SOURCE: TapImmune Inc.

February 10, 2015 07:01 ET

TapImmune's CEO Says Company Is Preparing "A Very Deep Pipeline in Multiple Indications" for Phase II Trials

LOS ANGELES, CA--(Marketwired - Feb 10, 2015) - TapImmune Inc. (OTCQB: TPIV), the emerging clinical-stage immunotherapy company which develops peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and infectious diseases has been grabbing the attention of biotech investors as they ready multiple products for Phase II Clinical Trials. Armed with impressive data results and money from a recent financing, Dr. Glynn Wilson, TapImmune's CEO sat down with BioMedReports to discuss the firm's pipeline progress and challenges.

BioMedReports: Can you please help us digest some of the key points from your recent analysis of Phase I clinical trials?

Dr. Glynn Wilson: Sure. This is very exciting data for the company. To have 20 out of 21 patients react with immune responses in a patient group that has already been through treatment is quite significant. The fact that those patients responded regardless of the type of cancer they had was a clear indication that this set of epitopes are very well processed and are working exactly as they should in the body. A robust T Cell response is probably the single most important piece of the immune system's ability to target and KILL cancer cells. We have seen multi-billion IPOs, and market caps emerge in the T Cell space this past year, all of them are autologous, that is the T Cells are harvested from patients and manipulated and expanded OUTSIDE the body then reintroduced. Our technology approach is to stimulate the same robust T Cell expansion but INSIDE the patient using a simple, cost effective, easily deliverable vaccine.

In order to kill tumor cells and maintain an effective immune response a comprehensive T CELL response is essential. If this is achieved combination therapies that may include anti-PD1/PD-L1 or antibodies such as Herceptin may work better. We are leading the field in T Cell vaccines and look forward to working with the leaders in the other areas to make a comprehensive and effective therapy a reality and available to the many patients waiting for one.

BioMedReports: Does this data suggest to us that we are seeing a possible new indication that the company will push forward into Phase II clinical trials?

Dr. Glynn Wilson: Yes, equally exciting is the fact that the her2 Negative patients responded well making this vaccine an excellent candidate for triple negative breast cancer. This is a therapeutic clinicians have long awaited and we are very pleased to be able to look seriously at making this one of the primary indications in our pipeline. There are limited treatment options for these patients after initial chemo and surgery.

BioMedReports: What are the implications of such a new indication -- i.e. can you talk about the market size for this type of drug?

Dr. Glynn Wilson: Triple negative breast cancer makes up 15-20% of the breast cancer patient population.

We believe this represents is a multi-billion dollar market opportunity. In contrast to monoclonal antibody approaches such as Herceptin for HER2/neu positive breast cancer our peptide vaccines are all designed to illicit a robust T Cell response, including the immune cells responsible for killing aberrant/cancer cells.

BioMedReports: From a valuation standpoint, what does adding yet another drug into the pipeline do for the company?

Dr. Glynn Wilson: Well, it gives us options in terms what we develop first, but more importantly it gives us a very deep pipeline in multiple indications. We now have possible drug candidates in Her2 posittive breast cancer in a much larger patient population than the 7B year Herceptin, Triple Negative Breast Cancer, another multi-billion market, Ovarian Cancer, similarly sized markets and some other indications that we believe would be well suited to the peptide vaccines we have.

BioMedReports: You just did a financing. Why, in the simplest terms possible, were the terms and timing of this financing good?

Dr. Glynn Wilson: This financing provides the company the immediate capital to meet its commitments and to make all the preparations for the upcoming Phase II clinical programs.

The funding was structured in such a way to offer the investors the option to invest more money as the company progresses and increases in valuation. These further investments, some of which are callable by the company under certain market metrics, have the potential to inject a further $10M in the medium term and on a fully exercised basis up to $34M. We believe that this structure along with potential grant funding will give us more than enough capital to execute all the clinical programs currently on deck.

BioMedReports: Can you discuss some of the challenges now facing the company?

Dr. Glynn Wilson: On the technical side, we need efficient integration of all the activities (manufacturing, regulatory, clinical) required for Phase II clinical trials.

On the market side, the intrinsic value of TPIV has not yet been embraced. We need to better communicate the extraordinary value we have in positioning TapImmune as the leading T Cell vaccine company. A robust T Cell response is probably the single most important piece of the immune system's ability to target and KILL cancer cells. We have seen multi-billion IPOs, and market caps emerge in the T Cell space this past year, all of them are autologous, that is the T Cells are harvested from patients and manipulated and expanded OUTSIDE the body then reintroduced back into patients, similar to the Dendreon approach. Our technology approach is to stimulate the same robust T Cell activation and expansion but inside the patient using a simple, cost effective, easily deliverable vaccine, and we have seen it working as mechanistically predicted.

An effective T Cell response can provide an essential component of what we believe will be combination approaches that will include monoclonal antibodies and anti-PD1/PD-L1 therapies.

We believe that through our approach which stimulates Helper T-cells, Killer T-cells and can also address improved antigen presentation we will lead the field in T Cell vaccines and we look forward to working with the leaders in the other areas to make a comprehensive and effective therapy a reality and available to the many patients waiting for one. So, we need to improve the visibility of the Company and outreach to collaborators and investors alike so that they better understand the differentiation of our approach and contribution it can make within the immunotherapy field. As we are successful this will allow us to trigger additional financing for our clinical trials and step us toward our goal to up-list to a major exchange like NASDAQ World Markets.

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