World's First CDH17/CLDN18.2 Bispecific ADC VBC108 Enters Clinical Development

July 10, 2026

Shanghai-based VelaVigo (Shanghai) Limited has submitted an Investigational New Drug (IND) application for VBC108, a bispecific antibody-drug conjugate (ADC) targeting CDH17 and CLDN18.2, marking the world's first dual-target ADC of its kind to enter clinical development.

China's Center for Drug Evaluation (CDE) officially accepted the application on July 10, 2026, with filing number CXSL2600730. The drug is classified as a Class 1 therapeutic biological product.

The IND acceptance represents a significant milestone in gastrointestinal cancer treatment, as VBC108 is designed to address tumors expressing either or both of the two target antigens, potentially expanding treatment options for patients with colorectal, gastric, and pancreatic cancers.

Dual-Target Strategy

VBC108 combines two distinct targeting mechanisms with a topoisomerase I inhibitor (TOPO1i) payload. The dual-specificity design aims to deliver three key advantages: enhanced tumor selectivity, expanded patient coverage, and improved drug delivery efficiency.

CDH17 (Cadherin 17) is widely overexpressed in gastrointestinal malignancies, with more than 80% of colorectal cancer tissues testing positive for the antigen. In normal tissue, CDH17 is restricted to tight junctions of gastrointestinal epithelial cells, but tumor development causes loss of cell polarity, exposing the antigen on cancer cell surfaces.

CLDN18.2 (Claudin 18.2) has emerged as a validated target in gastric cancer, with high expression in gastric and gastroesophageal junction adenocarcinomas. Multiple CLDN18.2-targeting ADCs have already advanced to late-stage clinical trials globally.

By simultaneously binding both targets, VBC108 theoretically achieves selective internalization only in tumor cells expressing both antigens, reducing off-target toxicity in normal tissues. The design also aims to cover patients with CDH17-only positive, CLDN18.2-only positive, or dual-positive tumors, potentially benefiting a broader gastrointestinal cancer population.

Preclinical Results

According to publicly available data, VBC108 has demonstrated significant antitumor activity in gastrointestinal cancer models with a favorable safety window, supporting its potential as a first-in-class therapy.

About VelaVigo

Founded in October 2021, VelaVigo focuses on innovative macromolecular technologies, with core investments in bispecific/multispecific antibodies, ADCs, and novel molecules. The company has established a comprehensive system spanning drug discovery, translational medicine, CMC, and early clinical development.

Headquartered in Shanghai Zhangjiang, VelaVigo maintains a wholly-owned subsidiary in Boston, USA. The company has built a pipeline of more than a dozen multispecific antibody and ADC molecules with first-in-class or best-in-class potential, primarily targeting oncology and autoimmune diseases.

Pipeline Progress

VelaVigo's pipeline includes several advanced candidates:

• VBC101: EGFR/c-Met bispecific ADC, submitted IND in August 2025, becoming the company's first product to enter clinical development
• VBC103: TROP2/Nectin-4 bispecific ADC, with overseas rights licensed to U.S.-based Avenzo Therapeutics
• VBC106: FRα/MSLN bispecific ADC, recently registered its first human Phase I/II clinical trial on ClinicalTrials.gov
• VBC108: CDH17/CLDN18.2 bispecific ADC, the subject of the current IND acceptance

Financing and Partnerships

In July 2025, VelaVigo announced the completion of a Pre-A+ funding round totaling over $60 million USD. The round was led by Shunwei Capital, with follow-on investments from Northern Light Venture Capital, Hankang Capital, and the Shanghai Biomedical Fund, among other notable investors.

The financing is primarily intended to advance core pipeline candidates into clinical development in both China and the United States.

Notably, in less than five years since its founding, VelaVigo has already secured overseas licensing partnerships for two products, demonstrating strong innovation capabilities and international vision.

Global CDH17 ADC Landscape

CDH17 is widely regarded as the next major target in gastrointestinal oncology following CLDN18.2. Since 2025, CDH17 ADC development has accelerated, with increased presentations at international conferences including AACR and ASCO.

As of July 2026, the global CDH17 ADC competitive landscape includes:

• AMT-676 (Multitude Therapeutics): CDH17 monoclonal ADC, Phase I clinical with 20% objective response rate
• SOT109 (Sotio): CDH17 monoclonal ADC, Phase I clinical
• ARB1002 (Arbrea Bio): CDH17 monoclonal ADC, Phase I clinical
• 7MW4911 (Mabwell): CDH17 monoclonal ADC using IDDC™ platform, IND approved
• HDM2017 (Simcere): CDH17 monoclonal ADC with TOPO1i payload, IND approved
• HLX69 (Henlius): CDH17 monoclonal ADC, preclinical stage
• VBC108 (VelaVigo): CDH17/CLDN18.2 bispecific ADC, IND accepted (first-in-class)

The majority of CDH17 ADCs in development are single-target monoclonal ADCs. VBC108's bispecific design represents a differentiation strategy, aiming to overcome single-target expression heterogeneity while improving efficacy and safety profiles.

Clinical Significance

Gastrointestinal cancers represent a major global health burden, with colorectal and gastric cancers alone accounting for more than 3 million new cases annually. Despite advances in targeted therapy and immunotherapy, the five-year survival rate for advanced gastrointestinal cancers remains poor, representing a significant unmet medical need.

In colorectal cancer, the number of approved ADC drugs remains limited, with most targeting niche antigens such as HER2. CDH17's positive expression rate of over 80% in colorectal cancer suggests that CDH17-targeting ADCs could benefit a broader patient population.

In gastric cancer, while CLDN18.2 ADCs have shown strong clinical efficacy, approximately 40-50% of patients are CLDN18.2-negative or low-expressing and cannot benefit from existing therapies. VBC108's dual-target design theoretically covers both CLDN18.2-positive and -negative gastric cancer patients, as long as tumors express CDH17.

Looking Ahead

The development of bispecific ADCs presents significantly greater technical challenges than single-target ADCs, requiring bispecific antibody construction, internalization efficiency optimization, and linker-payload adaptation. VBC108's advancement to the IND stage demonstrates VelaVigo's substantial capabilities in multispecific ADC platforms.

The IND acceptance for VBC108 represents just the first step. Subsequent clinical data readouts will be critical in validating the true value of this first-in-class bispecific ADC. Whether the gastrointestinal oncology field will see its next blockbuster target, and whether the CDH17/CLDN18.2 dual-target strategy can deliver on preclinical promise, are questions likely to be answered over the next one to two years.