Novavax Initiates Efficacy Trial of COVID-19 Vaccine in South Africa
August 17 2020 - 2:30AM
Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced the beginning of a Phase 2b clinical
trial in South Africa to evaluate the efficacy of NVX-CoV2373,
Novavax’ COVID-19 vaccine candidate. Dr. Shabir Madhi, Professor of
Vaccinology at Wits University, will lead the clinical trial, which
is supported in part by a $15 million grant from the Bill &
Melinda Gates Foundation. NVX‑CoV2373 is a stable, prefusion
protein made using Novavax’ proprietary nanoparticle technology and
includes Novavax’ proprietary Matrix‑M™ adjuvant.
“Because South Africa is experiencing a winter
surge of COVID-19 disease, this important Phase 2b clinical trial
has the potential to provide an early indication of efficacy, along
with additional safety and immunogenicity data for NVX-CoV2373,”
said Gregory M. Glenn, M.D., President, Research and Development at
Novavax. “We appreciate the continued support of the Bill &
Melinda Gates Foundation and CEPI, and our strong ongoing
collaboration with Wits University, all of whom are united with us
in our commitment to produce and deliver a safe, effective vaccine
across the globe.”
The randomized, observer-blinded,
placebo-controlled Phase 2b clinical trial of NVX-CoV2373 will
include two cohorts. One cohort will evaluate efficacy, safety and
immunogenicity in approximately 2,665 healthy adults. The second
cohort will evaluate safety and immunogenicity in approximately 240
medically stable, HIV-positive adults. This allows for evaluation
of the vaccine across a diverse, representative study population.
Novavax expects that, if approved in South Africa, its COVID-19
vaccine would ultimately be supplied to South Africa through
Novavax’ recently announced collaboration with the Serum Institute
of India.
“The major motivation for the COVID-19 vaccines
being evaluated at an early stage in South Africa is to generate
evidence in the African context on how well these vaccines work in
settings such as our own,” said Shabir Madhi, M.B.B.C.H., FCPaeds,
Ph.D. “I am pleased to work with Novavax as the principal
investigator in this clinical trial, following Novavax’ COVID-19
vaccine’s positive Phase 1 data, which provides strong rationale
for moving development forward in a larger subset of adults.”
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 to the U.S. Food and Drug Administration (FDA) and
an independent safety monitoring committee, and have also been
submitted for peer-review to a scientific journal and are posted
online at the preprint server medRxiv.org. Novavax intends to
initiate the Phase 2 portion of this trial in the U.S. and
Australia in the near future. This trial will include approximately
1,500 subjects and will include older adults.
The Coalition for Epidemic Preparedness
Innovations (CEPI) is funding the manufacturing of doses of
NVX-CoV2373 for this Phase 2b clinical trial.
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 will begin 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
InvestorsSilvia Taylor and Erika
Trahanir@novavax.com240-268-2022
MediaBrandzone/Speak Life ScienceAmy Speak
amy@speaklifescence.com617-420-2461
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