Adagio Therapeutics, Inc., (Nasdaq: ADGI), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of antibody-based solutions for infectious
diseases with pandemic potential, today summarized recent findings
reported in three separate publications that show ADG20, its lead
monoclonal antibody (mAb), has neutralization activity against the
Omicron (B.1.1.529) variant of SARS-CoV-2, and outlined initiatives
to address current and future SARS-CoV-2 variants of concern.
Adagio is evaluating ADG20 in its global Phase 2/3 clinical trials
for both the prevention and treatment of COVID-19. Adagio is
engaging with the U.S. Food and Drug Administration (FDA) regarding
potential protocol updates to its global Phase 2/3 clinical trials,
including an increased dose of ADG20 for the potential prevention
and treatment of COVID-19 resulting from the Omicron variant.
ADG20 Neutralizing Activity Against
OmicronRecently published in vitro studies examined the
neutralization potencies of large panels of mAbs against the
Omicron variant in both authentic and pseudovirus assays. Findings
across all three studies show that among mAbs in late-stage
clinical development or with Emergency Use Authorization (EUA),
ADG20 is one of only a few mAbs that demonstrated neutralizing
activity against Omicron. Across two distinct authentic
neutralization assays against Omicron, the data show that ADG20 had
an IC50, a measurement of neutralization potency, of approximately
0.4 to 1.1 µg/mL, which is comparable with the two other active
mAbs, sotrovimab and AZD7742.
“What is critical to assessing potential clinical effectiveness
of SARS-CoV-2 mAbs is the neutralization potency by the mAb against
a specific variant. While findings may show that ADG20 has reduced
potency against Omicron when compared to its high potency against
all other variants of concern, including Delta, the data support
that ADG20 is among the few mAbs to demonstrate neutralizing
activity against the Omicron variant and warrants its continued
development,” said Laura Walker, Ph.D., chief scientific officer
and co-founder of Adagio.
These data add to previously reported in vitro data from a
variety of preclinical studies that showed that ADG20 retains
activity against other variants of concern including Alpha, Beta,
Delta and Gamma, and that ADG20 retains neutralizing activity
against a diverse panel of circulating SARS-CoV-2 variants,
including the Lambda, Mu and Delta plus variants.
Clinical Trial Update to Address OmicronAdagio
is continuing evaluation of ADG20 in its EVADE and STAMP clinical
trials. Adagio is engaging with the FDA on dosing strategy,
including an increased dose of ADG20 and other protocol updates in
light of the spread of the Omicron variant. Adagio is pausing the
enrollment of new patients in the 300 mg dose arm in both
clinical trials as the company updates its protocols. Follow-up and
monitoring of patients previously administered ADG20 are continuing
per the original protocols.
Additional Efforts to Address Omicron and Future
VariantsIn addition to its clinical trial updates, Adagio
is pursuing multiple strategies to address both Omicron and
potential future variants that may emerge. Leveraging its exclusive
partnership with Adimab LLC, a global leader in antibody
engineering, Adagio is exploring the potential to engineer ADG20 to
further improve binding to the Omicron variant to enhance its
neutralization potency against Omicron while retaining its broad
neutralization against other SARS-CoV-2 variants of concern. In
parallel, Adagio is assessing several hundred mAbs from its
proprietary library of previously isolated SARS-CoV-2 antibodies
for their neutralization potency against Omicron. Such an
additional neutralizing mAb could be developed as a stand-alone
product or as part of a combination approach. These efforts are
underway, and the company anticipates preliminary findings from its
research in the first quarter of 2022.
“SARS-CoV-2 is a quickly evolving virus, and at Adagio, we are
committed to adapting just as quickly. It is abundantly clear that
no single product will fully address the evolving nature of the
COVID-19 pandemic, and that multiple preventative and therapeutic
solutions are needed. Based on both in-house data and third-party
findings, we are confident that ADG20 can be an important tool in
the fight against this virus,” added Tillman Gerngross, Ph.D.,
co-founder and chief executive officer of Adagio.
About ADG20ADG20, an investigational monoclonal
antibody targeting the spike protein of SARS-CoV-2 and related
coronaviruses, is being evaluated in global clinical trials for the
prevention and treatment of COVID-19, the disease caused by
SARS-CoV-2. ADG20 was designed to possess high potency and broad
neutralization activity against SARS-CoV-2 and additional clade 1
sarbecoviruses by targeting a highly conserved epitope in the
receptor binding domain. ADG20 was further engineered to provide an
extended half-life for durable protection. In vitro data from a
variety of preclinical studies have shown that ADG20 retains
neutralizing activity against all known SARS-CoV-2 variants of
concern. In a Phase 1 trial, ADG20 was well-tolerated with no
safety signals identified through a minimum of three months
follow-up across all cohorts. ADG20 has not been approved for use
in any country, and safety and efficacy have not yet been
established.
About Adagio TherapeuticsAdagio (Nasdaq: ADGI)
is a clinical-stage biopharmaceutical company focused on the
discovery, development and commercialization of antibody-based
solutions for infectious diseases with pandemic potential,
including COVID-19 and influenza. The company’s portfolio of
antibodies has been optimized using Adimab’s industry-leading
antibody engineering capabilities and is designed to provide
patients and clinicians with the potential for a powerful
combination of potency, breadth, durable protection (via half-life
extension), manufacturability and affordability. Adagio’s portfolio
of SARS-CoV-2 antibodies includes multiple non-competing, broadly
neutralizing antibodies with distinct binding epitopes, led by
ADG20. Adagio has secured manufacturing capacity for the production
of ADG20 with third-party contract manufacturers to support the
completion of clinical trials and initial commercial launch,
ensuring the potential for broad accessibility to people around the
world, if authorized or approved for use. For more information,
please visit www.adagiotx.com.
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,” “expects,” “intends,” “projects,” and
“future” or similar expressions are intended to identify
forward-looking statements. Forward-looking statements include
statements concerning, among other things, the timing, progress and
results of our preclinical studies and clinical trials of ADG20,
including the initiation, modification and completion of studies or
trials and related preparatory work, including our plans to
evaluate dosing regimens and other protocol updates in our clinical
trials, the period during which the results of our clinical trials
and other studies and research activities will become available,
and our research and development programs; our ability to obtain
and maintain regulatory approvals for our product candidates; our
pursuit of other strategies to address the Omicron variant,
including modification of clinical trial protocols; 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
impacts of the COVID-19 pandemic on our business, clinical trials
and financial position, unexpected safety or efficacy data observed
during preclinical studies or clinical trials, the predictability
of clinical success of ADG20 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, and the uncertainties and timing of the
regulatory approval process, including the outcome of our
discussions with regulatory authorities concerning our Phase 2/3
clinical trials. 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 Adagio’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2021 and in Adagio’s
future reports to be filed with the SEC. 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 Adagio undertakes no duty to update such
information except as required under applicable law.
Contacts:Media Contact:Dan
Budwick, 1ABDan@1abmedia.com
Investor Contact:Monique Allaire, THRUST
Strategic Communicationsmonique@thrustsc.com
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