Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical
company on a mission to protect the vulnerable from serious viral
infectious diseases, today announced that it has reached general
alignment with the U.S. Food and Drug Administration (FDA) on a
pathway to potential emergency use authorization (EUA) for VYD222
and anticipated follow-on monoclonal antibody (mAb) candidates
designed to prevent symptomatic COVID-19. The company plans to
leverage the pathway, which includes the use of serum neutralizing
titers as a correlate of protection (surrogate of clinical
efficacy) in an immunobridging approach to a pivotal clinical trial
of VYD222, to rapidly generate data to support a potential VYD222
EUA for the prevention of symptomatic COVID-19. Based on FDA
feedback, the use of a correlate of protection in an immunobridging
approach to a pivotal EUA-directed clinical trial may be a
reasonable approach for a new mAb candidate when clinical trial
data from a “prototype” mAb is available, provided that the new mAb
candidate: (1) is similar to the prototype mAb such that it
leverages a consistent manufacturing platform and has limited
structural and functional differences, and (2) has supportive
nonclinical data, such as favorable in vitro neutralization data
against currently circulating SARS-CoV-2 variants.
Invivyd plans to leverage this immunobridging pathway to
accelerate the clinical development of VYD222 and anticipated
follow-on mAb candidates, with ADG20 (adintrevimab) or future
proprietary mAbs serving as the prototype. The use of adintrevimab
as the potential prototype mAb is proprietary to Invivyd and
enabled by the robust safety data and clinically meaningful results
from a global Phase 2/3 clinical trial of adintrevimab for the
prevention of symptomatic COVID-19. 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. 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.
In June 2023, the company announced positive initial safety and
serum neutralizing titer data from the ongoing Phase 1 VYD222
clinical trial. Serum neutralizing titers are the same surrogate
marker planned for use in the primary endpoint in a pivotal VYD222
clinical trial.
“We are very encouraged by the recent feedback from the FDA and
appreciate their commitment to exploring alternative strategies to
expedite the development of mAbs for the prevention of symptomatic
COVID-19, such as the use of a correlate of protection as the
primary endpoint in a pivotal clinical trial, a strategy that we
are pleased to see further advance following the joint EMA-FDA
workshop last December where the approach was discussed,” said Dave
Hering, chief executive officer of Invivyd. “Given our previous
work developing adintrevimab and our platform-based approach to
rapid mAb discovery, we believe we are one of few companies
positioned to rapidly and serially generate data for potential EUA
submission for next-generation mAb candidates for the prevention of
symptomatic COVID-19. This potential pathway supports the company’s
vision and strategy of establishing a platform and stream of
optimized anti-SARS-CoV-2 mAb candidates that can be deployed to
keep pace with viral evolution and protect the vulnerable.”
Invivyd continues activities to prepare for a VYD222 pivotal
clinical trial and is pursuing a rapid initiation of that clinical
trial in order to support a potential EUA submission. The company
also continues to engage with global regulatory authorities
regarding the VYD222 clinical development program.
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 participants with 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. Due to the marked differences in
adintrevimab potency against these two variants, the EVADE trial
provided a unique opportunity to assess the relationship between
serum neutralizing titers and clinical protection against
symptomatic COVID-19 in the absence of pre-existing SARS-CoV-2
immunity. The company believes it can leverage these data, along
with its manufacturing platform, to support the accelerated
development of VYD222 and a stream of mAb candidates designed to
keep pace with SARS-CoV-2 evolution and protect the vulnerable.
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 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 possibility for VYD222 and
anticipated follow-on mAb candidates to follow a potential
development pathway for mAbs using immunobridging via serum
neutralizing titers and previously generated clinical trial data
from a prototype antibody; the company’s plans to utilize
adintrevimab as a prototype mAb to accelerate the clinical
development of VYD222; the company’s plans to pursue rapid
initiation of a VYD222 pivotal clinical trial using serum
neutralizing titers as a correlate of protection (surrogate
endpoint) to rapidly generate data for a potential VYD222 EUA
submission; the company’s beliefs about its competitive position;
the company’s vision and strategy of establishing a platform and
stream of optimized anti-SARS-CoV-2 mAb candidates that can be
deployed to keep pace with viral evolution and protect the
vulnerable; 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
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 ability to gain complete
alignment with the applicable regulatory authorities on the
clinical trial design and development pathway for VYD222 and
anticipated follow-on mAb candidates, including the use of an
immunobridging pathway, and the timing thereof; whether
adintrevimab is able to serve as a prototype mAb and the company is
able to leverage previously generated adintrevimab clinical trial
data in connection with the clinical development of VYD222 or
potential future Invivyd mAb candidates; the timing and progress of
the company’s discovery, preclinical and clinical development
activities, including the company’s ability to rapidly initiate a
VYD222 pivotal clinical trial and generate data for a potential
VYD222 EUA submission; 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 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 the company is able to
establish a platform and generate a stream of optimized
anti-SARS-CoV-2 mAb candidates that can be deployed to keep pace
with viral evolution and protect the vulnerable; 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 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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