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Research Report
Bempikibart (ADX-914): A Comprehensive Report on an Investigational Anti-IL-7Rα Monoclonal Antibody for Autoimmune Diseases
1. Introduction to Bempikibart (ADX-914)
Overview of the Drug
Bempikibart, also identified by its research code ADX-914 and formerly BMS-986265, is an investigational biologic therapeutic agent.[1] It is classified as a fully human IgG1 kappa monoclonal antibody.[1] The primary molecular target of bempikibart is the alpha subunit of the interleukin-7 receptor (IL-7Rα).[2] The Chemical Abstracts Service (CAS) Registry Number for bempikibart is 2622254-57-1.[7]
Development History and Developer
Bempikibart is currently under development by Q32 Bio Inc..[2] The development pathway of bempikibart has involved several entities. Q32 Bio regained full worldwide development and commercial rights to bempikibart from Amgen in November 2023.[11] Amgen had acquired these rights through its acquisition of Horizon Therapeutics.[11] Prior to Amgen's involvement, Horizon Therapeutics plc had entered into a collaboration and option agreement with Q32 Bio in August 2022 to co-develop bempikibart for autoimmune diseases. Under this agreement, Horizon was to fund Phase 2 trials, with Q32 Bio managing operational aspects.[11] The earliest developmental code name identified in the provided materials is BMS-986265, suggesting initial work may have been conducted by or in association with Bristol Myers Squibb before Q32 Bio took leadership of the program.[8] This sequence of acquisitions and collaborations—from Bristol Myers Squibb to Q32 Bio, then a partnership with Horizon, its subsequent acquisition by Amgen, and finally Q32 Bio's re-acquisition of full rights—illustrates a complex but not uncommon trajectory for pharmaceutical assets. Such transitions can influence development timelines and strategic priorities. Q32 Bio's ultimate consolidation of worldwide rights signifies a strong commitment to bempikibart's potential
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/08/19 | Phase 2 | Active, not recruiting | |||
2020/07/24 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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| 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 |
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| No UK EMC drug information found for this drug. | |||||
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