Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a
mission to protect the vulnerable from serious viral infectious
diseases, today announced that PEMGARDA™ (pemivibart), formerly
VYD222, a half-life extended monoclonal antibody (mAb), has
received emergency use authorization (EUA) from the U.S. Food and
Drug Administration (FDA) for the pre-exposure prophylaxis
(prevention) of COVID-19 in adults and adolescents (12 years of age
and older weighing at least 40 kg) who have moderate-to-severe
immune compromise due to certain medical conditions or receipt of
certain immunosuppressive medications or treatments and are
unlikely to mount an adequate immune response to COVID-19
vaccination. Recipients should not be currently infected with or
have had a known recent exposure to an individual infected with
SARS-CoV-2.
“The PEMGARDA EUA marks a transformational moment for Invivyd
and for the many moderately to severely immunocompromised people
who are vulnerable to COVID-19 disease in the U.S. This EUA
milestone represents strategic proof-of-concept for our company and
platform, affirming the unique strategy we embarked on over a year
ago: to use rapid innovation and surrogate markers to bring new
antibodies to market repeatedly,” said Dave Hering, Chief Executive
Officer of Invivyd. “PEMGARDA is the first authorized monoclonal
antibody from our proprietary platform approach. We are committed
to ongoing process improvement while working with global regulatory
agencies with the aim to increase the speed and efficiency of new
mAb candidate development even further. Additionally, we are
planning to explore the protective clinical benefits of mAb
prophylaxis for symptomatic COVID-19 disease in future
studies.”
Mr. Hering added, “We are proud that roughly one year after
initiating the Phase 1 trial of our mAb now known as PEMGARDA, we
are expecting to have product available for order imminently, with
initial supply already packaged and awaiting final release at our
U.S.-based third-party logistics provider. I’m deeply grateful to
our dedicated team members who made this achievement possible and
everyone else who has supported our work, especially our clinical
trial participants and investigators. Finally, we also appreciate
the continuous engagement from the FDA as they have worked with
urgency to make this medicine available to populations in serious
need.”
“People who are immunocompromised continue to be
disproportionally impacted by COVID-19 even after receiving
multiple vaccine doses,” said Cameron R. Wolfe, M.B.B.S., M.P.H.,
Professor of Medicine, Transplant Infectious Disease at Duke
University School of Medicine. “I’m excited to have PEMGARDA as an
additional COVID-19 preventive option for moderately to severely
immunocompromised adult and adolescent patients, such as solid
organ transplant recipients and those with hematological
malignancies. These types of patients, among others, continue to
have both an impaired response to vaccines and a higher risk for
severe COVID-19 outcomes.”
“COVID-19 continues to pose a significant threat and major
concern to those who are moderately to severely immunocompromised,”
said Jorey Berry, President and CEO of the Immune Deficiency
Foundation and a steering committee member of the Immunocompromised
Collaborative. “As such, we are delighted that a new monoclonal
antibody for pre-exposure prophylaxis of COVID-19 will be available
soon for certain vulnerable populations.”
Multiple medical conditions or treatments may result in
moderate-to-severe immune compromise and an impaired immune
response to COVID-19 vaccination including, for example,
hematologic malignancies (blood cancers) or treatment with
immunosuppressive therapy after a solid organ or stem cell
transplant.1 Observational studies have demonstrated that people
with immune dysfunction have a higher risk of COVID-19-related
hospitalization and death, despite vaccination, than the general
population.2-3
The EUA of PEMGARDA is based on the totality of scientific
evidence available, such as data showing that immunobridging was
established in the CANOPY clinical trial and that the calculated
serum neutralizing antibody titers against JN.1 were consistent
with the titer levels associated with efficacy in prior clinical
trials of adintrevimab (ADG20), the parent mAb for VYD222, and
other monoclonal antibody products. JN.1 is currently the dominant
variant circulating in the U.S. according to estimates from the
Centers for Disease Control and Prevention (CDC).4 PEMGARDA
(pemivibart) (4500 mg) is administered as an intravenous (IV)
infusion.
