|Micro-cap biotech with significant potential now has a forward looking trade catalyst in play|
|Thursday, 16 June 2011 01:54|
When we wrote about TPIV in early March, the stock ran from $.15 to as high as $.38. The firm had been quietly announcing a number of important strategic collaborations with big important players like the Aeras Global TB Vaccine Foundation and The Mayo Clinic.
These collaborations with internationally renowned scientists and clinicians spoke highly about the synergistic technologies which complimented the company's own TAP platform in the areas of tuberculosis, smallpox and breast cancer. The other thing we really liked about the firm was that their new management team appeared to leverage significant external resources in the development of their programs without burning a lot of cash. Our thesis was that the overhang, which had kept stock prices down after a previous financing, had been eliminated and price levels did begin to accelerate more smoothly than some anticipated because of the small size of the company's float.
Still, as many of our readers had been waiting for news from the company, the markets have seen a slow but steady decline and the significant milestone (TPIV's entry into human trials) seemed to be taking longer than impatient speculators were willing to wait. Some took profits and now we're just a few cents above the mark where we strated in March. Still, those who waited may finally start to see some rewards as shares of the company are starting to rise again and may continue to do so after a quiet, but key filing by the company on Wednesday sent shares up +20% and chart technicals looking far more attractive.
Before moving on, it's important to note that the company’s TAP vaccine performs a key step in moving characteristic markers called antigens to the surfaces of cells, but it also acts as an adjuvant or 'accelerant' to enhance targeted vaccines against infectious diseases. It turns on a homing beacon or lightbulb to let the immune system know where to attack and as one medical writer put it recently: “The company has engineered a remarkable, yet elegantly simple, way for the body to recognize tumor and infectious disease cells and provoke an aggressive immune response whereby the body's own killer T-Cells attack and eradicate harmful foreign bodies.”
On Wednesday, the company filed an SEC form 8-K, Regulation FD Disclosure which quietly announced that an investigative new drug application ("IND") for a Phase I clinical trial on a set of Her2/neu breast cancer antigens was filed by Principle Investigator, Dr. Keith Knutson of the Mayo Clinic, Rochester, MN where the study will be conducted. This is is the same technology that TapImmune has the exclusive option to license after Phase I studies have been completed. Now, subject to approval of the IND by the Food and Drug Administration, the Mayo Clinic and TapImmune will sign a Research Agreement and TapImmune will sponsor the clinical trial.
While we realize the company's TAP platform represents multiple lucrative shots on goal for investors, 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.
BioMedReports: We noticed that you filed an 8k disclosing that you or Mayo has filed IND Application with FDA. Can you expand on this event for us?
Dr. Glynn Wilson Ph.D: As we have reported previously, we are collaborating with the Mayo Clinic on the clinical evaluation of a set of Her2/neu breast cancer antigens. At the end of Phase I studies we have the exclusive option to license the technology. The filing of the IND for the Phase I studies by the Mayo Clinic represents an important first step.
BioMedReports: So what are the next steps?
Dr. Glynn Wilson Ph.D: The IND application will be reviewed by the FDA and they have 30 days to come back with any questions or comments. Once the IND is approved, the clinical trial can begin and we will enter into the next phase of our collaboration under a sponsored research agreement and will fund the Phase I trial.
BioMedReports: Where will the trial be done?
Dr. Glynn Wilson Ph.D: It will be conducted at the Mayo Clinic in Rochester MN, by the principle investigators Dr. Keith Knutson and Dr Amy Degnim.
BioMedReports: Can you offer any more detail on the criteria for the trials and why you are partnering with Mayo on this?
Dr. Glynn Wilson Ph.D: This filing is for an open-label prospective safety feasibility study that will examine the safety and immunological responses of a Her2/neu antigen in breast cancer patients that have completed any adjuvant chemotherapy and/or radiation therapy.
On the second part of your question, the clinical trial is sponsored by us as we believe that the ultimate therapy will improve on currently available treatments for this patient population. We are also evaluating this technology for the development of a Her2/neu positive breast cancer vaccine plus the Company’s proprietary TAP technology.
BioMedReports: Why is this a millstone event and why didn’t you issue a press release?
