CEO and President: Peter Hoang
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WSA: Good day from Wall Street, this is Juan Costello, Senior Analyst at The Wall Street Analyzer. Joining us today is Peter Hoang, the CEO and President for TapImmune Incorporated. The company trades on NASDAQ, ticker symbol TPIV. Thanks for joining us today there, Peter.
Peter Hoang: Morning, Juan. I really appreciate the opportunity to be here.
WSA:Certainly. So, starting off, please give us an overview of the company.
Peter Hoang: Sure. I’m Peter Hoang, President and CEO of TapImmune. TapImmune is a clinical stage company with three separate therapies, currently in clinical trials, and a preclinical platform technology that’s designed to increase antigen presentation, so a very nice technology that we use to enhance not only our platform technologies but potentially any cancer immunotherapy. So, our product candidates have received Orphan Drug Designation for ovarian cancer as well as FDA fast-track status for a platinum-sensitive ovarian cancer. Our clinical trials are funded in part by an aggregate of 17 million from two separate non-dilutive grants from the U.S. Department of Defense. And we’re currently advancing six clinical trials, including four separate Phase 2 clinical trials that are, today, enrolling patients at leading medical centers, including the Mayo Clinic, Memorial Sloan Kettering, The Moffitt, Sarah Cannon, UAB, Maryland Medical Center, and among others. So we’re pretty excited about the opportunity that we have with the company.
WSA: Certainly, and bring us up to speed on some of your current news including your most recent clinical update.
Peter Hoang: Absolutely. So I think that we’ve had a pretty active fourth quarter to date and we expect to have likewise an active fourth quarter going forward into the New Year. So as you may have seen, two weeks ago, we announced that we had completed enrollment on our first Phase 2 study. That is a dosing study in triple-negative breast cancer that we targeted towards 80 patients. We actually enrolled about 10% above that number because as you know, patients oftentimes come off proud, and we wanted to make sure that we had a full 80-patient data sets with that trial, that clinical trial is a very nice complement to our 280 patient efficacy trial, which is set to start later this quarter.
So as we told our investor base in our third quarter earnings call, the Mayo Clinic is currently enrolling patients for that large efficacy study, so this will be a study that is placebo-controlled and blinded and will give us a readout as to whether or not we’ve got single agent efficacy in our TPIV200 vaccine in triple-negative breast cancer. I think that’s a pretty exciting study. So, you know, with the closing of enrollment there, one of the really nice features about it is that we were able to really drive patient enrollment over the course of the last few quarters and close the enrollment of that trial almost two months ahead of schedule.
So as your listeners may know, the enrollment for clinical trials like ours–I think that you’re doing pretty well if you’re enrolling 0.3 patients per month per site at these clinical trials throughout the last year and into the first two quarters of this year. We were enrolling closer to 0.2 patients per trial – site per month. By focusing on the blocking and tackling, we have the outreach of making sure that we had motivated investigative partners and clinical sites, we were able to drive that late to almost 0.8 eight patients per site per month over the course of Q3 and Q4.
So I think that we’ve got very motivated clinical partners. And I think that we’re very, very pleased with the improvement in the clinical execution that we’ve been able to drive there. Additionally, coming up later in the quarter, I think that we should be able to announce the filing of the amended IND for our Phase 1 in TPIV110 product as well as to be able to talk about further development in terms of the IOP prosecution with respect to our preclinical platform PolyStart™. Most importantly, I think that we’re on the cusp of being able to announce the Phase 1 trial results pending publication of a paper that was authored by our critical investigators at the Mayo Clinic that will allow us to discuss in detail the survival data that we’ve seen in patients in our Phase 1 trial with TPIV200, which I think has real implications on what the potential outcomes of our Phase 2 trial in ovarian cancer are.
As, you know, we are currently enrolling patients in a Phase 2 efficacy study in first remission in ovarian cancer, that will be a 120 patients study that we are currently enrolling patients in. It is a study that will clearly drive patient results to statistical significance. And like the triple-negative breast cancer, probably 280 patients study, if we can show single-agent efficacy versus a placebo in that trial, I think that we have a real pathway to registration and approval of the product.
WSA: Great. So what are some of the key trends that you’re seeing right now in the sector and how is the company positioning itself to capitalize?
Peter Hoang: I think that that’s actually one of the really interesting things that brought me to this company. Many cancer vaccine approaches have struggled in the past. And one of the things that we do differently is that we take an approach that’s based on focusing on CD4 or helper cells. And this approach actually squarely aligned with the learning’s of the last five years. Well, if you’ve learned that CB8 T-cell, that is killer T-cell, seem to struggle when they act alone with tumors and every cancer vaccine approach that has been tried or, you know, basically all of the cancer vaccine approaches have been tried and will focus primarily on CD8 or killer T-cells.
