The Life Sciences Report: You took your doctorate in molecular genetics from Albert Einstein College of Medicine, and were a researcher at Regeneron Pharmaceuticals Inc. (REGN:NASDAQ), in its retrovirus core facility. What did you do there?
Joseph Pantginis: I am a retrovirologist by training. At Regeneron, in essence, I founded the core retrovirus facility, based on my Ph.D. work at the Albert Einstein College of Medicine, where we studied both feline and murine leukemia viruses. At Regeneron, I used retroviral vectors to deliver various genes into cell models and preclinical animal models for the company's research programs. This wasn't a typical post-doc program, where researchers focus on one gene, one protein or one project. I got to work with all of the different development programs at Regeneron.
TLSR: Give me an example.
JP: Sure. We used the retroviruses to deliver genes to mammalian cells that had been engineered. Other scientists at the company would then determine the effects of the gene that the viruses delivered on the cell. We wanted to know if a particular gene we had introduced might have an impact on reducing the growth of tumor cells, for example. By using a retrovirus, we could permanently implant a gene into the genome of the cells.
TLSR: Investigators are wary of using retroviral vectors in humans for the time being, but it's a great way to do research, isn't it?
JP: I would agree with that. I've always had levels of trepidation about using retroviruses in humans. A lot of progress has been made as to the types of vectors that could be used in humans, but my work was strictly on the preclinical side. It was basic research.
TLSR: What did you take from that experience? How does that inform your career as a sellside analyst?
JP: Not to be cliché, but it comes down to the scientific method: the ability to ask questions and analyze data. That's what you learn and practice as a scientist.
"Equity research has a very large teaching component, because you need to share information with people for sales and training, and especially with institutional investors."
Science is not black and white. When you look at data as a sellside analyst, you're translating that into clinical science, which is also—and especially—not black and white. When you get clinical data, you hope for a simple yes or no answer, but more times than not, that doesn't happen. You must have the ability to ask the right questions, go through the various analyses and handicap potential outcomes.
There's another side to being a sellside analyst. Equity research has a very large teaching component, because you need to share information with people for sales and training, and especially with institutional investors.
TLSR: Joe, the teaching component of the job requires you to explain the value proposition to the buyside. What do they need from you?
JP: One of the examples I've used many times is that an analyst can write a very extensive report, and know everything about the drug in development, but in the end that research has to link to an investment case. You may know all about a drug, but you have to link the science to the clinical data and try to look at the entire profile of the drug to determine the impact of news flow on the stock.
TLSR: You follow a lot of oncology-focused companies with early-stage molecules, many of which are still preclinical. When you're performing your initial diligence on a company, what do you look for?
JP: As you say, I do have a large focus in oncology. One of the things I look for, especially in emerging growth companies, is cutting-edge technology. I don't necessarily want to see a new version of chemotherapy.
At medical conferences, you're constantly hearing that the goal is moving toward targeted therapies and away from chemo. I think many physicians want to see chemo essentially go away, replaced with more targeted, personalized medicines. That is the cutting edge. Look at the growth of Regeneron over the last decade-plus. Although it has had a couple of high-profile failures along the way, it is now a commercial success with a market cap of about $30 billion ($30B). That success has been based on world-class, cutting-edge science. With smaller companies, success starts with cutting-edge technologies and an exciting mechanism backed by good science. You have to have a good starting point.
TLSR: I'd like to give our audience some sense of how you look at the drug development process. Even though you were on the preclinical side at Regeneron, you certainly were aware of what a data package might look like when the company would ultimately present an investigational new drug application to the U.S. Food and Drug Administration (FDA). How do you assess the chances of success in getting a drug through trials and regulatory hurdles?
JP: History tells us that 1 in 10 drugs makes it through development and regulatory processes to approval. That is a very rough estimate, and various disease indications are harder than others. Oncology drugs can get to the market easier than, let's say, neurological drugs. Drugs for Alzheimer's disease have a very high failure rate, as an example.
For a preclinical product, an analyst might assign a 0–10% chance of success. Phase 1 products can fall in the range of 5–15% probability, and a phase 2 product may have a 20–40% chance. A phase 3 product may have anywhere between a 40–90% chance of success. Analysts have to start with those basic guidelines, based on historical data.
