Adagene Announces Publication at ASCO of Interim Monotherapy Dose Escalation Data Showing Compelling Safety Profile of Anti-CTLA-4 SAFEbody® ADG126, with Repeat Dosing Across Dose Levels
27 May 2022 - 7:00AM
Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the
discovery and development of novel antibody-based therapies, today
announced the publication of data showing the potential
best-in-class safety profile of its anti-CTLA-4 monoclonal antibody
(mAb), ADG126. Interim results from the Phase 1 dose escalation
portion of an ongoing Phase 1b/2 trial of ADG126 are published in
an abstract on the American Society of Clinical Oncology (ASCO)
meeting website in conjunction with the 2022 Annual Meeting taking
place in Chicago from June 3-7, 2022.
Key data in the abstract, titled “Phase 1 study of ADG126, a
novel masked anti-CTLA-4 SAFEbody, that combines tumor-localized
activation with strong Treg depletion and soft ligand blocking in
patients with advanced solid tumors,” include the following:
- In this dose escalation of 16 patients with advanced metastatic
solid tumors, approximately one third received three or more lines
of prior therapies, and approximately one third had progressed from
immuno-oncology (IO) therapy. ADG126 was administered to this
heavily pretreated patient population intravenously as monotherapy
once every three weeks at doses up to 10 mg/kg.
- No dose-limiting toxicities or treatment-related SAEs were
observed and only Grade 1 treatment related adverse events (TRAEs)
were reported with repeat dosing across all dose levels; fatigue
(19%) and pruritis (13%) were most common.
- Plasma pharmacokinetics (PK) were approximately linear and the
activated ADG126 accumulated steadily during repeat dosing across
different dose levels. As the first clinical data validating the
SAFEbody precision masking technology, the approximately 1.7-fold
increase in half-life of total ADG126 is reflective of prolonged
exposures of activated ADG126 in the tumor microenvironment
(TME).
- In an early indication of antitumor activity, two heavily
pretreated patients with cold tumors (one ovarian and one uveal
melanoma) showed durable reductions in target lesions (over 20%)
and increased CD8+ T cells post-dosing. After the seventh cycle of
ADG126 treatment at 1 mg/kg the ovarian cancer patient also showed
a 77% reduction in CA-125 levels, an established biomarker of
clinical benefit for ovarian patients. This activity is likely due
to the accumulation of activated ADG126 in the TME upon repeat
dosing at 1 mg/kg. The uveal melanoma patient was
resistant/refractory to prior IO-IO combination therapy, having
progressed on the combination of nivolumab and ipilimumab.
- At the data cut-off of February 15, 2022, stable disease was
seen in 5/16 patients, including the ovarian cancer and uveal
melanoma patients. Dose escalation in this trial continues at 20
mg/kg and dose expansion has started at 10 mg/kg.
Commenting on the findings, Dr. Gary Richardson, OAM,
MBBS, FRACP, Group Director at Cabrini Health
Research, Neil Beauglehall Endowed Chair, Medical Oncology
Research, and Professor of Medicine at Monash
University, Australia, said, “With the emerging clinical data
evaluating this novel immunotherapy candidate ADG126, a masked
anti-CTLA-4 SAFEbody, we have the opportunity to detangle safety
from efficacy, and deeply understand the benefits of Treg depletion
while we optimize anti-CTLA-4 therapy as a cornerstone of future
therapy. Another exciting and surprising aspect of these interim
findings is that we see early signals of efficacy in certain ‘cold’
tumors with SAFEbody ADG126, which further builds on prior clinical
evidence with its parental antibody ADG116, targeting a unique
epitope of CTLA-4 to enable not only a safer but potentially better
therapy than the options we have available today.”
ADG126 SAFEbody applies precision-masking technology to the
parental anti-CTLA-4 antibody, ADG116, for conditional activation
in the TME to expand the therapeutic index and further address
safety concerns with existing CTLA-4 therapies. Binding to the same
unique epitope as ADG116, the masked ADG126 is designed to provide
enhanced safety and efficacy profiles due to the combination of the
potent Treg depletion in the TME and soft ligand blocking.
“Following these monotherapy dose escalation results, we look
forward to releasing further data in coming months to confirm if
the strong safety profile of ADG126 is preserved in combination
with anti-PD-1 therapy, consistent with our preclinical
observations,” said Peter Luo, Ph.D., Co-founder, Chief Executive
Officer and Chairman of Adagene.
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. Follow Adagene on WeChat, LinkedIn
and Twitter.
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 certain clinical results of ADG126,
the potential implications of clinical results of the product
candidate, and Adagene’s advancement of, and anticipated clinical
development, regulatory milestones and commercialization of Adagene
pipeline 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
KnoeflerAdagene650-739-9952ir@adagene.com
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