Well, there’s an increasing body of literature that supports the idea that without contribution from CD4 cells, the CD8 alone lack the ability to persist and expand and must out-compete a tumor, particularly cold tumors or aggressive one. Moreover, what we know now is that CD4 T-cells are required to generate memory for long lasting immunity in patients. And because we take a Class II approach unlike most cancer vaccines, we’re able to treat almost the entire adjustable patient population with a single vaccine formulation by selecting DR-restricted peptides. So we’re effectively able to create a truly off-the-shelf therapy.
One of the things that I talked about at the Piper Jaffray conference two days ago was an example of the power of a Class II approach. So if you take a B16 melanoma model, let’s say, you know, take a C57 black 6 mouse and put in that B16 melanoma model, if you use 10 million Class I, that is CD8 killer T-cells – though, in this case high affinity T-cells specific for female, they do nothing. The T-cells don’t resist, the tumor grows and the mouse dies. But interestingly enough, we use much fewer T-cells, so in this case a 100,000 versus 10 million Class II or CD4 helper T-cells.
In this case, specific for an engine we call trip one that has a similar expression level in the tumor. And guess what, the tumor melts away and the mice live. And, that’s what I think taking a Class II approach may help us do and take a much, much more effective approach towards vaccination. Many of the learning that we’re seeing in immune-oncology, point themselves towards the fact that what you really need is to get engagement from the patient’s own normal T-cells, that is the natural T-cell, what we call endogenous T-cells because when we look at the two primary approaches in immunotherapy today is checkpoint.
What we’ve learned is that checkpoints work really well in terms of being able to drive curative responses in some patients. But that number generally harbors around 20% to 40% in the indications where checkpoints work and what we’re finding more importantly is that the checkpoint primarily work in tumors that have high rates of mutation, which are hot tumors. When you move to a cold tumor where you don’t have high rates of mutation and what you find is that while these checkpoint inhibitors metaphorically remove the breaks from the immune system, allowing the immune system to function as it normally does, when you don’t have enough mutation in the tumor, the T-cells, the natural T-cells still don’t see enough tumor to take action and effectively drive a therapeutic response from the patient.
Likewise, with cell therapies, what we find is that in blood tumors where the tumors are everywhere, cell therapies work pretty well. But in solid tumors, what you find is that the T-cells struggle much more. So there’s only one cell therapy, that’s NY-ESO-1 based TCR that have ever shown efficacy in a solid tumor. And then, interestingly enough, what we’re finding is that, you know, not surprisingly because NY-ESO-1 is only on about 20% to 25% of tumors that the real therapeutic response is being driven by the fact that the NY-ESO-1 T-cells start a fire.
That is, they start inflammation, they kill some tumor cells, the 20% of the of the tumor cells that they can see, but really where the therapeutic effect is being driven is that effectively that inflammation, that necrosis of cancer cells is driving natural T-cells to participate and respond. And if the response is the natural immune system, this means endogenous T-cell, that’s really being able to drive the response by killing the remainder of the tumor. So all of this points to the fact that what you really need to do is to be able to drive a response by the endogenous T-cell, and that’s what our technology does.
Vaccination for folate receptor alpha or HER2/neu or any peptide payload that we care to deliver with our PolyStart™ program drives the antigen presentation. So tumors that were initially invisible to your body’s T-cells, that is when you take the brakes off with a checkpoint inhibitor or when you start a fire by being able to kill some tumor cells with a cell therapy like CAR Ts or TCRs. Now, what you need is you need to have your endogenous T-cells during the fight and take part if you really want to drive consistent response rates or responses in patients that are durable and not subject to near-term relapse. So that’s what our technologies do, they drive the ability of the main T-cells, endogenous T-cells to be able to respond to these tumors.
WSA:Great. So you just took over the CEO role and being intrigued by the technology. Can you talk about your background and experience, Peter, and some of the key management team there?
Peter Hoang: Yeah, absolutely. So I actually only took over about two months ago, I came on board at the end of September. Prior to coming to TapImmune, I spent the last five years primarily focused on the cell therapy side, so the CAR T and TCR world. I come most recently from Bellicum Pharmaceuticals, which is the CAR TCR Company that focuses on trying to create controllable T-cells. I ran business development, corporate development, and corporate strategy through the company. So, I’m basically focusing on all business operations outside of the balance sheet.
Before that, I’ve been at MD Anderson where I led the creation of all new ventures and new companies for the institution and the hallmark transaction that we like to look back on. And the experience at MD Anderson was also a CAR T transaction where we commercialized Professor Lawrence Cooper’s CAR T-cell technology based on using a transposase approach called Sleeping Beauty with a couple of companies that were doing, the ZIOPHARM and Intrexon. So that was the largest private institutions, the public company upfront deal of all time.
And I think it was a very successful transaction for those two companies, delivering about 2 billion of incremental market cap coming out of the announcement of that transaction. Before MD Anderson, I’ve been an investment banker for 16 years. So one of the skill sets that I’m hoping to bring to the role here at TapImmune is a thorough knowledge of the capital market and a real focus on being able to drive immediate accretive shareholder value through strategic transactions.
