Icosavax Reports Positive 12-Month Durability Data for VLP Vaccine Candidate IVX-121 Against RSV and Initial Evidence for Revaccination Potential
08 Agosto 2023 - 5:05PM
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
provided a 12-month immunogenicity update from its Phase 1b
extension trial of IVX-121 against Respiratory Syncytial Virus
(RSV) in older adults. These data demonstrate substantial
durability of neutralizing antibody (NAb) response against RSV at
twelve months after a single administration of IVX-121. The company
also reported initial evidence for revaccination potential with its
VLP-based vaccines, including robust immune responses against RSV-A
in Phase 1b extension trial participants who received 75 µg
unadjuvanted IVX-121 at one year after their first dose.
“We continue to believe that there is a need for
long-lasting, well-tolerated vaccines, particularly in
combinations. These 12-month immunogenicity data from our Phase 1b
extension trial of IVX-121 provide additional clinical evidence of
a potentially differentiated durability profile for our VLP-based
technology, as well as initial data supporting the potential for
revaccination to boost immune responses in the second year,” said
Adam Simpson, Chief Executive Officer of Icosavax.
IVX-121 (RSV) Phase 1b extension
12-month immunogenicity update
Icosavax has previously reported day 28 and day
180 data from the IVX-121 Ph 1/1b trial, which followed young and
older adult subjects through six months after administration of
either IVX-121 or placebo. Older adult subjects had the opportunity
to participate in a Phase 1b extension trial that allowed continued
evaluation through 12 months following their initial dose of
vaccine.
IVX-121 continued to be generally well-tolerated
with no safety concerns observed in this 12-month follow up. No
vaccine related serious adverse events (SAEs) were observed.
Data described below refer to RSV neutralizing
antibody (NAb) responses to a single administration of IVX-121 at
the 75 and 250 µg unadjuvanted dosage levels or placebo in older
adults at the designated timepoints. Geometric mean neutralizing
antibody titers (GMTs) were measured in international units (IU/mL)
using the WHO international reference standard.
GMTs for RSV-A at day 365 were maintained within
a range of ~45-50% relative to the GMTs at day 28 for the same
group of subjects. RSV-B titers were also durable, persisting at
~65-70% of the GMTs at day 28 for the same dosage groups.
IVX-121 (RSV) Phase 1b extension trial
revaccination data
The Phase 1b extension trial also evaluated immune responses one
month after revaccination, in older adult participants who received
IVX-121 (75 µg without adjuvant) approximately 12 months after
their initial dose of vaccine or placebo in the Phase 1b trial.
Revaccination with IVX-121 was generally well tolerated.
At one month after revaccination (month 13 overall), IVX-121
induced robust RSV-A immune responses with GMTs for RSV-A NAbs
increased to a range of ~70-115% of the GMTs observed one month
after the initial dose for the same subset of participants. RSV-B
titers did not increase following revaccination but remained at
~40-60% of the GMTs observed 28 days after the initial dose.
"Recent data and the initial ACIP recommendation for RSV
vaccines highlight potential opportunities for improvements in
durability and revaccination,” said Niranjan Kanesa-thasan, M.D.,
Chief Medical Officer of Icosavax. “I am pleased with these data
for IVX-121 and their support of potential differentiation of our
VLP technology."
Update on IVX-A12 (RSV/hMPV) Phase 2 topline interim
data milestone timing
IVX-121 is a component of Icosavax's lead vaccine candidate
IVX-A12, a potential first-in-class bivalent combination in Phase 2
for RSV and hMPV in older adults.
Icosavax is pleased to report that dosing has been completed in
its Phase 2 trial of IVX-A12, and the company now expects to
announce topline interim data by the end of 2023 versus the prior
guidance of 1Q 2024.
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 lead program is a combination vaccine candidate
targeting respiratory syncytial virus (RSV) and human
metapneumovirus (hMPV), and its pipeline includes additional
programs in influenza 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 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, including the potential for IVX-A12 to be
a first-in-class vaccine; and the company’s planned development
activities, including clinical trials and data readouts, and the
timing thereof. 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 possibility of disappointing results in
later clinical trials despite promising results in earlier
preclinical research or clinical trials; potential unexpected
adverse side effects or inadequate immunogenicity or efficacy of
IVX-121 or IVX-A12 that may limit their development, regulatory
approval, and/or commercialization; the company’s approach to the
development of vaccine candidates, including its IVX-A12
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; the company’s dependence
on third parties in connection with manufacturing, research, and
clinical testing; the risk that approved third party RSV vaccines
may make conducting clinical trials more difficult and costly and
otherwise adversely affect the company’s ability to successfully
develop, obtain regulatory approval of and commercialize its
vaccine candidates; approved vaccines and competing approaches
limiting the commercial value of the company’s vaccine candidates;
regulatory developments in the United States and other countries;
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 March 31, 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.
Icosavax’s Contacts
Media Contact:
Jessica Yingling, Ph.D.,
Little Dog Communications Inc.
jessica@litldog.com
858.344.8091
Investor Contact:
Laurence Watts
Gilmartin Group, LLC
laurence@gilmartinir.com
619.916.7620
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