Novavax Appoints Leadership Team to Advance NanoFlu through Regulatory Licensure
October 13 2020 - 8:00AM
Novavax, Inc. (Nasdaq: NVAX) Novavax, Inc. (Nasdaq: NVAX), a
late-stage biotechnology company developing next-generation
vaccines for serious infectious diseases, today announced the
formation of a leadership team to advance NanoFlu to regulatory
licensure and the promotion of Russell (Rip) Wilson, J.D./M.B.A.,
to Executive Vice President and the newly-created role of NanoFlu™
General Manager. Mr. Wilson will focus exclusively on leading
efforts to advance NanoFlu, the company’s influenza vaccine
candidate, through global licensure, as well as the exploration of
a combined influenza/COVID-19 vaccine that could be used in a
post-pandemic setting. Novavax announced results of its successful
NanoFlu pivotal Phase 3 clinical trial earlier this year and
intends to seek regulatory approval from the U.S. Food and Drug
Administration (FDA) under the accelerated approval pathway
previously granted to the company.
“The formation of this dedicated team enables
Novavax to accelerate all activities required to file a biologics
licensing application (BLA) for NanoFlu in parallel with the
extensive development and manufacturing work underway for
NVX-CoV2373, our COVID-19 vaccine candidate,” said Stanley C. Erck,
President and Chief Executive Officer. “I have full confidence in
Rip and our team, which has brought NanoFlu from inception through
successful Phase 3 testing. I am excited about the potential to
develop a combined influenza/COVID-19 vaccine for use after the
pandemic.”
Mr. Wilson joined Novavax in 2011 and was most
recently responsible for global business development, quality and
program management functions across the company’s entire pipeline.
In his new role, he will lead a team that will work closely with
the broader Novavax team to obtain licensure for NanoFlu from FDA
and other global authorities, as well as evaluate the development
of a pentavalent NanoFlu/NVX-CoV2373 vaccine.
“Currently available flu vaccines provide
inconsistent, inadequate protection against seasonal influenza,”
said Mr. Wilson. “NanoFlu has already completed its pivotal Phase 3
clinical trial, in which it achieved all of its primary endpoints,
so I am excited about the potential to provide this important
vaccine option to the patients who need it most, the
difficult-to-protect older adult population. I am committed to
leading our team to licensure with a strong sense of urgency.”
The new NanoFlu leadership team includes several
Novavax veterans who led the successful development of the vaccine
through completion of its successful pivotal Phase 3 clinical
trial. This team has also recently completed key activities related
to the development of NVX-CoV2373. In addition to Mr. Wilson, the
team will be comprised of the following leaders:
- Tim Hahn, Ph.D., Senior Vice
President of CMC for NanoFlu, has led all CMC activities for
NanoFlu since the beginning of the program. Most recently, Dr. Hahn
led the establishment of a global supply chain for Novavax’
Matrix-M adjuvant. Matrix-M is a key component of both the NanoFlu
and NVX-CoV2373 vaccines.
- Vivek Shinde, M.D., Vice President
of Clinical Development for NanoFlu, has served as the clinical
lead for the NanoFlu program since its inception and through Phase
3. Dr. Shinde also recently led the initiation of the Phase 2b
clinical trial in South Africa for NVX-CoV2373.
The new team will establish a separate NanoFlu
development unit within Novavax, building on the company’s
established knowledge base in the discovery and development of
innovative vaccines to prevent serious infectious diseases. The
team will also benefit from joint shared services with key
cross-functional departments within Novavax.
About NanoFlu™
NanoFlu is a recombinant hemagglutinin (HA)
protein nanoparticle influenza vaccine produced by Novavax in its
SF9 insect cell baculovirus system. NanoFlu uses HA amino acid
protein sequences that are the same as the recommended wild-type
circulating virus HA sequences. NanoFlu contains Novavax’ patented
saponin-based Matrix-M™ adjuvant.
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.
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 UK 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 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 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.
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
Media Brandzone/KOGS CommunicationEdna Kaplankaplan@kogspr.com
617-974-8659
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