U.S. FDA grants Fast Track designation for Polyphor’s innovative immuno-oncology candidate balixafortide in combination with eribulin as third line therapy for metastatic breast cancer

 Polyphor announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its novel immuno-oncology candidate balixafortide (POL6326), in combination with eribulin, for the treatment of patients with HER2-negative metastatic breast cancer who previously received at least two chemotherapeutic regimens in the metastatic setting. Balixafortide is a potent and highly selective antagonist of CXCR4, a G-protein coupled receptor (GPCR) that regulates the trafficking and homing of both cancer cells and cells of the patient’s immune system. It is the only CXCR4 antagonist in development for breast cancer and is the most advanced CXCR4 antagonist being developed in solid tumours,

The FDA’s Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need[i]. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a pharmaceutical company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

Giacomo Di Nepi, Chief Executive Officer of Polyphor, "We have already identified a development path for balixafortide with input from the FDA to conduct a single pivotal study in this indication. Fast Track designation is another positive step for the development of balixafortide and a recognition of the need for better treatments for this group of patients."

About Balixafortide (POL6326)

Balixafortide is a potent and highly selective antagonist of CXCR4, a G-protein coupled receptor (GPCR) that regulates the trafficking and homing of both cancer cells and cells of the patient’s immune system. CXCR4 plays a critical role in tumor growth, survival, angiogenesis and metastasis[ii]. High CXCR4 levels have been detected in almost all human tumor types, including breast cancer. High CXCR4 expression is known to correlate with aggressive metastatic behavior of cancer cells and a poor prognosis[iii].

Balixafortide is being developed to improve therapy outcomes in cancer, when used in combination with other agents. Balixafortide is the only CXCR4 antagonist in development for breast cancer and is the most advanced CXCR4 antagonist, being developed in solid tumours, being the first product candidate to reach proof of concept. The molecule was discovered based on Polyphor’s proprietary macrocycle technology platform. Balixafortide showed strong results in a Phase Ib/proof of concept clinical trial in combination with eribulin in patients affected with advanced metastatic breast cancer. The development path identified with the input of the FDA is to conduct a single pivotal study to achieve approval in HER-2 negative metastatic breast cancer patients who previously received at least two chemotherapeutic regimens in the metastatic setting. Additionally, there is the possibility of achieving an accelerated conditional approval based on interim results. Polyphor is also conducting preclinical work to establish the potential for balixafortide in combination with other drugs and in other oncology indications.

About Polyphor

Polyphor is a clinical stage, privately held Swiss specialty pharma company which has discovered and is developing the OMPTA (Outer Membrane Protein Targeting Antibiotics). The OMPTA are potentially the first new class of antibiotics against Gram-negative bacteria to have reached phase III stage in the last 50 years. The company’s lead product, murepavadin, (POL7080) is in Phase III development against Pseudomonas aeruginosa – recognized as a critical priority 1 pathogen by WHO. Polyphor is also developing an immuno-oncology candidate, balixafortide (POL6326), which has achieved clinical proof of concept in a Phase Ib/proof of concept study in combination with eribulin in patients with advanced breast cancer, and a pipeline of further preclinical antibiotics based on its OMPTA platform. Polyphor is based in Allschwil near Basel. 

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