Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a
mission to protect the vulnerable from serious viral infectious
diseases, today announced that it has requested Emergency Use
Authorization (EUA) from the U.S. Food and Drug Administration
(FDA) for VYD222, a broadly neutralizing, half-life extended
monoclonal antibody candidate, for the pre-exposure prevention of
COVID-19 in immunocompromised adults and adolescents. The EUA
submission was based on positive initial results from the CANOPY
Phase 3 pivotal clinical trial of VYD222, as well as ongoing in
vitro neutralization activity against relevant variants such as
JN.1.
"We are tremendously pleased by the fact that VYD222 continues
to demonstrate in vitro neutralization activity against the latest
dominant variant, JN.1, as well as other prevalent SARS-CoV-2
strains,” said Dave Hering, Chief Executive Officer of Invivyd. “We
believe that the demonstrated durability of VYD222 is reflective of
our strategy to select antibody candidates that target conserved
epitopes to achieve our stated goal of keeping pace with viral
evolution.”
Mr. Hering added, “The submission of the EUA request
for VYD222 represents an exciting
milestone for Invivyd that was only made possible thanks to
the unwavering dedication of our employees, the support of our
investigators, and the invaluable contributions of all those who
participated in the CANOPY trial. Many immunocompromised
people do not achieve full benefit from COVID-19 vaccines as their
immune systems are unable to provide sufficient defense against
SARS-CoV-2. If authorized, we believe VYD222 could provide these
vulnerable individuals with an important new preventive
option.”
Seth Ginsberg, President and Co-Founder, Global Healthy Living
Foundation, commented, "We are eagerly tracking the progress of new
monoclonal antibodies because there are still countless
immunocompromised people who remain vulnerable to the ravages of
COVID-19. Sustained innovation is what is needed to keep pace with
this virus, and we commend Invivyd and others working in this space
for their commitment and dedication to serving those who are in
urgent need of protection."
On December 18, 2023, Invivyd announced positive initial results
from the ongoing CANOPY pivotal clinical trial. VYD222 produced
high serum virus neutralizing antibody (sVNA) titer levels against
XBB.1.5 in the immunocompromised cohort. The company observed an
encouraging, potential early signal of strong clinical protection
from symptomatic COVID-19 in CANOPY, which would be expected based
on the high sVNA titer levels and dose selected. In addition, the
company believes that the initial results from CANOPY support an
immunobridging approach which utilizes in vitro VYD222 potency data
to calculate and efficiently determine the sVNA titer levels
against new SARS-CoV-2 variants as they emerge. Initial results
showed that the safety and tolerability profile of VYD222 remained
favorable with no study drug related serious adverse events
reported; adverse events attributed to VYD222 were Grade 1 or 2
(mild or moderate) in severity.
In vitro pseudovirus testing shows that VYD222 has potency
against various SARS-CoV-2 variants currently circulating,
including JN.1, which is currently the fastest growing variant in
the U.S., as well as HV.1, BA.2.86, XBB.1.5.10/EG.5, and HK.3.
If authorized, Invivyd aims to have VYD222 commercially
available rapidly thereafter.
About CANOPYThe CANOPY pivotal clinical trial
is an ongoing 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. In November 2023, Invivyd
announced the completion of enrollment in the CANOPY clinical
trial, with approximately 750 participants enrolled in two cohorts
(A and B) across multiple trial sites in the U.S. Cohort A
enrolled approximately 300 participants who are significantly
immunocompromised. For this cohort, the primary endpoints include
safety and tolerability and serum neutralizing titers against
relevant SARS-CoV-2 variants at Day 28, which will be calculated
based on the pharmacokinetic concentration of VYD222 from the
immunocompromised participants and the IC50 value for VYD222
against relevant SARS-CoV-2 variants. The primary efficacy analysis
uses 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 (ADG20) for the
prevention of symptomatic COVID-19 (EVADE), in which serum
neutralizing titers correlated with observed clinical efficacy. All
Cohort A participants received VYD222 administered via intravenous
(IV) infusion.
