ROCKVILLE, Md.

马里兰州罗克维尔

,

，

April 9, 2026

2026年4月9日

/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).

/PRNewswire/ -- OncoC4 Inc.，一家处于后期临床阶段的生物制药公司，今日宣布，在国家药品监督管理局（NMPA）批准其阿尔茨海默病治疗药物ONC-841的试验性新药（IND）申请后，已完成第一例受试者的给药，该药物正在进行一项1/2期临床试验。

The clinical trial registration number is CTR20260866..

临床试验注册号为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).

ONC-841 是全球首个也是唯一一个处于临床阶段的抗 SIGLEC 10 抗体。该药物最初被开发出来，并正在进行用于治疗实体瘤患者的二期试验。OncoC4 的新临床前研究表明，ONC-841 在恢复正常小胶质细胞清除大脑中致病性蛋白聚集体的功能方面具有新颖的活性（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..

受益于肿瘤学研究的安全性数据，新的1/2期AD临床试验获得了加速批准，以测试该产品用于AD治疗的安全性和临床活性。

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.

首位研究参与者已在中国首都医科大学宣武医院成功给药。本次临床研究的首席研究员是宣武医院的唐毅教授和魏翠柏教授。

'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.

“将我们的临床研究从癌症扩展到阿尔茨海默病（AD），展示了OncoC4的研究实力以及宣武医院作为世界著名阿尔茨海默病研究中心的基础设施。我们非常感谢宣武医院的同事们给予的合作，”首席执行官兼首席科学官刘阳博士表示。

'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.

“我们非常兴奋能够与OncoC4合作，探索靶向SIGLEC 10的潜力，这是AD发病机制中的新型检查点，为这种毁灭性疾病患者带来临床益处，”唐毅教授补充道，他是执行副总裁兼首席研究员。

About OncoC4

关于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.

总部位于马里兰州罗克维尔的OncoC4是一家私人控股的晚期临床阶段生物制药公司，专注于发现和开发用于治疗癌症和免疫疾病的新型生物制剂。OncoC4的研发管线包含具有首创新药和同类最优潜力的资产，针对肿瘤学和免疫疾病领域中全新及经过充分验证的靶点。

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..

其中，AI-081 是一款完全拥有的靶向 PD-1 和 VEGF 的双特异性抗体候选药物。ONC-841 是一种首创的抗 SIGLEC 10 抗体，目前正处于用于肿瘤适应症的 2 期临床试验和用于神经退行性疾病的 1 期临床试验。OncoC4 与 BioNTech 战略合作，共同开发选择性耗竭肿瘤微环境中的调节性 T 细胞（Treg）的 CTLA-4 靶向候选药物 gotistobart（BNT316/ONC-392），涵盖多个实体瘤适应症，其中包括一项正在进行的关键性临床试验，针对鳞状非小细胞肺癌。

More information:

更多信息：

www.oncoc4.com

www.oncoc4.com

.

。

CONTACTS

联系人

Media Relations

媒体关系

Pan Pan

盼盼

[email protected]

电子邮件地址

Investor Relations

投资者关系

Ryan Cui

崔瑞恩

[email protected]

[email protected]

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.

王鹏等。抗人SIGLEC 10单克隆抗体在多种转基因小鼠AD模型中的治疗活性。《阿尔茨海默病与痴呆》2025年，第21卷（增刊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.

王P等。携带未突变的人类SIGLEC 10基因簇转基因的小鼠会同时产生淀粉样斑块和Tau神经纤维缠结：一种晚发阿尔茨海默病模型。《阿尔茨海默病与痴呆》2025，21（增刊5）：e101773。

SOURCE OncoC4

来源：OncoC4

21

21

%

%

more press release views with

更多新闻发布观点

Request a Demo

请求演示