OncoC4 announces first participant's dosing in Phase 1/2 clinical trial of ONC-841 for the treatment of Alzheimer's disease
ROCKVILLE, Md., April 9, 2026 /PRNewswire/ -- OncoC4 Inc., a late clinical stage biopharmaceutical company, today announced first participant's dosing following the clearance of the Investigational New Drug (IND) application for a Phase 1/2 clinical trial of ONC-841, the company's investigational Alzheimer's disease therapy by the National Medical Product Administration (NMPA). The clinical trial registration number is CTR20260866.
ONC-841 is the world's first and only clinical stage anti-SIGLEC 10 antibody. The drug was initially developed, and is in a Phase 2 trial, for patients with solid tumors. New preclinical research by OncoC4 has revealed ONC-841's novel activity in normalizing microglia's function in clearance of pathogenic protein aggregates in the brain (1, 2). Benefitting from safety data from the oncology study, the new Phase 1/2 AD clinical trial received accelerated clearance to test the safety and clinical activity of the product for AD treatment.
The first study participant was successfully dosed at Xuanwu Hospital of Capital Medical University in China. The Principal Investigators for the clinical study are Professor Yi Tang and Professor Cuibai Wei at the Xuanwu Hospital.
"Extending our clinical study from cancer to AD showcases OncoC4's research engine and Xuanwu Hospital's infrastructure as the world's eminent AD research center. We are extremely grateful to our colleagues at Xuanwu for the collaboration, " said Dr. Yang Liu, CEO and Chief Scientific Officer.
"We are extremely excited to collaborate with OncoC4 to explore the potential of targeting SIGLEC 10, the novel checkpoints of AD pathogenesis, to bring clinical benefit for patients with this devastating illness", added Professor Yi Tang, Executive Vice President and Principal investigator.
About OncoC4
Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for the treatment of cancer and immunological diseases. OncoC4's pipeline features assets with first-in-class and best-in-class potential targeting both novel and well validated targets across oncology and immunological diseases. Among them, AI-081 is a fully owned bispecific antibody candidate targeting PD-1 and VEGF. ONC-841 is a first-in-class anti-SIGLEC 10 antibody currently in a Phase 2 trial for oncology indications and a Phase 1 trial for neurodegenerative diseases. OncoC4 has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a tumor microenvironment-selective Treg depletion candidate targeting CTLA-4, in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer.
More information: www.oncoc4.com.
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- Wang P, et al. Therapeutic activities of anti-human SIGLEC 10 mAb in multiple transgenic mouse AD models. Alzheimer's Dement. 2025, 21 (Suppl. 5): e101818.
- Wang P, et al. Mice carrying unmutated human SIGLEC 10 gene cluster transgene develop both amyloid plaques and Tau neurofilament tangles: a model for late onset Alzheimer's disease. Alzheimer's Dement. 2025, 21 (Suppl. 5): e101773.
SOURCE OncoC4
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