Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a
mission to protect the vulnerable from serious viral infectious
diseases, today announced positive initial results from the ongoing
CANOPY Phase 3 pivotal clinical trial of VYD222, a broadly
neutralizing, half-life extended monoclonal antibody candidate, for
the prevention of symptomatic COVID-19.
“We are pleased to share positive initial topline results from
CANOPY which bolster our belief that VYD222 holds the potential to
provide vulnerable people, particularly the immunocompromised (IC),
with meaningful protection from COVID-19,” said Dave Hering, Chief
Executive Officer of Invivyd. “VYD222 produced high serum
virus neutralizing antibody (sVNA) titer levels against XBB.1.5 in
the IC cohort, essentially replicating the titer levels observed in
our Phase 1 clinical trial of VYD222 in healthy volunteers. We are
also encouraged by the potential early signal of strong clinical
protection from symptomatic COVID-19 in the CANOPY clinical trial
to date, which would be expected given the high VYD222 sVNA titer
levels and dose selected. We look forward to continued engagement
with the FDA on these promising results, and we intend to submit a
request for Emergency Use Authorization (EUA) as soon as
practicable.”
Pete Schmidt, M.D., M.Sc., Chief Medical Officer at Invivyd
added, “The CANOPY clinical trial utilizes an innovative
immunobridging design in which pharmacokinetic (PK) data from
participants and potency data (IC50 values) are used to calculate
sVNA titer levels. As characterized in our Science Translational
Medicine paper, we believe calculated sVNA titer levels can be
bridged back to the titer levels and corresponding clinical
efficacy observed in EVADE, our pivotal clinical trial of ADG20 for
prevention of COVID-19. We are encouraged by the initial results
from CANOPY that we believe are supportive of an immunobridging
approach for VYD222. Calculating sVNA titers also allows us to
efficiently determine the sVNA titer levels against new SARS-CoV-2
variants as they emerge using in vitro VYD222 potency data.”
Dr. Schmidt continued, “There is a growing body of strong
scientific evidence showing that higher sVNA titer levels correlate
with higher protection from symptomatic COVID-19, and we believe
VYD222 holds the potential to be an important preventative option
for immunocompromised populations. We extend our deepest gratitude
to all our CANOPY trial participants, study teams, and Invivyd team
members who have enabled this important clinical research and look
forward to presenting additional findings from the CANOPY clinical
trial next year.”
Results showed that the safety and tolerability profile of
VYD222 remains favorable with no study drug related serious adverse
events reported to date. Adverse events attributed to VYD222 were
Grade 1 or 2 (mild or moderate) in severity.
The company also today reported that in vitro pseudovirus
testing shows VYD222 has potency against various SARS-CoV-2
variants currently circulating, such as HV.1, BA.2.86,
XBB.1.5.10/EG.5, and HK.3. Importantly, VYD222 continues to show
neutralizing activity against variants with the F456L mutation that
is found in the majority of variants in the U.S. currently.
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 VYD222VYD222 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 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
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 regulatory
plans and the timing thereof, including the company’s plans for
continued engagement with the U.S. FDA and intention to submit a
request for EUA as soon as practicable; the potential of VYD222 for
strong clinical protection from symptomatic COVID-19 based on early
signals observed in the CANOPY trial to date; the company’s belief
that the initial results from CANOPY are supportive of an
immunobridging approach for the development of VYD222, including
that calculated sVNA titer levels from CANOPY can be bridged back
to the titer levels and corresponding clinical efficacy observed in
EVADE; 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 company's belief that VYD222 holds
the potential to be an important preventative option for
immunocompromised populations, including providing meaningful
protection against COVID-19; the company's plans to present
additional findings from the CANOPY clinical trial next year; 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 rapidly generate the clinical data needed from the
CANOPY clinical trial to support a potential EUA submission for
VYD222; the company's interactions with the U.S. FDA regarding the
VYD222 and a potential EUA submission; 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 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 and timing of any such EUA submission; the
Company’s ability to manufacture sufficient clinical and commercial
quantities of VYD222; the complexities of manufacturing monoclonal
antibody therapies and the company’s reliance on contract
manufacturers to do so; 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.
Contacts:
Scott Young(781) 208-1747syoung@invivyd.com
Gabriella Linville-Engler(781) 208-0160gengler@invivyd.com
Invivyd (NASDAQ:IVVD)
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