Company Overview

TapImmune Inc. is a biotechnology company specializing in the development of innovative therapeutics and vaccines in the areas of oncology and infectious disease. The company’s lead product, the TAP vaccine performs a key step in moving characteristic markers called antigens to the surfaces of cells. Without TAP, there are no cancer markers, so the immune system fails to spot the rogue cells and the cancerous cells can grow undetected. The Company’s vaccine has shown effective restoration of TAP which restores and augments the marker (antigen) presentation and subsequent recognition and killing of cancer cells by the immune system. The TAP molecule also works as an adjuvant or ‘accelerant’ to enhance targeted vaccines against infectious diseases. Including TAP in the studied Smallpox Vaccine showed potency was increased by 100-1000 times. The company is currently developing AdhTAP for the commencement of toxicology studies leading to the initiation of Phase I clinical trials.

The company’s technologies have been featured on ABC News BusinessNow, B-TV, in BusinessWeek, Popular Mechanics and local news papers as well as many respected medical journals including the Journal of Immunology, Nature (Biotechnology), International Journal of Cancer, Cancer Research and PLoS Pathogens among others.

TPIV’s Vision

TapImmune’s technology has broad applications in developing therapeutic and preventative vaccines.

Their strategy is to build a patented proprietary product pipeline and capitalize on the breadth of the TAP technology through collaborative partnerships and license agreements.

To achieve success, TapImmune’s strategy for growth is to:

Technology

Technology Platform

The Immune System
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 the sub-cellular endoplasmic reticulum (ER) 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 do 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 TAP Technology
TapImmune’s vaccine technology is based on modulating the activity of the antigen processing 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 MHC class I complex. Nearly all cell types display MHC class I antigen on their surface and provide the information to the immune system. 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 class I complex and these are subsequently display on the infected cell’s surface. Cytotoxic T-Cells recognize foreign peptides bound to the MHC class I antigen on the cell surface and destroy infected cells to prevent the spread of this infection

For More Information On TapImmune’s Technology: CLICK HERE

Market Opportunity

Vaccines Review and Outlook 2010

PharmaLive Special Reports – August 1, 2010

The global vaccine market is expected to achieve $34 billion in sales by 2012. With an estimated annual growth rate of 14% during the next five years, vaccines will be the fastest-growing therapeutic area, even outpacing oncology.

The recently renewed interest in the vaccine sector is attributed to advances in technology, federal liability protection for developers, increasing global demand, and premium pricing for new products. The impact of vaccines on global health and economic development is enormous. Vaccines have saved more lives than any health intervention since global access to clean drinking water. According to the CDC, a dozen deadly diseases targeted by childhood vaccinations have been eliminated or have declined more than 90% during the past century in the United States.

Despite the availability of vaccines, there is massive unmet medical need in the battles against childhood diseases in developing nations, chronic diseases such as diabetes and cancer, and other wide-spread or up-and-coming conditions such as HIV/AIDS, meningitis, and dengue. Even the seasonal influenza segment holds significant opportunities to improve market penetration, shelf stability, and delivery.

One of the most striking vaccine advances in recent years is active immunotherapies, including the April 2010 FDA approval of Dendreon’s Provenge, a personalized vaccine targeting prostate cancer. Active immunotherapy stimulates the patient’s immune system to fight cancer while sparing the patient most of the adverse side effects associated with chemotherapy, radiation, and other biologics that target antigens. The anti-cancer activity persists long after a course of treatment. These vaccines feature new modes of action and present opportunities for development of combination therapies to provide exceptional long-term tumor control. Therapeutic vaccines are also being researched for the treatment of HIV, hepatitis C, and more. READ MORE

Cancer Vaccines – Pipeline Assessment and Market Forecasts to 2018

researchandmarkets.com

Summary
GlobalData, the industry analysis specialist, has released its new report, “Cancer Vaccines – Pipeline Assessment and Market Forecasts to 2018”. The report is an essential source of information and analysis on the global cancer vaccines market. The report identifies the key trends shaping and driving the global cancer vaccines market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global cancer vaccines sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