On top of that, I think you need to assess two key parameters. First, is this a "me-too" type of drug with a known mechanism? If that's the case, the chance of success could be increased. If it is a brand new, or novel, drug, you might start with a lower chance of success because the whole approach needs to be validated. That's part one.
"One of the things I look for, especially in emerging growth companies, is cutting-edge technology."
Part two is about assessing, or handicapping, the competitive landscape and the potential penetration of a new drug, if it works. Is it a first-in-class drug similar to, let's say, Pharmacyclics Inc.'s (PCYC:NASDAQ) ibrutinib, a Bruton's tyrosine kinase inhibitor targeting certain leukemias and lymphomas, which just received FDA approval for mantle cell lymphoma (MCL) patients under the brand name Imbruvica? Or is it a me-too drug, in the sense that there are already five drugs targeting the same particular mechanism. In the case of a me-too situation, a product's penetration would not be as high as for a first-in-class molecule. This would certainly impact valuation.
TLSR: You have a lot of names under coverage. Would you pick a name and give your investment theory?
JP: One of my real passions over the last decade or more has been cancer immunotherapy. We have seen a lot of trials and tribulations based on high-profile failures in phase 3. You finally had a regulatory and data success when Dendreon Corp.'s (DNDN:NASDAQ) Provenge (sipuleucel-T) was approved for prostate cancer back at the end of April 2010. But commercial issues have led to a lot of problems for the company.
I'm looking at two oncology-focused immunotherapy companies: Galena Biopharma Inc. (GALE:NASDAQ) and ImmunoCellular Therapeutics Ltd. (IMUC:OTCBB). There are multiple approaches to cancer vaccines, and these two companies are at different ends of the spectrum.
I'll start with Galena, which ties in very well with how I look at companies through the lens of the scientific method, asking the right questions. The company itself is also asking questions as it conducts clinical trials to develop data. Galena's lead product is a cancer vaccine called NeuVax (nelipepimut-S). It is a peptide vaccine consisting of nine amino acids, which is the smallest number that can be presented by the immune system to dendritic cells, which then activate those cells to target a tumor.
NeuVax is currently in a phase 3 study called PRESENT, targeting enrollment of about 700 patients. The vaccine is an adjuvant therapy (one that follows the principal treatment as an add-on to increase chances of survival) for breast cancer patients with low to intermediate levels of HER2 expression. Once a patient gets an initial therapy for breast cancer, whether it's surgery, radiation, chemo or a combination of those, the patient goes into what's called "watchful waiting." Physicians have traditionally been limited to waiting for the disease to recur.
"In the case of a me-too situation, a product's penetration would not be as high as for a first-in-class molecule. This would certainly impact valuation."
About 25% of these patients can be treated with Genentech/ Roche Holding AG's (RHHBY:OTCQX) monoclonal antibody Herceptin (trastuzumab), which is a multibillion-dollar drug. The reason Herceptin only addresses 25% of the market is because of the expression of its target, HER2, which must be elevated for the antibody to work. But Galena's vaccine can target cells that express low to intermediate levels of HER2. These patients are referred to as HER2-negative. So, NeuVax can address the 75% of patients who are HER2-negative and therefore not addressed by Herceptin.
I believe we'll get the interim analysis for NeuVax either later this year or early in 2014. But unless there is futility or some dramatic positive result, I don't think we'll get much data from that. You will probably see the typical announcement indicating the company will continue the study as planned.
TLSR: This may be risky for investors because the phase 1/2 study was not statistically significant, if I remember correctly.
JP: That is correct. But the goal of that phase 1/2 trial was to pick the right population of patients for the phase 3 PRESENT trial. It is a pet peeve of mine that some investors focus on the statistics of a phase 2 trial. These studies are not powered to deal with statistical significance—they are designed to see if there is any activity from the drug, which determines if a developer should then move into additional studies, and hopefully a pivotal study. It is never the goal to have a phase 2 study powered to show statistical significance.
TLSR: Go ahead with ImmunoCellular Therapeutics.
JP: ImmunoCellular is also a cancer vaccine company. Its approach is completely different from Galena's: ImmunoCellular uses an autologous cell-based approach, using the patient's own tumor to extract dendritic cells and design the vaccine, which is administered back to the patient to initiate an immune attack on the tumor.
