Full Press Release Details
Adagene Announces Clinical Collaboration with
Incyte to Evaluate Muzastotug (ADG126) in
Combination with Incyte's TGF R2xPD-1 Bispecific Antibody (INCA33890) in Patients
Microsatellite Stable Colorectal Cancer (MSS CRC)
Phase 1 study of INCA33890 and muzastotug expected
to begin in 2026 in 3L MSS CRC patients with and without liver metastases
Study will be sponsored and conducted by Incyte;
Adagene to provide clinical supply of muzastotug
Collaboration provides additional validation
of muzastotug as a potential backbone therapy for next-generation immuno-oncology combinations
SAN DIEGO and SUZHOU, China, April 2, 2026 (GLOBE
NEWSWIRE) -- Adagene Inc. ("Adagene") (Nasdaq:ADAG), a company transforming the discovery and development of novel
antibody-based therapies, today announced a clinical collaboration with Incyte (Nasdaq:INCY), to evaluate the combination of muzastotug
(ADG126) and INCA33890, a TGF R2 PD-1 bispecific antibody, in patients with microsatellite stable colorectal cancer (MSS
CRC) with or without liver metastases.
Muzastotug in combination with Merck's (known as MSD outside
of the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) has demonstrated encouraging overall
response rates and durable responses in a Phase 1b/2 trial in 3L MSS CRC patients. As a monotherapy, INCA33890 has demonstrated
promising clinical efficacy and safety in immune checkpoint sensitive and insensitive cancers, including MSS CRC with and without liver
metastases. Incyte has recently initiated a Phase 3 study (NCT07284849) evaluating bevacizumab and FOLFOX (standard of care chemotherapy)
with or without INCA33890 in 700 first-line MSS CRC patients.
"This strategic collaboration marks the second instance in which
Adagene's SAFEbody technology is being paired with a leading PD-1-based bispecific, further reinforcing muzastotug's
potential as a backbone immunotherapy with a wider therapeutic index for next-generation immuno-oncology combinations." said Peter
Luo, Ph.D., CEO and President of R&D at Adagene. "We look forward to the clinical insights this study may provide to support
our belief that muzastotug has the potential to both improve overall response rate and extend survival, meaningfully enhancing the clinical
benefit for patients."
"This collaboration allows us to explore a novel combination
approach for patients with microsatellite stable colorectal cancer, a disease that remains resistant to current immunotherapies,"
said Pablo J. Cagnoni, M.D., President, Head of Research & Development at Incyte. "By evaluating INCA33890 in combination
with muzastotug, we aim to better understand whether complementary mechanisms may help enhance anti-tumor immune responses particularly
for patients with liver metastases, who have an especially poor prognosis and limited treatment options."
Muzastotug, a masked anti-CTLA-4 SAFEbody with FDA
Fast Track designation, is currently being evaluated in multiple ongoing studies, including:
Under terms of the agreement, Incyte will sponsor and conduct
the study and Adagene will provide clinical trial supply of muzastotug. The planned dose escalation portion of the study will evaluate
safety and tolerability, followed by an efficacy expansion cohort in patients with chemotherapy-refractory MSS CRC patients with and without
liver metastases. MSS CRC is well-known to be largely non-responsive to anti-PD-1 / PD-L1 therapy. INCA33890 monotherapy has demonstrated
promising initial clinical efficacy and safety in immune checkpoint sensitive/insensitive tumors, including MSS CRC with and without liver
Adagene 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 globally unmet patient needs. The company has forged strategic collaborations with reputable global
partners that leverage its SAFEbody precision masking technology in multiple approaches at the vanguard of science.
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. The company's 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 tumor microenvironment, this allows for tumor-specific targeting of antibodies, while minimizing on-target off-tumor toxicity in
Adagene's lead clinical program, muzastotug (ADG126), is a masked,
anti-CTLA-4 SAFEbody with FDA Fast Track designation that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor
microenvironment. Muzastotug is currently in Phase 1b/2 and Phase 2 clinical studies in combination with anti-PD-1 therapy, particularly
focused on metastatic microsatellite-stable (MSS) colorectal cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform
can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates,
and bi/multispecific T-cell engagers.
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.
KEYTRUDA is a registered trademark of Merck Sharp &
Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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