Product Description
Motixafortide (formerly known as BL-8040/BKT140) is a novel selective inhibitor of the CXCR4 chemokine receptor. CXCR4, is a well validated therapeutic target that is involved in the mobilization and trafficking of hematopoietic stem cells, immune cells and cancer cells from the bone marrow and the lymph nodes to the peripheral blood. Motixafortide is being developed as a platform for several indications including mobilization of hematopoietic stem cells (HSCs) for autologous transplantations, treatment of solid tumors, and other hematological malignancies. (Sourced from: https://www.biolinerx.com/pipeline/bl-8040/overview)
Mechanisms of Action: CXCR4 Inhibitor
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous
FDA Designation: Orphan Drug - Pancreatic Cancer *
Approval Status: Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: BioLineRx
Company Location: MODI-IN L3 7177871
Company CEO:
Additional Commercial Interests: GenFleet Therapeutics (Australia)
Clinical Description
Countries in Clinic: China, Germany, Hungary, Italy, Japan, Korea, Spain, United States
Active Clinical Trial Count: 9
Recent & Upcoming Milestones
- Clinical Outcomes Reported - BioLineRx presented P2 Pancreatic Cancer results on 2025-05-31 for Motixafortide
- Clinical Outcomes Reported - BioLineRx presented P1 Anemia, Sickle Cell results on 2024-12-07 for Motixafortide
- Clinical Outcomes Reported - BioLineRx presented P2 Pancreatic Cancer results on 2024-06-01 for Motixafortide
Highest Development Phases
Phase 3: Hematopoietic Stem Cell Transplant|Multiple Myeloma
Phase 2: Adenocarcinoma|Pancreatic Cancer
Phase 1: Anemia, Sickle Cell
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| NCT05618301 | P1 |
Completed |
Anemia, Sickle Cell |
2025-06-24 |
23% |
2025-07-09 |
Primary Endpoints |
| NCT06547112 | P1 |
Recruiting |
Multiple Myeloma |
2026-01-31 |
23% |
2024-11-05 |
Primary Endpoints|Treatments|Trial Status |
| SCDSTEMM | P1 |
Recruiting |
Anemia, Sickle Cell |
2026-01-01 |
23% |
2024-09-20 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| AAAS9513 | P2 |
Recruiting |
Adenocarcinoma|Pancreatic Cancer |
2028-06-01 |
12% |
2025-03-12 |
|
| Morpheus-Pancreatic Cancer | P2 |
Completed |
Pancreatic Cancer|Adenocarcinoma |
2025-02-27 |
12% |
2025-04-19 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date |
| BL-8040 with pembrolizumab for treatment of pancreatic cancer - The COMBAT Study | P2 |
Active, not recruiting |
Pancreatic Cancer |
2021-10-05 |
2022-03-13 |
Treatments |
|
| BL-8040.SCM.301 | P3 |
Active, not recruiting |
Multiple Myeloma|Hematopoietic Stem Cell Transplant |
2028-09-30 |
2025-05-02 |
Treatments |
|
| GLS-020-31 | P3 |
Not yet recruiting |
Multiple Myeloma |
2026-08-31 |
9% |
2024-07-24 |
Primary Endpoints|Treatments |
| GENESIS | P3 |
Active, not recruiting |
Multiple Myeloma |
2020-12-22 |
12% |
2024-02-09 |
Primary Endpoints|Study Completion Date|Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
05/30/2025 |
News Article |
BioLineRx Announces New Pilot Phase Data from Phase 2 Combination Trial of Motixafortide in First-Line Pancreatic Cancer (PDAC) to be Presented at ASCO 2025 Annual Meeting |
|
05/20/2025 |
News Article |
BioLineRx to Report First Quarter 2025 Results on May 27, 2025 |
|
01/21/2025 |
News Article |
BioLineRx Issues Letter to Shareholders |
|
01/17/2025 |
News Article |
BioLineRx Announces Change to Ratio of American Depositary Shares to Ordinary Shares |