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
clinical trial of IVX-A12 against respiratory syncytial virus (RSV)
and human metapneumovirus (hMPV) 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.
“IVX-A12 is a potential first-in-class
combination vaccine candidate designed to address an unmet medical
need in older adults, and we believe these interim data for hMPV in
an older adult population also break new ground in the field. As
has been seen previously with prefusion F antigen approaches for
RSV, we expect that a combination vaccine displaying prefusion F
antigens for both hMPV and RSV, on our VLP technology, may
translate into significant protection against two leading causes of
pneumonia. We plan to expeditiously proceed towards a Phase 2 trial
for IVX-A12 in mid-2023 in older adults as we pursue our goal of
developing a broader viral respiratory vaccine,” said Adam Simpson,
Chief Executive Officer of Icosavax.
IVX-A12 Phase 1 Trial
Design
The ongoing 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 varying
dosage levels and ratios of RSV and hMPV VLPs in IVX-A12, with and
without CSL Seqirus’ proprietary adjuvant MF59®.
The trial enrolled 140 healthy older adults aged
60 to 75 years, of which 123 subjects were evaluable for
immunogenicity. Subjects were administered a single dose of
IVX-A12, at one of three combination dosage levels below, or
placebo:
- 150 µg total VLP
content (75 µg of IVX-121 (RSV) and 75 µg of IVX-241 (hMPV)), with
or without MF59®
- 225 µg total VLP
content (75 µg of IVX-121 and 150 µg of IVX-241), with or without
MF59®
- 300 µg total VLP
content (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 the potential for immunologic interference, with
subjects followed through 12 months after vaccination.
Topline Interim Results
Safety:
In this Phase 1 trial, IVX-A12 was generally
well-tolerated across all dosage groups as of Day 28.
- Solicited local
and systemic adverse events (AEs) were generally mild or moderate,
without dose-limiting reactogenicity.
- Across the five
dosage groups for IVX-A12 with or without adjuvant, the proportion
of subjects experiencing any systemic AE within seven days was
25-41%, and similar to 35% for placebo.
- The most common local and systemic
AEs were injection site tenderness, headache and myalgia.
- There were no vaccine related
serious adverse events (SAEs), clinical events of special interest,
or AEs leading to discontinuation.
Immunogenicity:
In this Phase 1 trial, IVX-A12 induced robust
immune responses against both RSV and hMPV at Day 28 in older
adults across dosage levels and with and without adjuvant.
- There was no
evidence of immune interference between RSV and hMPV VLPs when
administered in combination.
- Across dosage
groups, IVX-A12 induced geometric mean titers (GMTs) in RSV-A
neutralizing antibody titers (nAbs) of up to approximately 16,100
IU/mL compared to approximately 2,600 IU/mL for placebo at Day 28.
IVX-A12 induced GMTs in RSV-B nAbs of up to approximately 8,300
IU/mL compared to approximately 2,500 IU/mL for placebo at Day
28.
- There were
higher Day 28 post-vaccination levels of RSV A and RSV B nAbs
(IU/ml) observed in this IVX-A12 study than seen in the previous
Phase 1 clinical study of IVX-121 (RSV) alone.
- Across dosage
groups, IVX-A12 induced GMTs in hMPV-A nAbs of up to approximately
3,300 assay units/mL compared to approximately 900 assay units/mL
for placebo at Day 28. IVX-A12 induced GMTs in hMPV-B nAbs of up to
approximately 23,900 assay units/mL compared to approximately
11,500 assay units/mL for placebo at Day 28. No standardized
international units exist in the field for hMPV.
- High baseline
nAbs to RSV-A and RSV-B were observed, likely reflecting an
off-cycle RSV season following the COVID-19 pandemic.
- Geometric mean
fold rise (GMFR) at Day 28 was up to 4-fold in RSV-A and 3-fold in
RSV-B across all treatment groups. In a pre-specified sub-analysis
of data from subjects with the lowest tertile baseline nAbs titers,
the corresponding GMFRs for RSV-A and RSV-B were up to 11-fold and
7-fold, respectively.
- GMFR at Day 28
was up to 5-fold in hMPV-A and 4-fold in hMPV-B. In a pre-specified
sub-analysis of data from subjects with the lowest tertile baseline
nABs titers, the corresponding GMFRs for hMPV-A and hMPV-B were up
to 9-fold and 8-fold, respectively.
“The topline interim data from our Phase 1 trial
show that IVX-A12 was generally well tolerated and elicited a
robust response against both RSV and hMPV in older adults, with no
evidence of immune interference. This is an important result as
IVX-A12 is the only vaccine candidate in clinical development
targeting both RSV and hMPV in older adults, a vulnerable
population with a heightened risk of severe disease,” said Niranjan
Kanesa-thasan, M.D., Chief Medical Officer of Icosavax.
Next Steps
Based on these results, Icosavax now plans to
initiate a Phase 2 trial for IVX-A12 in RSV and hMPV in mid-2023.
The company plans to evaluate two formulations of IVX-A12 in this
next clinical trial.
Pending results from the planned Phase 2 trial,
Icosavax intends to conduct an IVX-A12 hMPV human challenge
clinical trial, which Icosavax considers the most relevant
proof-of-concept model for evaluating disease prevention for its
bivalent vaccine candidate incorporating stabilized prefusion F
proteins for each of RSV and hMPV. This hMPV human challenge model
is currently in development and builds on an established precedent
in the RSV field.
The IVX-121 (RSV) component of IVX-A12
(RSV/hMPV) previously demonstrated positive immunogenicity and
tolerability results in a Phase 1/1b study, and a subset of these
Phase 1b older adult subjects continue to be followed. In December
2022, Icosavax reported positive durability data at the six-month
timepoint, with twelve-month immunogenicity data expected in
mid-2023.
Registered Direct Offering
As separately announced, Icosavax has priced a
$67.8 million registered direct offering with select healthcare
investors. The company now expects its cash balance to be
sufficient to fund operations into 2H
2025.
Conference Call and Webcast
Icosavax will host a corresponding conference
call and live webcast at 6:00 p.m. ET / 3:00 p.m. PT on May 22,
2023 to discuss the topline interim Phase 1 results for IVX-A12.
Individuals interested in listening to the live conference call may
do so by using the webcast link in the “Investors” section of the
company’s website at www.icosavax.com. A webcast replay 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 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; the company’s planned
development activities, including clinical trials and data
readouts, and the timing thereof; and the sufficiency of the
company’s current cash, cash equivalents, and investments to fund
operations into 2H 2025. 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; difficulties
in developing an hMPV challenge model and the risk that the planned
challenge study may produce negative or inconclusive results based
on such model or otherwise; 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 recent and expected regulatory approval of 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; the potential for challenges
encountered in the manufacturing and scale up process, including
without limitation challenges that reduce drug product stability or
potency; competing approaches limiting the commercial value of the
company’s vaccine candidates; regulatory developments in the United
States and other countries; the risk that the company may use its
capital resources sooner than it expects; 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.com858.344.8091
Investor Contact:Laurence WattsGilmartin Group,
LLClaurence@gilmartinir.com619.916.7620
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