If you’re a biotech investor who has not yet heard of TapImmune, Inc. (NASDAQ: TPIV), this clinical-stage immune-oncology company is charging its way through the sector with its cutting-edge vaccine technologies that are attacking ovarian and breast cancer with a whole new vengeance.
I had the opportunity to chat with new President and Chief Operating Officer Dr. John Bonfiglio about his company’s rippling prospects, from impressive partnerships with the likes of the Mayo Clinic coupled with a grant from the Department of Defense, to a leap to the Nasdaq Capital Market.
With a Fast Track Designation and Orphan Drug Status under its wing, TapImmune is breaking down barriers at rapid speed and could very well have an up-and-coming commercial pipeline on its hands. One thing is clear: the firm is vaulting its course toward success with momentum under the capable leadership of Dr. Glynn Wilson, Chairman and CEO and Dr. John Bonfiglio.
Let’s dive in and see why TapImmune holds compelling clinical and commercial potential:
Julie Lamb: Dr. Bonfiglio, we think you have a great story to tell. I’d like to also wish you congratulations on your recent appointment as TapImmune’s President and Chief Operating Officer. What do you expect to bring to the company?
Dr. John Bonfiglio: I’ve been in pharmaceuticals and biotechnology for over 27 years and I’ve been a CEO or COO at several biotech companies that are either still in business or have been acquired, one of which is Peregrine Pharmaceuticals (NASDAQ: PPHM) and Cypress BioScience, Inc. These are just a couple of examples. But my specialty is focusing the company on getting clinical trials completed and adding value through the progression of the technology that’s in the company. And I feel that TapImmune is an ideal place to be, because the technology is so good and we really believe that we have an option here to do something exciting in the field of immuno-oncology.
Lamb: Speaking of the technology, how unique and potentially productive do you find the innovative vaccine technology at TapImmune?
Bonfiglio: If you have followed the progress cancer research in the last 10 years, there have been several attempts to develop cancer vaccines and most of them have fallen short, primarily for a couple of reasons. One is that most of these vaccines were derived from animal models. And as we know in the world of cancer, if I had a dime for every product that cured cancer in rats or mice, I’d be a millionaire. But what’s really important is deriving the product from humans, and that’s what this product has been derived from. We actually took patients and used the patient’s own immune systems to develop these new products.
The second thing is that until recently, most people believed that you only had to stimulate one compartment of the immune system in order to have a successful product. Now, it’s usually called the killer T cells or CD8 cells. It is now known that you not only have to stimulate those cells; you also have to stimulate another compartment called the helper T cells or CD4 cells. Our product actually stimulates both. We really believe that based on what we’ve seen so far, they have a far better chance of showing some critical efficacy than the previous products.
Lamb: Because you’re stimulating both this time.
Bonfiglio: Both compartments plus the other issue is memory T cells which are a component stimulating both of those. We believe we’re starting to stimulate memory cells as well, which means there could be a long-term effect associated with the product.
Lamb: How would you measure the value of your company’s clinical stage pipeline and where it is in the development process?
Bonfiglio: Right now it’s difficult to put a numerical value on the company. We believe we’re in early Phase II with our TPIV 200 product and that is a product that targets something called folate receptor alpha. That’s a target that is found on ovarian breast and non-small cell lung cancer. Trials right now are focused on ovarian and breast cancer and by the end of the year we’ll have four Phase II trials up and running with this product. Two of them we’re funding ourselves and one of them is being funded through the Mayo Clinic, our collaborator, with a grant from the Department of Defense for $13.3 million to do a large Phase II study in triple-negative breast cancer as a stand-alone agent.
The other trial is a collaboration between TapImmune, Memorial Sloan Kettering Cancer Center, and AstraZeneca. We’re looking at ovarian cancer patients that are very sick that have failed chemo and we’re trying to use our product in combination with AstraZeneca’s checkpoint inhibitor Durvalumab in order to see if we can help these patients.
In terms of the clinic, we have all these trials going on. The trial we’re running is an 80-patient trial in triple-negative breast cancer that has already started rolling in nine sites around the country. And the last trial is an ovarian cancer study that we’re doing in lactose sensitive patients. These are patients that are responding to chemo, but we believe our therapy could be used as a combination drug. We also received Fast Track Designation for this indication and was offered Orphan Drug Status for ovarian cancer.
In terms of the pipeline, I think we’re doing very well and I haven’t even discussed our other products which are coming to the market and to the clinic early next year, which is TPIV 110. If you look at other companies in our space that have Phase II’s going on, I think we’re undervalued from that perspective by counting our market capital in the 40 million-dollar range and I think it should be much higher.
Lamb: Those key collaborations are great and you recently started trading on the Nasdaq Capital Market. It’s clear your company is very much on the rise. What do those collaborations mean to an innovative company like TapImmune?
Bonfiglio: Well, I think a couple of things. One is like I mentioned earlier, this trial that’s being done at the Mayo Clinic with the grant from the Department of Defense. That’s essentially, to us, it’s $13.3 million’s worth of non-dilutive capital for a trial that we would have run ourselves eventually if we had raised in the capital to do it. So, from that perspective it’s good.
But more importantly is that when you have a grant like that, the Department of Defense uses the top advisors in clinical oncology to look at the grant and evaluate the data that came out of our Phase I program before they allocated the grant. So, we have independent vetting by the Department of Defense on the technology itself. Otherwise, they wouldn’t have given the Mayo Clinic the grant.
