Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a
mission to protect the vulnerable from serious viral infectious
diseases, today announced that the company’s Board of Directors has
appointed Jeremy Gowler as Interim Chief Executive Officer (CEO),
effective immediately, while the Board institutes a search for a
permanent CEO. Mr. Gowler succeeds Dave Hering.
“The Invivyd Board of Directors is positioning the company for
its next phase of growth,” said Marc Elia, Chairperson. “Invivyd is
poised to lead a brand-new paradigm in delivering novel, impactful
monoclonal antibody (mAb) therapies for the pre-exposure
prophylaxis (PrEP) of COVID-19, and we wish to fully unlock this
capability and associated value creation. In the interim, we are
pleased to align the day-to-day leadership of the company with
Jeremy, who is primarily responsible for our commercial execution,
and I personally look forward to partnering with him on the success
of the company. With PEMGARDA™, our novel pipeline mAb candidates
for COVID PrEP, and our strong balance sheet, we believe we have a
highly attractive and undervalued base on which to build a
class-leading company in virology. The Board would like to thank
Dave for his contributions in bringing the company from the
research phase through first emergency use authorization.”
“I am eager to work closely with the Invivyd Board and
strengthen engagement with key internal and external stakeholders,
while remaining focused on delivering a successful launch of
PEMGARDA. Invivyd has tremendous potential to reach and support
vulnerable populations and their caregivers with PEMGARDA and
beyond,” said Mr. Gowler.
About PEMGARDA
PEMGARDA™ (pemivibart) 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 provided evidence of clinical efficacy in a
global Phase 2/3 clinical trial for the prevention of COVID-19.
PEMGARDA 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 that has not been approved, but has been
authorized for emergency use by the U.S. FDA under an EUA 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. PEMGARDA is not authorized for use for treatment
of COVID-19 or post-exposure prophylaxis of COVID-19. 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. For additional information, please see the PEMGARDA full
product Fact Sheet for Healthcare Providers, including important
safety information and boxed warning.
To support the EUA for PEMGARDA, an immunobridging approach was
used to determine if PEMGARDA may be effective for pre-exposure
prophylaxis of COVID-19. Immunobridging is based on the serum virus
neutralizing titer-efficacy relationships identified with other
neutralizing human mAbs against SARS-CoV-2. This includes
adintrevimab, the parent mAb of pemivibart, and other mAbs that
were previously authorized for EUA. There are limitations of the
data supporting the benefits of PEMGARDA. Evidence of clinical
efficacy for other neutralizing human mAbs against SARS-CoV-2 was
based on different populations and SARS-CoV-2 variants that are no
longer circulating. Additionally, the variability associated with
cell-based EC50 value determinations, along with limitations
related to pharmacokinetic data and efficacy estimates for the mAbs
in prior clinical trials, impact the ability to precisely estimate
protective titer ranges.
The emergency use of PEMGARDA is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products
during the COVID-19 pandemic under Section 564(b)(1) of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the declaration is terminated or authorization revoked sooner.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is a 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.
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 anticipated
benefits of the company’s management transition; the company’s
anticipated next phase of growth, future prospects, and potential
value creation; the company’s expectations for the commercial
launch of PEMGARDA; the potential of the company to reach and
support vulnerable populations and their caregivers; the company’s
ongoing research and clinical development efforts; 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 design of
the company’s INVYMAB platform approach to facilitate the rapid,
serial generation of new mAbs to keep pace with evolving viral
threats; the company’s expectation that PEMGARDA is the first mAb
in a planned series of innovative, novel, impactful antibody
candidates; 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: potential challenges or disruptions to the business as
a result of the company’s management transition; 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
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
facilitate the rapid, serial generation of new mAbs to keep pace
with evolving viral threats; any litigation and other proceedings
or government investigations relating to the company; 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, 2023
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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