On April 7, 2016 TapImmune, Inc. (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 & metastatic disease, reported it has successfully completed formulation development, scale-up, GMP (Good Manufacturing Practice) manufacturing, and the release of TPIV 200, its multi-epitope folate receptor peptide vaccine for breast and ovarian cancer (Press release, TapImmune, APR 7, 2016, View Source [SID:1234510571]). The manufactured product contains five peptide antigens freeze dried in a single vial, ready for injection after reconstitution and addition of granulocyte-macrophage colony-stimulating factor (GM-CSF). TPIV 200 doses are now available for the upcoming Phase II clinical trials in both triple negative breast cancer and ovarian cancer.

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The initiation of Phase II clinical trials for TPIV 200 is the result of a successful Phase I study in ovarian and breast cancer which demonstrated that the vaccine was safe, well-tolerated, and generated a robust and lasting folate receptor alpha-specific T-cell response for most patients.

TapImmune has announced its plans to initiate, in 2016, several clinical trials with TPIV 200 vaccine including: a) a 280 patient Phase II trial in triple-negative breast cancer funded by a grant from the U.S Department of Defense (DOD) to the Mayo Clinic; b) a combination trial with a checkpoint inhibitor in ovarian cancer; and, c) at least two additional trials funded and administered by TapImmune.

"The successful release of our folate receptor vaccine represents an important milestone in the progression of TapImmune product pipeline and its technologies. The improved process achieved a formulation that may be reliably manufactured, is easy to prepare and administer to the patient at bed-side, while also being cost-competitive," stated Dr. Glynn Wilson, Chairman and CEO of TapImmune. "The experience we gained in completing this work is being directly applied to our formulation work for a second product in our pipeline, the HER2/Neu T-cell vaccine. Our objective is to file an investigational new drug (IND) application with the U.S. Food and Drug Administration for HER2/Neu vaccine trials in the next 12 months."

"The release of this first GMP batch of vaccine product will supply the first Tapimmune sponsored Phase II trial in breast cancer, for which at least six clinical sites are currently being screened and initiated, and also the Mayo Clinic sponsored Phase II study funded by the DOD," commented Patrick Yeramian, MD, Chief Medical Officer of TapImmune.