Adagene Announces Regulatory Update on Clinical Development Plan for Muzastotug in Microsatellite Stable Colorectal Cancer Following Productive Type B (End of Phase 1) Meeting with FDA
Adagene (NASDAQ:ADAG) has received positive feedback from the FDA following a Type B meeting regarding the clinical development plan for muzastotug (ADG126) in combination with Merck's KEYTRUDA for treating microsatellite stable colorectal cancer (MSS CRC).
The FDA has endorsed key aspects of the Phase 2 trial design, which will enroll approximately 60 patients across two dosing arms (10 mg/kg and 20 mg/kg). Early data shows promising results with ORR increasing from 17% at 10 mg/kg to 29% at 20 mg/kg, while maintaining Grade 3 TRAEs at approximately 20%.
The company plans to begin Phase 2 enrollment in 2H 2025, focusing on late-line MSS CRC patients without liver metastases. The trial's primary endpoint will be overall response rate (ORR), with secondary endpoints including duration of response, progression-free survival, and overall survival.
Adagene (NASDAQ:ADAG) ha ricevuto un riscontro positivo dalla FDA a seguito di un incontro di tipo B riguardante il piano di sviluppo clinico per muzastotug (ADG126) in combinazione con KEYTRUDA di Merck per il trattamento del carcinoma colorettale microsatellite stabile (MSS CRC).
La FDA ha approvato gli aspetti principali del disegno dello studio di Fase 2, che prevede di arruolare circa 60 pazienti distribuiti in due bracci di dosaggio (10 mg/kg e 20 mg/kg). I dati preliminari mostrano risultati promettenti con un tasso di risposta obiettiva (ORR) che aumenta dal 17% a 10 mg/kg al 29% a 20 mg/kg, mantenendo gli eventi avversi correlati al trattamento di grado 3 (TRAE) intorno al 20%.
L'azienda prevede di iniziare l'arruolamento per la Fase 2 nella seconda met脿 del 2025, concentrandosi su pazienti con MSS CRC in fase avanzata senza metastasi epatiche. L'endpoint primario dello studio sar脿 il tasso di risposta globale (ORR), mentre gli endpoint secondari includeranno la durata della risposta, la sopravvivenza libera da progressione e la sopravvivenza globale.
Adagene (NASDAQ:ADAG) ha recibido una respuesta positiva de la FDA tras una reuni贸n de Tipo B sobre el plan de desarrollo cl铆nico de muzastotug (ADG126) en combinaci贸n con KEYTRUDA de Merck para el tratamiento del c谩ncer colorrectal estable en microsat茅lites (MSS CRC).
La FDA ha aprobado aspectos clave del dise帽o del ensayo de Fase 2, que inscribir谩 aproximadamente a 60 pacientes divididos en dos grupos de dosis (10 mg/kg y 20 mg/kg). Los datos iniciales muestran resultados prometedores con una tasa de respuesta objetiva (ORR) que aumenta del 17% a 10 mg/kg al 29% a 20 mg/kg, manteniendo los eventos adversos relacionados con el tratamiento de grado 3 (TRAE) en aproximadamente un 20%.
La compa帽铆a planea iniciar la inscripci贸n de la Fase 2 en la segunda mitad de 2025, enfoc谩ndose en pacientes con MSS CRC en etapas avanzadas sin met谩stasis hep谩ticas. El objetivo principal del ensayo ser谩 la tasa de respuesta global (ORR), con objetivos secundarios que incluyen la duraci贸n de la respuesta, la supervivencia libre de progresi贸n y la supervivencia global.
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Adagene (NASDAQ:ADAG) a re莽u un retour positif de la FDA suite 脿 une r茅union de type B concernant le plan de d茅veloppement clinique de muzastotug (ADG126) en combinaison avec le KEYTRUDA de Merck pour le traitement du cancer colorectal stable au niveau des microsatellites (MSS CRC).
La FDA a approuv茅 les aspects cl茅s de la conception de l'essai de phase 2, qui enr么lera environ 60 patients r茅partis en deux groupes de dosage (10 mg/kg et 20 mg/kg). Les donn茅es pr茅liminaires montrent des r茅sultats prometteurs avec un taux de r茅ponse objective (ORR) passant de 17 % 脿 10 mg/kg 脿 29 % 脿 20 mg/kg, tout en maintenant les effets ind茅sirables li茅s au traitement de grade 3 (TRAE) 脿 environ 20 %.
