Invivyd Announces Dosing of First Participant in CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of Symptomatic COVID-19
September 11 2023 - 7:00AM
Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical
company on a mission to protect the vulnerable from serious viral
infectious diseases, today announced that the first participant has
been dosed in the CANOPY Phase 3 pivotal clinical trial of VYD222,
a broadly neutralizing, half-life extended monoclonal antibody, for
the prevention of symptomatic COVID-19. This clinical trial is
designed to rapidly generate the clinical data needed to support a
potential emergency use authorization (EUA) submission for VYD222.
CANOPY is expected to enroll approximately 750 participants in two
cohorts (A and B) including 300 individuals who are significantly
immunocompromised.
“The initiation of the CANOPY pivotal clinical trial marks a
major milestone for Invivyd, and it is a significant step in our
journey to rapidly advance VYD222 toward a potential EUA
submission,” said Dave Hering, Chief Executive Officer of
Invivyd. “Thanks to the hard work and dedication of our teams,
Invivyd is at the forefront of advancing new therapeutics to
address circulating viral threats. With our proprietary database of
potentially eligible individuals and a Day 28 primary efficacy
endpoint in the immunocompromised cohort, we expect CANOPY to
enroll quickly, and we remain on track to have initial primary
endpoint data around year end.”
Commenting on the milestone, Pete Schmidt, M.D., M.Sc., Chief
Medical Officer at Invivyd added, “In recent months we have seen
both the number of COVID-19 cases and disease related
hospitalizations increase at an alarming rate in vulnerable
populations. It is clear COVID-19 is going to remain a major global
health concern for the foreseeable future, and this increase comes
at a time when immunocompromised individuals have limited options
for the prevention of symptomatic COVID-19. It is this urgent
public health need that drives us to advance important new
therapeutics like VYD222 as quickly as possible.”
About CANOPY
The CANOPY pivotal clinical trial is a Phase 3 clinical trial
designed to evaluate protection against symptomatic COVID-19 after
receiving VYD222. The safety, tolerability, pharmacokinetic
profile, and immunogenicity of VYD222 will also be evaluated. The
clinical trial is expected to enroll approximately 750 participants
in two cohorts (A and B) running in parallel across multiple trial
sites in the U.S. Cohort A is expected to enroll approximately
300 participants who are significantly immunocompromised. For this
cohort, the company will use serum neutralizing titers against
relevant SARS-CoV-2 variants at Day 28 as the primary efficacy
endpoint. The primary efficacy analysis will use an immunobridging
approach comparing data obtained in the CANOPY clinical trial to
certain historical data from the company’s previous Phase 2/3
clinical trial of adintrevimab for the prevention of symptomatic
COVID-19, in which serum neutralizing titers correlated with
observed clinical efficacy. All Cohort A participants will receive
VYD222 administered via intravenous (IV) infusion.
Cohort B will enroll approximately 450 participants at risk of
exposure to SARS-CoV-2. The primary endpoint is safety and
tolerability. Cohort B participants will be randomized 2:1 to
receive VYD222 or placebo administered via IV infusion.
Invivyd is evaluating the 4500 mg dose of VYD222 in the CANOPY
trial. The company expects to have initial primary endpoint data by
late 2023 or early Q1 2024.