Cohort B enrolled approximately 450 participants at risk of
exposure to SARS-CoV-2. Participants were randomized 2:1 to receive
VYD222 or placebo administered via IV infusion. The primary
endpoints include safety and tolerability and the proportion of
participants with RT-PCR-confirmed symptomatic COVID-19 through 6
months.
Invivyd is evaluating the 4500 mg dose of VYD222 in the CANOPY
clinical trial.
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 more than 9
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 in
pseudovirus assays against various pre-Omicron and Omicron
variants, such as JN.1, HV.1, BA.2.86, XBB.1.5.10/EG.5, and HK.3.
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 InvivydInvivyd, 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. The company’s proprietary INVYMAB™
platform approach combines state-of-the-art viral surveillance and
predictive modeling with advanced antibody engineering. Leveraging
its INVYMAB platform approach, 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
StatementsThis 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 for VYD222 or any other product candidate, and
the timing thereof, including with respect to the ongoing CANOPY
phase 3 pivotal clinical trial and other research and development
plans for VYD222; the company’s regulatory and commercialization
plans for VYD222 or any other product candidate, and the timing
thereof; the potential of VYD222 for strong clinical protection
from symptomatic COVID-19 based on early signals observed in the
CANOPY clinical trial; the company’s belief that the initial
results from the CANOPY clinical trial are supportive of an
immunobridging approach for the development of VYD222; the ability
of the company to determine the sVNA titer levels against new
SARS-CoV-2 variants as they emerge using in vitro VYD222 potency
data; the continued and ongoing in vitro neutralization activity of
VYD222 against relevant and major SARS-CoV-2 variants; the
company’s belief that the demonstrated durability of VYD222 is
reflective of its strategy to select antibody candidates that
target conservative epitopes to achieve its stated goal of keeping
pace with viral evolution; the company's belief that VYD222 holds
the potential to be an important preventive option for
immunocompromised populations; the potential scope of an EUA for
VYD222, if granted, including disease state and patient population;
the potential for VYD222 to maintain an EUA, if granted, through
evolution of SARS-CoV-2 variants; the company’s continued
preparations and plans for commercial launch of VYD222 and the
ability to have VYD222 commercially available rapidly, if EUA is
granted; 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 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 generate the clinical data needed from the CANOPY
clinical trial to support a potential EUA for VYD222; the company's
interactions with the U.S. FDA regarding the EUA submission for
VYD222; the outcome of the VYD222 EUA submission and timing
thereof; the development and regulatory pathways for authorization
or approval of VYD222 or other product candidates; 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; the company’s
reliance on third parties with respect to virus assay creation and
product candidate testing and with respect to its 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 authorization or
approval process; whether VYD222 or any other product candidate is
able to demonstrate and sustain neutralizing activity against
relevant, major or predominant SARS-CoV-2 variants, particularly in
the face of viral evolution; the ability to maintain a continued
acceptable safety, tolerability and efficacy profile of VYD222 or
any other product candidate following EUA or approval, if granted;
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 for any other product
candidate in the future, and the outcome and timing of any such EUA
submission; the company’s ability to manufacture sufficient
commercial quantities of VYD222; the complexities of manufacturing
monoclonal antibody therapies and the company’s reliance on
contract manufacturers to do so; the company’s ability to establish
a sales, marketing and distribution infrastructure to commercialize
VYD222 or any other product candidates for which the company may
obtain regulatory approval or EUA; whether the company can obtain
and maintain third-party coverage and adequate reimbursement for
VYD222 or any other product candidate; 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; the company’s ability to continue as a going
concern; 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.
Contacts:
Scott Young(781) 208-1747syoung@invivyd.com
Gabriella Linville-Engler(781)
208-0160gengler@invivyd.com
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