Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical
company on a mission to protect the vulnerable from serious viral
infectious diseases, today announced additional 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.
The Phase 1 clinical trial of VYD222 enrolled 30 healthy
volunteers across three different dosing cohorts. In each cohort,
participants were randomized 8:2 to VYD222 or placebo. The initial
Phase 1 data showed 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 middle
VYD222 dose tested (2500 mg), geometric mean serum neutralizing
titers were 9647.0 (95% CI: 6115.4, 15218.0) against Omicron
XBB.1.5 at Day 7, with a geometric mean 92.82-fold rise (95% CI:
21.2, 406.6) from baseline to Day 7. At the highest VYD222 dose
tested (4500 mg), geometric mean serum neutralizing titers were
16864.7 (95% CI: 12825.5, 22176.1) against Omicron XBB.1.5 at Day
7, with a geometric mean 120.97-fold rise (95% CI: 31.4, 466.2)
from baseline to Day 7. The higher VYD222 dose levels tested in the
Phase 1 clinical trial are designed to provide additional
protection from potential loss of neutralization activity as
SARS-CoV-2 evolves over time. The results announced today add to
the positive initial Phase 1 data reported in June 2023, which
showed that the lowest VYD222 dose tested (1500 mg) resulted in
geometric mean serum neutralizing titers of 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.
Analysis of the serum neutralizing activity from samples
collected at different timepoints across all dose cohorts in the
Phase 1 clinical trial 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 further
inform its VYD222 dosing strategy.
“We are pleased to see a favorable safety and tolerability
profile as well as robust serum neutralizing titers against Omicron
XBB.1.5 for all the VYD222 dose levels tested in our ongoing Phase
1 clinical trial,” said Dave Hering, chief executive officer of
Invivyd. “We believe these high neutralizing titer values and fold
increases at this early timepoint are extremely encouraging as they
indicate the potential for VYD222 to protect longer between doses
and to provide additional protection from potential loss of
neutralization activity as SARS-CoV-2 evolves over time.”
Mr. Hering continued, “As a point of reference, we find it
encouraging to observe that even our lowest VYD222 dose tested in
our Phase 1 clinical trial resulted in higher titers against
Omicron XBB.1.5 than the maximum titers against XBB.1.5 from
investigational XBB-containing mRNA vaccines tested in humans that
were shared at the FDA’s recent vaccines advisory committee
meeting. Higher VYD222 doses tested in our Phase 1 clinical trial
have resulted, as expected, in higher titer levels that were well
above those reported mRNA COVID-19 vaccine titer levels. We believe
these initial Phase 1 clinical trial results support the potential
for VYD222 to provide safe, meaningful, durable protection for
vulnerable populations, such as immunocompromised people who may
not generate adequate protection from COVID-19 vaccines, and we
look forward to advancing VYD222 as fast as possible in
collaboration with global regulators, starting with the FDA.”
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 July
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.
References
U.S. Food and Drug Administration (FDA) Center for Biologics
Evaluation and Research (CBER) 182nd Meeting of the Vaccines and
Related Biological Products Advisory Committee (VRBPAC) 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
data from the Phase 1 VYD222 clinical trial to support the rapid
anticipated transition to a pivotal clinical trial; the company’s
belief that initial data from the Phase 1 VYD222 clinical trial
indicate the potential for VYD222 to protect longer between doses
and to provide additional protection from potential loss of
neutralization activity as SARS-CoV-2 evolves over time; the
potential for VYD222 to provide safe, meaningful, durable
protection for vulnerable populations, such as immunocompromised
people; the company’s plans to advance VYD222 as fast as possible
in collaboration with global regulators, starting with the FDA; the
company’s belief that it can leverage adintrevimab 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; 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
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, including
the use of an immunobridging pathway in the U.S., and the timing
thereof; whether the company is able to leverage adintrevimab data,
along with its manufacturing platform, to support the accelerated
development of VYD222 or other 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; 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 variants, particularly in the face of viral
evolution; 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.
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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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