PEMGARDA is Invivyd’s first authorized mAb and the first mAb to
receive EUA based on a rapid immunobridging trial design that is
expected to be repeatable to help address the need to mitigate
ongoing viral evolution. It was developed using INVYMAB™, the
company’s platform approach which combines state-of-the-art viral
surveillance and predictive modeling with advanced antibody
engineering. INVYMAB is designed to enable the rapid, serial
generation of durable mAbs targeting conserved epitopes that could
be deployed to keep pace with SARS-CoV-2 viral evolution or other
viral threats. With a commitment to serial innovation, Invivyd aims
to ensure that vulnerable populations, such as immunocompromised
people, have continuous access to innovative antibody
therapies.
The Company estimates it had approximately $200.6 million of
cash and cash equivalents as of December 31, 2023. The estimated
amounts are preliminary, have not been audited and are subject to
change upon completion of the Company’s audited financial
statements for the year ended December 31, 2023. In February 2024,
the Company sold shares of common stock totaling $40.5 million in
gross proceeds under its At-the-Market facility further
strengthening the Company’s balance sheet ahead of PEMGARDA launch.
Based on current operating plans and excluding anticipated cash
collections from PEMGARDA sales, Invivyd expects its existing total
cash and cash equivalents will enable the company to fund its
operating expenses and capital expenditure requirements into the
fourth quarter of 2024.
Interim CANOPY Clinical Data Update
CANOPY is an ongoing Phase 3 clinical trial of VYD222 (PEMGARDA)
for the pre-exposure prophylaxis of COVID-19 which enrolled adults
≥18 years of age in two cohorts. Cohort A is a single-arm,
open-label trial in adults who have moderate-to-severe immune
compromise (n=306); Cohort B is a 2:1 randomized,
placebo-controlled trial in which adults who do not have
moderate-to-severe immune compromise received VYD222 (n=317) or
placebo (n=162). The interim data presented below are subject to
further analysis.
Summary of CANOPY immunobridging data
An immunobridging approach was used in the CANOPY clinical
trial, utilizing the relationship between serum virus neutralizing
antibody (sVNA) titers and clinical efficacy that was demonstrated
in the previous EVADE clinical trial of adintrevimab (ADG20), the
parent mAb for VYD222, and clinical trials of other mAbs that were
previously authorized by the FDA. EVADE was a Phase 2/3 randomized,
double-blind, placebo-controlled clinical trial of adintrevimab for
PrEP and post-exposure prophylaxis of symptomatic COVID-19 in
SARS-CoV-2 naïve, unvaccinated individuals, which showed that a
neutralizing titer of 3514 on Day 90 was associated with
approximately 70% clinical efficacy in the PrEP cohort
(approximately 70% relative risk reduction in development of
symptomatic COVID-19 between the adintrevimab and placebo
arms).
The CANOPY trial was designed to utilize current relevant
SARS-CoV-2 variants in the analyses of neutralizing titers. The
primary immunobridging endpoint for Cohort A was based on
calculated sVNA titers on Day 28 following VYD222 administration
compared with the calculated Day 28 reference titer derived from
historical Day 90 data from the EVADE trial. The most relevant
SARS-CoV-2 variant circulating in the U.S. at the time of the
analysis (JN.1), was selected as the variant for the analysis of
the primary immunobridging endpoint.
Summary of initial CANOPY immunobridging data from Cohort A
(immunocompromised cohort):
- The Day 28 calculated sVNA titer for
VYD222 against JN.1 was 7365 (90% CI: 7148, 7589).
- The ratio between the Day 28 titer
for VYD222 against JN.1 of 7365 and a Day 28 adintrevimab reference
titer of 8944 was 0.82 (90% CI: 0.80, 0.85), showing that
immunobridging was established in the CANOPY clinical trial.