La soci茅t茅 pr茅voit de commencer le recrutement pour la phase 2 au second semestre 2025, en se concentrant sur les patients atteints de MSS CRC en phase avanc茅e sans m茅tastases h茅patiques. Le crit猫re principal de l'essai sera le taux de r茅ponse globale (ORR), les crit猫res secondaires incluront la dur茅e de la r茅ponse, la survie sans progression et la survie globale.
Adagene (NASDAQ:ADAG) hat nach einem Type-B-Meeting positives Feedback von der FDA zum klinischen Entwicklungsplan f眉r muzastotug (ADG126) in Kombination mit Mercks KEYTRUDA zur Behandlung von mikrosatellitenstabilem kolorektalem Krebs (MSS CRC) erhalten.
Die FDA hat wesentliche Aspekte des Designs der Phase-2-Studie genehmigt, die etwa 60 Patienten in zwei Dosierungsarmen (10 mg/kg und 20 mg/kg) einschlie脽en wird. Erste Daten zeigen vielversprechende Ergebnisse mit einer Ansprechrate (ORR), die von 17 % bei 10 mg/kg auf 29 % bei 20 mg/kg ansteigt, w盲hrend Grad-3-behandlungsbedingte Nebenwirkungen (TRAE) bei etwa 20 % bleiben.
Das Unternehmen plant, die Einschreibung f眉r Phase 2 in der zweiten H盲lfte des Jahres 2025 zu beginnen, mit Fokus auf Patienten mit sp盲ten MSS CRC ohne Lebermetastasen. Der prim盲re Endpunkt der Studie wird die Gesamtansprechrate (ORR) sein, sekund盲re Endpunkte umfassen Ansprechdauer, progressionsfreies 脺berleben und Gesamt眉berleben.
- FDA endorsement for high-dose ADG126 (10-20x higher than other anti-CTLA-4 antibodies)
- Promising efficacy with ORR increasing from 17% to 29% at higher doses
- Favorable safety profile with Grade 3 TRAEs maintained at ~20%
- No cycle limitations for ADG126 treatment approved by FDA
- Clear pathway to Phase 3 trial with FDA agreement on trial design
- Patient population limited to those without liver metastases
- Phase 2 trial requires additional patient enrollment before advancing to Phase 3
Insights
Adagene advances muzastotug to Phase 2 after FDA alignment on trial design, showing promising efficacy and safety in colorectal cancer.
This FDA regulatory update represents a significant milestone for Adagene's muzastotug (ADG126) development program. The Type B meeting has yielded clear alignment on critical Phase 2 trial parameters for their masked anti-CTLA-4 SAFEbody庐 in combination with Merck's pembrolizumab for microsatellite stable colorectal cancer (MSS CRC) patients.
The FDA has endorsed several key elements that significantly de-risk Adagene's clinical development pathway. First, the agreement on patient population targeting late-line MSS CRC patients without liver metastases provides crucial clarity on inclusion criteria. Second, the dose optimization strategy testing both 10 mg/kg and 20 mg/kg without cycle limitations is particularly notable given these doses are 10-20 times higher than typical anti-CTLA-4 antibodies - suggesting a potentially superior safety profile.
The preliminary efficacy signals are promising, with a dose-dependent response showing
The streamlined trial design (~30 patients per arm) without requiring monotherapy arms in either Phase 2 or 3 represents significant efficiency in the development pathway. The agreement on endpoints - ORR for Phase 2 and overall survival for Phase 3 - aligns with regulatory expectations for oncology approvals.
With Phase 2 enrollment expected in 2H 2025 and the backing of strategic partner Merck supplying pembrolizumab, Adagene has positioned itself on a clear path toward a potential registrational trial for this novel combination therapy addressing a significant unmet need in MSS CRC.
- Alignment gained on Phase 2 inclusion/exclusion criteria, primary and secondary endpoints, and study design, including sample size and dosing regimen
- Company expects to begin enrolling patients in Phase 2 in 2H 2025
SAN DIEGO and SUZHOU, China, July 15, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (鈥淎dagene or the Company鈥�) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced outcomes from its Type B meeting with the United States Food and Drug Administration (FDA). Adagene has received written feedback from the FDA on its clinical development plan to evaluate muzastotug (ADG126) in combination with Merck鈥檚 (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA庐 (pembrolizumab: 200 mg, Q3W) in patients with microsatellite stable colorectal cancer (MSS CRC).