GlobalData estimates that the global cancer vaccines market was worth $3,483.0m in 2010, after increasing at a compound annual growth rate (CAGR) of 63.7% during 2006–2010. During 2010–2018, the market is expected to record a CAGR of 12.7%, to reach $9,077.9m by 2018. This high growth is attributed to the increasing patient population of cancer. Cancer is the most common cause of death globally. The high growth rate is due to expected introduction of promising vaccines during the forecast period. The cancer vaccines market is divided into the prophylactic cancer vaccines market and the therapeutic cancer vaccines market. The prophylactic cancer vaccines market experienced high growth in the historic period due to the launch of Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) and Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant). Gardasil was approved in the US and Europe in 2006 and in Japan in 2011. Similarly, Cervarix was launched in Europe in 2008 and in the US and Japan in 2009. The Prophylactic cancer vaccines market is expected to grow in the forecast period to 2018 due to the label extension of Gardasil. In December 2010, the FDA approved a new indication for Gardasil, anal cancer and anal intraepithelial neoplasia grades 1, 2 and 3 in males and females between the age of 9 and 26, which is expected to drive the prophylactic cancer vaccine market. The expected launch of the first-in-class vaccine, V503 in 2014, is also expected to drive the prophylactic cancer vaccine market during the forecast period. V503 is a multivalent vaccine and is believed to provide greater protection from many strains of HPV (human papillomavirus) than the existing vaccines in the market, which are either tetravalent or bivalent, thereby lowering the risk of cervical cancer. The prophylactic cancer vaccine market will grow during the forecast period but will not show significant growth because V503 will uptake the market of Gardasil and there will be little change in the market. READ MORE

Collaborations

Mayo Clinic – Cancer

TapImmune Inc. has signed an exclusive Licensing Option agreement with Mayo Clinic, Rochester, MN, for clinical development of a breast cancer vaccine technology. The option to license this technology can be exercised after Phase I clinical trials under terms agreed between Mayo Clinic and TapImmune. Mayo Clinic will conduct a Phase I clinical trial in breast cancer patients who have a form of breast cancer that express Her2/neu receptors (also called Her2/neu breast cancer). Keith Knutson, M.D. will serve as Principal Investigator.

Her2/neu receptor related cancer is a very aggressive form of breast cancer that affects a subset of breast cancer patients. It is a well established therapeutic target, which helps our development goals from a regulatory standpoint. For example, Herceptin (a Her2/neu inhibitor by Genentech) is an approved drug with annual sales in excess of $4 Billion.

There are ongoing vaccine trials targeting Her2/neu. The major disadvantage (as we understand) of technologies that are currently in development are their inability to cover all or a majority of Her2/neu cancer patients and their ability for long-term protection. Some of them seem to be effective only in a subset of Her2/neu cancer patients due to the nature of the peptide epitopes used. Along with Mayo we believe this technology is could cover up to 90% of the Her2/neu patients and last a very long time (if not a life time), which is an improvement that could cover an additional 30% of the population who may not be covered by the other technologies that are currently in development.

Dr Glynn Wilson, Executive Chairman of TapImmune, stated, “The option to license this technology from Mayo Clinic represents a significant opportunity to add to our cancer vaccine portfolio and clinical research programs. We believe that this technology offers a number of advantages in the development of a breast cancer vaccine for a broad patient population.”

Mayo Clinic– Smallpox

TapImmune Inc. has a Sponsored Research & and Licensing Option Agreements with Mayo Clinic, Rochester, MN, for the development of a smallpox vaccine technology. Research will be conducted in the Vaccine Research Laboratory of Gregory Poland MD at Mayo Clinic to evaluate novel peptide antigens together with TapImmune’s proprietary TAP technology. TapImmune has also an exclusive Option to exercise the License the technology after research studies have been completed under terms agreed between Mayo Clinic and TapImmune.