- The Day 90 calculated sVNA titer for
VYD222 against JN.1, prior to redosing, was 3199 (90% CI: 2995,
3418).
- The titers against JN.1 are
projected to stay above the reference titer of 3514 for
approximately 77 days (median) following a single dose of VYD222
(Figure 1).
- The range of titers achieved against
JN.1 for 3 months following administration of VYD222 were
consistent with the titer levels associated with efficacy of other
SARS-CoV-2 targeting mAbs in prior clinical trials.6
Figure 1. Calculated sVNA titers against JN.1 based on observed
pharmacokinetic concentration by timepoints (Cohort A)
Figure 1 is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/bccd1b05-c199-4795-915c-fce5cbe3d651
Summary of CANOPY safety data
The safety of VYD222 (PEMGARDA) is based on exposure of 623
participants who received at least one dose of VYD222 4500 mg IV in
one of two cohorts in the ongoing CANOPY trial. 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
recruited 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. Cohort B participants
were randomized 2:1 to VYD222 (n=317) or placebo (n=162). Interim
safety data presented today included 296 people in Cohort A who
received a second dose of VYD222 three months after the initial
dose. In Cohort B, 450 participants received a second dose of
VYD222 or placebo three months after the initial dose. Cumulative
safety with the first two doses of VYD222 is assessed only in
Cohort A because unblinded safety data in Cohort B were not
available after Day 28.
Anaphylaxis was observed in four of 623 (0.6%) participants in
CANOPY, all in Cohort A. Two participants had anaphylaxis during
the first infusion, for whom treatment included diphenhydramine.
Two participants had anaphylaxis during the second infusion. All
four reactions led to permanent discontinuation of VYD222. Three
participants had complete resolution, and one participant had acute
resolution with sequelae related to a flare of an underlying
condition. For the two participants who experienced anaphylaxis
with the second dose, both incidents were reported as
life-threatening, and they experienced symptoms during the infusion
and following discontinuation of the infusion. Both participants
were treated with diphenhydramine and epinephrine. One participant
also received oral prednisone and metoprolol for an associated
flare of an underlying condition. Please see PEMGARDA Important
Safety Information below, including a boxed warning for
anaphylaxis.
The systemic infusion-related reactions and hypersensitivity
reactions observed in Cohort A are summarized in Table 1. The
severity of the reactions was generally mild (17/27) or moderate
(8/27), but two reactions were life-threatening.
Table 1. Cohort A (Open-label cohort with moderate-to-severe
immune compromise) – Systemic infusion-related reactions and
hypersensitivity reactions
Cohort A (n=306) |
VYD222 First Dose |
VYD222 First & Second Dose, Cumulatively |
Systemic infusion-related and hypersensitivity reactions |
20 total (20/306 = 7%)(20 mild or moderate, including 2
anaphylaxis*) |
27 total (27/306 = 9%)(17 mild and 8 moderate, including 2
anaphylaxis*; plus 2 life-threatening anaphylaxis) |
*These two events were initially classified as mild or moderate
hypersensitivity adverse reactions. Subsequently, during the review
of the EUA application, the FDA reclassified these hypersensitivity
adverse reactions as anaphylaxis adverse reactions.
Safety data through Day 28 from Cohort B (post-first dose only)
were also analyzed in support of the EUA filing, including
randomized data on systemic infusion-related and hypersensitivity
reactions, as shown in Table 2. As of Day 28, there were no
observations of anaphylaxis in the Cohort B VYD222 arm. Unblinded
safety data in Cohort B were not available yet after Day 28.
