Adagene Presents Two Posters at AACR 2026 with New Data Highlighting Muzastotug’s Potential as a Backbone Combination Therapy for Multiple Tumor Types

Rhea-AI Summary

Adagene (Nasdaq: ADAG) presented interim Phase 1b/2 data at AACR 2026 showing muzastotug in two triplet regimens produced higher response rates and manageable safety profiles in HCC and MSS CRC.

In HCC, the muzastotug triplet showed ORR 66.7% vs 32.5% (control) and mPFS 8.2 vs 5.5 months; in MSS CRC, dose-dependent ORRs were 25% (10 mg/kg) and 40% (15 mg/kg). FDA previously granted Fast Track for muzastotug+pembrolizumab in MSS mCRC without active liver metastases.

Positive

• HCC ORR 66.7% for muzastotug triplet
• mPFS 8.2 months with muzastotug triplet (HCC)
• MSS CRC dose-response: 25% (10 mg/kg) and 40% (15 mg/kg) ORR
• Fast Track designation for muzastotug+pembrolizumab in MSS mCRC (NLM)

Negative

• Very small cohorts: 6 HCC patients in muzastotug arm; 9 total in MSS CRC
• Grade ≥3 TRAEs 50% in muzastotug HCC arm (comparable to 45% control)
• Grade 3 TRAEs 25–60% reported in MSS CRC triplet arm
• MSS CRC population excludes patients with liver metastases (limits generalizability)

News Market Reaction – ADAG

-2.02%

-2.02% Session close to close

In the Apr 20 session, ADAG declined 2.02%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights encouraging Phase 1b/2 data for muzastotug-based triplets, with ORRs of...

Analysis

This announcement highlights encouraging Phase 1b/2 data for muzastotug-based triplets, with ORRs of 66.7% in HCC and up to 40% in late-line MSS CRC, along with manageable safety and no new signals. It extends prior Fast Track–supported progress in MSS CRC and reinforces the backbone-combination strategy. In assessing these results, investors may watch for larger patient cohorts, durability data, randomized Phase 2 readouts, and how future financings and regulatory milestones intersect with this evolving clinical profile.

Key Figures

ORR (HCC triplet): 66.7% ORR (HCC control): 32.5% ORR (MSS CRC 10 mg/kg): 25% +5 more

8 metrics

ORR (HCC triplet) 66.7% Muzastotug + atezolizumab + bevacizumab arm, Phase 1b/2 HCC

ORR (HCC control) 32.5% Atezolizumab + bevacizumab control arm, Phase 1b/2 HCC

ORR (MSS CRC 10 mg/kg) 25% Muzastotug 10 mg/kg + pembrolizumab + fruquintinib, MSS CRC

ORR (MSS CRC 15 mg/kg) 40% Muzastotug 15 mg/kg + pembrolizumab + fruquintinib, MSS CRC

mPFS (HCC triplet) 8.2 months Muzastotug triplet arm, Phase 1b/2 HCC

mPFS (HCC control) 5.5 months Atezolizumab + bevacizumab control arm, Phase 1b/2 HCC

ORR (HCC RECIST v1.1) 50.0% Muzastotug triplet arm, HCC by RECIST v1.1

Sample size (HCC triplet arm) 6 patients Muzastotug + atezolizumab + bevacizumab arm, Phase 1b/2 HCC

Historical Context

5 past events · Latest: Apr 14 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 14	Advisory board addition	Positive	-0.8%	Industry veteran added to Scientific and Strategic Advisory Board.
Apr 02	Equity offering	Negative	-13.4%	US$70.0M public offering of ADSs at US$3.75 per ADS.
Apr 02	Clinical collaboration	Positive	-13.4%	Collaboration with Incyte to study muzastotug plus INCA33890 in MSS CRC.
Apr 02	Clinical data update	Positive	-13.4%	Updated Phase 1b/2 KEYTRUDA combo data with improved ORR and PFS.
Apr 01	Earnings and pipeline	Positive	-13.4%	Full-year 2025 results and positive muzastotug clinical and cash runway update.

