On November 1, 2016 TapImmune, Inc. (OTCMKTS: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and metastatic disease, reported an update on the progression of a HER2neu vaccine into clinical trials (Press release, TapImmune, NOV 1, 2016, View Source [SID1234516164]). The vaccine (TPIV 110) consists of 4 proprietary Class II antigens and 1 proprietary Class I antigen. Both technologies were developed in the laboratory of Keith Knutson, Ph.D. and licensed from the Mayo Clinic.

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In a Phase I clinical trial on the 4 Class II antigens in HER2neu breast cancer patients performed at the Mayo Clinic, over 90 percent of patients developed a robust T-cell response against these antigens. Data on the novel Class I antigen, published in J. Immunol. (2013), 190, 479-488, showed that it was a naturally processed antigen which was at least four times more effective at killing human breast cancer cells than previously tested class 1 antigens. There is growing scientific evidence to suggest the mixture of Class 1 and Class 2 antigens is essential for obtaining a robust immune response with potential therapeutic effects.

As a result of this progress, and in accordance with the FDA, TapImmune plans to initiate clinical studies in 2017. The component peptides have been manufactured under GMP and a commercially viable formulation for the drug product has been developed. GMP manufacturing of the clinical supplies will begin toward the end of the year or early in Q1 2017. The Company expects to submit to the FDA an amended Investigational New Drug Application (IND) that includes the additional Type 1 antigen peptide at the end of 2016 or early in 2017. In addition to company-sponsored clinical trials, further studies on the treatment of ductal carcinoma in situ (DCIS) are being considered using non-dilutive capital.

"HER2neu is a well-known and important target in breast cancer treatments," said Dr. John Bonfiglio, President and CEO of TapImmune. "Our strategy is to highly leverage our HER2neu platform technology in treating this disease.".