Icosavax Announces Results from IVX-411 Drug Product Investigation and Outlines Additional Corporate Milestones
July 28 2022 - 4:05PM
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
announced the results from an end-to-end drug product investigation
of IVX-411, a VLP vaccine candidate displaying the SARS-CoV-2
receptor-binding domain (RBD). This investigation was initiated
following the company’s Phase 1/2 topline interim data results in
which the immunologic response observed for IVX-411 was
inconsistent with expectations based on known data for the
company’s platform and VLP technology.
The investigation involved a review of in vitro
antigen stability and characterization (drug substance
intermediate, drug substance, and drug product), and in vivo
potency, as well as a review of data and protocols relating to the
transport, storage, and administration of the vaccine. Icosavax
tested a range of relevant samples, including a lab-scale VLP
reference that was associated with robust and durable neutralizing
titers in Non-Human Primate studiesi, and the Icosavax clinical VLP
lot (GMP drug product) stored at 2-8 °C to assess its
stability.
Investigation Results:
Results of the investigation confirmed the
company’s initial hypothesis that the reduced potency observed for
IVX-411 was antigen-specific (i.e., related to the Receptor Binding
Domain (RBD) antigen), and data to date indicate that this
antigenic instability is not observed in other Icosavax vaccine
candidates, including for RSV and hMPV.
Specifically:
- The RBD antigen
component (Component A) of IVX-411 becomes unstable during
manufacturing and subsequent storage at 2-8 °C
- An in vivo
assessment in mice demonstrated that instability of the RBD antigen
on the VLP surface translated to a loss of potency for IVX-411
consistent with that seen in the company’s Phase 1/2 results
- No similar
pattern of instability has been seen in data to date with the
company’s IVX-121 (RSV) and IVX-241 (hMPV) antigen components
(Component A), or the fully assembled IVX-121 and IVX-241 VLPs, at
2-8 °C
“The results of our comprehensive IVX-411
investigation confirmed our original hypothesis that the
lower-than-expected immunogenicity for IVX-411 was likely
attributable to an antigen specific stability issue. These
findings, combined with subsequent corroboration from the positive
results of our Phase 1/1b study of IVX-121, reinforce the potential
for potency of well-structured antigens displayed on Icosavax’s two
component VLP platform,” said Adam Simpson, Chief Executive Officer
of Icosavax. “Looking ahead, we plan to incorporate the learnings
from this investigation into our current and future programs as
well as our antigen design capability. In addition, consistent with
the evolution of the field, we intend to focus on a bi-valent
strategy for COVID-19 candidate development, providing us with
optionality to include such a candidate as a potential future
component of our VLP combination vaccines.”
Adam Simpson continued, “Today we have also
announced additions to our near-term milestones, which I believe
highlight the expected continued progress and potential
value-creating opportunities for Icosavax.”
Near-Term Milestone
Expectations:
- IND submission
and initiation of a Phase 1 trial for IVX-A12 (RSV+hMPV) expected
in 2H 2022
- IVX-121 (RSV)
Phase 1b extension, 6-month immunogenicity data expected by early
2023
- IVX-121 (RSV)
Phase 1b extension, 12-month immunogenicity data expected in
mid-2023
- IVX-A12
(RSV+hMPV) Phase 1 topline interim data expected in mid-2023
- IVX-A12
(RSV+hMPV) Phase 2a initiation expected in 2H 2023
- COVID-19
bivalent candidate selection expected in 2023
- Flu program
candidate selection expected in 2023
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) and human metapneumovirus (hMPV),
as well as programs in severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) and 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.
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 interpretation of the results of its drug
product investigation of IVX-411, the company’s expectation
regarding the prophylactic and commercial potential of its vaccine
product candidates and its platform technology, and the company’s
milestone expectations. 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 company’s
approach to the development of vaccine candidates, which is a novel
and unproven approach; 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 potential for challenges encountered
in the manufacturing and scale up process, including without
limitation challenges that reduce drug product stability or
potency; the potential for delays in the development process
including without limitation in candidate development, IND
submission and the conduct of, and receipt of data from, clinical
trials; and other risks described in the company’s 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.com858.344.8091
Investor Contact:Laurence
WattsGilmartin Group, LLClaurence@gilmartinir.com619.916.7620
i Although the sources referenced in this press release are
believed to be reliable, the company makes no guarantees as to the
accuracy or completeness of the sources and does not intend to
incorporate into this press release the material contained in such
sources.
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