- Company continuing to work with the U.S. FDA on potential
for accelerated approval pathway
- Novavax intends to partner on both candidates to advance to
filing and commercialization
GAITHERSBURG, Md., Dec. 10,
2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a
global company advancing protein-based vaccines with its Matrix-M™
adjuvant, today announced that the first participants have
been dosed in its COVID-19-Influenza Combination (CIC) and
stand-alone seasonal influenza Phase 3 trial. The trial will
evaluate the immunogenicity and safety of the CIC and stand-alone
seasonal influenza vaccine candidates compared to Novavax's
updated 2024-2025 COVID-19 vaccine (NVX-CoV2705) and a
licensed seasonal influenza vaccine comparator in adults aged 65
and older.
"A combination vaccine for two vaccine-preventable diseases is
an important step forward for public health and the trial start is
a key step in advancing our late-stage pipeline, which we plan to
progress through strategic partnerships," said Ruxandra Draghia-Akli, MD, PhD, Executive Vice
President, Head of Research and Development, Novavax. "Our goal is
to get these assets to market as soon as possible, and we will work
with the U.S. FDA to assess the possibility of an accelerated
approval pathway."
The Company is working with the U.S. Food and Drug
Administration (FDA) to determine the potential of the current CIC
and stand-alone influenza trial to support accelerated approval.
While in the process of seeking alignment on accelerated approval
criteria with the U.S. FDA, Novavax has decided to recruit an
initial cohort of approximately 2,000 participants while continuing
this dialogue. Novavax anticipates being able to provide more
clarity and information on potential next steps by Q2 2025,
including if additional clinical work would be needed to achieve
registration for these assets.
The randomized Phase 3 trial builds on positive Phase 2 data and
aims to further evaluate the immunogenicity and safety of a
combination of Novavax's updated 2024-2025 COVID-19 vaccine,
trivalent nanoparticle stand-alone seasonal influenza vaccine
candidate and patented saponin-based Matrix-M adjuvant relative to
separate administrations of Novavax's updated 2024-2025 COVID-19
vaccine and a licensed seasonal influenza vaccine comparator. In
addition, the trial also aims to further evaluate the
immunogenicity and safety of Novavax's stand-alone influenza
vaccine, also containing Matrix-M.
The Company's FY 2025 financial guidance for combined Research
& Development and Selling, General and Administrative expense
of approximately $500 million is
inclusive of this CIC and stand-alone influenza initial planned
Phase 3 clinical activity and is subject to revisions and updates
as next steps are determined.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by
discovering, developing and commercializing innovative vaccines to
help protect against serious infectious diseases. Novavax, a global
company based in Gaithersburg,
Md., U.S., offers a differentiated vaccine platform that
combines a recombinant protein approach, innovative nanoparticle
technology and Novavax's patented Matrix-M adjuvant to enhance the
immune response. The Company's portfolio includes its COVID-19
vaccine and its pipeline includes its CIC and stand-alone influenza
vaccine candidates. In addition, Novavax's adjuvant is included in
the University of Oxford and Serum
Institute of India's R21/Matrix-M
malaria vaccine. Please visit novavax.com and
LinkedIn for more information.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its
operating plans and prospects, its updated combined annual Research
& Development and Selling, General and Administrative expense
target for FY 2025, the potential for its CIC and stand-alone
influenza study to be used for accelerated approval and the timing
of updates related thereto, are forward-looking statements.
Novavax cautions that these forward-looking statements are subject
to numerous risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. These risks and uncertainties include, without
limitation, challenges pursuing additional partnership
opportunities; challenges satisfying, alone or together with
partners, various safety, efficacy, and product characterization
requirements, including those related to process qualification,
assay validation and stability testing, necessary to satisfy
applicable regulatory authorities; challenges or delays in
conducting clinical trials or studies for its product candidates;
challenges or delays in obtaining regulatory authorization for its
product candidates, including for future COVID-19 variant strain
changes, its CIC vaccine candidate, its stand-alone influenza
vaccine candidate or other product candidates; manufacturing,
distribution or export delays or challenges; Novavax's substantial
dependence on Serum Institute of India Pvt. Ltd. and Serum Life
Sciences Limited for co-formulation and filling Novavax's COVID-19
vaccine and the impact of any delays or disruptions in their
operations; difficulty obtaining scarce raw materials and supplies
including for its proprietary adjuvant; resource constraints,
including human capital and manufacturing capacity; constraints on
Novavax's ability to pursue planned regulatory pathways, alone or
with partners; challenges in implementing its global restructuring
and cost reduction plan; challenges in obtaining commercial
adoption and market acceptance of its updated 2024-2025 formula
COVID-19 vaccine or any COVID-19 variant strain containing
formulation, or for its CIC vaccine candidate and stand-alone
influenza vaccine candidate or other product candidates; challenges
meeting contractual requirements under agreements with multiple
commercial, governmental, and other entities, including
requirements to deliver doses that may require Novavax to refund
portions of upfront and other payments previously received or
result in reduced future payments pursuant to such agreements and
challenges in amending or terminating such agreements; challenges
related to the seasonality of vaccinations against COVID-19;
challenges related to the demand for vaccinations against COVID-19
or influenza; challenges in identifying and successfully pursuing
innovation expansion opportunities; Novavax's expectations as to
expenses and cash needs may prove not to be correct for reasons
such as changes in plans or actual events being different than its
assumptions; and those other risk factors identified in the "Risk
Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" sections of Novavax's Annual
Report on Form 10-K for the year ended December 31, 2023, and subsequent Quarterly
Reports on Form 10-Q, 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 www.sec.gov and
www.novavax.com, 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
Luis Sanay, CFA
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
240-720-7804
media@novavax.com
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SOURCE Novavax, Inc.