Table 2. 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) –
Systemic infusion-related reactions and hypersensitivity
reactions
Cohort B (n=479) |
VYD222 First Dose (n=317) |
Placebo First Dose (n=162) |
Systemic infusion-related and hypersensitivity reactions |
4 total (4/317 =1%)(3 mild and 1 moderate) |
0 total |
Other than systemic infusion-related reactions and
hypersensitivity reactions described previously for Cohort A, the
most common (≥2%) treatment-emergent adverse events in Cohort A
across both the first and second dose cumulatively, irrespective of
causality, observed with VYD222 in participants who have
moderate-to-severe immune compromise in CANOPY were upper
respiratory tract infection (6%), infusion site
infiltration/extravasation/vein rupture (5%), viral infection (4%),
influenza-like illness (3%), fatigue (3%), headache (2%), nausea
(2%), and local infusion site reactions (2%).
This press release features downloadable multimedia content.
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Conference Call & Webcast
Invivyd will host a conference call and webcast today, Friday,
March 22 at 4pm ET. A live audio webcast will be available at
https://investors.invivyd.com/. Listeners can register for the
webcast via this link. Analysts wishing to participate in the
question-and-answer session should use this link. A replay of the
webcast will be available in the investor section of the company’s
website approximately two hours after the end of the call. Those
who plan on participating are advised to join 15 minutes prior to
the start time.
IMPORTANT SAFETY INFORMATION
WARNING: ANAPHYLAXIS
- Anaphylaxis has been observed
with PEMGARDA in 0.6% (4/623) of participants in a
clinical trial.
- Anaphylaxis was reported during the first and
second infusion of PEMGARDA.
- Anaphylaxis can be life-threatening.
- Prior to administering PEMGARDA, consider the potential
benefit of COVID-19 prevention along with the risk of
anaphylaxis.
- Administer PEMGARDA only in settings in which
healthcare providers have immediate access to medications to
treat anaphylaxis and the ability to activate the emergency medical
system (EMS), as necessary.
- Clinically monitor individuals during the infusion and
for at least two hours after completion of
the infusion.
- Discontinue PEMGARDA immediately if signs or
symptoms of anaphylaxis or any severe systemic reaction are
observed and initiate appropriate medications and/or supportive
therapy.
CONTRAINDICATIONS
PEMGARDA is contraindicated in individuals with previous severe
hypersensitivity reactions, including anaphylaxis, to any component
of PEMGARDA.
WARNINGS AND PRECAUTIONS
Hypersensitivity Including Anaphylaxis and
Infusion-Related ReactionsSerious hypersensitivity
reactions, including anaphylaxis, have been observed with PEMGARDA.
If signs and symptoms of a clinically significant hypersensitivity
reaction or anaphylaxis occur, immediately discontinue
administration, and initiate appropriate medications and/or
supportive therapy. Clinically monitor individuals during infusion
and observe for at least two hours after infusion is complete.
Risk of Cross-Hypersensitivity
With COVID-19 VaccinesPEMGARDA contains
polysorbate 80, which is in some COVID-19 vaccines and is
structurally similar to polyethylene glycol (PEG), an ingredient in
other COVID-19 vaccines. For individuals with a history of severe
hypersensitivity reaction to a COVID-19 vaccine, consider
consultation with an allergist-immunologist prior to PEMGARDA
administration.
Risk for COVID-19 Due to SARS-CoV-2 Viral Variants Not
Neutralized by PEMGARDACertain SARS-CoV-2 viral variants
may emerge that are not neutralized by monoclonal antibodies such
as PEMGARDA. PEMGARDA may not be effective at preventing COVID-19
caused by these SARS-CoV-2 viral variants. Inform individuals of
the increased risk, compared to other variants, for COVID-19 due to
emergent SARS-CoV-2 viral variants not neutralized by PEMGARDA. If
signs and symptoms of COVID-19 occur, advise individuals to test
for COVID-19 and seek medical attention, including starting
treatment for COVID-19 as appropriate.
ADVERSE REACTIONSThe most common adverse events
(all grades, incidence ≥2%) observed in participants who have
moderate-to-severe immune compromise treated with PEMGARDA included
systemic and local infusion-related or hypersensitivity reactions,
upper respiratory tract infection, viral infection, influenza-like
illness, fatigue, headache, and nausea.
