Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical
company on a mission to protect the vulnerable from serious viral
infectious diseases, today announced positive initial data from its
ongoing Phase 1 healthy volunteer clinical trial of its lead
investigational monoclonal antibody (mAb) candidate, VYD222. VYD222
is a broadly neutralizing, half-life extended mAb candidate in
development for the prevention of symptomatic COVID-19 in
vulnerable populations, such as immunocompromised people.
Initial Phase 1 data show that a single administration of VYD222
was generally well-tolerated at all three dose levels tested with
no serious adverse events (SAEs) reported to date. At the lowest
VYD222 dose tested (1500 mg), geometric mean serum neutralizing
titers were 3245.1 (95% CI: 1882.5, 5594.0) against Omicron XBB.1.5
at Day 7, with a geometric mean 38.87-fold rise (95% CI: 10.3,
146.8) from baseline to Day 7 (n=8). Omicron XBB.1.5 and other
related XBB sublineages are currently the dominant SARS-CoV-2
variants circulating globally. VYD222 was designed for broad
activity and has previously demonstrated in vitro neutralizing
activity against prior circulating SARS-CoV-2 variants and current
variants of concern, including Omicron sublineages up to and
through XBB.1.5. Higher VYD222 dose levels tested in the Phase 1
clinical trial are designed to provide greater protection from any
potential loss of neutralization activity as SARS-CoV-2 evolves
over time.
Analysis of the serum neutralizing activity from samples
collected at different timepoints across all dose cohorts is
ongoing, as is detailed pharmacokinetic analysis and modeling.
Invivyd intends to use these analyses, combined with published
clinical outcome data from prior clinical trials of vaccines and
mAbs for the prevention of symptomatic COVID-19, including data
from its Phase 2/3 clinical trial of adintrevimab for the
prevention of COVID-19 (EVADE), to inform VYD222 dose selection for
its pivotal clinical trial.
“We are very encouraged by our initial Phase 1 clinical trial
data, including the strong serum neutralizing titers against
Omicron XBB.1.5, which align with our preclinical in vitro testing
and are in a similar range to the titers shared at the recent
VRBPAC meeting from investigational XBB-containing mRNA vaccines
administered to adults who are not on immunosuppressive treatment,”
said Dave Hering, chief executive officer of Invivyd. “Based on
previously published clinical data from randomized controlled
clinical trials, we believe that monoclonal antibodies directed
against the receptor binding domain of the SARS-CoV-2 spike protein
offer an attractive safety profile, even at higher doses, and that
strong serum neutralization activity would be predictive of
clinical benefit. I look forward to continuing to work with urgency
to move VYD222 into a pivotal clinical trial and, if authorized, to
immunocompromised people in need.”
“With COVID-19 continuing to threaten millions of the most
vulnerable people in our communities, such as people receiving
chemotherapy or other immunosuppressive drugs, we are pleased that
the initial Phase 1 data support the potential for VYD222 to meet
an urgent medical need,” said Pete Schmidt, M.D. M.Sc., chief
medical officer of Invivyd. “Many immunocompromised people do not
respond optimally to COVID-19 vaccination, and would benefit
substantially from high-quality, immediate, and long-lasting
protection from symptomatic COVID-19.”
Invivyd plans to utilize initial data from the Phase 1 VYD222
clinical trial to help support the anticipated rapid transition to
a VYD222 pivotal clinical trial. Additionally, the company plans to
present additional results from the Phase 1 clinical trial at an
upcoming medical meeting.
About the Phase 1 Clinical Trial of VYD222
The ongoing VYD222 Phase 1 clinical trial is a randomized,
blinded, placebo-controlled, dose-ranging trial that will evaluate
the safety, pharmacokinetics, tolerability, and serum virus
neutralizing activity of VYD222 in healthy adult volunteers
(NCT05791318). The dose-ranging trial will evaluate three different
doses of VYD222, each administered as a single IV push. All doses
are designed to provide durability in the face of viral evolution
and flexibility at the time of regulatory submission. In May 2023,
Invivyd finished dosing all 30 participants in the trial; follow up
is ongoing.