Unlike current vaccination, which is a live virus approach, the technology of Dr. Poland attempts to use peptides to successfully vaccinate individuals. Even though smallpox was eradicated through worldwide vaccination in the latter part of 20th century, it is a feared bio-weapon that could have serious implications in a bio-terror scenario. In the aftermath of the terrorist attacks of 9-11-2001, there is a renewed interest in finding better vaccination approaches against diseases that could be used as bio-weapons. This is especially true in the case of smallpox due to its deadly nature. In addition, militaries of several countries, including US military, actively procure smallpox vaccine for use in military personnel.

Aeras

The Aeras Global TB Vaccine Foundation (www.aeras.org), one of the foremost non-profit Product Development Partnerships, is dedicated to the development of effective tuberculosis (TB) vaccine regimens that will prevent tuberculosis in all age groups and will be affordable, available and adopted worldwide. Aeras is funded primarily by government aid agencies and private foundations, including The Bill & Melinda Gates Foundation, where it received in excess of $280 million to develop and license an improved vaccine against TB for use in high burden countries. The Gates Foundation, which has recently announced its intentions to double its spending on vaccines to at least $10 billion, as vaccines are the world’s most cost-effective public health measure. This massive spend by the Gates Foundation is to offer vaccines for routine childhood diseases and to also seek improvements on current vaccines as well as establish new ones to protect children in poor countries, where. TB continues to be rampant. According to the World Health Organization (WHO), in 2007 there were an estimated 13.7 million chronic active cases of TB, 9.3 million new cases, and 1.8 million deaths from TB, mostly in developing countries.

Aeras Global TB Vaccine Foundation and TapImmune have entered into an R&D collaboration effort with an overall goal to evaluate the efficacy of TAP in concert with novel vaccine vectors encoding TB immunogens. Aeras is based in Rockville, Maryland, where it operates a state-of-the-art manufacturing and laboratory facility.

Recent TPIV News:

October 21 – TapImmune to Present at BIT’s 2nd Annual World Congress on Immunodiseases and Therapy in Guangzhou, China, November 18, 2011

Analysis of Data Showing Relationship Between TAP Levels, Disease Progression and Therapeutic Intervention to be Discussed

TapImmune Inc. (OTCBB:TPIV.OB – News), a biotechnology company developing immunotherapies, today announced that its Chairman and CEO, Dr. Glynn Wilson, is an invited speaker at BIT’s 2nd Annual World Congress on Immunodiseases and Therapy to be held in Guangzhou, China, November 18-20, 2011.

At this meeting, Dr. Wilson will review the role of TAP (Transporters Associated with Antigen Presentation) as a novel target for the development of vaccines for cancer and infectious disease, and the development pathway for TapImmune’s technologies. Analysis of clinical samples indicate that a variety of solid tumors (breast, melanoma, ovarian, cervical and lung) have deficiencies in TAP levels, and that TAP levels correlate with lesion size, disease stage, metastatic potential and speed of disease progression. Different TAP genotypes also correlate with cervical cancer risk from oncolytic human papillomaviruses. Collectively, these studies indicate that abnormal expression of TAP genes are part of a widespread mechanism that can result in impaired antigen presentation and immune escape of malignant cells in a variety of tumors. Strategies to restore TAP expression, including clinical programs, will be discussed.

TapImmune’s genetic vaccine technology is based on reintroducing TAP (TAP1/TAP2), thereby modulating the activity of the antigen processing machinery to increase effective presentation of antigens or markers to the immune system. The immune system can use this information to selectively destroy cancerous cells or to provoke an immune response against cells infected with pathogens.

TapImmune Inc.

2815 Eastlake Avenue East
Suite 300
Seattle, WA 98102
United States
Phone: 866-359-7541

Website:
http://www.tapimmune.com/