USE IN SPECIFIC POPULATIONS
PregnancyThere are insufficient data to
evaluate a drug-associated risk of major birth defects,
miscarriage, or adverse maternal or fetal outcomes. PEMGARDA should
only be used during pregnancy if the potential benefit outweighs
the potential risk for the mother and the fetus.
LactationThere are no available data on the
presence of PEMGARDA in human or animal milk, the effects on the
breastfed infant, or the effects on milk production. Maternal IgG
is known to be present in human milk. The developmental and health
benefits of breastfeeding should be considered along with the
mother’s clinical need for PEMGARDA and any potential adverse
effects on the breastfed infant from PEMGARDA.
Pediatric UsePEMGARDA is not authorized for use
in pediatric patients less than 12 years of age or weighing less
than 40 kg. The safety and effectiveness of PEMGARDA has not been
established in pediatrics.
EMERGENCY USE AUTHORIZATION (EUA) FOR
PEMGARDA
The U.S. Food and Drug Administration (FDA) has issued an EUA
for the emergency use of the unapproved product PEMGARDA for the
pre-exposure prophylaxis of COVID-19 in adults and adolescents (12
years of age and older weighing at least 40 kg):
- Who are not currently infected with SARS-CoV-2 and who have not
had a known recent exposure to an individual infected with
SARS-CoV-2 and
- Who have moderate-to-severe immune compromise due to a medical
condition or receipt of immunosuppressive medications or treatments
and are unlikely to mount an adequate response to
COVID-19 vaccination.
LIMITATIONS OF AUTHORIZED USE
- PEMGARDA is not authorized for use:
- For treatment of COVID-19, or
- For post-exposure prophylaxis of COVID-19 in individuals who
have been exposed to someone infected with SARS-CoV-2.
- Pre-exposure prophylaxis with PEMGARDA is not a substitute for
vaccination in individuals for whom COVID-19 vaccination is
recommended. Individuals for whom COVID-19 vaccination is
recommended, including individuals with moderate-to-severe immune
compromise who may derive benefit from COVID-19 vaccination, should
receive COVID-19 vaccination.
- In individuals who have recently received a COVID-19 vaccine,
PEMGARDA should be administered at least 2 weeks after
vaccination.
PEMGARDA may only be prescribed for an individual patient by
physicians, advanced practice registered nurses, and physician
assistants that are licensed or authorized under state law to
prescribe drugs.
PEMGARDA has been authorized by FDA for the emergency use
described above.
PEMGARDA is not FDA-approved for any use, including use for
pre-exposure prophylaxis of COVID-19.
PEMGARDA is authorized only for the duration of the declaration
that circumstances exist justifying the authorization of the
emergency use of PEMGARDA under Section 564(b)(1) of the Federal
Food Drug, and Cosmetic Act, 21 U.S.C. § 360bbb 3(b)(1),
unless the authorization is terminated or revoked sooner.
See full Fact Sheet for Healthcare Providers
and Fact Sheet for Patients, Parents, and
Caregivers for examples of medical conditions or
treatments that may result in moderate to severe immune compromise
and an inadequate immune response to COVID-19 vaccination, the
justification for emergency use of drugs during the COVID-19
pandemic, information on available alternatives, and additional
information on COVID-19. The FDA Letter of
Authorization is also available for reference.
The prescribing healthcare provider and/or the provider’s
designee is/are responsible for mandatory reporting of all serious
adverse events* and medication errors potentially related to
PEMGARDA within 7 calendar days from the healthcare provider’s
awareness of the event, using FDA Form 3500 (for information on how
to access this form, see below). The FDA requires that such
reports, using FDA Form 3500, include the following:
- Patient demographics and baseline characteristics (e.g.,
patient identifier, age or date of birth, sex, weight, ethnicity,
and race).
- A statement “PEMGARDA use for the pre-exposure prophylaxis of
COVID-19 under Emergency Use Authorization (EUA)” under the
“Describe Event, Problem, or Product Use/Medication
Error” heading.
