The Life Sciences Report: Thank you for joining us today, Kevin. Can you describe, in layman's terms, 3D Signatures Inc.'s (DXD:TSX.V; TDSGF:OTCQB; 3D0:FSE) TeloView platform and how it works?
Kevin Little: 3D Signatures has a proprietary platform technology that is able to use telomeres, which are the DNA sequences that cap the ends of chromosomes, to establish distinctive profile differences when we look at cells. For example, in the case of cancer, the differences can tell us which cells are going to respond to traditional therapies. In other indications, the pattern of organization of those telomeres tells us whether a patient is likely to progress more quickly down the path of disease. By labeling the telomeres and then using our proprietary technology and software analytics, we're able to build out a panel of different profiles that show us what's going on in terms of the biology within these cells.
TLSR: How is this technology differentiated from other diagnostics on the market?
KL: If we talk about genomics, a lot of companies play in that space. Think about a sort of classical Mendelian genetics, such as what we teach kids in high school about pea plants. We talk about the difference between the genotype, which is the sequence of DNA bases, and the phenotype, which is what the thing ends up looking like. Genotype is the genetics; phenotype is how big a plant grows, what color the flowers are.
I think a lot of technologies seek to get better at linking genotype to phenotype—looking at what's happening at the level of changes in DNA sequence and linking that to biological outcomes like disease or tumor aggressiveness. What I find really compelling about what 3D Signatures' technology does is that we're using these telomeres as a direct biomarker for the phenotype—a pattern that we can immediately show has biological significance.
TLSR: Can you explain the value of targeting the phenotype versus the genotype?
KL: For me, the proof is in the pudding. I think people can spend a lot of time trying to analyze a gene mutation or trying to track how mutations at the genome level actually translate into something you see in a person. To me, what's more relevant is what we see in the patient, what we see that has a clinical significance for people.
Our assay is a way of capturing the instability that goes on as a cell moves from a normal state to something else, something other, and we can monitor these changes dynamically over time. We take that as a snapshot in time, and can say clearly, "Something is happening in terms of the biology here." I've really always been drawn to this question of outcomes—that is what's drawn me into 3D Signatures. The platform can have very profound impacts quite quickly in what it's able to assess at the genetic level in terms of the activity in the cell, and what we see in phenotype, in the outcome with the patient.
The science is quite profound, and Dr. Sabine Mai, 3D Signatures' cofounder and principal inventor, has been able to demonstrate that it applies across many different disease states in a lot of different indications, primarily in the cancers and now also in the neurosciences. The technology has the ability to profile genomic instability, and that gives us a real-time readout of what's happening in that cell within that patient. I think that is profoundly different than what other companies and technologies are trying to do in terms of health outcomes.
TLSR: Are you talking about personalized medicine here?
KL: Absolutely. Running a 3D Signatures test on a patient sample produces a pattern of the organization of the telomeres in each cell that we analyze from that patient. This gives us the ability to inform clinicians how that specific person is likely to respond to traditional chemotherapy (in the case of Hodgkin’s lymphoma), or how aggressively their disease is likely to progress (in the case of prostate cancer). We are empowering patients and doctors to choose treatment options based on their individual status, not a population-wide probability.
TLSR: You're exploring applications in prostate cancer, blood cancers and Alzheimer's disease. Can you explain your methodology for each of these different indications and where they stand in terms of development?
KL: What's really important here is that we have a repeatable platform. By that, I mean we're not reinventing the process for each of the different disease areas we're investigating.
We have a variety of options available to us in terms of capturing the inputs, whether from a cheek swab in neurological indications, or from blood to isolate the circulating tumor cells, or from diagnostic tumor biopsies. But the next steps—in our laboratory processing and then our proprietary analysis software—is really where we've shown refinement, reproducibility and the ability to generate distinct telomere profile differences for many indications and conditions. The robustness and the reproducibility of the platform, time and time again, are really impressive.
So as far as the development time frames, our Hodgkin's lymphoma test is the one that we are focused on right now in a large clinical trial, with the goal to bring that through to market as a laboratory developed test (LDT) in Q1/18.
In prostate cancer, we're involved in the PRECISE trial, and are processing samples from PRECISE recruitment sites as they're coming online. That's going to be a very important trial for us, to be able to benchmark against on a large scale. The next couple of years, as results come out around PRECISE, will be very informative as to the impacts we can have in terms of clinical decisions around screening and monitoring of prostate cancer. We already have plans to engage in a shorter-term look at more aggressive forms of prostate cancer—late stage—and the need for surgical intervention and our ability to predict which patients are suitable candidates, again through a simple blood-based, a liquid biopsy test that we expect to develop over the next one to two years.
