Novavax Initiates COVID-19 Vaccine Clinical Trial Crossover
PR88849
GAITHERSBURG, Md., April 6, 2021 /PRNewswire=KYODO JBN/ --
-- Crossover allows participants to continue in trials and remain blinded
-- Ensures that all trial participants receive active vaccine
-- South Africa and UK crossover arms initiated; US/Mexico PREVENT-19 crossover
planned
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing
next-generation vaccines for serious infectious diseases, today announced the
initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373, the
company's COVID-19 vaccine candidate. Crossover ensures the administration of
active vaccine to all participants in the trials and has begun for Novavax'
Phase 2b trial in South Africa and its pivotal Phase 3 trial in the United
Kingdom.
Under Novavax' updated clinical trial protocols[1], all participants in the UK
and US Phase 3 trials will be offered the opportunity to receive an additional
round of injections. Participants who elect to do so will receive an additional
two-dose regimen of either vaccine (for those who originally received placebo)
or placebo (for those who originally received vaccine). Participants in the
South Africa Phase 2b trial will receive either active vaccine for those who
initially received placebo, or a booster dose of active vaccine for those who
initially received active vaccine. Participants across all three trials will
remain blinded to their courses of treatment to preserve the ability to assess
efficacy in each trial, and all will be followed for up to two years to monitor
the safety and durability of protection the vaccine. In the trials taking place
in South Africa and the United Kingdom, half of the participants initially
received the active vaccine while two-thirds of participants in PREVENT-19, the
trial being conducted in the US and Mexico, initially received active vaccine.
"The crossover arms ensure that all participants have access to an active
vaccine candidate while allowing Novavax to continue to monitor the safety and
efficacy of our vaccine over the long term," said Filip Dubovsky, M.D., Chief
Medical Officer, Novavax. "We are grateful to the volunteers who stepped
forward to take part in our clinical trials, without whom we would be unable to
develop, study and ultimately deliver what we hope will be a significant tool
in the fight against COVID-19."
The company is also planning a crossover in the PREVENT-19 study, for which the
company expects to read out initial clinical data during the second quarter. In
addition, the company is planning to expand the trial to include pediatric and
adolescent arms, which are also expected to begin in the second quarter.
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 and is adjuvanted with Novavax'
patented saponin-based Matrix-M(TM) 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 blocked the binding of
spike protein to cellular receptors and provided protection from infection and
disease. It was generally well-tolerated and elicited robust antibody response
in Phase 1/2 clinical testing.
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a trial in the
U.K that demonstrated efficacy of 96.4% against the original virus strain and
89.7% overall, and the PREVENT-19 trial in the U.S. and Mexico that began in
December 2020. It is also being tested in two ongoing Phase 2 studies that
began in August 2020: A Phase 2b trial in South Africa that demonstrated 48.6%
efficacy against a newly emerging escape variant, and a Phase 1/2 continuation
in the U.S. and Australia.
NVX-CoV2373 is stored and stable at 2 degrees - 8 degrees C, allowing the use
of existing vaccine supply chain channels for its distribution. It is packaged
in a ready-to-use liquid formulation in 10-dose vials.
About Matrix-M(TM)
Novavax' patented saponin-based Matrix-M(TM) 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 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(TM), 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(TM) 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, 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.
____________________
1 Clinical trial protocols (
) may be found in the Resources section of the Novavax website and will be
updated as appropriate.
Contacts:
Investors
Novavax, Inc.
Erika Schultz | +1-240-268-2022
ir@novavax.com
Solebury Trout
Jennifer Porcelli | +1-617-974-8659
jporcelli@soleburytrout.com
Media
Laura Keenan | +1-410-419-5755
Amy Speak | +1-617-420-2461
media@novavax.com
SOURCE Novavax, Inc.
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