FDA Grants Fast Track Status to Breast Cancer Therapy Candidate Balixafortide Combined with Halaven

FDA Grants Fast Track Status to Breast Cancer Therapy Candidate Balixafortide Combined with Halaven

The U.S. Food and Drug Administration granted fast track status to Polyphor’s immuno-oncology candidate balixafortide (POL6326) in combination with Halaven (eribulin mesylate) to treat a subset of patients with metastatic breast cancer.

The combination is being evaluated in patients with HER2-negative metastatic breast cancer who previously took a minimum of two chemotherapy regimens while metastatic.

Fast track designation is granted to speed up the development and review of potential medications for serious conditions and fill an unmet medical need. Treatment candidates that receive this designation benefit from more frequent communication with the FDA regarding clinical trials’ design and collection of all necessary data for approval. These therapies may also benefit from future accelerated approval and priority review.

“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,” Giacomo Di Nepi, CEO at Polyphor, said in a press release.

According to Polyphor, balixafortide is a potent and selective blocker of the CXCR4 receptor, which regulates immune and cancer cell migration.

CXCR4 also regulates tumor growth, survival, blood vessel formation, and metastasis. High levels of this receptor have been found in nearly all human cancer types, including breast cancer. High CXCR4 levels correlate with aggressive metastases and poor prognosis.

Balixafortide is being developed as a combo treatment for cancer. It is the only CXCR4 blocker in development for breast cancer and the most advanced CXCR4 blocker for solid tumors, Polyphor said.

The company recently met with the FDA to discuss results of a Phase 1 trial (NCT01837095), which showed that the balixafortide-Halaven combo is effective in patients with metastatic breast cancer. The combo treatment led to at least a stable disease in 67% of patients, while 38% showed tumor shrinkage.

Polyphor is now planning a pivotal clinical trial of balixafortide, which may lead to the compound’s availability for U.S. patients by 2021 — or even 2020 if it gets accelerated approval.

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