Adagene Announces FDA Clearance to Proceed with Phase 1b/2 Trial of Anti-CTLA-4 ADG126 SAFEbody® in Combination Therapy With Anti-PD-1 Antibody Pembrolizumab
March 16 2022 - 7:00AM
Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the
discovery and development of novel antibody-based therapies, today
announced FDA clearance to proceed with a Phase 1b/2 clinical trial
of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in
combination with the anti-PD-1 antibody pembrolizumab. The global
trial (ADG126-P001 / KEYNOTE-C98) will evaluate patients with
advanced/metastatic solid tumors at multiple sites in the U.S. and
Asia Pacific (APAC).
ADG126 SAFEbody is designed for conditional activation in the
tumor microenvironment (TME), as well as to enhance the efficacy
profile by potent Treg depletion and to maintain its physiological
function by soft ligand blocking in order to expand the therapeutic
index and further address safety concerns with existing CTLA-4
therapies.
“The FDA clearance of this trial represents a major step forward
in our wholly-owned CTLA-4 program. It builds on a strong safety
profile for ADG126 SAFEbody and its parental antibody ADG116,
respectively, as a single agent and the ability to achieve doses
that may unlock the full potential of CTLA-4 as a proven target for
strong ADCC-mediated Treg depletion in the TME. Our goal is to
establish the CTLA-4 pathway as the cornerstone of cancer treatment
in both single-agent and combination regimens,” said Peter Luo,
Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene.
“We are excited to initiate our clinical trial evaluating
combination therapy with ADG126, which leverages SAFEbody precision
masking technology to address toxicity limitations. This
multi-regional trial of ADG126 with pembrolizumab also reflects our
commitment to bringing highly differentiated therapies to cancer
patients globally.”
SAFEbody technology is designed to address safety and
tolerability challenges associated with many antibody therapeutics
by using precision masking technology to shield the binding domain
of the biologic therapy. Through activation in the TME, this allows
for tumor-specific targeting of antibodies, while minimizing
on-target off-tumor toxicity in healthy tissues.
The ADG126-P001 trial is expected to dose the first patients
soon. The trial is designed to evaluate safety and tolerability,
and to determine the recommended Phase 2 dose for ADG126 in
combination with pembrolizumab. The trial will begin with
dose-escalation (ADG126 at 6 mg/kg) followed by dose expansion at
the recommended dose for early efficacy evaluation. A combination
cohort of ADG126 with the anti-PD-1 therapy, toripalimab is also
being initiated in Australia.
About AdageneAdagene Inc. (Nasdaq:
ADAG) is a platform-driven, clinical-stage biopharmaceutical
company committed to transforming the discovery and development of
novel antibody-based cancer immunotherapies.
Adagene combines computational biology and artificial
intelligence to design novel antibodies that address unmet patient
needs. Powered by its proprietary Dynamic Precision
Library (DPL) platform, composed of NEObody™, SAFEbody®, and
POWERbody™ technologies, Adagene’s highly differentiated pipeline
features novel immunotherapy programs. Adagene has forged
strategic collaborations with reputable global partners that
leverage its technology in multiple approaches at the vanguard of
science.
For more information, please
visit: https://investor.adagene.com.
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SAFEbody® is a registered trademark in the United
States, China, Australia, Japan, Singapore, and
the European Union.
Safe Harbor Statement
This press release contains forward-looking statements,
including statements regarding potential impact of combination
trial of ADG126 and Anti-PD-1 antibody pembrolizumab, the potential
implications of clinical data for patients, and Adagene’s
advancement of, and anticipated clinical activities, clinical
development, regulatory milestones, and commercialization of its
product candidates. Actual results may differ materially from those
indicated in the forward-looking statements as a result of various
important factors, including but not limited to Adagene’s ability
to demonstrate the safety and efficacy of its drug candidates; the
clinical results for its drug candidates, which may not support
further development or regulatory approval; the content and timing
of decisions made by the relevant regulatory authorities regarding
regulatory approval of Adagene’s drug candidates; Adagene’s ability
to achieve commercial success for its drug candidates, if approved;
Adagene’s ability to obtain and maintain protection of intellectual
property for its technology and drugs; Adagene’s reliance on third
parties to conduct drug development, manufacturing and other
services; Adagene’s limited operating history and Adagene’s ability
to obtain additional funding for operations and to complete the
development and commercialization of its drug candidates; Adagene’s
ability to enter into additional collaboration agreements beyond
its existing strategic partnerships or collaborations, and the
impact of the COVID-19 pandemic on Adagene’s clinical development,
commercial and other operations, as well as those risks more fully
discussed in the “Risk Factors” section in Adagene’s filings with
the U.S. Securities and Exchange Commission. All forward-looking
statements are based on information currently available to Adagene,
and Adagene undertakes no obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise, except as may be required
by law.
Investor & Media Contact:
Ami Knoefler
Adagene
650-739-9952
ir@adagene.com
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