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

Pattern Detected

ADAG has often sold off on positive clinical, partnership, and earnings news, while reacting negatively but in line with a dilutive offering.

Recent Company History

Over the past weeks, Adagene has focused heavily on muzastotug (ADG126) and MSS CRC. On Apr 1, 2026, full-year 2025 results showed improving finances and clinical progress. On Apr 2, the company announced updated positive Phase 1b/2 data, a new Incyte collaboration, and a US$70.0M public offering, with shares dropping about 13.45%. A management addition on Apr 14 was also followed by a slight decline. Against this backdrop, the new AACR data extend the clinical narrative for muzastotug.

Key Terms

overall response rate, hepatocellular carcinoma, microsatellite stable colorectal cancer, RECIST v1.1, +4 more

8 terms

overall response rate medical

"resulted in much higher overall response rates (ORR) compared to the"

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.

hepatocellular carcinoma medical

"therapy in a Phase 1b/2 trial in locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) patients"

Hepatocellular carcinoma is the most common form of primary liver cancer, arising from the main functional cells of the liver. For investors it matters because its serious health impact drives demand for diagnostic tests, treatments and long-term care; progress in trials or approvals can change a drugmaker’s revenue outlook much like a successful product launch can reshape a company’s future.

microsatellite stable colorectal cancer medical

"Phase 1b/2 trial in late-line microsatellite stable colorectal cancer (MSS CRC) patients"

Microsatellite stable colorectal cancer is a form of colon or rectal cancer whose short, repeating DNA sequences (microsatellites) remain unchanged, indicating a low level of random mutations. That stability matters to investors because it influences how well certain therapies, especially immune-based drugs, are likely to work, shapes clinical trial design and market opportunity, and affects the valuation and risk profile of companies developing treatments for this patient group.

RECIST v1.1 medical

"Modified RECIST v1.1) as 1L therapy in a Phase 1b/2 trial"

RECIST v1.1 is a standardized set of rules used in cancer trials to measure how solid tumors change over time, defining when tumors shrink, grow, or stay the same based on imaging scans. Investors care because these consistent measurements determine key trial results and regulatory decisions—like whether a drug is seen as effective—so RECIST-based outcomes directly affect a therapy’s approval prospects, market potential, and company valuation.

progression free survival medical

"The median progression free survival (mPFS) was 8.2 months"

Progression free survival is the length of time during and after a treatment when a disease, such as cancer, does not get worse or spread. It is an important measure because longer periods of stability can indicate that a treatment is effectively controlling the condition. For investors, it provides insight into the potential durability and success of a therapy or medication.

overall survival medical

"and the median overall survival (mOS) was not yet reached"

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.

dose-limiting toxicities medical

"with no DLTs or Grade 4 or 5 treatment related adverse events"

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

treatment related adverse events medical

"no DLTs or Grade 4 or 5 treatment related adverse events"

Treatment-related adverse events are unwanted medical problems that are judged to be caused by a drug, device, or medical procedure. Like unexpected side effects from a new product, they can range from mild discomfort to serious harm, and they matter to investors because they directly affect regulatory approval, product labeling, legal exposure, development costs, and ultimately how widely and profitably a therapy can be used.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Triple combination of muzastotug + atezolizumab + bevacizumab resulted in much higher overall response rates (ORR) compared to the atezolizumab + bevacizumab control arm (66.7% vs. 32.5%, respectively by Investigator per HCC-specific Modified RECIST v1.1) as 1L therapy in a Phase 1b/2 trial in locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) patients

Triple combination of muzastotug + pembrolizumab + fruquintinib exhibited a dose-dependent response (25% and 40% ORR for 10 mg/kg and 15 mg/kg, respectively) in a Phase 1b/2 trial in late-line microsatellite stable colorectal cancer (MSS CRC) patients

