Adagene Announces Completion of Enrollment in Randomized Dose Optimization Phase 2 Trial of Muzastotug in Combination with KEYTRUDA® (pembrolizumab) in Microsatellite Stable Colorectal Cancer

Initial results are expected in the first half of 2027 to inform the muzastotug dose regimen for Phase 3.

Rhea-AI Summary

Adagene (ADAG) completed enrollment of 60 patients in its randomized Phase 2 trial of muzastotug combined with KEYTRUDA (pembrolizumab). The trial involves late-line microsatellite stable colorectal cancer, a colorectal cancer subtype, without liver metastases. Patients were randomized 1:1 between two induction and maintenance dosing regimens. Adagene expects initial results in the first half of 2027 to inform dose selection for Phase 3.

The primary Phase 2 endpoint is overall response rate; secondary endpoints measure response duration, survival without disease progression and overall survival. For Phase 3, the FDA agreed with the proposed standard-of-care control arm and confirmed that a muzastotug-only arm was unnecessary. Overall survival will be the primary Phase 3 endpoint. Sanofi made an additional equity investment associated with the trial. Adagene retains worldwide commercial rights to muzastotug.

4 points · 0 major

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointFDA agreement on the proposed Phase 3 control arm also confirmed no muzastotug monotherapy arm was required.
• Moderate pointSanofi's additional equity investment supports continued muzastotug development, Adagene said.
• Minor pointEnrollment of 60 patients is complete in the randomized Phase 2 muzastotug–pembrolizumab dose-optimization trial.
• Minor point. Forward-looking: it has not happened yet and may not happen.Initial results are expected in the first half of 2027 to inform Phase 3 dose selection.

Negative

• None.

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Details

Market move: ADAG +7.25% vs previous close. Phase 2 enrollment completion

+8.1% Peak Tracked

$2.05 – $2.35 Day Range

$144.02M Mkt Cap at Last Price

On Nov 9, the day this news came out, the latest delayed price for ADAG is 7.25% above the previous close. Argus tracked a peak move of +8.1% during the session. Our momentum scanner has recorded 3 alerts for this stock so far that day. The latest delayed price is $2.15. Relative volume is elevated at 2.3x what this stock usually trades by this time of day.

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Key Figures

Patients enrolled: 60 patients Randomization: 1:1 Initial results timing: 1H 2027 +2 more

Patients enrolled

60 patients

Randomized Phase 2 trial

Randomization

1:1

Two muzastotug dose-regimen arms

Initial results timing

1H 2027

Expected results from the Phase 2 trial

Arm A dosing

10 mg/kg Q3W for four doses, then 10 mg/kg Q6W maintenance

Muzastotug in combination with pembrolizumab

Arm B dosing

20 mg/kg Q6W for two doses, then 15 mg/kg Q6W maintenance

Muzastotug in combination with pembrolizumab

Previous Clinical trial Reports

1 past event · Latest: May 22

Same Type 1 event

1. May 22

   Phase 1b/2 data

   24h Move

   +12.0%

   Reported confirmed responses in MSS CRC at 20 mg/kg and median overall survival at 10 mg/kg.

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

Key Terms

microsatellite stable, ctla-4, overall response rate, duration of response, +2 more

6 terms

microsatellite stable medical

"patients with late-line 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.

ctla-4 medical

"a masked, anti-CTLA-4 SAFEbody"

CTLA-4 is a protein on certain immune cells that acts like a brake, helping to slow or stop immune responses. Drugs that block CTLA-4 release that brake and can boost the immune system’s ability to attack cancer, but they can also increase the risk of immune side effects. For investors, CTLA-4 is important because it’s a proven drug target with major commercial and regulatory implications for cancer therapies and related safety profiles.

overall response rate medical

"The primary endpoint of the Phase 2 trial is overall response rate (ORR)"

Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.

duration of response medical

"secondary endpoints include duration of response (DOR)"