- Information about the serious adverse event or medication error
(e.g., signs and symptoms, test/laboratory data, complications,
timing of drug initiation in relation to the occurrence of the
event, duration of the event, treatment required to mitigate the
event, evidence of event improvement/disappearance after stopping
or reducing the dosage, evidence of event reappearance after
reintroduction, clinical outcomes).
- Patient’s preexisting medical conditions and use of concomitant
products.
- Information about the product (e.g., dosage, route of
administration, NDC #).
Submit serious adverse event and medication error reports using
FDA Form 3500 to FDA MedWatch using one of the following
methods:
- Complete and submit the report online:
www.fda.gov/medwatch/report.htm.
- Complete and submit a postage-paid FDA Form 3500
(https://www.fda.gov/media/76299/download) and return by:
- Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787,
or
- Fax to 1-800-FDA (332)-0178, or
- Call 1-800-FDA (332)-1088 to request a reporting form.
In addition, please provide a copy of all FDA MedWatch forms
to:
Invivyd, Inc.Email: pv@invivyd.comOr
call Invivyd, Inc. at 1-800-890-3385 to report serious adverse
events.
The prescribing healthcare provider and/or the provider’s
designee is/are responsible for mandatory responses to requests
from FDA for information about serious adverse events and
medication errors following receipt of PEMGARDA.
*Serious adverse events are defined as:
- Death
- A life-threatening adverse event
- Inpatient hospitalization or prolongation of existing
hospitalization
- A persistent or significant incapacity or substantial
disruption of the ability to conduct normal life functions
- A congenital anomaly/birth defect
- Other important medical events, which may require a medical or
surgical intervention to prevent death, a life-threatening event,
hospitalization, disability, or congenital anomaly
You may report side effects related to Invivyd, Inc. products by
sending an email to medinfo@invivyd.com.
About PEMGARDA
PEMGARDA (pemivibart), formerly known as VYD222, is a half-life
extended investigational monoclonal antibody (mAb). PEMGARDA 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. PEMGARDA was designed for
broad activity and has demonstrated in vitro neutralizing activity
in pseudotyped virus-like particle and authentic virus
neutralization assays against major SARS-CoV-2 variants, including
JN.1, the dominant variant in the U.S. currently according to
estimates from the Centers for Disease Control and Prevention.
PEMGARDA targets the SARS-CoV-2 spike protein receptor binding
domain (RBD), thereby inhibiting virus attachment to the human ACE2
receptor on host cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use
is an investigational mAb with emergency use authorization in the
U.S. for the pre-exposure prophylaxis (prevention) of COVID-19 in
adults and adolescents (12 years of age and older weighing at least
40 kg) who have moderate-to-severe immune compromise due to certain
medical conditions or receipt of certain immunosuppressive
medications or treatments and are unlikely to mount an adequate
immune response to COVID-19 vaccination. Recipients should not be
currently infected with or have had a known recent exposure to an
individual infected with SARS-CoV-2. Anaphylaxis has been observed
with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers
includes a boxed warning for anaphylaxis. The most common adverse
events (all grades, incidence ≥2%) observed in participants who
have moderate-to-severe immune compromise treated with PEMGARDA
included systemic and local infusion-related or hypersensitivity
reactions, upper respiratory tract infection, viral infection,
influenza-like illness, fatigue, headache, and nausea.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is commercial-stage 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. INVYMAB is designed to facilitate the rapid, serial
generation of new monoclonal antibodies (mAbs) to keep pace with
evolving viral threats. In March 2024, Invivyd received emergency
use authorization (EUA) from the U.S. FDA for its first mAb in a
planned series of innovative antibody candidates. Visit
https://invivyd.com/ to learn more.
References
- Centers for Disease Control and
Prevention. People Who Are Immunocompromised. Available at:
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-who-are-immunocompromised.html.
Last accessed January 2024.