About VYD222
VYD222 is a broadly neutralizing, half-life extended monoclonal
antibody (mAb) candidate in development for the prevention of
symptomatic COVID-19 in vulnerable populations, such as
immunocompromised people. Globally, there are millions of
immunocompromised people, with an estimated 8-18 million in the
U.S. alone, who may not adequately respond to COVID-19 vaccination,
increasing their risk for severe outcomes from COVID-19. Currently,
there are no monoclonal antibodies authorized or approved in the
U.S. for the prevention of symptomatic COVID-19. VYD222 was
designed for broad activity and has demonstrated in vitro
neutralizing activity against various pre-Omicron and Omicron
variants, such as XBB.1.5 and XBB.1.5.10, an Omicron variant that
has the same mutations in the spike protein as EG.5. VYD222 was
engineered from adintrevimab, Invivyd’s investigational mAb that
has a robust safety data package and demonstrated clinically
meaningful results in global Phase 2/3 clinical trials for both the
prevention and treatment of COVID-19.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company on a
mission to rapidly and perpetually deliver antibody-based therapies
that protect vulnerable people from the devastating consequences of
circulating viral threats, beginning with SARS-CoV-2. Invivyd’s
technology works at the intersection of evolutionary virology,
predictive modeling, and antibody engineering, and is designed to
identify high-quality, long-lasting antibodies with the potential
to resist viral escape. The company is generating a robust pipeline
of product candidates which could be used in prevention or
treatment of serious viral diseases, starting with COVID-19 and
expanding into influenza and other high-need indications. Visit
https://invivyd.com/ to learn more.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “anticipates,” “believes,” “could,” “expects,”
“intends,” “potential,” “projects,” and “future” or similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. Forward-looking statements
include statements concerning, among other things, the company’s
ongoing research and clinical development plans and the timing
thereof, including with respect to VYD222; the company’s
expectation for its CANOPY Phase 3 pivotal clinical trial to
rapidly generate the clinical data needed to support a potential
EUA submission for VYD222; the company’s expectations regarding
enrollment in the CANOPY clinical trial and the timing of
anticipated initial primary endpoint data; the CANOPY clinical
trial design, including the company’s plans to use an
immunobridging approach comparing data obtained in the CANOPY
clinical trial to certain historical adintrevimab data; the
company’s ability to rapidly and perpetually deliver antibody-based
therapies that protect vulnerable people from the devastating
consequences of circulating viral threats, beginning with
SARS-CoV-2; the potential for the company’s product candidates to
be high-quality, long-lasting antibodies with the potential to
resist viral escape; the company’s plans to generate a robust
pipeline of product candidates which, if authorized or approved,
could be used in prevention or treatment of serious viral diseases,
starting with COVID-19 and expanding into influenza and other
high-need indications; and other statements that are not historical
fact. The company may not actually achieve the plans, intentions or
expectations disclosed in the company’s forward-looking statements
and you should not place undue reliance on the company’s
forward-looking statements. These forward-looking statements
involve risks and uncertainties that could cause the company’s
actual results to differ materially from the results described in
or implied by the forward-looking statements, including, without
limitation: the timing and progress of the company’s discovery,
preclinical and clinical development activities; the company’s
ability to rapidly generate the clinical data needed from the
CANOPY clinical trial to support a potential EUA submission for
VYD222; clinical trial site activation or enrollment rates that are
lower than expected; unexpected safety or efficacy data observed
during preclinical studies or clinical trials; the predictability
of clinical success of VYD222 or other product candidates based on
neutralizing activity in preclinical studies; the risk that results
of preclinical studies or clinical trials may not be predictive of
future results in connection with current or future clinical
trials; variability of results in models used to predict activity
against SARS-CoV-2 variants of concern; changes in expected or
existing competition; changes in the regulatory environment; the
uncertainties and timing of the regulatory approval process;
whether VYD222 or any other product candidate is able to
demonstrate and sustain neutralizing activity against predominant
SARS-CoV-2 variants, particularly in the face of viral evolution;
whether the company’s product candidates will be high-quality,
long-lasting antibodies that resist viral escape; whether the
company is able to successfully submit an EUA in the future, and
the outcome of any such EUA submission; whether the company’s
research and development efforts will identify and result in safe
and effective therapeutic options for infectious diseases other
than COVID-19; and whether the company has adequate funding to meet
future operating expenses and capital expenditure requirements.
Other factors that may cause the company’s actual results to differ
materially from those expressed or implied in the forward-looking
statements in this press release are described under the heading
“Risk Factors” in the company’s Annual Report on Form 10-K for the
year ended December 31, 2022 filed with the Securities and Exchange
Commission (SEC), and in the company’s other filings with the SEC,
and in its future reports to be filed with the SEC and available at
www.sec.gov. Forward-looking statements contained in this press
release are made as of this date, and Invivyd undertakes no duty to
update such information whether as a result of new information,
future events or otherwise, except as required under applicable
law.
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Contacts:
Scott Young(781) 208-1747syoung@invivyd.com
Gabriella Linville-Engler(781) 208-0160gengler@invivyd.com
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