TapImmune Inc. (OTCBB: TPIM)

Dear Reader,

Not so long ago the editors of StockUpTicks ventured northward to a Canadian resource show to locate a strong gold or uranium story to bring our readership. As attentive readers know, we are most interested in near-term resource companies and anything biotech. With the baby boomer demographic expanding by leaps and bounds as they age and hit their health care years, it's an economic certainty that the market is getting larger.

So, a funny thing happened on the way to the gold show. We had the opportunity to meet Denis Corin, the new CEO of TapImmune (OTCBB:TPIM). We sat down with Denis and some leading minds from another biotechnology company and let him explain to all of us the future of TapImmune and their science. Both StockUpTicks editors have some base understanding of infectious disease treatments and a little better than a layperson's perspective on oncology.

We left that meeting and rode the elevator back to our rooms. The doors had hardly closed when we looked at each other and said, "We want to bring this story to our readership and we want to personally be shareholders."

Well, we're pleased to say that both has occurred and now we can bring TapImmune's story to you. Since this is the initial profile there will be much more to follow. We strongly encourage you to forward this initial email to friends and relatives who are interested in biotechnology or oncology. Maybe even post a link to StockUpTicks.com and this profile on message boards or in chat rooms. We think this story is that interesting.

And we found it at a gold show!

The Editors

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About TapImmune

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TapImmune Inc. ("TapImmune" "TPIM") is a biotechnology company specializing in the development of innovative therapeutics and vaccines in the areas of oncology and infectious disease. TPIM technologies are based on an understanding of the function of a protein "pump" within cells that is essential in the processing of tumor antigens, known as TAP. Transporters Associated with Antigen Processing (TAP) are transporters responsible for supplying tumor-associated antigens and viral antigens used in the assembly of MHC class I surface molecules. MHC class I molecules are required for the recognition and destruction of tumor cells and virus infected cells by the cellular arm of the immune system. A wide variety of metastatic cancers evade destruction by the immune system due to absent or insufficient amounts of TAP, making the tumors unrecognizable by the immune system. 

TPIM's lead product, the TAP vaccine performs a key step in moving characteristic markers called antigens to the surfaces of cells allowing the subsequent recognition and killing of cancer cells by the immune system.. Without TAP, there are no cancer markers, so the immune system fails to spot the rogue cells and the cancerous cells can grow undetected. 

TPIM's vaccine has shown effective restoration of TAP and the TAP molecule also works as an adjuvant or ‘accelerant’ to enhance targeted vaccines against infectious diseases. Including TAP in the much studied Smallpox Vaccine, its potency was increased by 100-1000 times. TPIM is currently developing AdhTAP for the commencement of toxicology studies leading to the initiation of Phase I clinical trials. 

TapImmune Inc. was previously known as Genemax and on March 18, 2003, a production service agreement with Molecular Medicine BioServices, Inc., was entered into that called for the production of its clinical vector for delivery of the Transporters Associated with Antigen Processing genes. On February 16, 2004, TPIM scientists added to the company technology portfolio by expanding the license with the University of British Columbia, to include a technological method that identifies novel, tumor-associated antigens produced by cancers. On October 21, 2003, TPIM scientists entered into a Biological Materials Transfer Agreement with the National Institute of Allergy and Infectious Diseases in Canada . 

• Conduct preclinical vaccine programs and move successes through to human trials 
• Discover, acquire and develop technologies that modulate antigen presentation 
• Commercialize proprietary products through corporate alliances 
• Develop business partnerships that enhance the efficacy of other immunotherapeutic and vaccine products 

Traditional approaches to cancer treatments have included surgery, radiation therapy and chemotherapy. Because of the difficulty in removing or destroying all cancer cells, these approaches leave a high mortality rate and numerous side effects for many cancers. TapImmune’s alternative to the traditional approaches to cancer treatment is based on increased knowledge of the human genome and immune system. The TAP technology approach holds the potential of higher efficacy and lower side effects in cancer treatment and for protection to infectious diseases.