I think ImmunoCellular is in a very unique position. Of course, there are bear-case arguments that are hard to combat because the phase 1 study was in a relatively small number of patients. But, again, you have to look at the data from the perspective of tumor indications. One of the more exciting areas for cancer vaccine treatment is in the glioblastoma multiforme (GBM) space, and ImmunoCellular is going after that brain cancer. Even though the phase 1 study involved a relatively small number of patients, what I would speak to is the data, with about a 38-month median survival, which is significantly higher than the current standard of care.
That leads to another bear-case argument, which comes out in oncology studies in general. When a company does an open-label study and compares the data against historical controls, the bears say that because the study is not randomized, it really doesn't mean anything. Many times these arguments do hold water. But investors have to look at each particular tumor indication for perspective.
"It is a pet peeve of mine that some investors focus on the statistics of a phase 2 trial. These studies are not powered to deal with statistical significance—they are designed to see if there is any activity from the drug."
Let me use this analogy: If you pick something like lung or prostate cancer, and look at the literature for studies on a particular stage of disease, you'll see a very wide range of survival times. But you see the polar opposite in GBM. There haven't been any advances in the standard of care for quite some time: It's surgery, radiation, chemotherapy with Merck & Co. Inc.'s (MRK:NYSE) Temodar (temozolomide). The survival times are very tight, irrespective of the group or study. Unfortunately, if you're diagnosed with glioblastoma, you know exactly how long after your initial therapy the disease will recur. The same is true when your disease recurs; you have a very tight timeframe for how long you're expected to live. Based on these published survival times, I think ImmunoCellular, even though the phase 1 study was in a small number of patients, has shown very intriguing data, essentially doubling expected survival times—or more.
TLSR: OK, you've got my curiosity up. Tell me about the phase 2 study in progress.
JP: The company has designed a very robust phase 2 study for its glioblastoma vaccine, ICT-107 (autologous dendritic cells pulsed with immunogenic peptides from tumor antigens), with more than 200 patients. It is a randomized study, giving patients ICT-107 after they have received standard of care, with control group patients receiving their dendritic cells that have not been pulsed by the ICT-107 antigens, again following standard-of-care therapy. I think the top-line data from this study are going to be a major catalyst for ImmunoCellular. We could see that data either by the end of this year or, because many clinical sites are in various countries, it could slip into early 2014.
I don't want to sound too bullish, but since no new treatments have come out for GBM, I think the potential exists that if the survival times seen in phase 1 are approached, the company could potentially file early with the FDA while, at the same time, looking to do a confirmatory phase 3 study.
TLSR: Ethically it's hard to do double-blind studies on children with dire disease like GBM. But if this phase 2 trial is successful, could this therapy translate to pediatric setting? After all, we do have the historical controls showing short survival times.
JP: It should. The FDA might require a smaller, bridging study in a pediatric population. But that's a face value answer. I think you could include the pediatric population initially because of the very benign safety profile of ImmunoCellular's approaches. I think that immunotherapy has the ability to be easily translated into pediatrics.
TLSR: Some investors have been wary of ImmunoCellular's therapy because of its similarity to Dendreon's Provenge. What are the differences here?
JP: They are only alike in one way, and that is in the fact that they are autologous (patient-specific) therapies. Both need to take tumor tissue to generate the vaccine.
The important contrast is that when it makes its vaccine, ImmunoCellular can produce many doses. With Dendreon, the company generates one dose at a time, and the patient must return to the clinic three times to get blood drawn to make Provenge. The vaccine has to be sent back to the clinician and infused into the patient. You get multiple vaccine doses manufactured with one blood draw with ICT-107, and can sequentially dose a patient, including boosting. The more vaccine a patient gets, the better in my belief.
ICT-107's therapeutic advantage is also a margin advantage. A major knock against Dendreon is the single dose per tissue harvest, which makes the costs of goods sold (COGS) for Provenge very high. Right now, it's in the 50% range. The company was looking to bring COGS down with efficiencies to the 30% range, but is still having issues and just announced another restructuring to try to rein in costs. The COGS is much friendlier for the ImmunoCellular approach, where many doses can be manufactured from a single tissue harvest. Unfortunately, when investors hear about autologous therapies, some automatically think Dendreon and Provenge, with its very high COGS. But other companies have instituted automation processes and cost efficiencies to generate these vaccines.
