GAITHERSBURG, Md., April 23, 2021 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a biotechnology company developing next-generation
vaccines for serious infectious diseases, today announced the
pre-print publication of data from a Phase 2b clinical trial in children demonstrating 77
percent efficacy for a malaria vaccine candidate, R21, created by
the University of Oxford that includes
Novavax' Matrix-M™ adjuvant and is licensed to Serum Institute of
India (SII). Published online in
Preprints with The Lancet, this vaccine's high levels of
protective efficacy hold promise of becoming an important tool for
global malaria eradication.
The Phase 2b randomized,
controlled, double-blind trial was conducted at the Clinical
Research Unit of Nanoro (CRUN) / Institut de Recherche en Sciences
de la Santé (IRSS), Burkina Faso,
and recruited 450 participants from the catchment area of Nanoro, a
setting with highly seasonal malaria transmission.
In three study arms, participants aged 5-17 months received 5 mg
of R21 with either 25 mg or 50 mg of Matrix-M, or a rabies vaccine
as a control. The researchers reported a vaccine efficacy of 77
percent in the higher adjuvant dose group and 71 percent in the
lower adjuvant dose group. The publication reports that both
adjuvant dosage levels were well tolerated in young children with
no reported severe reactions to the vaccine. In addition,
participants vaccinated with R21/Matrix-M showed high titers of
malaria-specific anti-N-acetylneuraminic acid phosphatase (NANP)
antibodies 28 days after the third vaccination, which were almost
doubled with the higher adjuvant dose. After a fourth dose,
administered one year later, antibody levels were boosted to levels
similar to the peak titers achieved following the primary series of
vaccinations.
The Matrix-M component of the malaria vaccine will be
manufactured and supplied to SII by Novavax. Under Novavax'
agreement with Serum Institute, SII has rights to use Matrix-M in
the vaccine in regions where the disease is endemic and will pay
Novavax royalties on its market sales of the vaccine. Additionally,
Novavax will have commercial rights to sell and distribute the
SII-manufactured vaccine in certain countries, primarily in the
travelers' and military vaccine markets.
"These significant results support our high expectations for the
potential of this vaccine, which included reaching the WHO-stated
goal for a malaria vaccine with at least 75 percent efficacy," said
Adrian Hill, Lakshmi Mittal and
Family Professorship of Vaccinology; Director of the Jenner
Institute at the University of Oxford;
Co-Director, Oxford Martin Programme on Vaccines, and co-author of
the publication. "With the commitment by our commercial partner,
Serum Institute of India, to
manufacture at least 200 million doses annually in the coming
years, we believe this vaccine could have a major public health
impact."
There were an estimated 229 million cases of malaria worldwide
in 2019, with an estimated 409,000 deaths. Children under the age
of five are the most vulnerable, accounting for 67 percent of
deaths worldwide in 2019. A Phase 3 trial of the vaccine has begun
recruitment across five trial sites in four countries of differing
malaria transmission rates and seasonality in Africa to study large-scale safety and
efficacy.
"The team at Novavax is gratified to be a part of the
collaboration that has led to today's important advance for this
longstanding global health problem," said Gregory M. Glenn, M.D., President, Research and
Development, Novavax. "Novavax' Matrix-M adjuvant used with the
Oxford R21 antigen both minimizes the dose required and thereby
increases the number of doses available, and stimulates a highly
effective immune response that could protect the world's most
vulnerable population, children."
"We are excited to be working with Oxford
University and Novavax on the successful development of a
malaria vaccine," said Dr. Cyrus
Poonawalla, Chairman and Managing Director, Serum Institute
of India. "We are committed to
supplying 200 million doses of the vaccine annually after licensure
at a very cost-effective price."
The results, detailed in, 'Efficacy of a low dose candidate
malaria vaccine, R21 in adjuvant Matrix-MTM, with
seasonal administration to children in Burkina Faso: a randomized controlled
trial,' are available online here.
About R21
R21 was produced by expressing recombinant HBsAg virus-like
particles in Hansenula polymorpha, comprising the central repeat
and the C-terminus of the circumsporozoite protein (CSP) fused to
the N-terminal end of HBsAg10 and manufactured by the Serum
Institute of India Private Ltd (SIIPL). R21 was mixed immediately
prior to administration with Matrix-M™, a saponin-based vaccine
adjuvant produced by Novavax AB, Uppsala, Sweden.
Development of the R21/Matrix-M, vaccine which targets P.
falciparum malaria, has been accelerated by a collaboration
between the Jenner Institute at Oxford
University, the Serum Institute of India Pvt Ltd. and
Novavax, Inc. working with many clinical trial units in the UK and
Africa.
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 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™, 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™
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.
Contacts:
Investors
Novavax, Inc.
Erika Schultz | 240-268-2022
ir@novavax.com
Solebury Trout
Jennifer Porcelli | 646-378-2962
jporcelli@soleburytrout.com
Novavax Media
Amy Speak | 617-420-2461
Laura Keenan | 410-419-5755
media@novavax.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/malaria-vaccine-phase-2b-clinical-trial-results-published-in-preprints-with-the-lancet-301275699.html
SOURCE Novavax, Inc.