You also have the same thing going on with the Memorial Sloan Kettering Cancer Center. Their lead investigator is Dr. Connor, who looked at the data and said this is a natural fit, since our product stimulates the immune system and AstraZeneca’s product actually takes the brakes off the immune system so a patient’s immune system can act more efficiently. It’s a natural fit to use the two products together. What you have is essentially some major immune-oncology groups; the Mayo Clinic, the Department of Defense, AstraZeneca and Sloan Kettering all vetting our technology independent of our assessment of it and I think that’s very important.
Lamb: You mentioned earlier that TapImmune has received Fast Track Designation from the FDA, which I believe is for your TPIV 200 vaccine in ovarian cancer. What timeline do you see for reaching FDA approval and beyond that what can you tell us about goals for commercial prospects?
Bonfiglio: Let’s start with the Fast Track. Fast Track Designation allows the company to have much more communication with the FDA. You can call them and ask them questions about the trial much more than as the normal process occurs, which means there is a much better chance of getting the process right.
The second thing is that this also allows us to submit parts of the NDA or the submission in pieces instead of all at one time. For example, if our chemistry and manufacturing section of the submission is ready, we can submit it and have it reviewed while the clinical part is still going on. That saves a lot of time.
The third thing is that if the data are good from the study, it could actually lead to an accelerated approval. That means it will take less time for the FDA to come around and say yeah, you can put this drug on the market.
It’s a Phase II trial, so there’s still a chance that we may have to run a Phase III trial, but we’re not clear at this point in time. As far as timelines are concerned, it will be five years now from approval but we’re excited about getting Phase II data, because that will lead to the potential to have a major partner that could help us finish the development process. Also, you mentioned commercialization … I believe we would like to commercialize this through a commercial pharma-company rather than try to vertically integrate into a commercial company at this point.
Lamb: Do you have any commercial pharma-companies in mind for the next few years down the road?
Bonfiglio: When we start developing Phase II data, we will definitely be out there talking to companies.
But I can tell you if you look at what’s going on in the industry, there’s not going to be one drug that’s going to be the [holy grail drug] for cancer. It’s all going to be in combination. What makes us special is that these checkpoint inhibitors that had vast approval like Opdivo and Keytruda, from major pharma-companies, these are products that are designed to stop cancer from sending out signals that turn down your immune system, so it doesn’t act as fast and as active as it can.
Our job is designed to enhance the immune system so there’s a natural fit between what we’re doing and what these checkpoint inhibitors are doing. And in fact, the other issue is that checkpoint inhibitors, although they work, are very toxic in a lot of cases. So far, we have seen minimal toxicity in the Phase I study and in the patients we’ve dosed in Phase II, so we’re pretty excited about the potential of the uses of the one-two punch and the collaboration with AstraZeneca should hopefully help us with that.
Lamb: Regarding the financial picture, I know you mentioned that your collaborations help on that front. Do you think your company has enough cash to get through all the next upcoming steps, and do you think you’ll be looking for funding in the future?
Bonfiglio: We raised money this past year and have enough cash to get through most of 2017. With the kinds of programs we’re running, at some point this year we will be looking for capital. But it’s not critical at this point in time and we have enough money to comfortably get through most of the year.
Lamb: Could you please add a few brief comments on your recent uplisting to Nasdaq?
Bonfiglio: Sure. I joined the company in February of 2015 as a consultant. At that point, the company had a lot of issues with their finances, the clinical program and the stock prices were very low. In a short period of time, Glynn Wilson, the CEO, and I have not only managed to clear up the financials and attract good investors in, we managed to get the clinical programs going to the point where it made sense to try and do an uplifting onto a major market.
I think the importance of getting on to Nasdaq is the fact that we have more investors looking at the company, better awareness out there, and better trading volume. Not to mention the fact that you have investors that couldn’t invest in the OTC market like large institutions for example, and now can come in and invest in the company that’s on Nasdaq.
So overall, we think it was the right thing to do, and we believe that over the next six to eight months, or six months to a year, we’ll have enough news flow that will help to get the awareness even higher on Nasdaq.
Lamb: And higher awareness, higher visibility means more open doors for the company.
Lamb: In closing, what are the company’s sustainability goals to maximize shareholder value in the next 12 months?
Bonfiglio: Well, as I mentioned, we should be hearing about at least one site for the new ovarian cancer study opening by the end of the year. We will be filing an IND and opening a trial with our second product, TPIV 110, sometime in first quarter. That would be a trial using different targets, HER2-neu, which is a very well-known target that major companies like Roche have a product called Perceptive, which is a breast cancer clonal antibody, which targets the same target. We can help in that area.
We’ll also hopefully with the enrollment going strong at Sloan Kettering and it being an open-label trial, we may actually have some read-out of data sometime over the next 12 months on how that’s progressing. The trial would be that the company is running in triple negative breast cancer is an 80-patient trial that’s also open-label and we’ll have our first PSMB meeting in first quarter. The drug safety monitoring board will take a look at the early data from that trial and hopefully we’ll have some announcements on that. There should be some publications and presentations next year around the data from the Phase I trial, which looks very interesting indeed.
So, we’re very excited about the news flow and the fact that with two products coming out will help keep up the momentum. In addition, there is a pre-clinical product called PolyStart which is quite frankly a hidden gem in the company. And we’re doing some more in collaboration with the Mayo Clinic. This is a product that enhances immune responses in patients not only for cancer drugs but for infectious disease and other products. It’s a home-grown technology and we believe we’ll be able to have some data to report on that product sometime next year as well.