TapImmune Inc (OTCMKTS:TPIV) On The Verge Of A Breakout

TapImmune Inc (OTCMKTS:TPIV) is on the verge of some major developments in the biotech space. In December, 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.Then in February, the FDA granted Fast Track Designation for its cancer vaccine TPIV 200 in the treatment of ovarian cancer. The FDA has designated the investigation of multiple-epitope Folate Receptor Alpha Peptide Vaccine (TPIV 200) with GM-CSF adjuvant for maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer who achieved stable disease or partial response following completion of standard of care chemotherapy, as a Fast Track Development Program. Fast Track designation means that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product. CEO Dr. Glynn Wilson said:

"We believe that the FDA's decision to grant Fast Track designation to TPIV 200 for the treatment ovarian cancer significantly expedites our clinical development program. We look forward to starting Phase II trials in the near future to address this highly aggressive cancer. We believe that TPIV 200 has the potential to improve outcomes for ovarian cancer patients for whom current treatment modalities offer a relative short time to recurrence and a poor overall prognosis."

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.Another growth area for TPIV is PolyStart. PolyStart is a unique vaccine platform antigen expression system that 'elevates' the expression and consequently the processing and presentation of the desired antigenic peptide for the stimulation of T-killer and/or T-helper cells to recognize and kill cancer cells. This totally novel system creates a 4 (FOUR) fold or more increase in antigen presentation. This technology has unlimited application in oncology and infectious diseases not only in TapImmune's own platforms but can be applied to many others via licensing.PolyStart is extremely versatile as it can be administered in vivo or ex vivo in concert with essentially any nucleic acid-based composition (e.g., plasmid or minigene), RNA, or viral (replicating or non-replicating) delivery system. The technology elevates the expression of selected antigenic epitopes that are then naturally processed, presented and recognized by cells of a recipient patients' immune system. TapImmune plans to use this technology to provide additional potency to its next generation T-cell vaccines for cancer and will explore out-licensing opportunities for its use in other areas such as infectious disease.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.Currently trading at a $41 million market cap, TPIV is one of the most exciting biotech plays on the OTC markets. We see TPIV as being extremely undervalued considering how much the company has accomplished and that multiple phase 2 trials are starting this year. If the Phase II data proves worthwhile, we ‘re most likely looking at a multi-bagger with shares of TPIV.We will be updating Insider Financial as soon as we know more. For continuing coverage on TPIV, sign up for our free newsletter today and get our next hot stock pick!Disclosure: We have no position in TPIV and have not been compensated for this article.