It is my pleasure to provide an update to existing and potentially new shareholders on the progress we have made over the past few months.
Highlights from the below detailed update include:
-Positive progress at the MAYO clinic on the phase 1 HER2/neu clinical trial with interim results expected in the near term.
-New antigen acquisition and IND filing update making what we believe will be the most comprehensive HER2/neu product on the market with broader application in other cancers.
-Significant development of new IP including a novel expression system that has already proven to be a very valuable component of our own platforms or as a new stand-alone therapy.
-Successful advancement of the infectious disease (Smallpox) program at the Mayo Clinic and a broadening of the scope to include emerging pathogens posing global threats.
Corporate Update from Glynn Wilson, Chairman and Chief Executive Officer
In January we announced that a Company sponsored Phase I clinical trial in HER2/neu positive cancer patients had achieved a positive interim safety analysis on the first five breast cancer patients treated with a set of proprietary HER2/neu Class II peptide antigens at the Mayo Clinic, Rochester, MN. This was an important FDA-required checkpoint necessary in order to allow complete recruitment of the remaining patients; to date a total of eleven patients have been treated. This Phase I trial is being carried out in breast cancer patients who have completed standard Herceptin(R)- based therapy and are at risk of disease recurrence. The primary endpoints of the study are safety and immunogenicity. TapImmune plans to provide an update on the interim analysis of immune responses in the initial patients who have completed full treatment schedules.
In a significant advancement for our HER2/neu breast cancer vaccine program we previously announced licensing of a novel proprietary Class I peptide antigen (p373-382) from the Mayo Foundation for Education and Research. We believe that when added to the Class II antigens this Class I peptide provides TapImmune with the most comprehensive and competitive technical product for development of a HER2/neu breast cancer vaccine in a multi-billion dollar market, with expanded potential in colorectal cancer. To expedite progress towards a Phase II study, we plan to file an amendment to our current IND that will allow us to effectively include this Class I peptide antigen along with our previously disclosed Class II peptide antigens in a Phase Ib clinical study. We anticipate that this Phase 1b study will be led by our colleague Dr. Keith Knutson at the Vaccine and Gene Therapy Research Institute (VGTI Florida) at Port St Lucie, FL. It is anticipated that these studies will commence in Q4, 2013, ultimately leading to the initiation of a Phase II clinical trial combining both Class I and Class II peptide vaccine antigens.
I am particularly pleased to report that our core teams of molecular biologists and immunologists principally based in our Seattle laboratories have made truly outstanding progress, thereby achieving a key Company goal of creating a versatile novel nucleic acid-based expression technology that can be used in concert with our proprietary peptide antigens, or as a stand-alone therapy This technology platform was designed to over-express a strategically assembled linear array of peptide antigens in the presence of co-overexpressed TAP in order to facilitate robust cell surface expression for consequent immune recognition and cell killing. Our most recent work with this novel platform technology has clearly demonstrated that our nucleic acid-based vaccine expression system encoding TAP1 along with a peptide antigen array leads to appropriate cell surface expression of individual peptides followed by T-cell recognition and cell killing, using T-cells isolated from previously immunized individual patients. Importantly, these data are expected to represent a new intellectual property position for the Company and a new flexible technology platform which adds significantly to our already strong technology base.
These data are a milestone for TapImmune as they validate the continued development and use of this vector platform for cancer and infectious disease programs either in a prime and boost strategy with antigens or as a stand-alone adjuvant. These expression systems are already being used in our collaboration at the Mayo Clinic in the area of infectious disease (e.g., smallpox) and are being extended to encompass other human pathogens as well as our HER2/neu clinical program. Moreover, the manufacture of a nucleic acid-based expression/delivery system is cost effective and well understood. Our collaboration with the laboratory of Dr. Greg Poland at the Mayo Clinic has progressed according to plan and studies on the immunogenicity of novel smallpox antigens in mice treated with both antigens and TAP expression systems 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 market development will be facilitated through strategic corporate partnerships. The current concerns over the spread and pathogenicity of Middle Eastern Respiratory Syndrome virus (MERS), caused by a new coronavirus and which has caused death in ~50% of infected patients, highlights the need for such new and highly flexible approaches to vaccine design such as the ones being developed at TapImmune in collaboration with infectious disease experts.
It is also our aim to extend our ongoing collaboration with the Fred Hutchinson Cancer Research Center(FHCRC), Seattle, WA, in the area of melanoma. We plan to investigate the expression of TAP1/TAP2 in metastatic melanoma prior to patients being treated with autologous tumor-infiltrating lymphocytes and will map the correlation between TAP1/TAP2 expression and in vivo persistence and anti-tumor efficacy to determine the ultimate use of TAP1/TAP2 expression vectors in the treatment of melanoma.
We would like to take this opportunity to congratulate our long-term collaborator Dr. Keith Knutson who was recently appointed as Oncology Program Director at the Vaccine and Gene Therapy Research Institute of Florida, Port St Lucie, FL. We look forward to working closely with Keith to expand our activities in immunotherapy for the treatment of cancer and in particular the area of HER2/neu antigens and breast cancer. As Keith retains a joint-appointment at the Mayo Clinic he will continue to spearhead our Phase I clinical trial there.
Like all micro-cap biotech companies at a development stage we have faced the challenge of raising sufficient working capital, through a combination of equity and debt financings to fund and progress our operations. Our core team has done an outstanding job with the resources available to reach their milestones. Our laboratories in Seattle continue to serve us well, and in a most cost-effective manner. Our major financial objective for remainder of 2013 is to secure additional long-term capital to finance and accelerate our activities so that we can maintain our core focus on cancer clinical programs. We are confident that we will be able to bring in new financing based on the strength and breadth of our technologies and their application to significant clinical problems that require new treatment options. As we progress, the key value inflection targets are to progress our HER2/neu positive breast cancer clinical program through Phase II for Phase III corporate partnerships and to secure development partnerships for our infectious disease programs. Because of recent developments in our technologies and clinical program the fundamental strengths of TapImmune have been enhanced. Over the long term this gives us a unique opportunity to make a major contribution to global health care. I wish to thank our core staff and our collaborators for their outstanding efforts and dedication, and our long-term investors for their support in helping us reach these goals.
Chairman & CEO
About TapImmune Inc.
TapImmune Inc. is a vaccine technologies company specializing in the development of innovative immunotherapeutics for use in the areas of oncology and infectious disease. The Company's lead product candidates include peptide and nucleic acid-based vaccine technologies designed to restore and/or 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.
Glynn Wilson, Ph.D.
Chairman & CEO
SOURCE TapImmune Inc.