|Tuesday, 19 July 2011 08:04|
Aeras (www.aeras.org), is easily one of the foremost non-profit organizations developing new approaches for TB vaccines and is dedicated to the development of effective 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 some very big private foundations-- including the Bill & Melinda Gates foundation and the National Institute of Allergy and Infectious Diseases.
As mentioned earlier, the Aeras Global TB Vaccine Foundation and TapImmune signed a letter of intent for R&D collaboration with an overall goal to evaluate the efficacy of TAP in concert with novel TB vaccine candidates developed by Aeras. Aeras is based in Rockville, Maryland, where it operates a state-of-the-art GMP manufacturing and laboratory facility. We are hearing rumors that news on this collaboration may be forthcoming. While finding an effective vaccine for TB may not be an important or very lucrative effort for those in some of the leading, fully developed countries of the world, there are still tens of millions of chronic active cases of TB, and close to two million deaths from TB, mostly in developing countries so there is a great need for improved vaccine technologies.
TapImmune plans to evaluate its TAP technology for improving the efficacy of vaccines designed to combat a range of additional viral threats in the biodefense and infectious disease field. To expand its technology platform TapImmune also plans to enter additional technology collaborations for the development of DNA plasmid expression vectors that can deliver TAP genes into target cells.
TapImmune is also developing a TAP-based prophylactic vaccine which initial tests indicate may increase the efficacy of targeted prophylactic vaccines by up to 1000 times. TapImmune's TAP technology could significantly improve the efficacy of many current prophylactic vaccines and enhance the creation of new ones in the fight against many pandemic infectious diseases. A next generation smallpox vaccine is currently in preclinical development.
We also continue to anticipate news about the IND for the first Phase I study in TapImmune's program to develop a vaccine against HER-2/neu breast cancer. The technology entering the clinic targets a novel set of HER-2/neu antigens discovered in breast cancer patients with pre-existent immunity to these antigens (Clinical Cancer Research 16:825-34, 2010). This technology complements TapImmune's TAP technology that we envision as part of a final vaccine product. This technology is currently completing preclinical development. Currently, Herceptin® (trastuzumab: an intravenously delivered monoclonal antibody) is used in the treatment of HER-2/neu breast cancer. Sales of this product in 2009 were approximately US$5 billion (source: Roche AG's Pharmaceutical Division). TapImmune's vaccine approach has the potential to treat a broader HER-2/neu positive clinical population, and the market potential for their cancer vaccine is significant.
As we reported in mid June, TPIV filed an SEC form 8-K, Regulation FD Disclosure which quietly revealed that an investigative new drug application ("IND") for a Phase I clinical trial on a set of Her2/neu breast cancer antigens that the company has the exclusive option to license after Phase I studies had been filed. News about whether the IND has been accepted by the FDA is expected any day. There is definite chatter that things are looking very positive on that front as well. In that same June report we told you that we realized the company's TAP platform represents multiple lucrative shots on goal for investors, so we contacted Dr. Glynn Wilson Ph.D., Exec. Chairman and Chief Exec. Officer of the company to ask why the company had not made a bigger splash to call attention to this particular filing. His answers to our questions are here and worth reading given the pending developments.
The company's TAP platform presents multiple shots on goal for biotech speculators and is still one of our favorite biotech penny plays, whose shares we began tracking when they were trading at approximately $ 0.15. The fact that World class institutions, like Aeras, have identified the uniqueness and the potential TPIV's technology platform continues to be one of the reasons why we like this stock so much.
Disclosure: Long TPIV