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Stem cell mobilizer: Burixafor


TaiGen's stem cell mobilizer Burixafor is the company's first fully in-house developed product, a First-in-Class drug with an IND under US FDA. With a variety of potential applications in a number of disease indications, if proven effective in clinical trials Burixafor will be able to address several unmet medical needs. The molecule is a potent and selective chemokine receptor antagonist which can rapidly mobilize stem cells and progenitor cells from the bone marrow into peripheral circulation. Burixafor also has potential application in chemosensitization treatment of leukemia patients, delaying the relapse after chemotherapy. In addition to hematological indications, Taigen and its collaborator have shown Burixafor’s efficacy in animal models of ischemic tissue repair such as strokes, myocardial infarction, and ischemic limb claudication. To this end, TaiGen plans to initiate clinical trials of Burixafor as a chemotherapy sensitizer in China shortly.


For patients undergoing leukemia stem cell transplantation, current conventional therapy is to inject granulocyte colony-stimulating factor (G-CSF) to stimulate the proliferation of hematopoietic stem cells, which are then collected for later transplantation. However, if administration of G-CSF does not bring about the desired result, current practice is to use Mozobil (Sanofi) to then be injected together with G-CSF. Burixafor in comparison could be used as a monotherapy in certain type of patients without combination with G-CSF. Phase II clinical trials are currently underway in the US, with Phase IIa already completed. In December 2013 preliminary data from these trials was presented at American Society of Hematology Annual Meeting in New Orleans, US.



Item Burixafor Mozobil *
Market Positioning First-line Second-line after patients failed hematopoietic stem cell mobilization by G-CSF.
Indications:
Stem Cell Transplantation
Can be used alone without G-CSF in multiple myeloma patients.
Immediate collection of hematopoietic stem cells after first day of administration.
Only 2-4 hematopoietic stem cell collections needed to collect for two transplants.
Lower the number of hematopoietic stem cell collection sessions needed and reduced costs.
Can only be used with G-CSF.
Lengthy and costly procedure – G-CSF has to be administered for 4 days in advance.
Inconvenient dosing schedule – need to be given 11 hours prior to stem cell collection.
Side effects Minimal side effects in healthy volunteers and patients from clinical trials. Side effects of G-CSF include bone pain, risk of spleen rupture.
Other indications Chemosensitization; myocardial infarction; ischemic limb diseases Chemosensitization

*Mozobil is originally developed by AnorMed which was acquired by Genzyme in 2006. It is now part of Sanofi. Mozobil was approved as a stem cell mobilizer for autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma by US FDA in 2008.


Drugs for stem cell transplantation currently on the market


G-CSF (Neupogen, Amgen)

Plerixafor injection (Mozobil, Genzyme)


Market positioning and competitive advantage


The current stem cell collection for transplantation in leukemia patients were to first administered G-CSF to stimulate and collect hematopoietic stem cells required, if necessary followed by Mozobil. In comparison, stem cell collection with Burixafor in certain patients may not require combination with G-CSF and therefore can reduce the number of expensive steps in the process (white blood cell extraction and separation, etc).

Burixafor can act as a stem cell mobilizer in a wide range of indications including chemotherapy sensitization, myocardial infarction and ischemic limb diseases thus the market potential is huge.