ADG126 is a masked, anti-CTLA-4 SAFEbody庐 that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on MSS CRC. To date, over 150 patients have received ADG126, either as monotherapy or in combination with anti-PD-1 therapy. Adagene has completed patient enrollment for the MSS CRC dose expansion cohorts of the ADG126 + pembrolizumab combination (NCT05405595). The phase 2 trial will be conducted primarily to identify which of the two doses of ADG126 will be used in the phase 3 trial.
Key Outcomes from the FDA Type B Meeting
- Patient Population: Future trials will enroll late-line patients with MSS CRC without liver metastases, including those with peritoneal metastasis/involvement.
- Dose and Regimen: Phase 2 will randomize patients to either 10 mg/kg or 20 mg/kg of ADG126 in combination with pembrolizumab, using an induction-maintenance regimen, without cycle limitations of ADG126.
- Phase 2 Trial Design: Approximately 30 patients will be enrolled in each arm of the Phase 2 study, without a requirement for an ADG126 monotherapy arm.
- Phase 3 Trial Design: The FDA agreed with Adagene鈥檚 proposed standard-of-care (SOC) control arm for the Phase 3 clinical trial and confirmed that an ADG126 monotherapy arm is also not required in the pivotal study.
- Phase 2 Endpoints: The primary endpoint of the Phase 2 trial will be overall response rate (ORR). Secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
- Phase 3 Endpoints: The primary endpoint of the Phase 3 trial will be OS. Secondary endpoints will include PFS, DOR and ORR.
鈥淩eceiving the FDA鈥檚 endorsement to explore ADG126 at doses 10 to 20 times higher than other anti-CTLA-4 antibodies, without limitations on treatment cycles, has demonstrated a nearly two-fold increase in ORR from
Peter Luo, Ph.D., CEO and President of R&D at聽Adagene added, 鈥淥ur Phase 1b/2 trial has produced robust dose-dependent efficacy data with a potential best-in-class safety profile, identifying two optimized dose levels for the Phase 2, consistent with Project Optimus. With the FDA鈥檚 endorsement to advance into the Phase 2 part of the clinical trial, we鈥檇 like to thank our strategic partner, Merck, for supplying pembrolizumab to support this exciting randomized dose optimization cohort to identify a single dose to take into Phase 3, a critical step towards registrational trial for FDA approval.鈥�
础产辞耻迟听础诲补驳别苍别
Adagene Inc.聽(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庐聽precision masking technology in multiple approaches at the vanguard of science.
Powered by its proprietary聽Dynamic Precision Library聽(DPL) platform, composed of NEObody鈩�, SAFEbody, and POWERbody鈩� technologies, Adagene鈥檚 highly differentiated pipeline features novel immunotherapy programs. The company鈥檚 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 in tumor microenvironment, while minimizing on-target off-tumor toxicity in healthy tissues.
Adagene鈥檚 lead clinical program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/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/multi-specific T-cell engagers.
For more information, please visit:聽.
Follow Adagene聽on聽,听听补苍诲听.
SAFEbody庐聽is a registered trademark in聽the聽United States, China, Australia, Japan, Singapore, and the聽European Union.
KEYTRUDA庐聽is a registered trademark of聽Merck Sharp & Dohme LLC, a subsidiary of聽Merck & Co., Inc.,听Rahway, NJ, USA
Safe Harbor Statement
This press release contains forward-looking statements, including statements regarding the impact of Sanofi鈥檚 strategic investment and Adagene鈥檚 relationship with Sanofi; the expected timeframe for funding Adagene鈥檚 operating plan with current cash and cash equivalents and the proceeds from Sanofi鈥檚 investment; certain clinical results of ADG126, the potential implications of clinical data for patients, and Adagene鈥檚 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鈥檚 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鈥檚 drug candidates; Adagene鈥檚 ability to achieve commercial success for its drug candidates, if approved; Adagene鈥檚 ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene鈥檚 reliance on third parties to conduct drug development, manufacturing and other services; Adagene鈥檚 limited operating history and Adagene鈥檚 ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene鈥檚 ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, as well as those risks more fully discussed in the 鈥淩isk Factors鈥� section in Adagene鈥檚 filings with the聽U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to聽Adagene, and聽Adagene聽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
Corey Davis
LifeSci Advisors
FAQ
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