Adagene Presents Clinical Data for Anti-CTLA-4 SAFEbody® ADG126 Reinforcing Best-in-Class Safety Profile at Repeat Doses and Showing Early Efficacy Profile in Advanced/Metastatic Solid Tumors
18 Abril 2023 - 10:17AM
Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the
discovery and development of antibody-based therapies, today
announced interim results from its combination dose escalation
studies of the masked, anti-CTLA-4 SAFEbody, ADG126, presented at
the AACR Annual Meeting in Orlando, Florida, April 14-19, 2023.
Two poster presentations on ADG126 SAFEbody
reported results of ongoing phase 1b/2 trials at multiple dosing
regimens (6 mg/kg and 10 mg/kg) in combination with either
pembrolizumab or toripalimab, as well as updated data for ADG126
monotherapy in heavily pre-treated patients.
Both posters, “Interim results of a phase 1b/2
study of ADG126 (a masked anti-CTLA-4 SAFEbody®) monotherapy and in
combination with toripalimab (an anti-PD-1 antibody) in patients
(pts) with advanced / metastatic solid tumors” and “Initial results
of a phase 1b/2 study of ADG126 (a masked anti-CTLA-4 SAFEbody®) in
combination with pembrolizumab (an anti-PD-1 antibody) in patients
with advanced/metastatic solid tumors,” may be viewed on the
company’s website here.
Key findings include:
- Best-in-class Safety Profile Reinforced in Combination
with Anti-PD-1: In dose escalation studies of ADG126
in combination with anti-PD-1 treatments, ADG126 continues to
demonstrate a best-in-class safety profile at doses from 6 mg/kg up
to 10 mg/kg. The combination was well tolerated with no
dose-limiting toxicities observed with repeat cycles, including in
patients who received four or more cycles in the combination cohort
with toripalimab.Across 31 patients in combination dose escalation
cohorts of ADG126, a total of seven (22.6%) Grade 3 TRAEs were
reported, suggesting a safety profile comparable to anti-PD-1
monotherapy and a best-in-class safety profile in combination with
anti-PD-1, even at much higher doses. This has been achieved
without aggressive safety management for immune-mediated
diarrhea/colitis, such as infliximab
infusion.
- Confirmed Clinical Responses & Tumor Shrinkage in
Combination with Anti-PD-1: In the heavily pre-treated
patient groups, clinical responses and tumor shrinkage were
observed during combination dose escalation. The posters summarize
patient case studies demonstrating clinical benefit, including
three confirmed partial responses and multiple cases of prolonged
stable disease with tumor shrinkage in patients who received ADG126
plus anti-PD-1 therapies. Of note, two cases of significant tumor
shrinkage (20% reduction and higher in target lesions) were
observed in MSS CRC patients with liver metastasis who received
ADG126 plus toripalimab.
- Compelling Monotherapy Safety Profile with Prolonged
Stable Disease Supports ADG126 Mechanism: An additional
cohort of 30 patients who received ADG126 monotherapy showed a
compelling safety profile for ADG126, with no Grade 3 or higher
TRAEs reported at repeat doses up to 20 mg/kg.
- Across all dose levels, the disease control rate was 37% among
27 evaluable patients.
- Prolonged stable disease was observed in five patients, with
notable tumor shrinkage observed in an ovarian cancer patient who
received 25 cycles at 1 mg/kg and a non-small cell lung cancer
patient (NSCLC) who received 14 cycles at 20 mg/kg.
- Analysis of a clinical sample from a hepatocellular carcinoma
(HCC) patient previously treated with atezolizumab and bevacizumab
demonstrated Treg depletion, supporting the mechanism of action for
ADG126.
- Combination Dose Expansion Ongoing in MSS CRC:
Dose expansion cohorts are currently underway evaluating ADG126 in
combination with anti-PD-1 therapy with an update planned later in
2023. The cohorts evaluate disease control rate, progression free
survival, overall survival and objective response rate. Multiple
dosing schedules are being evaluated, including ADG126 10 mg/kg
every three and six weeks.
Further, the strong safety profile of ADG126 has enabled a
randomized clinical trial that is being initiated in collaboration
with Roche to evaluate ADG126 in combination with atezolizumab and
bevacizumab as a first-line treatment for patients with
advanced/metastatic HCC. The trial is being sponsored and conducted
by Roche.
Solid Tumor Potential Shown for ADG153, a masked,
anti-CD47 IgG1 SAFEbody
A third poster, “ADG153, a novel masked anti-CD47 IgG1 SAFEbody,
demonstrates strong in vivo anti-tumor activities in preclinical
solid tumor models and preferential CD47 target engagement in the
tumor microenvironment,” reported preclinical data for ADG153. The
data demonstrated strong in vivo anti-tumor activities in solid
tumor models and a robust safety profile due to preferential CD47
target engagement in the tumor microenvironment.
The three posters are available on the company’s website
at www.adagene.com/pipeline/publications in accordance
with the AACR embargo policy.
About AdageneAdagene Inc. (Nasdaq: ADAG) is a
platform-driven, clinical-stage biotechnology 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
ADG126 and ADG153, the potential implications of clinical and
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 Knoefler
650-739-9952
ir@adagene.com
Adagene (NASDAQ:ADAG)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Adagene (NASDAQ:ADAG)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024