Adagene Inc.

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

Adagene dosed the first patient in a Phase 1 study combining its masked anti-CTLA-4 SAFEbody muzastotug with Incyte's TGFβR2 × PD-1 bispecific INCA33890 in third-line MSS colorectal cancer patients, including those with liver metastases. Under the collaboration first announced in April 2026, Incyte is sponsoring and conducting the study while Adagene supplies clinical muzastotug. The milestone validates muzastotug's potential as a backbone combination therapy, though it is an early-stage trial with no data readout expected near term.

•4d ago

Adagene Announces NMPA Clearance of Investigational New Drug Application for ADG138, a Novel HER2xCD3 Double-Masked Bispecific T-Cell Engager

China's National Medical Products Administration has cleared Adagene's investigational new drug application for ADG138, a double-masked HER2×CD3 bispecific T-cell engager built on the company's proprietary SAFEbody precision masking technology. A first-in-human Phase 1 study of ADG138 in advanced solid tumors is expected to begin in China in the fourth quarter of 2026. Preclinical data showed tumor regression in models refractory or resistant to Enhertu (DS-8201), with ADG138 tolerated at doses over 300-fold higher than an unmasked T-cell engager and markedly reduced cytokine release.

•1mo ago

Adagene Announces that Third Arc Bio Has Selected First Lead Candidate under Amended Strategic Collaboration for Development of Masked CD3 T Cell Engagers Utilizing SAFEbody® Technology

Adagene's partner Third Arc Bio selected the first lead candidate under their amended strategic licensing agreement covering masked CD3 T cell engagers generated with Adagene's NEObody and SAFEbody technology platforms. Under the amended terms, Third Arc Bio will sponsor and fund clinical development of the program, and total potential development and commercial milestone payments to Adagene have increased, though no specific dollar amounts were disclosed. Adagene retains a no-cost option to develop and commercialize the candidate molecules in Greater China, Singapore and South Korea, preserving regional upside for the filer. The milestone adds external validation for the SAFEbody masking platform, whose lead clinical asset muzastotug (ADG126) holds FDA Fast Track designation and is in Phase 1b/2 and Phase 2 studies for MSS metastatic colorectal cancer.

•1mo ago

Adagene Achieves Milestone in Collaboration with Exelixis for Advancement of SAFEbody® Antibody-Drug Conjugate Candidates

Adagene achieved a preclinical milestone for XB404, a SAFEbody antibody-drug conjugate designed to target ROR1/2-expressing tumors, triggering a $2.0 million milestone payment from collaboration partner Exelixis. A second payment to Adagene was also triggered by Exelixis' selection of candidates for another SAFEbody ADC program, though that amount was not disclosed. Under the license, Adagene remains eligible for development and commercialization milestones plus royalties on net sales, adding modest non-dilutive funding and third-party validation of its masking technology platform.

•1mo ago

Adagene Reports Six Months 2026 Financial Results and Provides Corporate Updates

Adagene reported a cash position of $127.9 million as of June 30, 2026, providing a runway into late 2028, while recognizing $1.6 million in revenue from collaboration milestones. Interim data from a Phase 1b/2 study in first-line hepatocellular carcinoma showed a 66.7% overall response rate for the muzastotug triplet, significantly outperforming the 32.5% rate in the control arm. The company advanced new collaborations with Sanofi and Incyte and remains on track to report results from a randomized Phase 2 trial in MSS CRC in the first half of 2027.

•2mo ago