OncoC4 Initiates First-in-Class Anti-SIGLEC 10 Antibody Trial for Alzheimer's Disease Treatment
核心洞察
OncoC4 (搜索) has dosed the first participant in a Phase 1/2 clinical trial of ONC-841, the world's first clinical-stage anti-SIGLEC 10 (搜索) antibody for Alzheimer's disease treatment.
The investigational therapy demonstrates novel activity in normalizing microglia function to clear pathogenic protein aggregates in the brain, based on new preclinical research findings.
The trial received accelerated regulatory clearance from China's NMPA, benefiting from existing safety data from ongoing Phase 2 oncology studies of the same compound.
OncoC4 (搜索) Inc. has achieved a significant milestone in Alzheimer's disease research by dosing the first participant in a Phase 1/2 clinical trial of ONC-841, marking the first clinical evaluation of an anti-SIGLEC 10 (搜索) antibody for neurodegenerative disease treatment. The National Medical Product Administration (NMPA) cleared the Investigational New Drug application for the study, which has been assigned clinical trial registration number CTR20260866.
Novel Mechanism Targets Microglial Function
ONC-841 represents the world's first and only clinical-stage anti-SIGLEC 10 (搜索) antibody, originally developed for solid tumor treatment and currently in Phase 2 oncology trials. Recent preclinical research conducted by OncoC4 (搜索) has revealed the compound's novel activity in normalizing microglia function, specifically enhancing the clearance of pathogenic protein aggregates in the brain. This mechanism of action positions SIGLEC 10 as what researchers describe as "novel checkpoints of AD pathogenesis."
The therapeutic approach leverages existing safety data from the ongoing oncology studies, which enabled the Alzheimer's disease trial to receive accelerated regulatory clearance. This cross-indication development strategy demonstrates the potential for repurposing oncology-focused immunomodulatory agents for neurodegenerative diseases.
Clinical Trial Leadership and Infrastructure
The first study participant was successfully dosed at Xuanwu Hospital of Capital Medical University in China, with Professor Yi Tang and Professor Cuibai Wei serving as Principal Investigators. Professor Tang, who also holds the position of Executive Vice President at the institution, expressed enthusiasm for the collaboration, stating: "We are extremely excited to collaborate with OncoC4 (搜索) to explore the potential of targeting SIGLEC 10 (搜索), the novel checkpoints of AD pathogenesis, to bring clinical benefit for patients with this devastating illness."
Dr. Yang Liu, OncoC4 (搜索)'s CEO and Chief Scientific Officer, emphasized the significance of the institutional partnership, noting: "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."
Broader Pipeline Development
OncoC4 (搜索)'s therapeutic portfolio extends beyond ONC-841, featuring multiple assets with first-in-class and best-in-class potential across oncology and immunological diseases. The company's pipeline includes AI-081, a bispecific antibody candidate targeting PD-1 (搜索) and VEGF (搜索), and maintains a strategic collaboration with BioNTech for the co-development of gotistobart (BNT316/ONC-392), a tumor microenvironment-selective Treg depletion candidate targeting CTLA-4 (搜索) in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer.
The Rockville, Maryland-based biopharmaceutical company's approach to targeting both cancer and neurodegenerative diseases through immunomodulatory mechanisms represents a novel strategy in addressing unmet medical needs across multiple therapeutic areas.