- Evans, Rachael A et al. “Impact of
COVID-19 on immunocompromised populations during the Omicron era:
insights from the observational population-based INFORM study.” The
Lancet regional health. Europe vol. 35 100747. 13 Oct. 2023.
- Singson, Jason Robert C et al.
“Factors Associated with Severe Outcomes Among Immunocompromised
Adults Hospitalized for COVID-19 - COVID-NET, 10 States, March
2020-February 2022.” MMWR. Morbidity and mortality weekly report
vol. 71,27 878-884. 8 Jul. 2022.
- Centers for Disease Control and
Prevention. Covid Data Tracker. Available at:
https://covid.cdc.gov/covid-data-tracker/#variant-proportions. Last
accessed: March 2024.
- 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).
- Stadler, Eva et al. “Monoclonal
antibody levels and protection from COVID-19.” Nature
communications vol. 14,1 4545. 28 Jul. 2023,
doi:10.1038/s41467-023-40204-1.
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,”
“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
potential of PEMGARDA as a mAb for pre-exposure prophylaxis
(prevention) of COVID-19 in adults and adolescents who have
moderate-to-severe immune compromise; the company’s plans related
to the commercialization of PEMGARDA, including its expectations
regarding availability and supply of PEMGARDA; the ability of the
company’s INVYMAB platform approach to enable the rapid, serial
generation of durable mAbs targeting conserved epitopes that could
be deployed to keep pace with SARS-CoV-2 viral evolution or other
viral threats; the company’s ongoing research and clinical
development efforts and future plans, and the timing thereof; the
company’s expectation that PEMGARDA is the first mAb in a planned
series of innovative antibody candidates; the potential
repeatability of an immunobridging trial design for mAb candidates
to help address the need to mitigate ongoing viral evolution; the
company’s commitment to ongoing process improvement while working
with global regulatory agencies with the aim to increase the speed
and efficiency of new mAb candidate development; the future of the
COVID-19 landscape, particularly for vulnerable populations; the
company’s aim to ensure vulnerable populations have continuous
access to innovative antibody therapies; the ongoing in vitro
neutralizing activity of PEMGARDA 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 company’s preliminary estimate of its cash and
cash equivalents balance as of December 31, 2023; the anticipated
timeline of the company’s cash runway; 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: how long the EUA granted by the FDA
for PEMGARDA will remain in effect and whether the EUA is revoked
or revised by the FDA; the company’s ability to build and maintain
sales, marketing and distribution capabilities to successfully
commercialize PEMGARDA; changes in expected or existing
competition; the timing and progress of the company’s discovery,
preclinical and clinical development activities; the outcome of the
company’s engagement with regulators regarding mAb candidate
development; whether the company is able to utilize an
immunobridging trial design for future mAb candidates; 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; unexpected safety or
efficacy data observed during preclinical studies or clinical
trials; the ability to maintain a continued acceptable safety,
tolerability and efficacy profile of PEMGARDA or any other product
candidate following regulatory authorization or approval; the
predictability of clinical success of the company’s 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, and interim data are subject
to further analysis; 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 PEMGARDA 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 complexities of manufacturing mAb therapies; the company’s
dependence on third parties to manufacture, label, package, store
and distribute clinical and commercial supplies of its product
candidates; whether the company is able to provide sufficient
commercial supply of PEMGARDA to meet market demand; whether the
company can obtain and maintain third-party coverage and adequate
reimbursement for PEMGARDA or any other product candidate; the
company’s ability to leverage its INVYMAB platform approach to
enable the rapid, serial generation of durable mAbs that keep pace
with SARS-CoV-2 viral evolution or other viral threats; any
litigation and other proceedings or government investigations
relating to the company; any change in the preliminary estimate of
the company’s cash and cash equivalents balance as of December 31,
2023 upon completion of the company’s audited financial statements
for the year ended December 31, 2023; 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:
Media Relations(781) 208-1747media@invivyd.comInvestor
Relations(781) 208-1747investors@invivyd.com
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