New data are further evidence that muzastotug’s masking technology uncouples efficacy from typical anti-CTLA-4 toxicity; it reduces peripheral toxicity and allows high-dose anti-CTLA-4 therapy specifically within the tumor microenvironment (TME) to potentially improve efficacy of current immunotherapies in advanced HCC and MSS CRC patients

SAN DIEGO and SUZHOU, China, April 17, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today presented new data from two ongoing Phase 1b/2 studies of muzastotug in triple combination regimens at the American Association of Cancer Research (AACR) annual meeting 2026, held April 17-22 in San Diego. Results support muzastotug’s mechanistic advantages over traditional anti-CTLA-4 therapies, and its continued development as a potential backbone therapy in combination regimens for difficult-to-treat cancers. FDA has previously designated muzastotug in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), as a Fast Track product for adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) without current or active liver metastases.

"At AACR, Adagene shared new data from two triplet regimens supporting muzastotug’s potential as a combination backbone for multiple tumor types,” said Peter Luo, Ph.D., CEO and President of R&D at Adagene. “In HCC, adding muzastotug to the atezolizumab plus bevacizumab combo resulted in higher efficacy, with a safety profile consistent with historical studies of the doublet alone. In MSS CRC, adding muzastotug to pembrolizumab plus fruquintinib showed dose-dependent response rates, with no DLTs or Grade 4 or 5 treatment related adverse events. As muzastotug continues to generate more data in additional settings, we are increasingly convinced that its intentionally designed wider therapeutic index has potential to improve the efficacy of current immunotherapies without worsening the toxicity for patients with difficult to treat solid tumors.”

Final copies of the two posters from AACR can be found on the Pipeline Publications section of the company’s website.

AACR Poster Presentations

Abstract CT054

The MORPHEUS-Liver study (NCT04524871) is a Phase 1b/2 open-label randomized umbrella study designed to evaluate immunotherapy-based combinations as first line therapy in patients with locally advanced or metastatic hepatocellular carcinoma (HCC). As of July 11, 2025, six patients had been randomized to the triple combination of muzastotug (6 mg/kg Q6W), atezolizumab and bevacizumab and 40 patients had received atezolizumab and bevacizumab in the active control arm. Interim results from patients in the muzastotug arm (18.8 months median duration of follow-up) demonstrated a 66.7% overall response rate (ORR; 4/6) using HCC-specified modified RECIST v1.1 criteria¹. ORR was 50.0% (3/6) using RECIST v1.1 criteria. The median progression free survival (mPFS) was 8.2 months (same for both RECIST criteria) and the median overall survival (mOS) was not yet reached at the data cut but was greater than 22 months.

These results compared favorably to the 40 patients in the active control arm (17.2 months median duration of follow-up) that demonstrated an ORR of 32.5% (13/40) using HCC-specified modified RECIST v1.1 criteria, mPFS of 5.5 months, and mOS of 17.5 months. Using RECIST v1.1 criteria, the ORR was 17.5% (7/40) and the mPFS was 4.3 months. The mOS in the doublet control arm was largely overlapping with that reported in the IMbrave150 Phase 3 study^2,3 (19.2 months), which served as the basis for approval of atezolizumab (Tecentriq®) for HCC in 2020⁴.

The triplet regimen of muzastotug, atezolizumab and bevacizumab was well-tolerated with safety data comparable to the doublet active control arm of atezolizumab and bevacizumab. Grade 3 or greater TRAEs were 50% (3/6) in the muzastotug arm and 45% (18/40) in the active control arm, which supports the potential for continuous dosing with muzastotug. Muzastotug was safely administered continuously at 6 mg/kg Q6W in a triplet setting, which is twice the dose of ipilimumab in the currently approved HCC doublet regimen, (capped at 3 mg/kg Q3W for only 4 cycles)⁵. In addition, encouraging durability was observed with responses maintained beyond 84 weeks in some patients. Ongoing muzastotug plus atezolizumab treatment after bevacizumab discontinuation suggests potential flexibility to modify individual agents during safety-related interruptions while preserving durable clinical benefit.

