Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical company
leveraging its innovative virus-like particle (VLP) platform
technology to develop vaccines against infectious diseases, with an
initial focus on life-threatening respiratory diseases and a vision
of creating pan-respiratory vaccines for older adults, today
announced the initiation of a Phase 1 clinical trial of IVX-A12, a
combination bivalent RSV and hMPV VLP vaccine candidate, in older
adults.
IVX-A12 is comprised of IVX-121, Icosavax’s RSV
prefusion F protein VLP vaccine candidate, and IVX-241, Icosavax’s
hMPV prefusion F protein VLP vaccine candidate. The company
previously announced positive topline interim Phase 1/1b results
for IVX-121 in June 2022.
With this trial initiation, IVX-A12 becomes the
first combination bivalent vaccine candidate against both
respiratory syncytial virus (RSV) and human metapneumovirus (hMPV)
to enter the clinic, and the first candidate from Icosavax’s novel
VLP platform to receive IND authorization in the U.S.
“The initiation of a Phase 1 trial for IVX-A12
is an important step towards our vision for creating
pan-respiratory vaccines, and I am pleased with the execution by
our team. Not only is IVX-A12 Icosavax’s first combination bivalent
VLP vaccine candidate, it is also the most advanced vaccine
candidate against both RSV and hMPV in older adults, and the only
clinical stage VLP in this space,” said Adam Simpson, Chief
Executive Officer of Icosavax. “The inclusion of a proprietary
prefusion hMPV-F component in a combination RSV/hMPV vaccine
candidate is differentiating from the current RSV candidates in
Phase 3 development, and is intended to address two leading causes
of pneumonia in one shot.”
Simpson continued, “In older adults, RSV is
estimated to cause approximately 177,000 hospitalizations and
14,000 deaths each year in the U.S. alonei, and data support
similar morbidity and mortality for hMPV. As such, we look forward
to sharing topline results from this first trial of a combined RSV
and hMPV vaccine candidate in mid-2023, and thereafter plan to
initiate a Phase 2 trial of IVX-A12 in 2H 2023.”
IVX-A12 Phase 1 Trial
Design
The Phase 1 clinical trial of IVX-A12 is a
randomized, observer-blinded, placebo-controlled, multi-center
study designed to evaluate the safety and immunogenicity of
multiple dosage levels of IVX-A12, with and without CSL Seqirus’
proprietary adjuvant MF59®.
The company anticipates enrolling up to 120
healthy older adults aged 60 to 75 years. Subjects will be
administered a single shot of IVX-A12, at one of three combination
dosage levels below, or placebo:
- 75 µg of IVX-121
and 75 µg of IVX-241, with or without MF59®
- 75 µg of IVX-121
and 150 µg of IVX-241, with or without MF59®
- 75 µg of IVX-121
and 225 µg of IVX-241, without MF59®
The objective of the Phase 1 study of IVX-A12 is
to evaluate safety, and immunogenicity against both RSV and hMPV,
as well as to assess immunologic non-interference. Icosavax
anticipates announcing topline interim results from this Phase 1
trial in mid-2023, with subjects thereafter followed through 12
months after vaccination. Contingent upon a positive outcome from
this trial, the company then expects to initiate a Phase 2 trial
for IVX-A12 in 2H 2023.
The IVX-121 (RSV) component of IVX-A12
(RSV/hMPV) demonstrated robust immunogenicity and favorable
tolerability in a prior Phase 1/1b study, and a subset of these
Phase 1b older adult subjects continue to be followed, with
six-month immunogenicity data expected by early-2023 and 12-month
immunogenicity data in mid-2023.
About Icosavax
Icosavax is a biopharmaceutical company
leveraging its innovative VLP platform technology to develop
vaccines against infectious diseases, with an initial focus on
life-threatening respiratory diseases and a vision for combination
and pan-respiratory vaccines. Icosavax’s VLP platform technology is
designed to enable multivalent, particle-based display of complex
viral antigens, which it believes will induce broad, robust, and
durable protection against the specific viruses targeted.
Icosavax’s pipeline includes vaccine candidates targeting
respiratory syncytial virus (RSV) and human metapneumovirus (hMPV),
as well as programs in severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) and influenza. Icosavax was formed in
2017 to advance the breakthrough VLP technology from the Institute
for Protein Design at the University of Washington with the goal to
discover, develop, and commercialize vaccines against infectious
diseases. Icosavax is located in Seattle.
For more information,
visit www.icosavax.com.
Forward-Looking Statements
Statements contained in this press release
regarding matters that are not historical facts are forward-looking
statements. The forward-looking statements are based on the
company’s current beliefs and expectations and include, but are not
limited to: the company’s expectation regarding the opportunities
for, and the prophylactic and commercial potential of, its vaccine
candidates and technology platform and the company’s ability to
advance its IVX-A12 development program and achieve the noted
development milestones in 2023. Actual results may differ from
those set forth in this press release due to the risks and
uncertainties inherent in the company’s business, including,
without limitation: the early stage of the company’s development
efforts; the company’s approach to the development of vaccine
candidates, including its combination bivalent RSV/hMPV VLP vaccine
candidate, which is a novel and unproven approach; potential delays
in the development process including without limitation in the
enrollment, conduct of, and receipt of data from, clinical trials;
potential unexpected adverse side effects or inadequate
immunogenicity or efficacy of the company’s vaccine candidates that
may limit their development, regulatory approval, and/or
commercialization; results from preclinical studies or early
clinical trials not necessarily being predictive of future results;
the company’s dependence on third parties in connection with
manufacturing, research, and clinical testing; the potential for
challenges encountered in the manufacturing and scale up process;
competing approaches limiting the commercial value of the company’s
vaccine candidates; and other risks described in the company’s
prior filings with the Securities and Exchange Commission (SEC),
including under the heading “Risk Factors” in the company’s
quarterly report on Form 10-Q for the quarter ended June 30, 2022
and any subsequent filings with the SEC. You are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof, and the company undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement, which is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
Media Contact: Jessica
Yingling, Ph.D., Little Dog Communications Inc.
jessica@litldog.com858.344.8091
Investor Contact:Laurence
WattsGilmartin Group,
LLClaurence@gilmartinir.com 619.916.7620
___________________________________i Havers F, June 2022 ACIP
presentation: Epidemiology and Burden of Respiratory Syncytial
Virus in Older Adults in the U.S. (
https://www.cdc.gov/vaccines/acip/meetings/slides-2022-06-22-23.html)
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