Adagene Presents Data Demonstrating First and Best-in-Class Potential for Differentiated Preclinical Antibody Candidates at American Association for Cancer Research (AACR) Annual Meeting 2022
09 April 2022 - 3:09AM
Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the
discovery and development of novel antibody-based therapies, today
announced preclinical data showcasing the potential first and
best-in-class profile of new antibody candidates. Data are being
presented at the American Association for Cancer Research (AACR)
Annual Meeting, taking place in New Orleans, Louisiana from April
8-13, 2022. Posters are available in the Publications section of
the company’s website at www.adagene.com.
“We are encouraged by the preclinical data presented across four
posters at AACR, showing the first and best-in-class profiles for
our differentiated preclinical candidates, designed to achieve
safe, potent and durable responses. These include ADG206, a masked,
IgG1 Fc-engineered anti-CD137 therapy and ADG153, a masked
anti-CD47 IgG1 antibody, and ADG138, a novel, double masked
HER2xCD3 bispecific T-cell engager (TCE) for solid tumors. All
three of these candidates are designed for improved efficacy while
incorporating precision masking peptides to ensure safety of such
powerful modalities,” said Peter Luo, Ph.D., Co-founder, Chief
Executive Officer and Chairman of Adagene. “Additionally, we are
establishing a new paradigm for CD28 TCEs by targeting a unique,
highly conserved epitope for local activation, and leveraging
SAFEbody to ensure ultimate safety and mitigate known risks of this
target. We are very excited to show potential differentiation of
these preclinical candidates, and spotlight our ability to create
first/best-in-class product candidates that can be safely and
effectively combined together as we aspire to cure cancer.”
Key takeaways from the four posters include:
ADG206, an anti-CD137 agonistic
POWERbody™ with tailor-made efficacy and
safety profiles by strong crosslinking and tumor selective
activation for single agent and combinational cancer
immunotherapy (#2868)
- This masked, IgG1 Fc-engineered anti-CD137 POWERbody combines
conditional activation in the tumor microenvironment with strong
agonistic activity through heightened FcγR-mediated crosslinking
for therapeutic potential in either single agent or combination
regimens.
- Preclinical data demonstrated that ADG206 was well tolerated
and had robust anti-tumor activity as a single agent in multiple
tumor models, with 4-fold stronger anti-CD137 agonistic activity of
its activated form than a benchmark antibody in development (analog
of urelumab) for T cell co-activation.
- ADG206 also demonstrated enhanced anti-tumor activity in
combination with other checkpoint inhibitors, including anti-PD-1
or anti-CTLA-4 therapy.
- Adagene is preparing to submit an IND or equivalent filing for
ADG206 during 2022.
ADG153-G1 SAFEbody, a differentiated masked anti-CD47
antibody of IgG1 subclass, demonstrates in vivo anti-tumor activity
consistent with enhanced ADCC/ADCP effects and significantly
reduced RBC-related and antigen sink liabilities
(#4257)
- This masked anti-CD47 IgG1 SAFEbody
is differentiated by its strong antibody-dependent cellular
cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis
(ADCP) activity designed to realize the full potential of anti-CD47
therapy for both hematologic and solid tumor indications.
- Preclinical data demonstrated that
ADG153 IgG1 was well tolerated, did not induce human
hemagglutination and significantly reduced anemia-related and
antigen sink liabilities. In particular, ADG153 IgG1 at a 10 mg/kg
dose demonstrated only an 8 percent decrease in red blood cell
counts, compared to a 49 percent decrease with a benchmark antibody
which is in IgG4 format (analogue of magrolimab).
- Results also showed that ADG153 IgG1
demonstrated greater anti-tumor activity than the benchmark.
- Adagene is preparing to submit an IND or equivalent filing for
ADG153 during 2022.
ADG138, A Novel HER2×CD3 POWERbody™ Integrating
Bispecific TCE with Precision Masking to Control Cytokine Release
Syndrome and On-Target Off-Tumor Toxicity for Single Agent and
Combination Therapies in HER2-Expressing Solid Tumors
(#2869)
- This novel HER2xCD3 POWERbody is masked on both arms with an
impressively high therapeutic index relative to its parental
non-masked TCE in both HER2 high and low expressing solid tumors,
supporting its development for HER2-expressing solid tumors as a
single agent and in combination with other immune modulating
agents.
- Preclinical data demonstrated the excellent safety profile of
ADG138, including 100-fold greater reduction in cytokine release
compared to its parental TCE.
- Results showed that ADG138 has potent anti-tumor activity in
HER2 high and low expressing tumors, as well as
resistant/refractory tumors, relative to a benchmark antibody
(DS-8201, a HER2 targeting antibody drug conjugate commercially
available in specific indications). ADG138 also had synergistic
anti-tumor activity in HER2 positive tumors when combined with
anti-CD137 or anti-PD-1 therapy, or tumor targeted CD28 bispecific
antibody.
- ADG138 is currently in IND-enabling studies.
Tumor-targeted CD28 bispecific
POWERbody™ for safe and synergistic T
cell-mediated immunotherapy (#2888)
- CD28 bispecific POWERbody TCEs exhibit enormous potential to
fulfill the promises of safe and durable T cell-mediated
synergistic immunotherapies when combined with CD3 bispecific
POWERbody TCEs and/or checkpoint inhibitors.
- Enabled by Adagene’s suite of antibody platform technologies,
preclinical data demonstrated the potential to mitigate the serious
safety concerns of CD28 activation and make custom designed
antibodies targeting a highly conserved epitope with broad species
reactivity.
- Multiple tumor associated antigen (TAA)xCD28 POWERbodies are in
progress, such as B7-H3xCD28 and HER2xCD28, which can also be
combined with the company’s CD3 TCEs to achieve safe, powerful and
durable immunotherapy for solid tumors through combination of the
fundamental mechanisms and pathways across the cancer immunity
cycle.
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 StatementThis press release
contains forward-looking statements, including statements regarding
the preclinical studies of ADG138, ADG206, ADG153 and a
tumor-targeted CD28 bispecific POWERbody™, the potential
implications of preclinical findings of these product candidates,
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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