Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage
biotechnology company advancing differentiated biologics for the
treatment of atopic dermatitis (AD), asthma, chronic obstructive
pulmonary disease and other inflammatory and immunology (I&I)
indications, today announced two abstracts co-written with Apogee’s
research partner, Paragon Therapeutics, Inc., highlighting the
company’s lead product candidate, APG777, a fully optimized and
half-life extended antibody targeting IL-13 for the treatment of
AD, have been accepted as e-posters at the upcoming 2023 European
Academy of Dermatology and Venereology (EADV) Congress, held
October 11-14, 2023, in Berlin, Germany and virtually.
“We are excited to share our preclinical findings on APG777
during the EADV Congress, which underscore the potential advantages
of APG777 over current therapeutic agents targeting IL-13,
including half-life,” said Carl Dambkowski, M.D., Chief Medical
Officer of Apogee Therapeutics. “With currently available biologic
treatments dosed every 2 or 4 weeks for patients with atopic
dermatitis, the potential significant reduction in injection burden
to every two- or three-month dosing that we believe APG777 will
offer could be paradigm shifting for atopic dermatitis. We are
eagerly awaiting our Phase 1 clinical trial results next year and
are enthusiastic about exploring its potential in addressing a
spectrum of I&I conditions beyond AD, including asthma and
more.”
The e-posters will be available for viewing during the EADV
Congress beginning on Wednesday, October 11, 2023, and details are
as follows:
Title: APG777, a high-affinity humanized IgG1
mAb targeting IL-13, demonstrates prolonged half-life in non-human
primatesAuthors: Eric Zhu, Ph.D., Jason Oh, Ph.D.,
Carl Dambkowski, M.D. and Hussam Shaheen, Ph.D.
Title: APG777, a humanized IgG1 mAb, binds to
IL-13 with high affinity and potently blocks IL-13 signaling in
multiple in vitro assaysAuthors: Eric Zhu, Ph.D.,
Hussam Shaheen, Ph.D, Carl Dambkowski, M.D. and Jason Oh, Ph.D.
Full session details be accessed via the EADV program.
About APG777
APG777 is a novel, subcutaneous extended half-life monoclonal
antibody targeting IL-13 for the potential treatment of atopic
dermatitis (AD). In head-to-head preclinical studies, APG777 showed
equivalent or better potency to lebrikizumab in the inhibition of
IL-13 signaling. AD is a chronic inflammatory skin disorder that
affects approximately 40 million adults and 18 million children in
the United States, France, Germany, Italy, Japan, Spain and the
United Kingdom, 40 percent of which have moderate-to-severe
disease. Based on preclinical studies, Apogee believes that APG777
can be dosed either every two or every three months in maintenance,
which, if clinical trials are successful, would represent a
significant improvement compared to first generation IL-13
antibodies that are dosed every two to four weeks. A Phase 1
clinical trial of APG777 in healthy volunteers is ongoing, and the
company expects initial safety and pharmacokinetic data in
mid-2024. Pending data from the Phase 1 trial, the company
anticipates filing an IND application for a Phase 2 trial in AD,
which would begin in 2024. Based on initial clinical data, the
company may initiate a Phase 2 trial in asthma and plans to further
evaluate opportunities to develop APG777 for other I&I
indications, including alopecia areata (AA), chronic rhinosinusitis
with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU),
eosinophilic esophagitis (EoE) and prurigo nodularis (PN).
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company
seeking to develop differentiated biologics for the treatment of
atopic dermatitis (AD), asthma, chronic obstructive pulmonary
disease (COPD) and other inflammatory and immunology indications
with high unmet need. Apogee’s antibody programs are designed to
overcome limitations of existing therapies by targeting
well-established mechanisms of action and incorporating advanced
antibody engineering to optimize half-life and other properties.
The company’s two most advanced programs are APG777 and APG808,
which are being initially developed for the treatment of AD and
COPD, respectively. Based on a broad pipeline and depth of
expertise, the company believes it can deliver value and meaningful
benefit to patients underserved by today’s standard of care.
About Paragon Collaboration
In February 2022, Apogee entered into an antibody discovery
option and license agreement with Paragon Therapeutics, Inc.
(Paragon). As part of the agreement, Paragon identifies, evaluates
and develops antibodies directed against certain mutually agreed
therapeutic targets of interest to Apogee. The collaboration
currently includes three selected targets, IL-13, IL-4Rα, and
OX40L. Apogee has exercised its option for each research program
and has been granted an exclusive, worldwide license to develop,
manufacture and commercialize the antibodies and products directed
to the selected targets. From time to time, Apogee can choose to
add additional targets to the collaboration by mutual agreement
with Paragon.
Forward Looking Statements
Certain statements in this press release may constitute
“forward-looking statements” within the meaning of the federal
securities laws, including, but not limited to, our expectations
regarding plans for our current and future product candidates and
programs, plans for our current and future clinical trials, plans
for clinical trial design, the anticipated timing of the initiation
of and results from our clinical trials, potential clinical benefit
and half-life of APG777 and any other potential programs, potential
additional indications for APG777. Words such as “may,” “might,”
“will,” “objective,” “intend,” “should,” “could,” “can,” “would,”
“expect,” “believe,” “design,” “estimate,” “predict,” “potential,”
“develop,” “plan” or the negative of these terms, and similar
expressions, or statements regarding intent, belief, or current
expectations, are forward-looking statements. While Apogee believes
these forward-looking statements are reasonable, undue reliance
should not be placed on any such forward-looking statements, which
are based on information available to the company on the date of
this release. These forward-looking statements are based upon
current estimates and assumptions and are subject to various risks
and uncertainties (including, without limitation, those set forth
in Apogee’s filings with the U.S. Securities and Exchange
Commission (the SEC)), many of which are beyond the company’s
control and subject to change. Actual results could be materially
different. Risks and uncertainties include: global macroeconomic
conditions and related volatility, expectations regarding the
initiation, progress, and expected results of our preclinical
studies, clinical trials and research and development programs;
expectations regarding the timing, completion and outcome of our
clinical trials; the unpredictable relationship between preclinical
study results and clinical study results; the timing or likelihood
of regulatory filings and approvals; liquidity and capital
resources; and other risks and uncertainties identified in our
Registration Statement on Form S-1, as amended, declared effective
by the SEC on July 13, 2023, and subsequent disclosure documents we
may file with the SEC. Apogee claims the protection of the Safe
Harbor contained in the Private Securities Litigation Reform Act of
1995 for forward-looking statements. Apogee expressly disclaims any
obligation to update or alter any statements whether as a result of
new information, future events or otherwise, except as required by
law.
Investor Contacts:
Noel KurdiVP, Investor RelationsApogee
TherapeuticsNoel.kurdi@apogeetherapeutics.com
Alex StrausTHRUST Strategic
Communicationsalex@thrustsc.com
Media Contact:
Dan Budwick1AB Mediadan@1abmedia.com
Apogee Therapeutics (NASDAQ:APGE)
Historical Stock Chart
From May 2024 to Jun 2024
Apogee Therapeutics (NASDAQ:APGE)
Historical Stock Chart
From Jun 2023 to Jun 2024