Clinical studies to date have identified a large number of cancers deficient in TAP including but not limited to HPV related cancers such as melanoma, lung, prostate, breast and ovarian cancer. TapImmune believes these tumors would be responsive to the TAP therapeutic vaccine. In preclinical trials for melanoma and lung carcinoma, animal survival rates of 70% were achieved using TAP vaccine therapy and 100% survival when TAP was administered ex-vivo. 

The current estimates for cancer treatments such as chemotherapy represent approximately a $10 billion market. Cancer vaccines will become a major player in the vaccine market rising from current levels of $135 million to more than $8 billion by 2012. (Washington UPI – Feb 2007)

Prophylactic vaccines require the use of adjuvants to generate adequate protective immunity to prevent or treat diseases. As a result, most vaccines are combined with an adjuvant that enhances the ability of an injected vaccine to stimulate an immune response and thus protect the recipient by preventing or treating diseases. TapImmune’s vaccine adjuvant has shown 100 times greater potency than non-adjuvanted vaccines in animal studies when combined with vaccines.

Currently, there is only one FDA-approved adjuvant available for use in humans. The need to immunize entire populations against a growing number of infectious diseases will require greater efficiency of the primary vaccine inoculae. 

The TapImmune Technology Platform

Think of a cell as a small engine. It burns fuel and oxygen, and gives off exhaust. Looking at exhaust tells you a lot about the condition of a vehicle’s engine.
The same holds true for a cell. When something goes wrong inside it, a cell sends out the biochemical equivalent of a puff of black smoke. Specialized white blood cells tag the offenders. Other cells -the immune system’s hit men- move in for the kill.

Among the white blood cells is a group called T cells, so named because they originate in the thymus gland. A subset of T cells are responsible for killing virus infected cells and cancer cells, and many cancer cells have the ability to emit a warning signal (“destroy me”), in the form of a compound called tumor antigen peptide, which is very often missing. This hides the cancer cells from the immune system, and they grow into tumors that eventually kill the person.

Research has shown that cancer cells produce a warning signal, but it is not being pumped to the surface. Closer investigation reveals that the gene that told the cell to produce a protein called TAP was disabled. Loss of TAP expression in tumors is highly correlated with disease progression and lower survival rates in humans. 

TAP technology is a method of restoring the ability of the body’s immune system to recognize the cancer cells as foreign, thereby boosting the natural process for destroying the cancerous cells. 

The cellular arm of the immune system is critical in protecting us against malignant cells that develop into deadly, metastatic cancers. The immune system is able to distinguish between normal cells and cancerous or virus infected cells by monitoring a molecule on the cell surface called the major histocompatibilty complex (MHC) class I. 

The MHC molecule contains a small protein fragment referred to as a peptide which, in combination with the MHC molecule, is able to stimulate the killer T-cells of the immune system. This peptide fragment is derived from the degradation of cellular proteins within the cytoplasm of the cell by the proteasome enzyme complex.

These peptides are transported into a sub-cellular endoplasmic reticulum (ER) compartment by transporters associated with antigen processing (TAP). Inside the ER peptides combine with other proteins to form functional MHC class I (MHC plus peptide). The functional MHC is transported to the surface of the cell where the functional MHC complex is presented to the immune system. 

Functional MHC generated from normal peptides within normal cells does not stimulate the killer T-cells of the immune system. However, if the peptide fragments are not normal because they were generated from viral proteins inside an infected cell (viral antigens) or from proteins made exclusively by cancerous cells (tumor antigens) then stimulation of killer T-cells occurs. The killer cells then multiply and kill the abnormal virus infected cell or cancerous cells.

TapImmune’s vaccine technology is based on modulating the activity of the antigen presentation machinery (APM) to increase effective presentation of antigens to the immune system. Transporters associated with antigen processing (TAP) play a major role in the antigen processing pathway by supplying suitable antigenic peptides to the major histocompatibility complex class I (MHC-I). 

