TapImmune Inc (OTCMKTS:TPIV) Tapping Into Big Things

TapImmune Inc (OTCMKTS:TPIV) has emerged as one of the most exciting names on the OTC markets. TPIV is on the verge of some huge developments in the biotech space. We think 2016 could be TapImmune's year judging from what we're hearing. Helping to drive this momentum is that fact that TPIV is backed by billionaire Kenneth Dart. We see a number of catalysts that will propel shares of TPIV higher over the coming months.For those not familiar with TPIV, it's a clinical-stage immunology-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease. TPIV'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. TPIV's technologies may be used as stand-alone medications or in combination with current treatment modalities.TapImmune has been conducting its research in partnership with the prestigious Mayo Clinic in Rochester, Minnesota. Lately there's been some positive developments with results showing that 90% of patients produce robust T-cell immunity suggest that TPIV 100 may be useful in several therapeutic applications including: prevention of disease recurrence when administered following standard-of-care treatment in women with no evidence of disease; administered as a combination therapy including in HER2 metastatic patients; and used before surgery to potentially induce tumor regression. As CEO of TapImmune Dr. Glynn Wilson said:

"These encouraging data provide the rationale and catalyst for TapImmune to start Phase II clinical trials on TPIV 100. There is a clear and unmet need for more efficacious treatment in a larger population of HER2+ breast cancer patients and the data show TPIV 100 has the potential to address this need through several different therapeutic applications, pre, post and in conjunction with current standard of care treatments."

TPIV 200 is just as exciting. Last month, TPIV received Orphan Drug Designation from the U.S. Food & Drug Administration's Office of Orphan Products Development (OOPD) for its cancer vaccine TPIV 200 in the treatment of ovarian cancer. The TPIV 200 ovarian cancer clinical program will now receive benefits including tax credits on clinical research and 7-year market exclusivity upon receiving marketing approval. This is a big deal for a tiny company like TPIV.Indeed, the drug looks quite promising. TPIV 200 is a multi-epitope peptide vaccine that targets Folate Receptor Alpha which is overexpressed in multiple cancers including over 90% of ovarian cancer cells. In Phase I clinical studies conducted at the Mayo Clinic in patients with breast and ovarian cancer this vaccine was shown to be safe and well tolerated and to give robust cellular immune responses in 20 out of 21 evaluable patients. Further, the data showed that 16 out of 16 patients in the observation stage still showed immune responses. Data from the Phase I studies were published in the Journal of Clinical Oncology covering the American Society of Clinical Oncology meeting in May 2015. Multiple Phase II studies will examine the efficacy of this vaccine in ovarian and triple negative breast cancer.Approximately 21,290 women were diagnosed with ovarian cancer in 2015 and an estimated 14,180 will die from the disease according to the American Cancer Society. Because ovarian cancer tends to be detected at a later stage of the disease, the 5-year survival rate for ovarian cancer is 45%. Current treatment options are surgery, radiation and chemotherapy. There is currently no FDA approved cancer vaccine available for ovarian cancer.Besides the science behind TPIV, we like the firm's capital structure. Billionaire Kenneth Dart is the company's largest shareholder with 25 million shares and 15 million warrants exercisable at $.50, $.75, and $1.25. It's obvious that he's in TPIV to hit a home run. In terms of smart money, it doesn't get much smarter than Kenneth Dart who knows his way around the biotech space. Further helping TPIV is that the company is sitting on over $6 million in cash.

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TapImmune is one of the most exciting biotech plays on the OTC markets with smart money behind it. If the Phase II data proves worthwhile, we 're most likely looking at a multi-bagger with shares of TPIV. We'll be updating our subscribers as more details emerge on TPIV. Be sure to sign up below to stay current on what's going on with TPIV and all of our other hot stock picks!

Disclosure: We have no position in TPIV either long or short. We were not compensated for this article.