Invivyd Presented Joint Industry Rationale on Potential Expedited Development Pathways for Monoclonal Antibodies at FDA-EMA Workshop
19 Dezember 2022 - 1:00PM
Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical
company on a mission to protect humanity from serious viral
respiratory diseases, was invited to participate in an FDA-EMA
workshop on SARS-CoV-2 monoclonal antibodies held on December 15,
2022. Invivyd's chief scientific officer, Laura Walker, Ph.D.,
alongside Eli Lilly and Company and Regeneron Pharmaceuticals,
Inc., presented a joint industry approach for anti-spike monoclonal
antibody development to keep pace with SARS-CoV-2 variants. The
meeting featured presentations by scientists, clinicians,
regulators, and industry representatives to discuss alternative
strategies to support the expedited availability of novel
monoclonal antibody therapies including those based on development
stage products that have reported positive safety and efficacy data
in clinical trials.
The industry presentation highlighted the significant unmet
medical need for therapeutic options to prevent and treat COVID-19
along with scientifically sound, data driven policy change
recommendations to shorten development timelines and keep pace with
the rapid evolution of variants.
“There is a sound scientific basis for relying on evidence from
first generation mAbs and vaccines to support development of new
mAbs through the use of standardized neutralization assays to
determine correlation of neutralization titers and protection
against the development of symptomatic SARS-CoV-2 infection,” said
Laura Walker, Ph.D. “We are very pleased that both the FDA and
EMA dedicated time listening to industry & academic experts on
potential pathways to expedite the availability of new products
that retain activity against circulating strains,” added Dr.
Walker.
About Invivyd(Nasdaq: IVVD)Invivyd, Inc.,
formerly Adagio Therapeutics (Nasdaq: ADGI), is a
biopharmaceutical company on a mission to protect humanity from
serious viral respiratory diseases. The company is developing
antibodies to transcend the limits of naturally occurring immunity
and provide superior protection from viral diseases, beginning
with COVID-19. Invivyd’s technology works at the intersection
of evolutionary virology, predictive modeling, and
antibody engineering, and is designed to identify
high-quality, long-lasting antibodies with a high barrier to viral
escape. The company is generating a robust pipeline of products
for use in both prevention and treatment of disease. NVD200,
Invivyd’s first antibody combination product candidate for the
prevention and treatment of COVID-19, includes a re-engineered
version of adintrevimab, an investigational monoclonal antibody
which demonstrated clinically meaningful results against multiple
variants of concern in global Phase 2/3 clinical trials for the
prevention and treatment of COVID-19, prior to the emergence of
Omicron. The safety and efficacy of adintrevimab have not been
established. The company also has multiple discovery stage
candidates for the prevention of seasonal influenza.
Visit www.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 ability for Invivyd,
other companies or combination of companies and industry
representatives to influence regulators to change or adopt new
development pathways or timelines; the interest or acceptance by
regulatory authorities of regulatory and clinical strategies to
support potentially expedited development of novel monoclonal
antibody therapies; the potential for success and or expedited
discovery, development, or commercialization of antibody therapies
for COVID-19; the continued unmet need for prevention and treatment
of COVID-19; the viability and acceptability of new regulatory
strategy, policy or approach to drug development and the potential
of the same to maintain pace with changing COVID-19 variants; the
future of the COVID-19 landscape including the expectation of
continued evolution and emergence of new variants and subvariants;
our ongoing research and clinical development plans and the timing
thereof; our plans to advance adintrevimab, NVD200, or other early
stage candidates as a potential prophylaxis and treatment option
for COVID-19, including disease caused by most variants, as either
a single or combination agent, including our intention to initiate
clinical development of NVD200 in the first quarter of 2023; the
potential for adintrevimab and NVD200 to demonstrate activity
against predominant SARS-CoV-2 variant(s) in the U.S. and globally;
our plans, technology and resources to develop therapeutic or
preventative options for other infectious diseases, such as
additional coronaviruses and seasonal influenza, in the U.S. and
globally; and other statements that are not historical fact. We may
not actually achieve the plans, intentions or expectations
disclosed in our forward-looking statements and you should not
place undue reliance on our forward-looking statements. These
forward-looking statements involve risks and uncertainties that
could cause our actual results to differ materially from the
results described in or implied by the forward-looking statements,
including, without limitation: the ability for Invivyd and/or other
companies, scientists, clinicians or industry representatives to
impact the strategy, policy or approach to drug development drafted
or applied by regulatory authorities, including the FDA and EMA;
the impact of any such change on the speed or success of
development and commercialization of antibodies for the prevention
and/or treatment of COVID-19; the ability of the company to
generate and utilize tools to discover and develop antibodies to
treat current and potential future variants;; the impacts of the
COVID-19 pandemic on our business and those of our collaborators,
our clinical trials and our financial position; unexpected safety
or efficacy data observed during preclinical studies or clinical
trials; the predictability of clinical success of adintrevimab,
NVD200, or other pipeline candidates or combination of candidates
based on neutralizing activity in pre-clinical studies; variability
of results in models used to predict activity against SARS-CoV-2
variants of concern; clinical trial site activation or enrollment
rates that are lower than expected; changes in expected or existing
competition; changes in the regulatory environment; the
uncertainties and timing of the regulatory approval process,
including the outcome of our discussions with regulatory
authorities concerning our clinical trials; whether adintrevimab,
NVD200, or any other pipeline candidate or combination of
candidates is able to demonstrate activity against predominant
SARS-CoV-2 variant(s) in the U.S. and globally; whether we are able
to successfully submit an emergency use authorization in the
future, and the outcome of any such emergency use authorization
submission; whether research and development efforts will improve
efficacy of adintrevimab against predominant variants or identify
additional monoclonal antibodies or combination of antibodies for
the prevention and treatment of COVID-19 and other infectious
diseases; whether research and development efforts will identify
and result in safe and effective therapeutic or preventative
options for other infectious diseases in the U.S. or globally and
whether we have adequate funding to meet future operating expenses
and capital expenditure requirements. Other factors that may cause
our 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 our Annual Report on
Form 10-K for the year ended December 31, 2021 and our Quarterly
Report on Form 10-Q for the quarter ended September 30, 2022, each
filed with the Securities and Exchange Commission (the “SEC”), and
in our other filings with the SEC, and in Invivyd’s future reports
to be filed with the SEC and available at www.sec.gov. Such risks
may be amplified by the impacts of the COVID-19 pandemic.
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.
Media Contact: Tony Berry, Evoke Canale 774-317-0422
anthony.berry@evokegroup.com
Investor Contact:Chris Brinzey, ICR
Westwicke339-970-2843chris.brinzey@westwicke.com
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