Invivyd Announces Interim Exploratory Data on VYD222 from Ongoing CANOPY Clinical Trial
March 22 2024 - 2:28PM
Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a
mission to protect the vulnerable from serious viral infectious
diseases, today announced interim exploratory COVID-19 clinical
event data for VYD222, an investigational, monoclonal antibody
(mAb) in development for the pre-exposure prophylaxis of COVID-19.
The data announced today from the ongoing Phase 3 CANOPY clinical
trial reflect and add further to the initial potential signal of
clinical protection from symptomatic COVID-19 shared in December
2023, and may be useful in updating prior published work that
analyzed the relationships between serum virus neutralizing
antibody (sVNA) titers and protection in patients who had no prior
exposure to vaccination or natural infection.1
“While these interim clinical efficacy data are exploratory and
not part of the primary immunobridging endpoint of the CANOPY
clinical trial, we believe they further our efforts to understand
the relationship between sVNA titers and clinical efficacy in
individuals who have some level of vaccine- or infection-induced
immunity,” said Dave Hering, Chief Executive Officer. “As we
continue to build out our company and advance the science
describing monoclonal antibody pre-exposure prophylaxis (PrEP), we
believe we can incorporate these findings into future prospectively
designed clinical studies that seek to establish formal
relationships between neutralizing titers and protection.
Exploratory data such as provided in today’s update are important
for broad reflection as they represent some of the first data from
a clinical trial conducted with a monoclonal antibody in a
population that has acquired prior immune exposure from either
vaccination or natural infection. By contrast, studies of prior
authorized COVID-19 PrEP mAbs largely relied on participants
required by protocol to be naïve to vaccination or prior
infection2. As such, these people would presumably have no baseline
titers. We continue to explore how measured titers compare with
calculated titers and look to assess if higher levels of protection
in future studies may be possible with lower levels of additional
titers conferred from mAbs.”
The ongoing CANOPY Phase 3 clinical trial is designed to
evaluate the safety and tolerability of VYD222 and to assess
immunobridging from VYD222 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). Symptomatic
COVID-19 event collection in the CANOPY clinical trial is a
secondary exploratory endpoint designed to allow Invivyd to
contemplate further discovery and development work only. The CANOPY
clinical trial enrolled participants in two cohorts. Cohort A is a
single-arm, open-label trial in adults who have moderate-to-severe
immune compromise including complex underlying medical conditions
(n=306). Cohort B is a randomized, placebo-controlled cohort that
enrolled adults without moderate-to-severe immune compromise who
are at risk of acquiring SARS-CoV-2 due to regular unmasked
face-to-face interactions in indoor settings. All CANOPY Cohort A
participants received VYD222 administered via intravenous (IV)
infusion. Cohort B participants were randomized 2:1 to
receive VYD222 or placebo administered via IV infusion.
Updated Findings
As previously disclosed by the company in December 2023, a
potential early signal of clinical protection from symptomatic
COVID-19 confirmed by RT-PCR was observed. Invivyd is now providing
an update on the clinical cases of confirmed symptomatic COVID-19
through Day 90. Beyond today’s update, additional cases of COVID-19
have occurred in Cohorts A and B post Day 90. These data are
planned to be analyzed at Day 180 and presented when available.
Cohort B (Randomized, placebo-controlled cohort without
moderate-to-severe immune compromise at risk of acquiring
SARS-CoV-2 due to regular unmasked face-to-face interactions) —
Proportion of participants with RT-PCR-confirmed symptomatic
COVID-19 (exploratory data):
|
As of December 1, 2023(median 67 days
follow-up) |
Through Day 90 |
VYD222 |
0% (0/322) |
0.3% (1/314) |
Placebo |
3% (5/162) |
5% (8/159) |
Cohort A (Open-label cohort with moderate-to-severe immune
compromise) — Proportion of participants with RT-PCR-confirmed
symptomatic COVID-19 (exploratory data):
|
As of December 1, 2023(median 35 days
follow-up) |
Through Day 90 |
VYD222 |
0% (0/306) |
1% (3/298) |
Additional COVID-19 events have occurred in Cohort A (unblinded)
and Cohort B (randomized, not yet analyzed) post Day 90, but the
company has not yet analyzed the data. Invivyd plans to provide a
Day 180 update and a more complete analysis of the observed
relationships between sVNA titers, both calculated and measured,
and events of confirmed symptomatic COVID-19 when these data are
available.
About VYD222 VYD222 is a neutralizing,
half-life extended monoclonal antibody (mAb) candidate being
investigated for the pre-exposure prophylaxis (prevention) of
COVID-19 in immunocompromised adults and adolescents. VYD222 was
designed for broad activity and has demonstrated in
vitro neutralizing activity in pseudotyped virus-like particle
and authentic virus neutralization assays against various
pre-Omicron and Omicron variants, including JN.1. 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.
References
- Schmidt, Pete et al.
“Antibody-mediated protection against symptomatic COVID-19 can be
achieved at low serum neutralizing titers.” Sci. Transl. Med.15,
eadg2783 (2023); Follmann, Dean et al. “Examining protective
effects of SARS-CoV-2 neutralizing antibodies after vaccination or
monoclonal antibody administration.” Nature communications vol.
14,1 3605. 17 Jun. 2023.
- Ison, Michael, et al. “Prevention of
COVID-19 Following a Single Intramuscular Administration of
Adintrevimab: Results From a Phase 2/3 Randomized, Double-Blind,
Placebo-Controlled Trial (EVADE).” Open Forum Infectious Diseases,
Volume 10, Issue 7, July 2023; Levin, Myron J et al. “Intramuscular
AZD7442 (Tixagevimab-Cilgavimab) for Prevention of
Covid-19.” The New England Journal of Medicine vol.
386,23 (2022): 2188-2200.
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,” “estimates,” “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 activities, as well as future potential research and
clinical development efforts; the potential of VYD222 for clinical
protection from symptomatic COVID-19 based on early signals shown
by interim data from the CANOPY clinical trial; the company’s plans
to provide any future public updates on symptomatic COVID-19 events
in the CANOPY clinical trial, including the timing thereof; the
potential for exploratory clinical efficacy data from the CANOPY
clinical trial to be hypothesis generating for future discovery and
development work of the company, and the possibility of updating
prior published work that analyzed the relationships between sVNA
titers and protection; the in vitro neutralizing activity of VYD222
against major SARS-CoV-2 variants; the company’s 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 ability of the
company to leverage its INVYMAB platform approach 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; the company’s business strategies and
objectives; 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 risk that
results of preclinical studies or clinical trials may not be
predictive of future results, and interim data are subject to
further analysis; unexpected safety or efficacy data observed
during preclinical studies or clinical trials; the predictability
of clinical success of the company’s product candidates based on
neutralizing activity in preclinical studies; 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; whether VYD222 or any other product candidate
is able to demonstrate and sustain neutralizing activity against
major SARS-CoV-2 variants, particularly in the face of viral
evolution; the company’s ability to leverage its INVYMAB platform
approach to generate a robust pipeline of product candidates which,
if authorized or approved, could be used in prevention or treatment
of serious viral diseases; the uncertainties and timing of the
regulatory authorization or approval process, and available
development and regulatory pathways for authorization or approval
of the company’s product candidates; changes in the regulatory
environment; 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.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
Contacts:
Scott Young(781) 208-1747syoung@invivyd.com
Gabriella Linville-Engler(781) 208-0160gengler@invivyd.com
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