Icosavax Initiates Phase 1/1b Trial of VLP Vaccine Candidate Against Respiratory Syncytial Virus
September 09 2021 - 8:00AM
Icosavax, Inc. (NASDAQ: ICVX), a biopharmaceutical company
leveraging its innovative virus-like particle (VLP) platform
technology to develop vaccines against infectious diseases, today
announced the initiation of a Phase 1/1b clinical trial of IVX-121,
a VLP displaying a Respiratory Syncytial Virus (RSV) stabilized
pre-fusion F antigen, in healthy adults and older adults. Assuming
favorable results from the IVX-121 Phase 1/1b clinical trial and
favorable preclinical data from its
human Metapneumovirus (hMPV) VLP candidate, Icosavax
plans to thereafter initiate a Phase 1 clinical trial of its
IVX-A12 bivalent RSV/hMPV vaccine candidate.
“I am delighted with the clinical progress
Icosavax has recently made. The initiation of our second clinical
trial in just three months bears testament to the concerted effort
our team exerted in the development and manufacturing of our
vaccine candidates,” said Adam Simpson, Chief Executive Officer of
Icosavax. “As part of our core strategy, we plan to transition
IVX-121, our RSV monovalent VLP candidate, into a combination
vaccine with RSV and hMPV, IVX-A12. With the vision of creating
combination VLP vaccines, we believe that developing a bivalent
vaccine targeting two of the leading viral causes of pneumonia in
older adults could represent a compelling offering for both
providers and patients. Currently, neither RSV nor hMPV have
approved vaccines; IVX-A12 has the potential to prevent disease
caused by both viruses in a single shot.”
The Phase 1/1b clinical trial of IVX-121 is a
randomized, observer-blind, placebo-controlled multi-center study
designed to evaluate the safety and immunogenicity of three dose
levels of non-adjuvanted and aluminum-adjuvanted IVX-121 in healthy
adults, including older adults. The trial will inform the dose of
IVX-121 to be evaluated in combination with the Icosavax hMPV VLP
candidate IVX-241 for the anticipated Phase 1 clinical trial of the
RSV/hMPV bivalent vaccine candidate IVX-A12.
The Phase 1 part of the trial is expected to
enroll up to 90 healthy adults in Belgium. The Phase 1b part of the
trial is expected to enroll up to 217 healthy older adults. It is
anticipated that a subset of the older adult subjects will be
followed for 12 months after vaccination to assess durability of
immune response to IVX-121.
Following the completion of the Phase 1/1b clinical trial of
IVX-121, Icosavax intends to shift its development of the VLP
vaccine candidate for RSV to an RSV/hMPV bivalent combination
vaccine strategy. The company plans to submit an investigational
new drug application (IND) to the U.S. Food and Drug Administration
(FDA) in the first half of 2022 and, thereafter, initiate a Phase 1
clinical trial of IVX-A12.
About Virus-Like Particles (VLP)
VaccinesVLPs enable multivalent display of antigens in a
manner that closely resembles viruses but contain no genetic
material. Approved vaccines that are derived from naturally
occurring VLPs have shown efficacy when formulated as combination
vaccines and have shown the ability to induce high and sustained
levels (titers) of neutralizing antibodies (nAbs) in adults, which
have generally been associated with protective immunity. However,
VLPs engineered to display complex viral antigens have in general
been difficult to develop or successfully manufacture at scale,
limiting the pathogens that can be addressed by this approach.
Icosavax’s VLP vaccine technology is designed to enable robust,
durable and broad immune responses against a broader array of
pathogens than has been possible with naturally occurring VLPs and
to overcome the manufacturing challenges experienced with other VLP
technologies.
About IVX-121, RSV VLP Vaccine
CandidateIVX-121 targets respiratory syncytial virus
(RSV), a major cause of viral pneumonia for which no vaccine has
been FDA approved. IVX-121 incorporates a stabilized pre-fusion F
antigen licensed from NIAID/NIH that has been previously studied in
healthy adults (DS-Cav1; Lancet 2021). RSV F is known to
undergo major structural changes that allow viral entry into the
host cell, and during that process, critical protective epitopes
are lost. Protein design methods have stabilized pre-fusion F,
leading to improved neutralizing responses in humans.
About IcosavaxIcosavax 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. 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), human
metapneumovirus (hMPV), and severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2). 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 exclusively licensed the VLP technology for use in several
fields, including RSV and hMPV, from the University of Washington.
For SARS-CoV-2, Icosavax has a non-exclusive, worldwide (excluding
South Korea) license from the University of Washington that will
convert to an exclusive license in North America and Europe in
2025. Icosavax is located in Seattle.
Forward Looking
StatementsStatements contained in this press release
regarding matters that are not historical facts are forward-looking
statements. The forward-looking statements are based on our current
beliefs and expectations and include, but are not limited to: our
expectations regarding the potential therapeutic benefits of our
product candidates, including IVX-121 and IVX-A12, the expected
timing to file an IND and initiate a clinical trial of IVX-A12 and
the potential advantages of our VLP technology. Actual results may
differ from those set forth in this press release due to the risks
and uncertainties inherent in our business, including, without
limitation: the early stage of our development efforts; our VLP
technology and our plan to pursue a combination bivalent RSV/hMPV
VLP vaccine candidate, both of which are novel and unproven;
potential delays in the commencement, enrollment, and completion of
clinical trials and preclinical studies; our dependence on third
parties in connection with manufacturing, research, and preclinical
and clinical testing; unexpected adverse side effects or inadequate
efficacy of our product 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 and other risks described in our
prior filings with the Securities and Exchange Commission (SEC),
including under the heading “Risk Factors” in our Registration
Statement on Form S-1 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 we
undertake 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.com+1.858.344.8091
Investor Contact: Laurence
WattsGilmartin Group,
LLClaurence@gilmartinir.com+1.619.916.7620
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