Icosavax Announces Topline Interim Phase 1/2 Results for IVX-411 Against SARS-CoV-2
March 25 2022 - 7:00AM
Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical company
leveraging its innovative virus-like particle (VLP) platform
technology to develop vaccines against infectious diseases, today
announced topline interim results from its ongoing Phase 1/2
clinical trial of IVX-411, a VLP vaccine candidate displaying the
SARS-CoV-2 receptor-binding domain (RBD).
“While IVX-411 was immunogenic and
well-tolerated in these initial topline data, the level of response
was below our expectations given what we know about VLPs, including
from clinical studies in COVID-19 and from our own preclinical
data,” said Niranjan Kanesa-thasan, M.D., Chief Medical Officer of
Icosavax.
“Icosavax remains committed to its novel VLP
platform and vision for combination and pan-respiratory vaccines,”
said Adam Simpson, Chief Executive Officer of Icosavax. “We plan to
investigate the potential causes of these discordant clinical
results, including manufacture, shipment, and administration of the
product. As COVID-19 becomes endemic, it continues to be a
strategic priority for Icosavax. With regard to our lead program in
RSV, we look forward to sharing topline, interim data for IVX-121
in 2Q 2022, with the Phase 1 initiation of our first combination
vaccine candidate, IVX-A12 against RSV and human metapneumovirus
(hMPV), anticipated in 2H 2022.”
The ongoing Phase 1/2 clinical trial
(IVX-411-01) is a randomized, observer-blinded, placebo-controlled
study to evaluate the safety and immunogenicity of IVX-411 in
SARS-CoV-2 naïve (N=84) and previously vaccinated (N=84) adults 18
to 69 years of age. Naïve subjects received two doses, given 28
days apart, of IVX-411 at 5, 25 or 125 ug dosage levels or placebo,
with or without adjuvant. Previously vaccinated subjects were
boosted with a single dose of IVX-411 at 5, 25 or 125 ug or
placebo, with or without adjuvant, at 3-6 months following
completion of primary licensed vaccine regimen (mRNA or
adenoviral). A supplemental analysis was also conducted to assess
whether sera from subjects immunized with IVX-411 neutralize the
SARS-CoV-2 Omicron variant.
Safety
In this topline interim data, IVX-411 was
generally safe and well-tolerated. Solicited local and systemic
adverse events (AEs) were all mild or moderate, without
dose-limiting reactogenicity. The most common local and systemic
AEs were injection site tenderness, and headache and fatigue,
respectively. There were no serious AEs deemed to be related to
vaccine, AE of special interest, or AEs leading to
discontinuation.
- In the naïve
setting, across the six dosage groups for IVX-411 with or without
adjuvant, the proportion of subjects experiencing any systemic AE
within seven days of any dose was 33-67%, versus 50% for
placebo.
- In the booster
setting, across the six dosage groups, 17-42% of subjects
experienced any systemic AE within seven days of the booster dose,
versus 25% for placebo.
Immunogenicity
In the naïve setting, a clear adjuvant effect on
immunogenicity and a dose response were observed with IVX-411;
however, the level of immune response in this initial data was
comparable to or below the Human Convalescent Sera (HCS)
control.
- At day 49 (or
three weeks following the second dose), responses were up to 154
IU/mL across dosage groups in the live virus neutralization assay
(HCS: 281 IU/mL), and up to 592 BAU/mL across groups in the spike
IgG assay (HCS: 361 BAU/mL).
In previously vaccinated subjects, these initial
data showed that IVX-411 boosted immunity following primary
vaccination with an mRNA or adenovirus vaccine, and adjuvanted and
unadjuvanted groups were generally similar.
- Pre- versus
post-boost fold increases of up to 5x (599 IU/mL) for wild type
virus were observed at day 28 post boost.
- For the Omicron
variant, neutralizing antibody titers were up to 8-fold lower than
observed for wild type virus in the same assay.
Icosavax anticipates providing an update on its
end-to-end investigation after its completion.
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
possible safety and immunogenicity of IVX-411; the IVX-411-01,
IVX-121 and IVX-A12 clinical trials (including projected timing of
clinical trial milestones); IVX 411 development plans and the
potential of the company’s VLP technology. 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 company’s dependence
on third parties in connection with the manufacture and shipment of
clinical supplies, and research and preclinical and clinical
testing, including with respect to formulation, administration and
other activities; 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 a clinical trial; the
potential for the end-to-end drug product investigation to produce
inconclusive results; the potential that, even if the investigation
identifies a root cause or contributing factors for the discordant
immunogenicity data, the company may be unable to resolve all
ambiguity; the potential that any errors or other unknown factors
that may have affected the interim immunogenicity data in the
IVX-411-01 clinical trial may have impacted the safety data as
well; the potential for the investigation into IVX-411 interim
results to impact the results of the company’s ongoing trial for
IVX-121; the possibility of unexpected adverse side effects or
inadequate immunogenicity or efficacy of IVX-411 that may limit its
development, regulatory approval, and/or commercialization as a
monovalent vaccine or in a combination or pan-respiratory vaccine;
the possibility of disappointing results in later clinical trials
despite promising results in earlier preclinical research or
clinical trials; potential delays or difficulties in the
commencement, enrollment, and completion of clinical trials;
competing approaches limiting the commercial value of the company’s
vaccine candidate and VLP vaccine technology; regulatory
developments in the United States and other countries; potential
disruption to our 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 September 30, 2021 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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