Duration of response is the length of time a patient’s condition stays improved after a treatment until it starts to worsen again; think of it as how long a freshly charged battery continues to power a device. For investors, longer duration of response implies a treatment provides sustained benefit, which can boost a drug’s commercial value, support stronger regulatory labeling and payer coverage, and reduce the need for additional therapies.

progression-free survival medical

"progression-free survival (PFS), and overall survival (OS)"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"progression-free survival (PFS), and overall survival (OS)"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

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- Enrollment of 60 patients complete; initial results expected in 1H 2027 to inform dose regimen for the Phase 3 trial
- Adagene continues to own worldwide commercial rights to muzastotug

SAN DIEGO and SUZHOU, China, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today announced completion of enrollment in its randomized Phase 2 dose-optimization trial of muzastotug (ADG126), a masked, anti-CTLA-4 SAFEbody^®, in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), in patients with late-line microsatellite stable colorectal cancer (MSS CRC) without liver metastases.

“Completing enrollment in this randomized trial is an important step toward identifying the dose regimen of muzastotug for the Phase 3 registration trial,” said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. “We acknowledge Sanofi’s additional equity investment associated with this trial, which supports continued development of muzastotug in solid tumors, including MSS CRC, where dose-limiting challenges have restricted the use of anti-CTLA-4 therapies. As we look ahead to initial results in the first half of 2027, we hope new data will validate muzastotug’s broad applicability and combinability, further enhanced by its induction and maintenance dosing regimens. This could position muzastotug as a transformative next-generation backbone for combination therapies across multiple indications, in both early- and late-line treatment settings. It could also unlock value in indications where legacy CTLA-4/PD-1 based combinations are already FDA-approved, as well as in historically refractory tumors like MSS CRC.”

About the Phase 2 Trial
The randomized Phase 2 trial (NCT05405595) was incorporated into the existing protocol for the Phase 1b/2 study following a 2025 meeting with the U.S. Food and Drug Administration (FDA). The primary endpoint of the Phase 2 trial is overall response rate (ORR), and secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

The study enrolled 60 patients, randomized 1:1 into one of two treatment arms evaluating different dose regimens of muzastotug in combination with pembrolizumab. Both arms use induction to rapidly establish activated muzastotug exposure in tumors, followed by maintenance to sustain exposure and potentially improve ORR and OS:

• Arm A: Muzastotug 10 mg/kg every three weeks (Q3W) for four doses, followed by 10 mg/kg every six weeks (Q6W) maintenance
• Arm B: Muzastotug 20 mg/kg Q6W for two doses, followed by 15 mg/kg Q6W maintenance
  
  

As previously announced in July 2025, the following elements of the Phase 3 trial design were also confirmed following a meeting with the FDA:

• Patient Population: Trials will enroll late-line patients with MSS CRC without liver metastases, including those with peritoneal metastasis/involvement.
• Phase 3 Trial Design: The FDA agreed with Adagene’s proposed standard-of-care (SOC) control arm for the Phase 3 clinical trial and confirmed that a muzastotug monotherapy arm was not required.
• Phase 3 Endpoints: The primary endpoint of the Phase 3 trial will be OS. Secondary endpoints will include PFS, DOR and ORR.
  
  

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/
Follow Adagene on WeChat, LinkedIn and X.

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 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, 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Adagene expect results from the Phase 2 muzastotug trial?

Adagene expects initial results in the first half of 2027. The randomized dose-optimization trial completed enrollment of 60 patients, and the results are intended to inform the muzastotug dose regimen for Phase 3.

What dosing regimens is Adagene testing in the Phase 2 muzastotug trial?

The trial compares two muzastotug induction and maintenance regimens, each combined with pembrolizumab. Arm A uses 10 mg/kg every three weeks for four doses, followed by 10 mg/kg every six weeks. Arm B uses 20 mg/kg every six weeks for two doses, followed by 15 mg/kg every six weeks.

Which patients will Adagene's Phase 3 muzastotug trial enroll?

The Phase 3 trial will enroll late-line patients with microsatellite stable colorectal cancer without liver metastases, including patients with peritoneal metastasis or involvement. These population criteria were confirmed following a meeting with the FDA, as previously announced in July 2025.