safe and efficacious
vaccines that will ultimately end the worldwide COVID-19 pandemic,”
said Stanley C. Erck, President and Chief Executive Officer,
Novavax. “We continue to make meaningful progress as we work to
test, manufacture and ultimately deliver NVX-CoV2373 with
unprecedented speed, as well as put partnerships in place that
would ensure widespread and equitable access worldwide.”
Two of the three planned late-stage efficacy
trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and
more than 20,000 participants have been dosed to-date. The primary
efficacy endpoints for these trials have been harmonized and
reviewed by global regulatory agencies in order to facilitate
regulatory approval and ensure that the results are generalizable
across global populations. In alignment with Novavax’ commitment to
transparency, Phase 3 clinical trial protocols are posted to the
company’s website at Novavax.com/resources upon finalization.
United Kingdom (U.K.) pivotal Phase 3
trial update
Novavax completed enrollment of 15,000
participants in a pivotal Phase 3 clinical trial being conducted in
the U.K. to determine efficacy and safety of NVX-CoV2373. The U.K.
Vaccines Taskforce and National Institute for Health Research
played pivotal roles in the rapid recruitment and enrollment of
volunteers.
Interim data in this event-driven trial are
expected as soon as early first quarter 2021, although the timing
depends on the overall COVID-19 rate in the region. These data are
expected to serve as the basis for licensure application in the
U.K., European Union and other countries. More than 25 percent of
enrollees in the trial are over the age of 65, while a large
proportion of volunteers had underlying co-morbid medical
conditions generally representative of the population.
South Africa Phase 2b trial
update
The Phase 2b trial taking place in South Africa
to evaluate safety and provide an early indication of efficacy is
now fully enrolled. A total of 4,422 volunteers are taking part in
the trial, which includes 245 medically stable, HIV-positive
participants.
This trial is expected to increase the body of
efficacy data of NVX-CoV2373 in racially and geographically diverse
populations as well as in older adults. As in the U.K.,
availability of efficacy data depends on the illness rate in South
Africa and may be available as soon as the first quarter 2021. The
trial is being conducted in collaboration with Professor Shabir
Mahdi and Wits University and is funded in part by the Bill &
Melinda Gates Foundation. The Coalition for Epidemic Preparedness
Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373
for this Phase 2b clinical trial.
U.S./Mexico pivotal Phase 3 trial
update
Novavax expects its pivotal Phase 3 clinical
trial in the United States and Mexico to begin in the coming weeks.
More than 100 trial sites have been selected with some alternate
sites in place, should they be needed.
Preliminary blinded data on NVX-CoV2373 in older
adults needed to proceed to Phase 3 has previously been positively
reviewed by the Food and Drug Administration (FDA). Additional
clinical data from the Phase 2 trial conducted in the U.S. and
Australia are expected to be unblinded in Q1 and will be targeted
for publication.
Novavax will use vaccine material produced at
commercial scale for this trial. Therefore, the Company has been
working closely with the FDA to complete trial-initiation gating
activities related to its commercial-scale production at FUJIFILM
Diosynth Biotechnologies in Research Triangle Park, North
Carolina.
Novavax was awarded $1.6 billion in funding from
the U.S. government to meet its Operation Warp Speed goals to
expedite the delivery of millions of doses of safe, effective
vaccines for COVID-19. The award is funding the U.S. and
Mexico pivotal Phase 3 trial and manufacturing scale-up.
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 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. NVX-CoV2373 is
being evaluated in a Phase 3 trial in the U.K. and two ongoing
Phase 2 studies that began in August: a Phase 2b trial in South
Africa, and a Phase 1/2 continuation in the U.S. and Australia.
Novavax has secured $2 billion in funding for its global
coronavirus vaccine program, including up to $399 million in
funding from the Coalition for Epidemic Preparedness Innovations
(CEPI) and more than $1.6 billion from the U.S. Government’s
Operation Warp Speed program.
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 undertaking
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.
Both vaccine candidates incorporate Novavax’ proprietary
saponin-based Matrix-M™ adjuvant 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 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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