All cells display MHC-I on their surface and provide the information to the immune system on the status of the cell. The immune system uses this information to selectively destroy cancerous cells or those infected with pathogens. When a virus infects a cell, the viral protein components are degraded by the proteasome into smaller peptide components; TAP then facilitates the binding of the foreign peptides of viral origin to the MHC-I and subsequent display on the infected cell’s surface. 

Cytotoxic T-Cells recognize foreign peptides bound to the MHC-I on the cell surface and destroy infected cells to prevent the spread of this infection.

A TAP gene is delivered to  the cell by an adenoviral or vaccinia vector TAP expression restores the assembly of functional MHC class I molecules

Restored Immune Recognition The immune system kills cells which have antigenic MHC class I restricted antigens on their cell surface.

In many cancers the tumor antigen peptide is missing from MHC class I because the assembly of this complex has been disrupted. This occurs in many tumors because TAP is expressed at very low levels. As a consequence, tumor antigen peptides generated in cancerous cells are not transported into the ER, thus preventing the assembly of functional MHC. 

This results in the MHC on the cell surface missing the tumor antigen peptides that identify the cell as being cancerous. These cells, without functional MHC on their cell surface, are hidden from the cellular arm of the immune system and grow into tumors that eventually kill the person. 

Loss of TAP expression in tumors is highly correlated with disease progression and survival rates in humans. Clinical studies on melanoma, when examining primary and metastatic tumors, show a clear and significant correlation between TAP expression and survival. Clinical studies on resected tumors correlate metastasis of breast cancer, prostate cancer, colorectal cancer, small cell lung cancer, renal cancer, squamous cell carcinoma, cervical cancer, and laryngeal papillamatosis, with low or absent TAP expression.

The AdhTAP vaccine resurrects MHC I expression allowing their recognition by Killer T cells. TAP reconstitutes cancer markers to be recognized for destruction in the target cells. Effective against the majority of solid tumors and advantageous over tumor-specific vaccines. Not dependent on patient’s genetics as with other immunotherapy approaches.

This same vaccine also has applications as an adjuvant against numerous infectious diseases. Significantly reduces the amount of vaccine inoculate required to achieve prophylactic levels.  Reduces the batch size that is required to immunize a population.  Allows the production of adequate doses of vaccines to be available in times of acute need.

TapImmune’s strategy is to enter Phase I / II clinical trials with the innovative TAP vaccine for oncology and infectious disease.  TPIM will also seek partnerships for follow-on development. The key elements of the company’s near term strategy are: Commence production of clinical grade vaccine Complete preclinical studies for AdhTAP vaccine File IND and initiate Phase I clinical trials for oncology Replicate smallpox efficacy studies for the MVA-TAP vaccine (for business development purposes)  The above work plan will progress concurrently.

International Journal of Cancer: 120 (1935-1941) 2007
TAP expression reduces IL-10 expressing tumor infiltrating lymphocytes and restores immunosurveillance against melanoma 
Qian-Jin Zhang, Robyn P. Seipp, Susan S. Chen, Timothy Z. Vitalis, Xiao-Lin Li1, Kyung-Bok Choi, Andrew Jeffries, and Wilfred A. Jefferies Link [+]

Science Direct: Vaccine: 25 (2331-2339) 2007
Tumour immunity and T cell memory are induced by low dose inoculation with a non-replicating adenovirus encoding TAP1
Yuanmei Lou, Robyn P. Seipp, Bing Cai, Susan S. Chen, Timothy Z. Vitalis, Kyung Bok Choi, Andrew P. Jeffries, Rayshad S. Gopaul, Xiao-Lin Li, Barbara Seliger, Terry W. Pearson, Wilfred A. JefferiesLink [+]

