Icosavax Announces Positive Topline Interim Phase 2 Results for Combination VLP Vaccine Candidate IVX-A12 Against RSV and hMPV in Older Adults
12 Dezembro 2023 - 4:00AM
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 positive topline interim results from its Phase 2
clinical trial of IVX-A12 against respiratory syncytial virus (RSV)
and human metapneumovirus (hMPV) in older adults.
“We’re delighted to announce positive topline
interim data from our Phase 2 trial of IVX-A12, our potential
first-in-class combination vaccine candidate against RSV and hMPV,”
said Adam Simpson, Chief Executive Officer of Icosavax. “We believe
that IVX-A12 has the potential to address a significant unmet need
and, as the furthest advanced RSV and hMPV combination vaccine in
the clinic, to build on an emerging, large market
opportunity.”
IVX-A12 Phase 2 Trial
Design
The ongoing Phase 2 clinical trial of IVX-A12 is
a randomized, observer-blinded, placebo-controlled, multi-center
trial designed to evaluate the safety and immunogenicity of a
single dose of RSV and hMPV combination VLP vaccine IVX-A12, with
and without CSL Seqirus’ proprietary adjuvant MF59® (MF59).
The trial enrolled 264 healthy older adults aged 60 to 85 years,
of which 241 subjects were evaluable for immunogenicity. Subjects
were administered a single dose of either IVX-A12 at the 300 µg
combination dosage level (150 µg of RSV VLP (IVX-121) and 150 µg of
hMPV VLP (IVX-241)), with or without MF59, or placebo.
Topline Interim Results
Topline interim safety and immunogenicity data
from this trial were generally consistent with the previously
reported Phase 1 data for IVX-A12.
Safety:
IVX-A12 was generally well-tolerated across both
dosage groups.
- Solicited local
and systemic adverse events (AEs) collected within seven days of
vaccination were generally mild to moderate without severe events.
No cases of fever were reported in any group.
- For unadjuvanted
IVX-A12, the proportion of subjects experiencing any systemic AE
within seven days was 32%, and similar to placebo (36%).
- The most common
local and systemic AEs were injection site tenderness, injection
site pain, and myalgia.
- There were no
vaccine related serious adverse events (SAEs), clinical events or
AEs of special interest (AESIs), or AEs leading to
discontinuation.
Immunogenicity:
IVX-A12 induced robust immune responses against
both RSV and hMPV at Day 28 across both formulations with and
without adjuvant. For unadjuvanted IVX-A12:
- IVX-A12 induced
geometric mean titers (GMTs) in RSV-A neutralizing antibody titers
(nAbs) of approximately 12,200 IU/mL compared to approximately
2,000 IU/mL for placebo at Day 28. IVX-A12 induced GMTs in RSV-B
nAbs of approximately 5,500 IU/mL compared to approximately 1,300
IU/mL for placebo at Day 28.
- IVX-A12 induced
GMTs in hMPV-A nAbs of approximately 1,600 assay units/mL compared
to approximately 400 assay units/mL for placebo at Day 28. IVX-A12
induced GMTs in hMPV-B nAbs of approximately 15,300 assay units/mL
compared to approximately 6,700 assay units/mL for placebo at Day
28. No standardized international units exist in the field for
hMPV.
“The positive Phase 2 data announced today for
IVX-A12 are very encouraging and mark another milestone in the
field for RSV and hMPV vaccination in older adults, a vulnerable
population with heightened risk of severe disease,” said Niranjan
Kanesa-thasan, M.D., Chief Medical Officer of Icosavax.
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 incorporates
antigen design capabilities and technology 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 lead program is a combination
vaccine candidate targeting respiratory syncytial virus (RSV) and
human metapneumovirus (hMPV). Its pipeline includes additional
candidates that provide optionality as potential components of
future combination and pan-respiratory vaccines, including
influenza and 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 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 potential for IVX-A12 to
be a first-in-class combination vaccine candidate against RSV and
hMPV. 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 risk that results of a
clinical trial at a particular time point may not predict final
results and that an outcome may materially change as follow-up of
subjects continues and following more comprehensive reviews of the
data; the company’s approach to the development of vaccine
candidates, including its development of a 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 commencement, enrollment, conduct of, and
receipt of data from, clinical trials; 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; the company’s dependence on
third parties in connection with manufacturing, research, and
clinical testing; the risk that third party marketed RSV vaccines
may make conducting clinical trials more difficult and costly and
otherwise adversely affect the ability to successfully develop,
obtain regulatory approval of and commercialize its vaccine
candidates; the potential for challenges encountered in the
manufacturing and scale up process; competing approaches and
approved vaccines limiting the commercial value of the company’s
vaccine candidates; regulatory developments in the United States
and other countries; the company’s ability to fund its operating
plans with its current cash, cash equivalents and investments; 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 September 30, 2023 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.com619.916.7620
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