Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology
company developing next-generation vaccines for serious infectious
diseases, announced updates on its Phase 3 clinical development
program of NVX-CoV2373, its COVID-19 vaccine candidate. NVX‑CoV2373
is a stable, prefusion protein made using Novavax’ nanoparticle
technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.
The Company also announced that it will present data from its
ongoing Phase 1/2 clinical trial, including new Phase 2
reactogenicity data, on Friday, October 30 during the United States
(U.S.) Center for Disease Control and Prevention’s (CDC) Advisory
Committee on Immunization Practices’ (ACIP) meeting.
U.K. Phase 3
Clinical Trial Update
Novavax has enrolled over 5,500 participants to
date in the United Kingdom (U.K.) trial, which it has expanded to
15,000 volunteers. The increased enrollment is likely to facilitate
assessment of safety and efficacy in a shorter time period. Novavax
expects this trial to be fully enrolled by the end of November, and
dependent on the overall COVID-19 attack rate, interim data in this
event-driven trial are expected as soon as early first quarter
2021. These data are expected to serve as the basis for global
licensure.
“We are pleased with the significant progress
made in our Phase 3 clinical trial since it began in the United
Kingdom at the end of September,” said Gregory M. Glenn, M.D.,
President of Research and Development at Novavax. “We are grateful
for the support of the U.K. Government’s Vaccines Taskforce (VTF)
and the National Institute for Health Research (NIHR) for our
pivotal trial. Recognizing the recent, large increase in the number
of COVID-19 cases in the U.K., as well as the rapid progress in
participant enrollment for our trial, in consultation with the VTF
and NIHR, we adjusted our plans and increased enrollment.”
In alignment with Novavax’ commitment to
transparency, the Company has posted the protocol for this trial on
its website at https://www.novavax.com/resources#protocols.
U.S.
Phase 3 Clinical
Trial Update
Novavax currently expects the pivotal clinical
trial to begin in the United States and Mexico by the end of
November. The Company has made significant progress in large-scale
manufacturing, with delays experienced versus original timing
estimates.
Novavax has been developing large-scale
manufacturing processes at multiple sites around the world and
plans to use production from its contract manufacturing site at
FUJIFILM Diosynth Biotechnologies’ Morrisville, North Carolina site
in this Phase 3 clinical trial.
Additional Phase 3
Clinical Trial Information
United Kingdom
Novavax’ first pivotal Phase 3 clinical trial,
begun in September in partnership with the U.K. Government’s
Vaccines Taskforce, will be expanded from 10,000 to 15,000
volunteers, some of whom have been recruited through the National
Health Service (NHS) Vaccine Registry. The trial protocol calls for
unblinding of data once 152 participants have achieved mild,
moderate or severe endpoints. Two interim analyses are planned once
66 and 110 endpoints have occurred.
United States/Mexico
Novavax’ pivotal Phase 3 clinical trial is being
conducted with support from the U.S. Government through Operation
Warp Speed. The trial design is harmonized with those of other
leading companies, and calls for the enrollment of up to 30,000
participants in the U.S. and Mexico, with proportional
representation among diverse populations most vulnerable to
COVID-19 distributed across race/ethnicity, age and those living
with co-morbidities. The trial protocol will be posted on Novavax’
website upon initiation.
ACIP Presentation Friday, October
30
Novavax’ Senior Vice President and Chief Medical
Officer, Filip Dubovsky, M.D., will present an update during a
public meeting of the CDC’s ACIP between 10:00 am and 12:30 am ET
on Friday, October 30. For more information, please visit
www.cdc.gov/vaccines/acip/meetings/index.html.
About NVX-CoV2373NVX-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. NVX-CoV2373 contains purified protein
antigen and cannot replicate, nor can it cause COVID-19. In
preclinical trials, NVX-CoV2373 demonstrated induction of
antibodies that block binding of spike protein to receptors
targeted by the virus, a critical aspect for effective vaccine
protection. In the Phase 1 portion of its 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. NVX-CoV2373 is also 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 $388 million in funding from the Coalition for
Epidemic Preparedness Innovations (CEPI).
About NovavaxNovavax,
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 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:
InvestorsErika
Trahanir@novavax.com240-268-2022
MediaBrandzone/KOGS CommunicationEdna
Kaplankaplan@kogspr.com617-974-8659
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