PLoS Pathogens:Volume 1 (Issue 4/ e36) December 2005
Using the TAP Component of the Antigen-Processing Machinery as a Molecular Adjuvant 
Timothy Z. Vitalis, Qian-Jin Zhang, Judie Alimonti, Susan S. Chen, Genc Basha, Alex Moise, Jacqueline Tiong, Mei Mei Tian, Kyung Bok Choi, Douglas Waterfield, Andy Jeffries, Wilfred A. JefferiesLink [+]

Cancer Research 65 (7926-7933) September 1, 2005
Restoration of the Expression of Transporters Associated with Antigen Processing in Lung Carcinoma Increases Tumor-Specific Immune Responses and Survival. Yuanmei Lou, Timothy Z. Vitalis, Genc Basha, Bing Cai, Susan S. Chen, Kyung Bok Choi, Andrew P. Jeffries, W. Mark Elliott, Derek Atkins, Barbara Seliger, and Wilfred A. Jefferies Link [+]

Cancer Research 16 (7485-7492 ) August 15, 2005
Identification of Mechanisms Underlying Transporter Associated with Antigen Processing Deficiency in Metastatic Murine Carcinomas 
A. Francesca Setiadi, Muriel D. David, Susan S. Chen, John Hiscott and Wilfred A. Jefferies Link [+]

Journal of Immunology 172 (5200-5205) May 2004
CTL-Dependent and -Independent Antitumor Immunity Is Determined by the Tumor Not the Vaccine
Jaina Leitch, Katie Fraser, Cecilia Lane, Kelley Putzu, Gosse J. Adema, Qian-Jin Zhang, Wilfred A. Jefferies, Jonathan L. Bramson and Yonghong Wan Link [+]

Nature Biotechnology18 (515-520), May 2000
TAP expression provides a general method for improving the recognition of malignant cells in vivo
Judy Alimonti, Qian-Jin Zhang, Reinhard Gabathuler, Gregor Reid, Susan S. Chen, and Wilfred A. Jefferies Link [+]
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TapImmune in the Media and TPIM Press Releases

Press Release Source: WallStreet Direct, Inc. 
Friday July 6, 7:00 am ET 

NEW YORK, July 6 /PRNewswire/ -- On July 3, Denis Corin, Chief Executive Officer of TapImmune, Inc. (OTC Bulletin Board: TPIM - News) updated the investment community in an all-new interview with www.wallst.net. Topics covered in the interview include an overview of the company and its growth strategy, recent press releases, market opportunity, and upcoming milestones investors should watch for. To hear the interview in its entirety, visit http://www.wallst.net, and click on "Interviews." The interview can be accessed either by locating the company's ticker symbol under the appropriate exchange on the left-hand column of the "Interviews" section of the site, or by entering the company's ticker symbol in the Search Archive window.

You may view the entire release HERE

VANCOUVER, British Columbia, June 28, 2007 (PRIME NEWSWIRE) -- TapImmune Inc. (OTC BB:TPIM.OB - News), a biotechnology company specializing in the development of immunotherapeutics for cancer and vaccines for infectious diseases, announced today that it has fulfilled its financial obligation to The University of British Columbia for the proposed acquisition of its key Transporter Associated with Antigen Processing (TAP) technology platform and patents. All financial terms with The University of British Columbia have been met. Technology assignment and transfer is expected to be completed in the next week.

The Company (previously GeneMax Corp) had been operating under an exclusive world-wide license from The University of British Columbia (UBC) for the use of TAP as an immunotherapy in the treatment of a broad spectrum of metastatic cancers deficient in this molecule. Initial animal studies have shown that restoring TAP can significantly improve outcomes and survival by up to 70%. This technology was discovered by Dr. Wilf Jefferies, a world expert in and professor of Immunology and Microbiology at the Michael Smith Laboratories at The UBC.

In addition, the use of TAP as a molecular adjuvant for reviving and optimizing vaccines against infectious disease was also discovered. This exciting discovery has far reaching potential applications in fighting and eradicating viral diseases in humans and many additional veterinary applications. The initial proof of concept studies showed a 100 to 1000 fold increase in the potency of a targeted vaccine.

