As we start Breast Cancer Awareness Month for 2016 we remember all our friends and loved ones who have been affected by cancer. Over the past year, we have seen amazing progress in the field of immuno-oncology which works by stimulating the body's own immune system to recognize and fight cancer. There is growing evidence and belief that this approach will be a major force in the treatment of breast cancer.

I am delighted to report that since October of last year, TapImmune has made significant progress in our development of T-cell vaccines for the treatment of breast and ovarian cancer with the initiation of multiple Phase II clinical trials to determine the efficacy of these vaccines. A Phase II clinical trial in triple negative breast cancer, sponsored by TapImmune, is recruiting a total of 80 patients at 8 different clinical centers in the U.S. and the first patients have already been treated. This trial will study dosage and the effect of boost strategies in patients who are at high risk for recurrence after chemotherapy. A large 280 patient study in triple negative breast cancer at the Mayo Clinic is expected to start at the end of this year. This study is being funded by a grant of $13.3 million from the U.S. Department of Defense to the Mayo Clinic, with TapImmune supplying the TPIV 200 vaccine.

A Phase II clinical trial in ovarian cancer patients who are resistant to platinum chemotherapy has started at Memorial Sloan Kettering Cancer Institute in New York. This trial is significant in that it combines TPIV 200 with AstraZeneca's checkpoint inhibitor durvalumab. By the end of the year, we expect to start an additional Phase II study in ovarian cancer patients who are responsive to platinum, in an approach to provide a maintenance therapy that will reduce cancer relapse and extend progression-free survival. We received Fast Track Designation for TPIV 200 for this indication from the U.S. FDA in February of this year.

We have also been completing formulation and manufacturing for TPIV 110 for the treatment of Her2neu positive breast cancer and expect to start Phase II clinical trials in this indication at the start of 2017. On June 7, 2016 we announced that we had converted our License Option for TPIV 110 with the Mayo Clinic into a worldwide exclusive license agreement to enable us to commercialize this vaccine.

There has been so much progress in the immuno-oncology field over the past year, that this approach is now perceived in the medical community as the most promising treatment for cancer. Emerging treatments and combination therapies incorporating immuno-oncology are destined to become the standard of care to potentially turn breast cancer into a manageable disease. We are proud to be at the forefront of immuno-oncology for breast cancer treatment and we are greatly encouraged by our recent clinical progress. For us, we start National Breast Cancer Awareness Month in 2016 with renewed purpose towards our ultimate goal to save lives in indications that are in great need of new therapies.

For more detail regarding our clinical development programs and recent news please visit www.tapimmune.com. We also encourage you to visit our website and that of 26.2 with Donna to view amazing stories of breast cancer survivors. If you or someone you know has an interest in enrolling in a TapImmune sponsored clinical trial, please visit clinicaltrials.gov.

Glynn Wilson, Ph.D Chairman & CEO

TapImmune Inc. published this content on 01 October 2016 and is solely responsible for the information contained herein.
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