SEATTLE, WA--(Marketwire - Nov 5, 2012) - TapImmune Inc. (
To our current and future shareholders, I am pleased to take this opportunity to update the progress we have made over the past few months.
A company sponsored Phase I clinical trial in HER2/neu positive breast cancer has started at the Mayo Clinic, Rochester, MN. Patients enrolled in this trial have completed standard Herceptin-based therapy and are at a high risk of disease recurrence, and are now being administered a formulation comprised of a proprietary set of four class II peptide antigens. The primary endpoints of the study are safety and immunogenicity. The first four patients have been treated and we expect to release the corresponding interim safety analysis shortly. Based upon the safety analysis of five patients, the remaining patients in this trial will then be treated and data will be released as it becomes available. In the interim, we invite you to review the details of this clinical trial protocol at http://clinicaltrials.gov/ct2/show/NCT01632332?term=her-2%2Fneu+vaccine&rank=3.
The above mentioned Phase I study represents a first step in the clinical development of TapImmune's HER-2/neu breast cancer vaccine program and therefore constitutes a major milestone for our Company. Additional clinical studies are planned to evaluate the safety and immunogenicity of a novel proprietary Class I peptide antigen (see below). In addition, our scientists are currently evaluating novel proprietary intracellular expression vectors encoding TAP1/TAP2 along with Class I and Class II HER2/neu peptide antigen arrays as a novel 'boost' strategy component for further clinical studies and as part of a multi-component breast cancer vaccine.
The in-licensing of the above mentioned novel proprietary Class I antigen from the Mayo Foundation for Education and Research represented a significant advancement in the development of our HER2/neu vaccine for breast cancer. The peer reviewed manuscript describing the scientific foundation of this approach, authored by Dr. Keith Knutson and colleagues at The Mayo Clinic, has been accepted for publication in The Journal of Immunology, November/December 2012. Studies presented in this publication confirm that the newly identified HER2/neu Class I antigen (p373-382) is naturally processed from HER2/neu proteins and is able to stimulate cytotoxic T-cells to recognize and destroy HER2/neu positive breast cancer cells. An overall strategy for our development of a HER/neu vaccine was presented at the Third Annual Cancer Vaccines and Active Immunotherapy Summit held in Boston on June 28 this year. A scientific white paper, authored by Mark Reddish, Head of Development at TapImmune, detailing the uniqueness of our strategy can be found on TapImmune's website.
We strongly believe that the comprehensive scientific underpinnings of our overall approach, to elicit the production of both T-helper cells and T-killer cells, will provide the Company and its Shareholders with highly competitive product candidates for the treatment of HER2/neu positive breast cancer with additional applications in ovarian and colorectal cancer.
In May we entered into a Material Transfer Agreement with the Fred Hutchinson Cancer Research Center (FHCRC), Seattle, WA. The initial aim of this collaboration is to determine levels of TAP1/TAP2 in tissues taken from melanoma patients in a clinical trial at FHCRC using adoptive T-cell therapy and to correlate these levels with clinical outcomes.
Regarding our Programs for the development of vaccines aimed at viral pandemics/biodefense, collaborations with the Mayo Clinic have progressed well and studies on the immunogenicity of novel smallpox antigens in mice treated with both antigens and TAP expression vectors are ongoing. We plan to complete animal efficacy and human safety studies through non-dilutive grant funding in collaboration with Dr. Greg Poland and colleagues at the Mayo Clinic and anticipate that further development will be completed through strategic corporate partnerships. The use of non-dilutive grant funding to progress this area, allows the Company to focus the majority of its internal resources on HER2/neu breast cancer.
I am pleased to report that our facilities at 1551 Eastlake Avenue, Seattle have exceeded our expectations and allowed us to continue to recruit top-class scientific staff while at the same time effectively leverage world class resources made available to us and manage our cash flow. We have added technical staff in the areas of molecular biology and immunology. Our small core team (7 scientists) has allowed us to establish in-house technical expertise in molecular biology (expression vector development) and immunology to underpin our current and future development projects and to optimally work with external collaborators. It has also allowed us to make significant progress in the refinement and focus of clinical programs to take advantage of new antigens, the emerging field of vaccinomics and vaccine development strategies. In addition, it has allowed us to start generating new intellectual property (IP) to add to our core TAP IP and the antigen IP from the Mayo Clinic that we have either licensed or have exclusive options to license.
Over the past few months we have, in a challenging financing climate, raised sufficient working capital to fund and progress our operations. We continue to make good progress with the resources available to us. With the start of clinical programs and our focus on securing non-dilutive financing from a number of sources, I am confident that our current pathway will secure longer term capital to finance and accelerate our activities. The strength of our science and development approaches is becoming more widely appreciated, particularly as our clinical program generates data and as we embrace additional collaborations with leading institutions and corporations.
While the pathway to successful product development takes time and significant resources, we have put in place the technical and corporate fundamentals for success. The strength of our product pipeline gives us a unique opportunity to make a major contribution to global health care. I wish to thank our staff for their outstanding efforts and our long-term investors for their support in helping us reach this goal. The next year promises to be an exciting and rewarding one.
Chairman & CEO
About TapImmune Inc.
Taplmmune Inc. is a vaccine technologies company specializing in the development of innovative expression vector based immunotherapeutics and vaccines in the areas of oncology and infectious disease. The Company's lead product candidates, include vaccines designed to restore and augment antigen presentation and subsequent recognition and killing of cancer cells by the immune system. The Company is developing cancer vaccines that combine the use of novel antigens together with its TAP expression technology. Unlike other vaccine technologies that address only the initiation of immune responses, TAP expression also has the unique ability to enhance the effector function of mature killer T cells. This enhancement of effector function is potentially complementary to any/all vaccine approaches that are designed to enhance cellular responses.
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 statements.