Abstract CT083

A Phase 1b/2 single arm study (NCT05405595) is evaluating the triple combination of muzastotug, pembrolizumab and fruquintinib in patients with advanced and metastatic microsatellite stable (MSS) colorectal cancer (CRC). As of February 21, 2026, nine patients have been treated with the triple combination — four (4) patients at a dose of 10 mg/kg every 6 weeks (Q6W) of muzastotug and five (5) patients at a dose of 15 mg/kg Q6W of muzastotug. All patients were without liver metastases (NLM). Interim results demonstrated a 25% ORR (1/4) among patients in the 10 mg/kg arm (6.7 months median follow-up), and a 40% ORR (2/5) among patients in the 15 mg/kg arm (5.9 months median follow-up).

The triplet regimen was well-tolerated with no new safety signals relative to known CTLA-4, PD-1, and fruquintinib monotherapy and combination safety data. There were no dose-limiting toxicities, 25 – 60% Grade 3 TRAEs, and no Grade 4 or Grade 5 TRAEs. Given that fruquintinib is known to be active in MSS CRC patients with liver metastases, the triple combination may have therapeutic benefit beyond the NLM population being evaluated in this study.

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 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.
Follow Adagene on WeChat, LinkedIn and X.

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.

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding certain clinical results of ADG126, 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, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.com

Media Contact:
Lindsay Rocco
Elixir Health PR
862-596-1304
lrocco@elixirhealthpr.com

___________________

¹ BMJ Open. 2022 Jun 1;12(6):e052294. Unlike RECIST v1.1 which measures the longest diameter of the entire lesion (including necrotic areas), HCC-specified modified RECIST v1.1 evaluates the longest diameter of the viable (arterially enhanced) portion of the target lesion. It was developed to address the limitations of conventional RECIST v1.1, which may underestimate treatment efficacy due to persistent necrotic tumor size, and may better correlate to overall survival in HCC.
² N Engl J Med 2020;382:1894-1905
³ J Clin Oncol 39, 267(2021) Volume 39, Number 3_suppl
⁴ May 29, 2020; FDA press release
⁵ April 11, 2025; FDA press release

FAQ

What were the HCC response rates reported for Adagene's muzastotug triplet (ADAG) at AACR 2026?

The muzastotug triplet achieved a 66.7% ORR by HCC-specific modified RECIST v1.1. According to the company, this compared with 32.5% ORR in the atezolizumab plus bevacizumab control arm with longer median follow-up.

How did muzastotug affect progression-free survival in the HCC Phase 1b/2 study (ADAG)?

Median PFS with the muzastotug triplet was 8.2 months by both RECIST metrics. According to the company, the control doublet showed a mPFS of 5.5 months in the same study population.

What were the MSS CRC interim ORRs for muzastotug plus pembrolizumab and fruquintinib (ADAG) at AACR 2026?

Interim results showed dose-dependent ORRs: 25% at 10 mg/kg and 40% at 15 mg/kg of muzastotug. According to the company, nine non-liver-metastasis patients were evaluable across the two dose cohorts.

Were there safety concerns reported for muzastotug triplet combinations in the presented studies (ADAG)?

No new safety signals or DLTs were reported and there were no Grade 4 or 5 TRAEs in MSS CRC. According to the company, Grade ≥3 TRAEs were reported at 50% (HCC triplet) and 25–60% (MSS CRC triplet) ranges.

Does the FDA have any special designation for Adagene's muzastotug programs (ADAG)?

Yes — muzastotug in combination with pembrolizumab has Fast Track designation for adult MSS metastatic colorectal cancer without active liver metastases. According to the company, that designation aims to expedite development for this patient group.