Adagene Expands SAFEbody® Collaboration and License Agreement with Exelixis to Develop Third Novel Masked Antibody-Drug Conjugate
Adagene (Nasdaq: ADAG) has expanded its collaboration with Exelixis by amending their 2021 agreement to develop a third novel masked antibody-drug conjugate (ADC). Under the expanded agreement, Exelixis will use Adagene's SAFEbody technology platform to create a masked monoclonal antibody targeting solid tumors.
The SAFEbody platform is designed to make antibodies invisible until reaching tumor cells, avoiding unwanted binding to healthy cells. Adagene will receive development and commercialization milestones plus royalties on net sales. The company's lead SAFEbody candidate, ADG126, is advancing in a Phase 1b/2 study for metastatic microsatellite-stable colorectal cancer, with Phase 2 expected to start by end of 2025.
Adagene (Nasdaq: ADAG) ha ampliato la sua collaborazione con Exelixis modificando l’accordo del 2021 per sviluppare una terza nuova ADC (anticorpo‑farmaco coniugato mascherato). Secondo l’accordo ampliato, Exelixis utilizzerà la piattaforma tecnologica SAFEbody di Adagene per creare un anticorpo monoclonale mascherato mirato ai tumori solidi.
La piattaforma SAFEbody è progettata per rendere gli anticorpi invisibili fino a raggiungere le cellule tumorali, evitando legami indesiderati con le cellule sane. Adagene riceverà traguardi di sviluppo e commercializzazione, oltre a royalties sulle vendite nette. Il candidato principale SAFEbody dell’azienda, ADG126, procede in uno studio di Fase 1b/2 per il cancro colorettale metastatico microsatellite-stable, con l’inizio della Fase 2 previsto entro la fine del 2025.
Adagene (Nasdaq: ADAG) ha ampliado su colaboración con Exelixis al enmendar su acuerdo de 2021 para desarrollar una tercera ADC (anticuerpo monoclonal conjugado con fármaco) enmascarada. Bajo el acuerdo ampliado, Exelixis utilizará la plataforma SAFEbody de Adagene para crear un anticuerpo monoclonal enmascarado dirigido a tumores sólidos.
La plataforma SAFEbody está diseñada para hacer que los anticuerpos sean invisibles hasta alcanzar las células tumorales, evitando unirse de forma indeseada a células sanas. Adagene recibirá hitos de desarrollo y comercialización, además de regalías sobre las ventas netas. El candidato principal de SAFEbody de la empresa, ADG126, avanza en un estudio de Fase 1b/2 para cáncer colorrectal metastásico microsatellite-stable, con la Fase 2 prevista para comenzar a finales de 2025.
Adagene (Nasdaq: ADAG)가 Exelixis와의 협력을 확장하여 2021년 계약을 수정하고 세 번째 신규 은폐 항체-약물 연결체(ADC)를 개발합니다. 확장된 계약에 따라 Exelixis는 Adagene의 SAFEbody 기술 플랫폼을 사용하여 고형 종양을 표적으로 하는 은활성화된 단일클론 항체를 만들 것입니다.
SAFEbody 플랫폼은 항체를 종양세포에 도달할 때까지 보이지 않도록 설계되어 건강한 세포에 대한 원치 않는 결합을 피합니다. Adagene는 개발 및 상용화 마일스톤과 순매출에 대한 로열티를 받게 됩니다. 회사의 주요 SAFEbody 후보물질인 ADG126은 전이성 마이크로위성-스테이블 대장암(microsatellite-stable colorectal cancer)에서 1b/2상 연구를 진행 중이며 2상은 2025년 말 시작될 것으로 예상됩니다.
Adagene (NASDAQ : ADAG) a étendu sa collaboration avec Exelixis en modifiant leur accord de 2021 afin de développer une troisième ADC masquée novel (anticorps anticorps-conjugué médicament masqué). Dans le cadre de l’accord élargi, Exelixis utilisera la plateforme SAFEbody d’Adagene pour créer un anticorps monoclonal masqué ciblant les tumeurs solides.
La plateforme SAFEbody est conçue pour rendre les anticorps invisibles jusqu’à ce qu’ils atteignent les cellules tumorales, évitant les liaisons indésirables avec les cellules saines. Adagene recevra des jalons de développement et de commercialisation, ainsi que des royalties sur les ventes nettes. Le candidat phare SAFEbody de la société, ADG126, progresse dans une étude de phase 1b/2 pour un cancer colorectal métastatique microsatellite-stable, la phase 2 devant commencer d’ici la fin 2025.
Adagene (Nasdaq: ADAG) hat seine Zusammenarbeit mit Exelixis durch die Änderung des Vertrags von 2021 erweitert, um eine dritte neuartige maskierte Antikörper-Wirkstoff-Konjugation (ADC) zu entwickeln. Im Rahmen des erweiterten Vertrags wird Exelixis die SAFEbody-Technologieplattform von Adagene nutzen, um einen maskierten monoklonalen Antikörper zu entwickeln, der auf solide Tumore abzielt.
Die SAFEbody-Plattform ist so konzipiert, dass Antikörper unsichtbar bleiben, bis sie Tumorzellen erreichen, um unerwünschte Bindungen an gesunde Zellen zu vermeiden. Adagene erhält Entwicklungs- und Vermarktungsmeilensteine sowie Tantiemen auf Nettoumsatz. Der führende SAFEbody-Kandidat des Unternehmens, ADG126, kommt in einer Phase-1b/2-Studie für metastasierenden mikrosatelliten-stabilen kolorektalen Krebs voran, wobei der Start der Phase 2 bis Ende 2025 erwartet wird.