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. As of June
2023, 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 previously circulating
SARS-CoV-2 variants and current variants of concern, including
Omicron sub-lineages up to and through XBB.1.5. 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. The company believes the
adintrevimab clinical data have the potential to support
accelerated development of VYD222.
About the Phase 2/3 Clinical Trial of Adintrevimab for
the Prevention of COVID-19 (EVADE)
EVADE was a multi-center, double-blind, placebo-controlled,
randomized Phase 2/3 clinical trial of adintrevimab for
post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP)
of symptomatic COVID-19 in SARS-CoV-2 naïve, unvaccinated
individuals (NCT04859517). Eighty-eight sites randomized 2,582
participants in 8 countries. Eligible participants were adults (≥18
years) and adolescents (12 to <18 years) whose circumstances
placed them at risk of acquiring SARS-CoV-2 infection. The PrEP
cohort included participants whose advanced age (≥55 years) or
health status placed them at risk for developing severe COVID-19 or
COVID-19 complications, such as chronic cardiopulmonary disease,
diabetes, obesity, or an immune compromised state. The efficacy
portion of EVADE was conducted during the emergence and global
spread of SARS-CoV-2 variants Delta and Omicron BA.1/BA.1.1.
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.
References
U.S. Food and Drug Administration (FDA) Center for Biologics
Evaluation and Research (CBER) 182nd Meeting of the Vaccines and
Related Biological Products (VRBPAC) Advisory Committee Meeting on
June 15, 2023: https://www.fda.gov/media/169539/download
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 future of
the COVID-19 landscape; the company’s ongoing research and clinical
development plans and the timing thereof, including with respect to
the clinical development of VYD222; the company’s plans to utilize
initial data from the Phase 1 VYD222 clinical trial to help support
the anticipated rapid transition to a pivotal clinical trial, as
well as its plans to present additional results from the Phase 1
VYD222 clinical trial at an upcoming medical meeting; the company’s
belief that mAbs directed against the receptor binding domain of
the SARS-CoV-2 spike protein offer an attractive safety profile,
even at higher doses, and that strong serum neutralization activity
would be predictive of clinical benefit; the potential for VYD222
to meet an urgent medical need; the company’s belief that
adintrevimab clinical data have the potential to support
accelerated development of VYD222; the company’s beliefs about its
competitive position; estimates regarding the size of the company’s
target patient populations and the potential market opportunity for
its product candidates; the company’s ability to rapidly and
perpetually deliver antibody-based therapies that protect
vulnerable people from the devastating consequences of circulating
viral threats; the potential for VYD222 and other 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
threats, 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 ability to gain alignment with
the applicable regulatory authorities on the clinical trial design
and development pathway for VYD222 and the timing thereof; the
timing and progress of the company’s discovery, preclinical and
clinical development activities; the ability of the company to
generate and utilize tools to discover and develop a pipeline of
antibodies to treat current and potential future SARS-CoV-2
variants; the impacts of the COVID-19 pandemic on the company’s
business and those of its collaborators, the company’s clinical
trials and its financial position; unexpected safety or efficacy
data observed during preclinical studies or clinical trials; the
predictability of clinical success of VYD222 or other pipeline
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;
clinical trial site activation or enrollment rates that are lower
than expected; changes in expected or existing competition; changes
in the regulatory environment; the uncertainties and timing of the
regulatory approval process, including the outcome of the company’s
discussions with regulatory authorities concerning its clinical
trials and platform-based approach to development; whether VYD222
or any other product candidate or combination of candidates is able
to demonstrate and sustain neutralizing activity against
predominant SARS-CoV-2 variant(s); whether VYD222 or other product
candidates will be high-quality, long-lasting antibodies with the
potential to resist viral escape; whether the company is able to
successfully submit an emergency use authorization (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 (the “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. Such risks may
be amplified by the impacts of the COVID-19 pandemic.
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.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
Contacts
Media Contact:Kate Burdick, Evoke
Canale860-462-1569kate.burdick@evokegroup.com
Investor Contact:Chris Brinzey, ICR
Westwicke339-970-2843chris.brinzey@westwicke.com
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