Adagene Announces Dosing of First Patient in Phase 1 Study of Muzastotug in Combination with Incyte’s INCA33890 in Patients with Microsatellite Stable Colorectal Cancer

Incyte sponsors and conducts the combination trial, while Adagene provides the clinical supply of muzastotug.

Rhea-AI Summary

Adagene (ADAG) announced first-patient dosing in a Phase 1 study combining muzastotug with Incyte’s INCA33890 for microsatellite stable colorectal cancer.

The open-label trial, in which treatment is known, includes dose escalation and expansion in third-line patients whose cancer progressed on prior therapies, with or without liver metastases, meaning cancer spread to the liver. Incyte is sponsoring and conducting the study, while Adagene supplies muzastotug under the collaboration announced in April 2026. Adagene said the study will evaluate whether the combination can deepen and sustain antitumor responses with an acceptable safety profile.

Positive

• Minor pointFirst-patient dosing advances the Phase 1 muzastotug–INCA33890 combination study in previously treated colorectal cancer.
• Minor pointIncyte collaboration provides study sponsorship and execution, with Adagene supplying muzastotug.

Negative

• None.

Key Figures

Trial phase: Phase 1 First patient dosed: 1 patient

Trial phase

Phase 1

Combination study of muzastotug and INCA33890 in MSS CRC

First patient dosed

1 patient

Milestone in the combination study

Previous Clinical trial Reports

2 past events · Latest: May 22

Same Type 2 events

1. May 22

   Clinical results

   24h Move

   +12.0%

   Muzastotug plus pembrolizumab reported 29% confirmed ORR in MSS CRC at 20 mg/kg.

2. Dec 16

   FDA designation

   24h Move

   +13.8%

   FDA granted Fast Track to muzastotug plus pembrolizumab for MSS metastatic colorectal cancer.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

microsatellite stable, anti-CTLA-4, TGFβR2, PD-1, +2 more

6 terms

microsatellite stable medical

"patients with microsatellite stable colorectal cancer"

Microsatellite stable describes a tumor whose short, repeating DNA sequences (microsatellites) show few or no errors, meaning the cancer’s internal “spell-check” system is largely intact. For investors, this matters because microsatellite stability is a biomarker that helps predict how likely a tumor is to respond to certain therapies and clinical trials, affecting drug development prospects, regulatory decisions, and the size of the potential patient market.

anti-CTLA-4 medical

"a masked anti-CTLA-4 SAFEbody"

Anti-CTLA-4 is a class of drugs that block the CTLA-4 protein, a natural “brake” on immune cells, allowing the immune system to better recognize and attack cancer cells. For investors, these therapies can represent large commercial opportunity if clinical trials and regulatory approvals succeed, but they also carry significant development, safety and regulatory risks—like releasing a parking brake to boost performance while increasing the chance of losing control.

TGFβR2 medical

"Incyte’s TGFβR2 × PD-1 bispecific antibody"

tgfβr2 (also written TGF-βR2 or TGFBR2) is the gene and protein that encodes the type II receptor for transforming growth factor‑beta (TGF‑β), a cell-surface serine/threonine kinase. The receptor binds TGF‑β ligands, pairs with a type I TGF‑β receptor, and initiates intracellular signalling by phosphorylating downstream SMAD proteins, thereby changing gene expression, cell growth, differentiation, and immune responses. Loss, mutation, or altered activity of TGF‑βR2 disrupts this signalling cascade and is therefore a common mechanism cited in studies of cancer, fibrosis, and inflammatory disorders.

PD-1 medical

"TGFβR2 × PD-1 bispecific antibody"

PD-1 is a protein found on certain immune cells that acts like a brake, signaling the immune system to slow down and avoid damaging healthy tissue. Drugs that block PD-1 release that brake so immune cells can better attack cancer cells; because such therapies can produce large clinical benefits, regulatory approvals, trial outcomes, pricing and market uptake for PD-1 drugs can materially affect a drugmaker’s prospects and investor returns.

bispecific antibody medical

"TGFβR2 × PD-1 bispecific antibody"

A bispecific antibody is a specially designed protein that can attach to two different targets at the same time. Think of it as a custom-made connector that brings two things together—such as a disease cell and an immune system component—helping the body fight illnesses more effectively. For investors, understanding bispecific antibodies is important because they represent innovative therapies that could lead to new treatments and potentially lucrative market opportunities.

dose escalation medical

"an open-label dose escalation and expansion trial"

Dose escalation is the process of gradually increasing the amount of a treatment or substance over time. In finance, it can refer to slowly raising investments or commitments to manage risk and assess performance. For investors, understanding dose escalation helps gauge how companies or strategies adjust their approaches, which can impact future growth or stability.

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Phase 1 study to evaluate the combination of muzastotug, a masked anti-CTLA-4 SAFEbody, and INCA33890, Incyte’s TGFβR2 × PD-1 bispecific antibody, in 3L MSS CRC patients with and without liver metastases

SAN DIEGO and SUZHOU, China, Oct. 28, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today announced the dosing of the first patient in a Phase 1 study evaluating the combination of muzastotug and INCA33890, Incyte’s TGFβR2 × PD-1 bispecific antibody, in patients with microsatellite stable colorectal cancer (MSS CRC).

The Phase 1 study is an open-label dose escalation and expansion trial in third-line MSS CRC patients with and without liver metastases who have progressed on prior therapies. Per the terms of the study collaboration first announced in April 2026, Incyte is sponsoring and conducting the study and Adagene is providing clinical supply of muzastotug.

“Building on the clinical activity observed with muzastotug plus pembrolizumab, this study will evaluate whether adding muzastotug to Incyte’s TGFβR2 × PD-1 bispecific can deepen and sustain antitumor responses in MSS colorectal cancer, including patients with liver metastases,” said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. “The combination brings together muzastotug’s intended intratumoral Treg-depleting activity and INCA33890’s inhibition of two pathways that suppress T-cell function. The study will assess whether these complementary mechanisms can broaden clinical benefit with an acceptable safety profile based on the optimized doses in combination with PD-1. The strength of muzastotug as a potential backbone therapy for multiple indications continues to be recognized through several collaborations with leading biopharmaceutical companies, reflecting its differentiated safety profile relative to legacy CTLA-4 therapies.”

About Adagene

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 healthy tissues.

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 microsatellite stable (MSS) metastatic 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/multi-specific 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.

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding the Phase 1 study of muzastotug (ADG126) in combination with INCA33890, the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated preclinical 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 Contacts:
Raymond Tam
Raymond_tam@adagene.com

Corey Davis
LifeSci Advisors
cdavis@lifesciadvisors.com

Media Contact:
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com

FAQ

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What is Adagene’s Phase 1 muzastotug and INCA33890 study evaluating?

The study evaluates muzastotug combined with INCA33890 in third-line microsatellite stable colorectal cancer patients whose disease progressed on prior therapies. It includes patients with and without liver metastases and uses an open-label dose escalation and expansion design.

How do the treatments in Adagene’s muzastotug–INCA33890 trial work?

Muzastotug is a masked anti-CTLA-4 antibody, while INCA33890 is Incyte’s bispecific antibody targeting TGFβR2 and PD-1. Adagene describes the intended combination as pairing depletion of immune-suppressing regulatory T cells within tumors with inhibition of two pathways that suppress T-cell function.