"This acquisition is a milestone achievement for the company and essentially results in the birth of a new independent entity. I believe it will give our shareholders significant value going forward and firmly places our destiny in our own hands," said Denis Corin, recently appointed President and CEO. "This past year has been strategically important for the company. We have had to do some restructuring and have refocused our development programs to move our technology from the lab to the clinic and have positioned us very well to enter the $13 billion world wide vaccine market."

You may view the entire release HERE
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The Management and Directors of TPIM

Management and Directors

Alan P. Lindsay
Director and Chairman of the Board
Alan Lindsay has extensive experience in building companies and taking them public on recognized stock exchanges.  He is currently Chairman, President and CEO of MIV Therapeutics, Inc. (MIVT-OB).  Before coming to MIVT, Mr Lindsay was the Chairman, President and CEO of Azco Mining Inc. listed on the TSX and AMEX.  He was also the Chairman of GeneMax Pharmaceuticals Inc., the predecessor non-reporting company, which he co-founded in 1999 and assisted with financing prior to leaving the company in 2001.  Prior to this, Mr. Lindsay was responsible for building a significant business and marketing organization in Vancouver, Canada, for Manulife Financial, a major international financial services corporation.

Denis D Corin
President, Chief Executive Officer
Denis Corin is a management consultant with experience in large pharmaceutical (Novartis), diagnostic instrumentation companies (Beckman Coulter) as well as the small cap biotech arena (MIV Therapeutics). He holds a double major, Bachelors degree in Economics and Marketing from the University of Natal, South Africa.

Dr. Wilfred Jefferies, D.Phil.
Principle Scientist
Dr. Jefferies oversees technical development at TapImmune.  He previously founded Synapse Technologies Inc., subsequently acquired by Biomarin Pharmaceuticals Inc.  A world expert in understanding immune responses against pathogens and tumors, he is the lead researcher and inventor of GeneMax’s scientific technologies.  Dr. Jefferies holds a BSc in biochemistry from the University of Victoria and a DPhil degree in molecular immunology from Oxford University.

Patrick A. McGowan
Secretary, Chief Financial Officer and Principal Accounting Officer
Patrick McGowan is a management consultant specializing in assisting public companies with financing, regulatory filings, administration and business plans.  He is currently the CFO of MIV Therapeutics, Inc. (MIVT-OB) where he is responsible for negotiations with attorneys, auditors and financial institutions, and the day to day business operations of MIVT.  Previously he served as CEO of American Petro-Hunter, Inc.  Mr. McGowan obtained his Masters of Business Administration from the University of Western Ontario and his Bachelors of Science from the University of Oregon.

Glynn Wilson, Ph.D.
Director
Dr. Wilson was President of Auriga Laboratories, Inc. which develops pharmaceutical products based on patented drug delivery technologies.  He has held a number of high-profile senior management positions in global pharmaceutical organizations and start-up drug delivery companies.

He is a recognized leader in the development of drug delivery systems with extensive experience in such technologies.  Dr. Wilson was Worldwide Leader of Drug Delivery at SmithKline Beecham Pharmaceuticals where he was involved in the development of products involving new drug delivery systems.  In addition, he was a founding member of the Advanced Drug Delivery Group at Ciba-Geigy. 

As Executive Vice President for Research and Development at Tacora Corporation, he was responsible for conceiving and developing lead products and providing leadership in the merging of Tacora Corporation with Access Pharmaceuticals.

Scientific Advisors

Dr. Terry Pearson is a professor of Biochemistry and Microbiology at the University of Victoria. His current research involves development of new diagnostic methods using the human plasma proteome and mass spectrometry.  Dr. Pearson was involved with the early stages of development of monoclonal antibodies in Cambridge, England and takes a particular interest in alternate methods for their derivation, production and use in immunodiagnostics and in vaccine development.
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Financial Highlights For  TapImmune Inc.

TO CONTACT TPIM

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