TapImmune Announces Commercialization Pathway For Its HER2neu Vaccine

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, is providing an update on the progression of a HER2neu vaccine into clinical trials. 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.
In a Phase I clinical trial on the four 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.”
About TapImmune Inc.
TapImmune Inc. is an immuno-oncology company specializing in the development of innovative technologies for the treatment of cancer, including metastasis, and infectious disease. The Company’s peptide or nucleic acid-based immunotherapeutics, comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patients’ killer T-cells, helper T-cells and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. The Company’s technologies may be used as stand-alone medications or in combination with current treatment modalities.
TapImmune has applied to join the Nasdaq National Markets and is waiting for completion of the Nasdaq review.  Please visit the Company’s website at www.tapimmune.com for details.
Forward-Looking Statement Disclaimer
This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements”. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update the forward-looking statements.
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SOURCE TapImmune, Inc.

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https://www.tapimmune.com