Product Description
A bispecific antibody composed of a human, Fc-silenced immunoglobulin G1 (IgG1) monoclonal antibody targeting the tumor-associated antigen (TAA) Claudin18.2 (CLDN18.2; A2 isoform of claudin-18) fused with a single chain variable fragment (scFv) targeting 4-1BB (CD137; tumor necrosis factor receptor superfamily member 9; TNFRSF9), with potential immunostimulating and antineoplastic activities. Upon administration, anti-CLDN18.2/anti-4-1BB bispecific antibody TJ-CD4B simultaneously targets and binds to CLDN18.2 expressed on tumor cells and 4-1BB expressed on a variety of leukocyte subsets including activated T lymphocytes. Upon CLDN18.2 binding, the 4-1BB activation signal is induced and TJ-CD4B acts as a conditional 4-1BB agonist in the tumor microenvironment (TME), resulting in T-cell co-stimulation and T-lymphocyte-mediated anti-tumor activity. CLDN18.2, a tight junction protein and stomach-specific isoform of claudin-18, is expressed on a variety of tumor cells. Its expression in healthy tissues is strictly confined to short-lived differentiated epithelial cells of the gastric mucosa. 4-1BB, a surface glycoprotein of the tumor necrosis factor receptor superfamily, is an inducible costimulatory receptor that plays a key role in T-cell proliferation, survival and cytolytic activity. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-claudin182-anti-4-1bb-bispecific-antibody-tj-cd4b)
Mechanisms of Action: CLDN18.2 Inhibitor, 4-1BB Inhibitor
Novel Mechanism: Yes
Modality: Bispecific Antibody
Route of Administration: Intravenous
FDA Designation: Orphan Drug - Gastrointestinal Cancer *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: I-Mab Biopharma
Company Location:
Company Founding Year: 2016
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
- Clinical Outcomes Expected - NovaBridge announced they will present P2 Gastrointestinal Cancer results in YE27 for Givastomig
- Clinical Outcomes Reported - NovaBridge presented P1 Gastrointestinal Cancer results on 2026-01-06 for Givastomig
- Clinical Trial Start Expected - NovaBridge announced they will initiate a P2 Gastrointestinal Cancer trial in 1Q26 for Givastomig
Highest Development Phases
Phase 2: Adenocarcinoma|Esophageal Cancer|Gastrointestinal Cancer
Phase 1: Oncology Solid Tumor Unspecified
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04900818 |
TJ033721STM101 | P1 |
Recruiting |
Esophageal Cancer|Adenocarcinoma|Gastrointestinal Cancer |
2025-12-01 |
12% |
2025-01-04 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
CTR20220747 |
CTR20220747 | P1 |
Recruiting |
Oncology Solid Tumor Unspecified |
None |
2025-04-29 |
Patient Enrollment|Start Date|Treatments|Trial Status |
|
NCT07432295 |
GIVA-2 | P2 |
Recruiting |
Gastrointestinal Cancer|Adenocarcinoma|Esophageal Cancer |
2030-03-01 |
12% |
2026-02-26 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/20/2026 |
News Article |
NovaBridge Announces Open Market Purchases by Executive Chairman, Fu Wei |
|
01/06/2026 |
News Article |
NovaBridge Presents Positive Givastomig Dose Expansion Data from the Phase 1b Combination Study in Patients with 1L Metastatic Gastric Cancer |
|
12/30/2025 |
News Article |
NovaBridge to Ring the Nasdaq Opening Bell on Friday, January 2, 2026 |
|
12/26/2025 |
News Article |
ABL Bio Receives Upfront Payment for License, Research and Collaboration Agreement for Grabody Platform and Equity Investment from Lilly |
