On August 11, 2011 TapImmune reported that following FDA IND approval, it will sponsor a Phase I HER-2/neu targeted therapeutic vaccine trial in HER-2/neu positive breast cancer patients at the Mayo Clinic (Press release TapImmune, AUG 11, 2011, View Source [SID:1234501503]).
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The trial stems from a technology license option and sponsored research agreements between Mayo Clinic and TapImmune and is based on research on novel immunogenic peptide epitopes of the HER-2/neu antigen discovered in breast cancer patients with pre-existing immunity to HER-2/neu. The trial is jointly led by Keith Knutson, Ph.D and Amy Degnim, M.D. Mayo Clinic. According to Dr Knutson, "HER-2/neu is associated with aggressiveness in breast cancer and in our preclinical mouse studies we found that boosting HER-2/neu-specific immunity blocks tumor growth. In the planned human clinical trial, the goal will be to determine whether we can also boost immunity to HER-2/neu in patients, hopefully paving the way to asking whether vaccination blocks tumors in humans".
In the upcoming trial, HER-2/neu positive breast cancer patients will be given the vaccine mixed with GM-CSF as an adjuvant to enhance immunity. The trial aims to evaluate the safety of this vaccine as well as immune responses.
According to TapImmune’s Chairman and CEO, Dr Glynn Wilson, this major milestone event for the company represents the first step in the development of a novel HER-2/neu vaccine that augments both CD4 T-helper cells and CD8 cytotoxic T-cells. This technology may ultimately work synergistically with TapImmune’s core TAP technology with the aim of producing a robust and long-acting immune response in a broad population of HER-2/neu positive breast cancer patients. "Immunotherapies are increasingly playing a major role in oncology to prolong patient survival and quality of life. TapImmune is delighted to be collaborating with leaders at the Mayo Clinic to translate pioneering research into new treatments."
The trial is due to commence recruitment in the 4th quarter of 2011. Under the terms of the technology license option agreement with the Mayo Clinic, TapImmune has an exclusive worldwide option to become the exclusive licensee for sale of any resulting commercial vaccines.