TLSR: You are also targeting multiple antigens with ICT-107, and with the other therapeutic candidates in the ImmunoCellular pipeline, correct?
JP: ICT-107 targets six different antigens. A couple of the antigens are associated with what's called cancer stem cells. Chemotherapy generally kills the very fast-dividing cells, but there is always some population of cells that becomes resistant to chemotherapy or other therapies. These cause recurrence of the tumor and seeding of metastasis. Some of the antigens in ImmunoCellular's vaccine target proteins known to be associated with cancer stem cells. You could correlate that the immune responses generated that led to increased survival times in phase 1 are due to the targeting of cancer stem cells.
TLSR: Could you mention another company, please?
JP: Two, companies, Verastem Inc. (VSTM:NASDAQ) and MEI Pharma Inc. (MEIP:NASDAQ), are in the hot target space of oncology.
Verastem has a lead product called VS-6063 (defactinib), which is a focal adhesion kinase (FAK) inhibitor. It is now in a pivotal phase 2 study in mesothelioma. Again, I am talking about technology that has come from world-class leading science. This FAK inhibitor and its technology came from the Whitehead Institute for Biomedical Research at the Massachusetts Institute of Technology. There has been extensive research in VS-6063's involvement in cancer stem cells and its ability to inhibit cancer stem cell growth.
Verastem is also playing in the hot area of PI3K inhibitors with one of its follow-on products, VS-5584, in advanced solid tumors. As this earlier-stage, phase 1 PI3K program moves forward, I think Verastem's visibility is going to be significantly boosted.
"When a company does an open-label study and compares the data against historical controls, the bears say that because the study is not randomized, it really doesn't mean anything. But investors have to look at each particular tumor indication for perspective."
MEI is an earlier-stage company—it used to be called Marshall Edwards Inc. CEO Dan Gold has accomplished a major turnaround for this company, bringing in intellectual property and bringing everything in house. Its lead product, pracinostat, is a histone deacetylase (HDAC) inhibitor, a hot target that has been volatile with regard to its popularity. I think it's firmly planted as a popular therapeutic target once again, and MEI is now in an acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) study. The company also recently acquired a PI3K inhibitor, which should enter the clinic next year. If the data pan out, intriguing partnering opportunities or even potential acquisition targets could appear.
TLSR: Joe, on Oct. 21 you raised your target price on MEI from $16 to $20, based on the entirety of the pipeline. But you also said the raise was based on the strength of a very interesting, first-in-human study of mitochondrial inhibitor ME-344 in a heavily pretreated population of solid tumor patients. Five of 21 of the subjects demonstrated a doubling of progression-free survival versus the patients' previous therapy. We're all optimists, and we tend to think in terms of how well that molecule might perform in patients who are chemo-naïve. Is there a catalyst in the future that might lead to trials in earlier-stage patients?
JP: Possibly. Right now, MEI has to generate clinical data from its three lead products. A point that needs to be made about the ME-344 announcement is that these were heavily pretreated patients, and yet there was a doubling of the progression-free survival interval. Once a tumor recurs, it is fully expected that the next therapies will provide less of a benefit as the cancer progresses. As a patient goes to second-, third-, fourth- and even fifth-line therapies, it is expected that any potential benefit will be less at each successive stage. MEI's data were intriguing and encouraging. Again, even though it's a small number of patients and a small, earlier-stage study, it goes against the grain of what you would expect from subsequent therapies.
TLSR: What are the near-term catalysts, if any?
JP: Pracinostat needs to get AML data out early next June, at the American Society of Clinical Oncology (ASCO) meeting in Chicago, as well as MDS data out at the American Society of Hematology (ASH) conference in 2014. Based on preclinical data, playing in the PI3K inhibitor sandbox with PWT143, a very selective molecule, is important because it appears to be a differentiated product—but again it's still only in preclinical studies. The Street is not going to assign that much value to it. And we don't assign value to preclinical products; we are assessing the science. PWT143 will enter the clinic next year. Once it does that, I think MEI's value proposition would change as well.
