General Information of Synthetic Binding Protein (SBP) (ID: SBP000574)
SBP Name
beta-Hairpin mimetic Balixafortide
Synonyms
POL6326
Design Method Traditional methods (Site-directed mutagenesis and/or Directed evolution)
Highest Status Phase III
Protein Scaffold Information of This SBP
Scaffold ID PS016
Scaffold Info
[1] , [2]
Scaffold Name Beta-Hairpin mimetic
Scaffold Class Non-Antibody
Fold Type Beta-Sheets + Beta-Turn
Binding Target(s) of This SBP (BTS)
BTS Name Details Mechanism Application Affinity Research Organization Ref
C-X-C chemokine receptor type 4
BTS Info
Inhibitor Multiple myeloma [ICD-11: 2A83.Y]; Breast cancer [ICD-11: 2C6Z]; Metastatic breast cancer in combination with eribulin [ICD-11: 2E0Y]; Acute myocardial infarction [ICD-11: BA41.Z]; Hematopoietic stem cell mobilization;SARS-CoV-2 infection (COVID-19) [ICD-11: XN109] Kd: 2 nM Polyphor [1] , [2]
Clinical Trial Information of This SBP
EUCTR2008-005046-23-DE Click to show the Detail
Indication Multiple Myeloma
Phase Phase II
Title A Phase IIa, Proof of Concept Study to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of POL6326 in Patients with Multiple Myeloma
Status Authorised
Sponsor Polyphor AG
EUCTR2012-003229-91-AT Click to show the Detail
Indication Large Reperfused ST-Elevation Myocardial Infarction
Phase Phase II
Title CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI) A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Multi-centre Study of POL6326, a CXCR4 Antagonist, in Patients with Large Reperfused ST-Elevation Myocardial Infarction-CATCH-AMI
Status Not Recruiting
Sponsor Polyphor AG
EUCTR2012-003229-91-CZ Click to show the Detail
Indication Large Reperfused ST-Elevation Myocardial Infarction
Phase Phase II
Title CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI) A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Multi-centre Study of POL6326, a CXCR4 Antagonist, in Patients with Large Reperfused ST-Elevation Myocardial Infarction-CATCH-AMI
Status Not Recruiting
Sponsor Polyphor AG
EUCTR2012-003229-91-DE Click to show the Detail
Indication Large Reperfused ST-Elevation Myocardial Infarction
Phase Phase II
Title CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI) A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Multi-centre Study of POL6326, a CXCR4 Antagonist, in Patients with Large Reperfused ST-Elevation Myocardial Infarction-CATCH-AMI
Status Not Recruiting
Sponsor Polyphor AG
EUCTR2012-003229-91-GB Click to show the Detail
Indication Large Reperfused ST-Elevation Myocardial Infarction
Phase Phase II
Title CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI) A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Multi-centre Study of POL6326, a CXCR4 Antagonist, in Patients with Large Reperfused ST-Elevation Myocardial Infarction-CATCH-AMI
Status Not Recruiting
Sponsor Polyphor AG
EUCTR2012-003229-91-HR Click to show the Detail
Indication Large Reperfused ST-Elevation Myocardial Infarction
Phase Phase II
Title CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI) A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Multi-centre Study of POL6326, a CXCR4 Antagonist, in Patients with Large Reperfused ST-Elevation Myocardial Infarction-CATCH-AMI
Status Not Recruiting
Sponsor Polyphor AG
EUCTR2012-003229-91-HU Click to show the Detail
Indication Large Reperfused ST-Elevation Myocardial Infarction
Phase Phase II
Title CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI) A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Multi-centre Study of POL6326, a CXCR4 Antagonist, in Patients with Large Reperfused ST-Elevation Myocardial Infarction-CATCH-AMI
Status Not Recruiting
Sponsor Polyphor AG
EUCTR2012-003229-91-PL Click to show the Detail
Indication Large Reperfused ST-Elevation Myocardial Infarction
Phase Phase II
Title CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI) A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Multi-centre Study of POL6326, a CXCR4 Antagonist, in Patients with Large Reperfused ST-Elevation Myocardial Infarction-CATCH-AMI
Status Not Recruiting
Sponsor Polyphor AG
NCT01105403 Click to show the Detail
Indication Multiple Myeloma
Phase Phase II
Title A Phase IIa, Proof of Concept Study is to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of?POL6326?in Patients With Multiple Myeloma
Status Completed
Sponsor Polyphor Ltd
NCT01413568 Click to show the Detail
Indication Advanced Hematological Malignancies
Phase Phase I; Phase II
Title A Phase I/II Study Evaluating the Safety and Efficacy of Intravenous?POL6326?for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies
Status Completed
Sponsor Polyphor Ltd
NCT01837095 Click to show the Detail
Indication Metastatic Breast Cancer
Phase Phase I
Title A Phase I Dose Escalation Study of?POL6326?With Eribulin in Patients With Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer
Status Completed
Sponsor Polyphor Ltd
NCT01841476 Click to show the Detail
Indication Healthy
Phase Phase I
Title POL6326?-A Phase I, Open, Single Intravenous Infusion Dose, Pharmacokinetic and Pharmacodynamic Study in Healthy Volunteers Who Are Volunteering as Haematopoietic Stem Cell (HSC) Donors
Status Completed
Sponsor Polyphor Ltd
NCT01905475 Click to show the Detail
Indication Large Reperfused ST-Elevation Myocardial Infarction
Phase Phase II
Title CXCR4 AnTagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI). A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Multi-centre Study of?POL6326, a CXCR4 Antagonist, in Patients With Large Reperfused ST Elevation Myocardial Infarction
Status Completed
Sponsor Polyphor Ltd
NCT03786094 Click to show the Detail
Indication Breast Cancer
Phase Phase III
Title An International, Phase III, Multicenter, Randomized, Open-Label Trial Comparing?Balixafortide?in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
Status Active, not recruiting
Sponsor Polyphor Ltd
NCT04826016 Click to show the Detail
Indication Advanced Breast Cancer
Phase Phase I; Phase II
Title POL6326 (Balixafortide) Plus Nab-paclitaxel or Eribulin in Patients With HER2-negative Advanced Breast Cancer
Status Withdrawn
Sponsor MedSIR
References
1 In vitro-engineered non-antibody protein therapeutics. Protein Cell. 2018 Jan;9(1):3-14.
2 DRUGBANK online. Balixafortide