April 3, 2014, Seattle WA, TapImmune Inc. (OTCQB: TPIV), A clinical stage immunotherapy company specializing in the development of innovative vaccine technologies for the treatment of cancer and infectious disease is pleased to update shareholders and investors on the most recent corporate events and milestones for the year ahead. Glynn Wilson TapImmunes’ CEO provided insights in an interview on the floor of the NASDAQ recently which can be seen by navigating to the following link: <Click here to View CEO Interview>
Management believes that the TapImmune platform technologies combine to make the most comprehensive vaccines in development today. The comprehensive approach of stimulating both the helper and killer T cell response to cancer antigens is essential in having an effective and long lasting killing effect on tumor and infected cells.
On March 3rd the company announced positive interim data on the Phase l clinical trial in Her2/neu positive breast cancer. The TPIV vaccines address a significant unmet market need. They are applicable to a much larger and broader patient population than current ‘standard of care’ therapies like Herceptin by Roche which is useful for only 15-20% of the Her2neu Breast Cancer patient population. Herceptin is not designed to kill tumor cells (it slows tumor growth). 2013 Herceptin sales exceeded $6B. TPIV vaccine is applicable to over 50% of the Her2neu patient population AND is also not limited to breast cancer indications. Her2neu is a target for TPIV in both Colorectal and Ovarian cancer where there are very few therapeutic options.
The TPIV Her2neu vaccine combination is unique in that it is designed to stimulate KILLER T Cells and the HELPER T Cells that are needed to SUSTAIN the KILLER cells for a LONG LASTING vaccine that kills tumor cells. In regard to our killer T-cell antigen, Ppublished data also supports a 5 fold increase in killing efficacy compared to the development vaccine Neuvax by Galena. TPIV100 is completing Phase 1 with Phase lb/ll scheduled to start in Q4 2014.
On March 19th the company announced the licensing of a late stage phase l clinical program in ovarian cancer (Folate Receptor Alpha). We are very excited about the opportunity this therapeutic presents. Folate receptor alpha is expressed in nearly 50% of breast cancers and in addition, over 95% of ovarian cancers, for which the only treatment options are surgery and chemotherapy, leaving a very important and urgent clinical need for a new therapeutic. Time to recurrence is relatively short for this type of cancer and survival prognosis is extremely poor after recurrence. In the US alone, there are approximately 30,000 ovarian cancer patients newly diagnosed every year. Importantly this patient population has very few treatment options and as a result we hope to present a Phase 2 advancement plan in late 2014 with an application for Orphan Drug Status pending discussions with the FDA. Orphan drug status is allowed by the FDA in cases where the disease affects fewer than 200,000 people in the USA and makes allowances for an accelerated regulatory process and sales of the drug for 7 years without competition.
On March 20th the company announced the filing of new intellectual property for PolyStartTM. This is a unique vaccine platform Antigen Expression Systems that ‘boosts’ the presentation of the desired naturally processed antigenic peptides on the surface of the cell for the Killer T Cells to recognize, activate, expand and kill. This totally novel system creates a 4 (FOUR) fold increase in antigen presentation and in current studies in smallpox has shown to be working very well. Nobody has this technology and it has unlimited application in oncology and infectious diseases not only in our own platforms but can be applied to many others via licensing. Ideal candidates include adoptive T-cell methodologies such as Provenge, and check point inhibitors such as Yervoy and many more…
Infectious Disease and National Preparedness is another very significant market and ideal preventive and therapeutic area for TPIV vaccine composition. Along with novel peptides and the PolyStart expression system the TPIV vaccine platform can address multiple infectious diseases as well as pandemic and biodefense threats. The last DHHS contract for a smallpox vaccine stockpile contract was worth over $2 Billion.
Upcoming 2014 milestones include:
- Second set of interim data on immune responses in the Her2/neu trial.
- Initial interim Data on the Folate Receptor Alpha trial in breast and ovarian cancer.
- Final data on pre-clinical small animal studies in smallpox at Mayo Clinic and decision on advancement to non-human primates and license deal and partnering opportunities.
- Major financing
- Up listing to NASDAQ in 2014
Chairman and CEO, Dr Glynn Wilson, added “we are excited by the significant news we have announced in the last few weeks in addition to the near term catalysts represented by the clinical trial advancements we anticipate and hope that you share our enthusiasm and positive outlook for the rest of the year”.
About TapImmune Inc.
TapImmune Inc. is an immunotherapy company specializing in the development of innovative vaccine technologies for the treatment of cancer and infectious disease. The Company’s vaccine compositions, peptide or nucleic acid-based, 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. The Company’s vaccine compositions may be used as stand-alone medications or in combination with current treatment modalities. Please visit the Company’s website at www.tapimmune.com for details.
Forward-Looking Statement Disclaimer: This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements”. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update the forward-looking statement