Another company in the oncology space is TG Therapeutics Inc. (TGTX:NASDAQ). It has a potentially better follow-on to Roche/Genentech's old monoclonal antibody Rituxan (rituximab). Roche's monoclonal antibody Gazyva (obinutuzumab; GA101) was recently approved and we believe provides important validation to TG's ublituximab, which is designed to have the same mechanism. Ublituximab has better Rituxan-like properties. It has demonstrated much higher antibody-dependent cellular cytotoxicity activity, which we think differentiates it from the multibillion-dollar Rituxan. It has shown very nice data in lymphoma patients, and that includes patients who have failed multiple prior courses of Rituxan and were about to enter hospice care. When they went on ublituximab, they were shown to have complete responses. A very nice turnaround, even though it was a small number of patients. But, again, you have to look at this from the perspective of these patients. To them it looks pretty good.
TG also has a PI3K delta inhibitor. Infinity Pharmaceuticals Inc. (INFI:NASDAQ) is a potential competitor. We're going to get intriguing data at the ASH meeting on this drug in a phase 1 study, including, for the first time, the clinical activity of the drug and further confirmation of its one-per-day pharmacokinetics compared to Infinity's twice-per day-dosing.
TLSR: Go to another name, please.
JP: Even though Stemline Therapeutics Inc.'s (STML:NASDAQ) product is unique, the approach has been validated by a drug called Ontak (denileukin diftitox), from Eisai Inc. (ESALF:OTCPK). Stemline's lead product, SL-401, has shown what I consider to be very intriguing data in both third-line AML patients and an orphan indication lymphoma called blastic plasmacytoid dendritic cell neoplasm (BPDCN). The company is starting pivotal studies in these indications in Q2/14. The fact that there are no current standards of care across the board for BPDCN, and no standards of care for third-line AML, makes Stemline's drug very interesting.
Stemline has a second product that will see more visibility once the pivotal studies get going. It's SL-701, which happens to be a GBM vaccine as well. It has shown intriguing data, not only in adults but in the pediatric population too, showing nice tumor regression, including in the recurrent environment.
I think Stemline has had very positive discussions with the FDA. It is constantly discussing the regulatory path forward for SL-401. The types of indications that the company is going after can have abridged timelines. The data that Stemline has presented, especially at the last ASCO, support the activity of SL-401 in these two lymphoma and leukemia indications. The size of the pivotal studies could be quite small. If the drug does get accelerated approval, which will be based on priority review, Stemline could conduct an ongoing confirmatory phase 3 trial.
TLSR: This stock has been very weak over the past four weeks, having lost more than 35% of its value. This appears to be about profit-taking, but your new target price is $55, which implies a double from current levels. Are investors abandoning the stock because the next catalysts are so far away? Basically, what you're looking at here is initiation of two pivotal trials, SL-401 in BPDCN in Q1/14 and in AML in H2/14. Am I reading this properly?
JP: Yes. Let me mention that in December we should get an update on the BPDCN patients and follow-up data from the earlier phase 1-2 study, from which we will get important data regarding durability of the therapy. The first part of your assessment about the stock weakness was correct. I've seen this for many stocks, including names like Celldex Therapeutics (CLDX:NASDAQ). Stemline is more than double what it was a year ago, even with the pullback. As you know there has been quite a biotech bubble, and some steam has been let off significantly from some of these stocks.
TLSR: Can you speak to Cytori Therapeutics Inc. (CYTX:NASDAQ)? I know you follow this one.
JP: Cytori is an interesting company right now. It has had a lot of ups and downs over the last several years. The company made an intriguing announcement on Nov. 6 with the equity investment from Lorem Vascular, which will market Cytori's cell therapy technology in China, including Hong Kong, Malaysia, Singapore and Australia. Cytori gets $24 million ($24M) for 8M shares of its stock at $3/share. Cytori gets $12M now and $12M in 60 days, around the end of this year.
If you start with the initial investment case, Cytori has approval of its Celution system for regenerative medicine in both Japan and Europe. The company's focus now, in Europe, is on various ongoing translational studies, getting physicians used to the Celution system and getting physicians to do various studies to generate clinical data. The same is true in Japan.