WSA: Certainly. And, so as far as investors in the financial community, Peter, what are some of the key drivers that you want them to better understand about TPIV?
Peter Hoang: Sure. Well, you know, I think that one of the things that should interest the investors is the same thing that caught my attention when the opportunity at TapImmune first came up, which is that in my mind there is a really compelling shareholder value proposition here. The company today is traded at 30 million dollars, which is really surprising and almost mind-blowing given the fact that when you look at this company, you have to recognize that this is a clinical stage company with six active clinical trials at some of the premier cancer treatment institutions on the planet.
You know, like I said, the Mayo Clinic, Memorial Sloan Kettering, The Moffitt, Sarah Cannon, UAB, Maryland Medical Center, and the list goes on and on. We are running multicenter trials at upwards of 20 centers for many of our Phase 2 trials with products that have in my mind, a real pathway to approval as single-agent therapy. Moreover, we have on top of that a preclinical platform that may be transformative in terms of its ability to enhance the effect of any immunotherapy, using it either as a prime boost from vaccine approaches or potentially as enhancement approaches in conjunction with other companies’ checkpoint inhibitors or their cell therapies.
You know, on top of that what I’d point out is that our technologies are fundamentally differentiated from every cancer vaccine approach that has been tried in the past. Now, I do believe that that technology will be validated, not only for my scientifically sound perspective, which we know today, but, from the point of view of actual patient results in clinical trials. So, remember that this is technology that was generated out of some of the best research at the Mayo Clinic and vetted and funded twice by the U.S. Department of Defense. So I think that from a value standpoint, there is a pretty compelling value opportunity here at TapImmune.
WSA: So, are there other goals and milestones here over the course of the next six to 12 months that perhaps you didn’t cover?
Peter Hoang: Yeah, absolutely. So, as you know, we’re very focused on these near-term milestones. In the next few weeks, we expect to be able to announce the dosing of our first patient in that 280-patient efficacy trial. That trial by the way is fully funded by the U.S. Department of Defense, and so it will require no additional capital resourcing from the company because it’s fully funded by the U.S. Department of Defense. In addition, like I said, I think that we should be in a position imminently to announce the detailed results of our Phase 1 trial. So as we said in the Q3 conference call, that manuscript was submitted to one of the leading clinical oncology journals in the industry.
We have received reviewer commentary. You know, I’ve seen the comments, I think that they are reasonable, straightforward and addressable. Our investigators at the Mayo who are the authors of that manuscript are reflecting the changes that the reviewers had requested. And at this point we’re in the hands of editorial review. So I can’t predict the exact date of release but I do believe that the release of that data and publication in the paper will be imminent. And I do think that that will have very interesting implications for our Phase 2 trials.
In addition to the milestones that I’ve talked about the following – the amended IND and the additional patent protection on PolyStart™ – by the way, the PolyStart™ technology now has an allowance from the U.S. Patent Office that allows us to protect using that technology with any peptide payload, which allows us extremely broad use of the technology. But in the coming year, we’re looking forward to having some fairly important milestones as well. As you may know, we expect in the New Year that the Mayo Clinic will be dosing the first patient and initiating the Phase 1-2 trial using the TPIV100 vaccine.
That is the one that is targeted to Her2/neu in a study in ductal carcinoma in situ, DCIS. DCIS is a particularly interesting indication for us because as many of your listeners really know, DCIS is, in many ways, a precursor to other forms of breast cancer. And so this trial may well be informative about the use of a cancer vaccine on a prophylactic basis, which much more resembles to use of vaccines in an infectious disease setting. In addition, I think that next year, we’ll be in a position to look at the interim results from the triple-negative breast cancer dosing study that we’ve just closed the enrollment on. So I think that we’ve gotten active by a year ahead of us in terms of milestones and announcements.
WSA: Certainly. So, once again, joining us today is Peter Hoang, the CEO and president for TapImmune Incorporated. The company trades on NASDAQ, ticker symbol TPIV, currently trading at $2.77 a share and market cap is close to 30 million. And before we conclude here, Peter, to briefly recap some of your key points, why do you believe investors should consider the company as a good investment opportunity today?
Peter Hoang: Well, like I said. I think that there’s a pretty compelling value proposition here with the number of clinical trials we have, particularly the number of advanced stage clinical trials in Phase 2 that have the ability to result in multiple approved products in multiple indications as well as a potentially transformative preclinical platform technology that can be partnered with virtually anybody in the immunotherapy space with technology that has been originated out of one of the premier cancer research institutions in the country, and then vetted and funded twice by the U.S. Department of Defense. I think that there is a substantial value appreciation opportunity here if we’re able to execute on all the things that we hope to be able to.
WSA: Well, we certainly look forward to continuing to track the company’s growth and report on your upcoming progress. And we’d like to thank you for taking the time to join us today, Peter, and update our investor audience on TapImmune. It’s always great having you guys on.
Peter Hoang: Thank you. It’s my pleasure to be here.