Balixafortide
Also known as: POL6326
Balixafortide is an investigational CXCR4-blocking peptide studied with eribulin for metastatic breast cancer. The randomized Phase 3 program failed to improve outcomes over chemotherapy alone, outweighing an earlier uncontrolled signal.
Quick Facts
What is balixafortide?
Polyphor, later Spexis, developed balixafortide as POL6326. It was infused with eribulin for HER2-negative metastatic breast cancer. The peptide remains unapproved, and development has effectively ended.
How does it work?
CXCR4 signaling with CXCL12, also called SDF-1α, influences cell trafficking, the tumor microenvironment and immune behavior. Laboratory work proposed that blocking this pathway could improve chemotherapy responsiveness. That mechanism motivated the eribulin combination but did not establish clinical benefit.
Sources: [1]
Is it FDA-approved?
Balixafortide is not approved. The program is effectively discontinued following failure of its pivotal trial.
What does the research show?
| Trial | Design and result |
|---|---|
| Phase 1 | A single-arm study in heavily pretreated metastatic breast cancer reported partial responses in about 30% of evaluable participants. |
| Phase 3 FORTRESS | The company reported in 2021 that the randomized eribulin-controlled trial missed its primary endpoint; response and clinical-benefit rates were similar with and without balixafortide. |
The controlled trial does not support meaningful added benefit, despite the encouraging early single-arm observations.
Sources: [2]
References and further reading
This reference draws on Superpower’s Peptide Library and the research linked below. Peptide Dossier’s editorial team adapted and integrated the material on .
- 10.1016/S1470-2045(18)30147-5How does it work?Cited in: How does it work?
- clinicaltrialsarena.comWhat does the research show?Cited in: What does the research show?
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Disclaimer: This article is for informational and educational purposes only. It is not intended as medical advice. The information presented is based on published research and should not be used as a substitute for professional medical guidance. Always consult a qualified healthcare provider before starting any peptide protocol. Some peptides discussed may not be approved for human use by the FDA or equivalent regulatory bodies.