In H1/14, we're going to see the phase 2 data from the ATHENA study in chronic heart failure patients.
Again, regenerative medicine is a risky proposition. It's very volatile. It's a headline-driven space, but one thing that has provided a lot of buoyancy to the space is cash flow from agencies and groups such as the California Institute for Regenerative Medicine, which is throwing millions of dollars—$20M grants here, $40M grants there—to various companies working in regenerative medicine.
TLSR: If the ATHENA study is your driver right now, what's your case for it?
JP: The ATHENA study is based on intriguing earlier-stage data that the company generated from both heart failure patients as well as heart attack patients. The company has presented excellent visuals with its clinical reports of actual functional remodeling of the heart and, I would go so far as to say, tissue healing in the damaged areas where you might have seen an infarct.
With that said, and with all the volatility we've seen in this stock, it's been languishing. The upcoming clinical data will be a major catalyst for the company, giving confidence not only to investors but also to the physician community in the U.S. with regard to Celution and Cytori's regenerative medicine approach.
TLSR: Lorem Vascular has committed up to $531M in license fees. Does that mean buying consumables?
JP: First, Lorem is providing the equity investment into Cytori. Cytori has provided an exclusive license for the Celution system for 30 years. Cytori is going to get a milestone fee, or a licensing fee, for this exclusive license every year. On top of that, there will be the purchase of the actual Celution system machines, as well as the consumables for the Celution process. You have the licensing fees, which are part of the $531M over 30 years based on revenue milestones. Then you also have the sale of the Celution system and consumables through the transfer pricing.
TLSR: The ATHENA trial is only 45 patients, versus the 27 patients that we saw in the phase 1 PRECISE trial, where mortality was only slightly improved versus placebo. We had tremendous upward move in this stock after the Lorem Vascular deal was announced— the company's value shot up by $90M. I wonder if you think the ATHENA trial is going to move the needle even further on this stock, if the data are good?
JP: I do. Even though, like you said, it only includes up to 45 patients, I think it's a well-designed study.
This phase 2 clinical data from ATHENA will be very important for the regenerative medicine space because currently stem cells are still considered a relative science experiment. So much of the industry is in early-stage development; there are not a lot of late-stage data.
TLSR: It's been a pleasure, Joe.
JP: You bet. I appreciate it. It was great talking with you.
Joseph Pantginis, Ph.D., joined ROTH Capital Partners in 2009. Prior to joining Roth Pantginis was a senior biotech analyst at Merriman Curhan Ford (now Merriman Holdings Inc.). Pantginis was also a senior biotechnology analyst at Canaccord Adams, focusing on the oncology, inflammation and infectious disease spaces. Prior to Canaccord Adams he was a biotech analyst at several firms, including JbHanauer & Co., First Albany Corp., Commerce Capital Markets Inc. and Ladenburg Thalmann & Co., Inc. Prior to his tenure on Wall Street, Pantginis served as an associate manager/scientist of Regeneron Pharmaceuticals' Retrovirus Core Facility. Pantginis received a master's degree in business administration (finance) from Pace University; a doctorate in molecular genetics and a master's degree from Albert Einstein College of Medicine; and a bachelor's degree from Fordham University.
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DISCLOSURE:
1) George S. Mack conducted this interview for The Life Sciences Report and provides services to The Life Sciences Report as an independent contractor. He or his family own shares of the following companies mentioned in this interview: None.
2) The following companies mentioned in the interview are sponsors of The Life Sciences Report: Cytori Therapeutics Inc. Streetwise Reports does not accept stock in exchange for its services or as sponsorship payment.
3) Joseph Pantginis: I or my family own shares of the following companies mentioned in this interview: None. I personally am or my family is paid by the following companies mentioned in this interview: None. My company has a financial relationship with the following companies mentioned in this interview: Parmacyclics Inc., Galena Biopharma Inc., MEI Pharma Inc., Verastem Inc., TG Therapeutics Inc., Stemline Therapeutics Inc., Celldex Therapeutics Inc. I was not paid by Streetwise Reports for participating in this interview. Comments and opinions expressed are my own comments and opinions. I had the opportunity to review the interview for accuracy as of the date of the interview and am responsible for the content of the interview.
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