Adagene (ناسداك: ADAG) قد وسّعت تعاونها مع Exelixis من خلال تعديل اتفاقهما في عام 2021 لتطوير ثالث مضاد جسيم-دواء مقنع (ADC) جديد. وفق الاتفاق الموسع، ستستخدم Exelixis منصة SAFEbody التقنية من Adagene لإنشاء جسم مضاد وحيد النسيلة مقنع يستهدف الأورام Solid.
تم تصميم منصة SAFEbody لجعل الأجسام المضادة غير مرئية حتى تصل إلى خلايا الورم، لتفادي الارتباط غير المرغوب بالخلايا السليمة. ستتلقى Adagene مراحل التطوير والتسويق إلى جانب عوائد على المبيعات الصافية. المرشح الرئيسي SAFEbody للشركة، ADG126، يتقدم في دراسة من المرحلة 1b/2 لسرطان القولون والمستقيم المتHJ؟ metastasized microsatellite-stable، ومن المتوقع بدء المرحلة 2 بنهاية 2025.
Adagene（纳斯达克股票代码：ADAG） 通过修订其与 Exelixis 的2021年协议，扩大了合作范围，开发第三种新型隐 masking 的抗体药物偶联物（ADC）。在扩展后的协议下，Exelixis 将使用 Adagene 的 SAFEbody 技术平台 来打造针对实体肿瘤的隐 masked 单克隆抗体。
SAFEbody 平台设计为让抗体在到达肿瘤细胞前保持不可见，避免对健康细胞的非特异性结合。Adagene 将获得开发和商业化里程碑以及净销售额的特许权使用费。公司的领先 SAFEbody 候选药物 ADG126 正在进行转移性微卫星不稳定性稳定性（microsatellite-stable）结直肠癌的1b/2期研究，预计2025年末前后启动2期。
- Expansion of existing partnership demonstrates validation of SAFEbody technology
- Company eligible for development milestones, commercialization milestones, and royalties
- Lead candidate ADG126 advancing to Phase 2 clinical trials by end of 2025
- None.
Insights
Adagene expands its partnership with Exelixis, strengthening revenue potential while validating its innovative SAFEbody technology for safer cancer therapies.
This expanded collaboration represents a significant commercial validation of Adagene's SAFEbody platform technology. The amendment to their 2021 agreement enables Exelixis to develop a third masked antibody-drug conjugate (ADC) using Adagene's proprietary technology against a solid tumor target from Exelixis' pipeline.
The SAFEbody technology addresses a critical challenge in cancer therapeutics - the off-target toxicity that occurs when therapeutic antibodies bind to healthy cells. By engineering antibodies that remain "masked" until they reach the tumor microenvironment, Adagene's platform potentially enables greater safety and improved therapeutic windows for potent cancer treatments.
This deal structure follows the typical biotech partnering model where Adagene will receive development and commercialization milestones plus royalties on net sales. While specific financial terms weren't disclosed, such arrangements typically include tiered royalties that could represent significant long-term value if products reach commercialization.
The mention of ADG126's ongoing Phase 1b/2 study in metastatic microsatellite-stable colorectal cancer with Phase 2 trial commencement expected before year-end provides investors with a tangible clinical milestone. This lead program serves as an important proof-of-concept for the SAFEbody platform that Exelixis is now leveraging more broadly.
For Adagene, this expanded partnership demonstrates continuing external validation of their technology platform while potentially providing additional non-dilutive funding to support their pipeline development. For a biotech company, securing multiple deals with an established partner like Exelixis suggests their platform technology offers meaningful advantages over competing approaches.
SAN DIEGO and SUZHOU, China, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG) today announced an amendment to the 2021 collaboration and license agreement with Exelixis. Under the terms of the amended agreement, Exelixis will utilize Adagene’s SAFEbody technology platform to generate a masked monoclonal antibody from the company’s pipeline for the development of an antibody-drug conjugate (ADC) against an Exelixis-nominated solid tumor target.
Adagene is eligible to receive development and commercialization milestones and royalties on net sales of products developed around this target.
Peter Luo, Ph.D., Chief Executive Officer of Adagene said, “Our SAFEbody technology enables an antibody or ADC to be invisible until it reaches the tumor microenvironment, resulting in a wide therapeutic index, as seen with ADG126. Our evolving partnership with Exelixis highlights the potential of conditional masking to safely deliver a payload or immune modulating antibody directly to tumor cells. We are very pleased to continue to collaborate with Exelixis and look forward to the company’s development of SAFE-ADC® that leverage our SAFEbody technology.”
Biologic cancer therapy targets are expressed at high levels in cancer cells, but many are also expressed at lower levels on healthy cells. Binding to healthy cells may lead to unwanted safety or tolerability issues. Adagene’s SAFEbody platform is designed to overcome this challenge by masking antibodies to healthy cells while preferentially binding to the target in tumor cells.
Adagene’s most advanced SAFEbody candidate, ADG126, is currently in a Phase 1b/2 study in metastatic microsatellite-stable (MSS) colorectal cancer (CRC), with the Phase 2 trial commencement expected before the end of 2025.
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, 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 MSS 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.
Adagene Contacts:
Raymond Tam
raymond_tam@adagene.com
Corey Davis
LifeSci Advisors
cdavis@lifesciadvisors.com
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