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Research Report
Izalontamab Brengitecan: A Comprehensive Report on a First-in-Class Bispecific Antibody-Drug Conjugate
Executive Summary
Izalontamab brengitecan (iza-bren) is an investigational, first-in-class antibody-drug conjugate (ADC) representing a significant advancement in targeted oncology. Its innovative molecular architecture features a tetravalent, bispecific antibody, Izalontamab, designed to simultaneously target two critical drivers of tumor proliferation: the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). This antibody is conjugated to a potent topoisomerase I inhibitor payload, Ed-04, via a cleavable linker. This dual mechanism—concurrently blocking key oncogenic signaling pathways while delivering a cytotoxic payload—is engineered to overcome the resistance mechanisms that often limit therapies targeting a single pathway.
The development of iza-bren, originated by SystImmune and its parent company Sichuan Baili Pharmaceutical, has been significantly accelerated by a strategic partnership with Bristol Myers Squibb (BMS). This collaboration, valued at up to $8.4 billion, underscores the asset's potential and provides BMS a formidable entry into the highly competitive ADC landscape. The clinical development program is exceptionally broad, with numerous trials ongoing in China across a wide range of solid tumors, complemented by a global pivotal program led by BMS.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/08 | Not Applicable | Not yet recruiting | |||
2025/05/29 | Phase 3 | Not yet recruiting | |||
2025/05/23 | Phase 2 | Not yet recruiting | |||
2025/05/18 | Phase 2 | Recruiting | |||
2025/05/08 | Phase 2 | Not yet recruiting | |||
2025/04/30 | Phase 2 | Recruiting | Sichuan University | ||
2025/03/04 | Phase 3 | Recruiting | |||
2025/02/20 | Phase 3 | Recruiting | |||
2025/01/22 | Phase 2 | Recruiting | |||
2024/10/01 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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