Breast cancer vaccine to reduce recurrences

Breast cancer vaccine to reduce recurrences

A cancer vaccine that may significantly reduce breast cancer recurrence rates has been developed using technology based on the E75 peptide of human epidermal growth factor receptor 2 (HER2/neu). The E75 vaccine, commercially known as NeuVax™, uses the patient's own immune system to fight breast cancer by targeting HER2/neu, a protein that is commonly expressed in breast cancer cells. NeuVax™ stimulates the patient's cytotoxic T-cells, or killer T-cells, to target and kill cells that express any level of HER2.

Successful Phase I and Phase II clinical trials of the E75 vaccine, which showed breast cancer recurrence rates that were reduced by half, were supported through the Uniformed Services University of the Health Sciences (USU) and achieved the primary endpoint of 90% disease-free survival after 5 years of followup. Based on the Phase II clinical trial results, the Food and Drug Administration (FDA) granted NeuVax™ a special protocol assessment for the Phase III clinical trial, which is being conducted by the technology transfer recipient and commercial partner, Galena Biopharma.

The E75 peptide technology was successfully transferred to Galena Biopharma, a biopharmaceutical company with a focus on developing targeted cancer therapies to treat major unmet medical needs and advance cancer care. The efforts of Col. George E. Peoples, M.D., the lead USU inventor on the E75 peptide technology; John E. Baker, the federal laboratory representative at the time of the technology transfer; and Dr. Mark G. Scher, the technology transfer professional, were key to the successful negotiations for the agreements to transfer this technology. After being approached by Apthera, Inc. (now Galena) about the E75 peptide technology, Dr. Peoples, an oncology expert, connected Apthera with Dr. Scher, who led the negotiations for the license agreements. Mr. Baker worked with the U.S. Army to transfer the Army's ownership rights in the E75 vaccine technology to USU, which then led to the marketing and licensing of the technology to current licensee Galena.

In January 2012, Galena began enrollment in a multicenter Phase III clinical trial of NeuVax™ for patients with Node Positive breast cancer, with the goal of proving the potential benefit of the vaccine. In addition to this pivotal Phase III clinical trial, Galena has Phase I and Phase II clinical trials ongoing for the treatment of Node-Negative breast cancer with NeuVax™, the treatment of breast cancer with a combination of NeuVax™ and Herceptin® (Genentech, Inc.), and the treatment of prostate cancer with NeuVax™.

It is estimated that 20% of women diagnosed and treated for breast cancer will experience a recurrence and die, accounting for 40,000 deaths per year in the U.S. If successful, NeuVax™ could prevent up to 50% of the recurrences and save lives.

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Mid-Atlantic