Icosavax Announces Positive Topline Interim Phase 1/1b Results for VLP Vaccine Candidate IVX-121 Against RSV
29 June 2022 - 6:05AM
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 1/1b
clinical trial of IVX-121, a VLP displaying a prefusion stabilized
Respiratory Syncytial Virus (RSV) F antigen, in young and older
adults.
“I’m delighted to share these topline, interim
data from our Phase 1/1b trial in RSV, in which IVX-121
demonstrated a robust immunologic response in both young and older
adult groups. Importantly, we believe these Phase 1/1b data provide
initial validation of our underlying VLP technology. They also
reaffirm our strategy to combine multiple pathogen targets in one
vaccine,” said Adam Simpson, Chief Executive Officer of Icosavax.
“As planned, Icosavax will now progress development of IVX-121
combined with a human metapneumovirus (hMPV) VLP, as our IVX-A12
bivalent vaccine candidate. We believe IVX-A12 could be unique in
providing protection against these two leading causes of pneumonia,
each of which currently lack an approved vaccine.”
IVX-121 Phase 1/1b Trial
Design
The Phase 1/1b clinical trial of IVX-121 is a
randomized, observer-blinded, placebo-controlled, multi-center
study designed to evaluate the safety and immunogenicity of three
dose levels of IVX-121, with and without aluminum hydroxide
adjuvant, in healthy young and older adults.
The Phase 1 part of the trial enrolled 90
healthy young adults aged 18-45 years. The Phase 1b part of the
trial enrolled 130 healthy older adults aged 60-75 years. Subjects
were administered a single dose of IVX-121 at one of three dose
levels (25, 75, 250 µg), with or without aluminum hydroxide
adjuvant, or placebo.
The primary outcomes of the study were safety
and immunogenicity up to 28 days post-vaccination; neutralizing
antibodies to RSV-A and RSV-B were measured in international units
(IU/mL) using the WHO international reference standard. The trial
was intended to inform the dose of IVX-121 to be evaluated in
combination with Icosavax’s hMPV VLP in an upcoming Phase 1
clinical trial of the company’s RSV/hMPV bivalent vaccine candidate
IVX-A12.
Topline Results
Safety:
In this Phase 1/1b study, IVX-121 was generally
well-tolerated across all dosage groups.
- Solicited local
and systemic adverse events (AEs) were generally mild or moderate,
without dose-limiting reactogenicity.
- In the older
adult target population, across the six dosage groups for IVX-121
with or without adjuvant, the proportion of subjects experiencing
any systemic AE within seven days was 11-33%, and similar to 21%
for placebo.
- The most common
local and systemic AEs were injection site tenderness, headache and
fatigue.
- There were no
serious AEs related to vaccine, AEs of special interest, or AEs
leading to discontinuation.
Immunogenicity:
In this Phase 1/1b study, IVX-121 induced a
robust immune response in both young and older adult groups.
- The data indicated a
dose-independent response, including at the lowest non-adjuvanted
dose (25 µg).
- No additional
benefit from the aluminum hydroxide adjuvant was observed at any
dosage level in either portion of the study.
- Geometric mean titers for RSV-A and
RSV-B were in comparable ranges for both groups.
Young Adults (Phase 1):
- In young adults,
across dosage groups, IVX-121 induced Geometric Mean Titers (GMTs)
in RSV-A neutralizing antibodies (nAbs) of up to 7,687 IU/mL
compared to 1,100 IU/mL for placebo at Day 28.
- These titers
corresponded to a Geometric Mean Fold Rise (GMFR) versus baseline
up to 10-fold for IVX-121 at Day 28.
Older Adults (Phase 1b):
- GMT responses in
IU/mL for older adults were comparable with those for young adults.
- Across dosage
groups, IVX-121 induced GMTs in RSV-A nAbs of up to 7,561 IU/mL
compared to 1,692 IU/mL for placebo at Day 28.
- GMFR at Day 28
was up to 6-fold, reflecting higher baseline titers in the older
adults group.
“These topline interim data from our Phase 1/1b
trial indicate that IVX-121 was generally well tolerated and
elicited a strong and consistent response against RSV in healthy
young and older adults. These data are particularly encouraging for
the vulnerable older adult population with co-morbidities and
increased risk for severe disease and hospitalization,” said
Niranjan Kanesa-thasan, M.D., Chief Medical Officer of Icosavax.
“The immunogenicity of IVX-121, even at very low microgram dosage
levels, and its favorable tolerability to the highest dose level,
makes it well suited to a combination vaccine approach.”
Icosavax plans to submit an IND for IVX-A12 to
the U.S. Food and Drug Administration (FDA) and thereafter initiate
a Phase 1 clinical trial in 2H 2022. This study will examine safety
and immunogenicity of bivalent (RSV/hMPV) formulations,
incorporating a single RSV dosage level and multiple hMPV dosage
levels.
Interim data from the Phase 1/1b IVX-121 trial
will also support a Phase 1b extension study, in which eligible
older adults from the Phase 1b cohort will be followed out to 12
months to assess durability of response.
Conference Call and Webcast
Icosavax will host a conference call and a live
webcast at 4:30 p.m. ET / 1:30 p.m. PT on June 28, 2022 to discuss
the topline interim Phase 1/1b results for IVX-121. Individuals
interested in listening to the conference call may do so by dialing
(844) 467-8978 for domestic callers, or (929) 517-0913 for
international callers and reference conference ID: 6829745; or from
the webcast link in the investor relations section of the company's
website at www.icosavax.com. The webcast will be available in the
investor relations section on the company's website for 30 days
following the completion of the call.
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), human metapneumovirus (hMPV) and
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and
an emerging program in 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.
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 potential for the company’s VLP platform to result
in safe and effective vaccines against infectious diseases; the
potential for IVX-A12 to serve as a safe and effective combination
vaccine and provide protection against RSV and hMPV; and the
company’s specific plans and anticipated timing to file an IND
submission and initiate a Phase 1 trial for IVX-A12. Actual results
or developments 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 fact that
topline results are based on preliminary analysis of key safety and
immunogenicity data, and such data may change following a more
comprehensive review of the data related to the clinical trial and
such topline data may not accurately reflect the complete results
of the clinical trial; the risk that interim results of a clinical
trial do not predict final results and that one or more of the
outcomes may materially change as follow-up on the outcome of any
particular subject continues, as more subject data become available
and following more comprehensive reviews of the data; the
possibility of unexpected adverse side effects or inadequate
immunogenicity or efficacy of IVX-121 or IVX-A12 that may limit
development, regulatory approval, and/or commercialization; the
possibility of disappointing results in later clinical trials
despite promising results in earlier preclinical research or
clinical trials; the possibility that cross study comparisons may
not prove accurate as clinical data accrue or due to the inherent
limitations of cross study comparisons; potential delays or
difficulties in submission of an IND and the commencement,
enrollment, and completion of the Phase 1b extension study for
IVX-121, the planned Phase 1 trial for IVX-A12 and other clinical
trials; the company’s approach to the discovery and development of
vaccine candidates, which is novel and unproven; competing
approaches limiting the commercial value of the company’s vaccine
candidates and VLP vaccine technology; regulatory developments in
the United States and other countries; potential disruption to the
company’s operations and continued conduct of clinical trials from
the COVID-19 pandemic or the conflict in Ukraine; 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, 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.com+1.858.344.8091
Investor Contact: Laurence
WattsGilmartin Group,
LLClaurence@gilmartinir.com+1.619.916.7620
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