Dr. Glynn Wilson Ph.D: The filing of the IND is an important first step. Approval by the FDA will represent a key milestone for TapImmune as it will be the first sponsored program that we will have in the clinic. We have an exclusive option to license this technology at the end of Phase I. There is a large patient population that we believe can benefit from the ultimate product and alone or with our TAP technology it has the potential to satisfy an important unmet medical need for a larger percentage of HER2/neu positive breast cancer patients.
We did not issue a Press Release as the IND application is from the Mayo Clinic and under our Option Agreement with them this announcement is under their control. Not unrealistically they take the position that the major news is the approval of the IND by the FDA. At that time we will be in a position to issue a press release. It should be emphasized that the timing of this announcement depends on the FDA. If they have no comments within 30 days we can start clinical. If they have substantive comments it could take much longer.
BioMedReports: This isn't the only program you're (working or collaborating) with the Mayo on is it?
Dr. Glynn Wilson Ph.D: No we have a collaboration with the lab of Greg Poland at the Mayo Clinic to look at combining TAP with their novel smallpox antigens. The previous smallpox vaccines stockpiled by the US govt have been live virus or more recently attenuated virus. Our approach is a peptide-based vaccine with the potential to be more widely used, cheaper to produce and with a better shelf life. Studies at the Mayo to select the best antigens to combine with TAP are ongoing.
BioMedReports: We've heard that another program is getting attention as a bio-defense play from some of the same early investors in SIGA Technologies and Cleveland Biolabs. Why would they be interested in your TAP platform?
Dr. Glynn Wilson Ph.D: Through its unique mechanism TAP has the potential to improve the efficacy of many antigens/vaccines in the bio-defense and infectious disease arena. In addition, the use of TAP could be synergistic to other (non-vaccine) approaches.
BioMedReports: Are you already exploring some of those potentials? I mean, have you started to do any work in this area specifically with anyone?
Dr. Glynn Wilson Ph.D: The Mayo smallpox collaboration is our starting point in the biodefense arena. Our other infectious disease collaboration (while not in biodefense) is with the Aeras Global TB vaccine Foundation where we are combining TAP with their second generation TB vaccines. We will be exploring collaborations with other specialist players in the Biodefense space including a strategy to take advantage of government grants in this area.
BioMedReports: Can you explain why the use of TAP along with Mayo's approach to solving the Her2/neu cancer riddle is important or why use of your platform here is significant?
Dr. Glynn Wilson Ph.D: Our preclinical work demonstrated the effectiveness of TAP alone in improving survival and reducing tumor burden of highly metastatic cancers in animals. For our initial clinical trials we looked for antigen technologies that would be synergistic with TAP to create a robust and long-acting cellular immune response. TAP stimulates the MHC Class I pathway for cytotoxic T-cell stimulation. The Mayo Her2/neu technology stimulates the MHC Class II pathway for T-helper cells. In combining the two we are addressing two significant of the major issues that have inhibited the development of an effective vaccine - how to get a robust cytotoxic T-cell response (cytotoxic T-cells can infiltrate tumors and kill tumor cells) and how to get a long-acting response that does not require frequent booster doses. With respect to current therapies, the monoclonal antibody, Herceptin (2009 sales ~ $5billion) can effectively treat patients that have high levels of the Her2/neu antigen ~ 30-40% of Her2/neu positive patients leaving a large unsatisfied market.
As we mentioned before, TapImmune's technologies have been featured on ABC News, in BusinessWeek, Popular Mechanics as well as various newspapers and respected medical journals, but now the 30 day clock starts on this important catalyst. Can Mayo researchers get the IND they just filed approved by the FDA? Would you bet against them?
Aside from the intrigue of this micro-cap penny play with a forward looking catalyst, we're reminded that some of the same investors who made a fortune betting early on bio-defense plays SIGA Technologies (Nasdaq: SIGA) and Cleveland BioLabs (Nasdaq: CBLI) are now placing their bets that TPIV will advance their own smallpox program “quite significantly” in the days and months ahead. In addition, the management team has once again told us that they anticipate building out some of their own in-house programs with TAP and that they continue to look at attractive partnership opportunities as other groups and firms have begun to approach them with the belief that TAP is a broadly-based technology that is synergistic with many other vaccine technologies and with multiple therapeutic applications.
Disclosure: Still Long TPIV