TLSR: When can we expect the readout for the prostate trial?
KL: I believe PRECISE goes on for about 24 months. We'll have some evidence along the way, and that's where we see the opportunity to engage in a second, shorter time window.
TLSR: Where is your technology in terms of the approval process? Do you have a timetable as to when you'll begin to start filing applications or marketing products?
KL: With the LDT work in Hodgkin's lymphoma, discussions are underway right now with potential clinical lab partners to bring that test to market. We have quite an impressive group in terms of our business advisory board, which is exploring the regulatory frameworks for that test. We're engaging early on in discussions with regulators to make sure we anticipate things ahead of time.
TLSR: If you were to tell us what the endgame is, can you describe prospects in terms of a partnership or acquisition? Or does 3DS want to take its products all the way to the market on its own?
KL: From a strategy standpoint, the great thing is that all are options, and they're not mutually exclusive. The fact that we have a platform enables us to choose the business models and relationships we believe will best suit the clinical utility of the platform for each indication.
Bringing the test through as an LDT in Hodgkin's ourselves may be the best way to get the product into clinicians' hands to help people. Prostate may be a different market opportunity for us, and if the partnership opportunities are different, we have that kind of flexibility. That is the advantage of having a platform with a lot of different avenues to pursue. Speaking from the scientific and clinical development side, it's a really nice position to be in—to be able to engage in dialogue with potential partners around the best way to move forward together, or to be able to take something to market on our own as the best way to get the product to where it can have the best outcome.
TLSR: What makes 3DS a compelling investment at this point?
KL: There have been some great news stories out there about the company, and we've certainly been growing and bringing on new people, myself included. I've been absolutely amazed by the depth of talent at 3DS. Yes, it's a relatively small team, but in terms of the scientists and clinical lab technologists, I'm not sure I've ever seen this kind of depth and breadth of experience.
I would also point out that we have so much evidence across different indications that demonstrates the effectiveness of the platform, which is exciting. From a clinical impact standpoint, our ability to affect decisions around people's health is incredibly compelling. This isn't just early stage, or theoretical. There's a wonderful breadth of evidence that already shows how this platform has clinical relevance and I think that makes it very compelling for anyone, whether investor, scientific partner or industry partner.
My undergraduate work was in ecology and evolutionary theory, and my graduate work in genetics and genomics—I was even part of a start-up company during my graduate training, where we were trying to develop tests that could characterize how the genome is organized in cells and use that for biomarkers. I went on to do postdoctoral work in translational neurosciences, and looked at the impact of things like the damage chemotherapy can do to cognition. Starting from that sort of ecology-evolutionary background, my perspective has been shaped by time frames and how networks of things interact. The things that really get me excited about what 3D Signatures can do are from that big picture view. 3DS has a big picture view as to what's going on in terms of biology and genomic instability, and how this platform has the ability to have significant impact in so many areas.
And it's moving fast. The people are driven. 3DS really is a wonderful, exciting place to be, and a wonderful opportunity for the stakeholders and partners who are involved with it.
TLSR: Thank you so much, Kevin.
Dr. Kevin Little is the chief scientific officer of 3D Signatures, overseeing the design, development and implementation of the company's research and clinical programs. Prior to his position at 3DS, Little worked as an independent consultant, offering strategic advisory services to help facilitate new life sciences collaborations for public and private sector clients, including Thomson Reuters, Illumina, Janssen, McGill University and the Global Alliance for Genomics and Health. Little previously led the PERFORM Centre, a $36 million health research and community services complex, as the founding chief administrative officer. Before returning to Canada to lead the start-up of the PERFORM Centre, Little spent several years leading the New Zealand government's economic development efforts to build strategic investment relationships across the biotechnology industry sector. Little holds a Bachelor of Science degree in biology from the University of Victoria, and earned his Ph.D. in experimental medicine from McGill University, specializing in DNA repair and functional human genomics.
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Disclosure:
1) Tracy Salcedo conducted this interview for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She owns, or her family owns, shares of the following companies mentioned in this interview: None. She is, or members of her immediate household or family are, paid by the following companies mentioned in this article: None.
2) 3D Signatures Inc. is a sponsor of Streetwise Reports. Streetwise Reports does not accept stock in exchange for its services. Click here for important disclaimers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) 3D Signatures Inc. had final approval of the content and is wholly responsible for the validity of the statements. Opinions expressed are the opinions of Kevin Little and not of Streetwise Reports or its officers.
4) Kevin Little: I was not paid by Streetwise Reports to participate in this interview. 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. I or my family own shares of the following companies mentioned in this interview: 3D Signatures Inc.
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