As CEO of 3D Signatures (OTCQB:TDSGF; TSXV:DXD; FSE:3D0) since last September, Jason Flowerday is putting the diagnostic company on people’s radar. Unlike most diagnostic companies, 3DS’ proprietary imaging software, known as TeloView, goes beyond identifying whether a patient suffers from a specific condition. By analyzing a patient’s chromosomal arrangement, or signature, TeloView can help doctors tailor personalized treatment and manage each individual patient. With two decades of executive life sciences management and start-up experience, including successive roles at Bayer and J&J, Mr. Flowerday’s mission at 3DS is to transform a highly promising platform technology into a commercial reality with U.S. partners, focusing on those tests that can deliver early value and broaden the company’s development program. In this interview with BioTuesdays, Mr. Flowerday discusses recent advances in 3DS’ lead diagnostic programs and their application to drug development.
Let’s begin with a brief history of 3DS.
The company was co-founded in 2014 by Dr. Sabine Mai, our principal inventor. She began her research over 20 years ago and discovered that the 3-dimensional arrangements of telomeres, which are located at the tips of each chromosome, represent a new class of biomarkers. Her research explored 13 different cancers and Alzheimer’s disease and concluded that by analyzing telomeres and their organization, we have the potential to determine how a disease will progress and if a patient will respond to specific treatment. This information enables clinicians to measure the appropriateness and effectiveness of different treatment options for each individual patient.
Can you give us a description of your technology?
Using fluorescent markers and high-resolution microscopes, the location of each telomere within the cell nucleus can be visualized and digitally analyzed. And using 3DS’ TeloView software platform, the 3-dimensional organization of telomeres within a given cell becomes highly predictive of the disease status of a particular patient. So what all this means is that we have the ability to identify the structural organization of a patient’s chromosomes, which is a measure of genomic instability. And by mapping telomere signatures and measuring the level of genomic instability, we can potentially predict the aggressiveness of a disease and drug responsiveness. The technology is well developed and supported by 22 clinical studies on over 2,000 patients in 13 different cancers and Alzheimer’s disease.
What’s the state of your patent protection?
Our intellectual property includes 16 issued and pending patents in the U.S., Canada and Europe, which cover prognostic, risk predictive and monitoring tests for multiple cancers and diseases.
Let’s discuss your lead diagnostic programs. Can you update your progress in Hodgkin’s lymphoma (HL)?
We are in the final stages of validating our Telo-HL test in a study of 250-to-300 retrospective HL patients and hope to have the test on the market by the first quarter of 2018. This is a prognostic test for clinicians with newly diagnosed HL patients to determine a patient’s likelihood of responding to standard chemotherapy or whether a patient is likely to fail standard chemotherapy and relapse. So Telo-HL is designed to stratify HL patients at the point of diagnosis into non-relapsing and relapsing patients. Relapsing patients may then be considered for alternative treatments at the time of diagnosis rather than waiting until they have failed multiple rounds of standard chemotherapy. There is currently no biomarker available that can predict patient response to standard chemotherapy in HL patients.
What’s the status of your test for prostate cancer?
We’ve made significant progress this year in further validating our liquid biopsy test for prostate cancer. In a clinical trial, we demonstrated an incredibly accurate ability to predict which patients required a prostatectomy and which did not. And when we compared our 3-dimensional technology against the current biopsy-based test, we were more than twice as accurate at determining which patients had an aggressive form of the disease and may have needed surgery.
What sets your prostate cancer test apart from other diagnostics?
Our test is a liquid biopsy and by using a blood sample, we are able to capture circulating tumor cells and analyze patients with localized and metastatic forms of prostate cancer. In the trial I just referenced, 50 patients had a prostatectomy. But on post-surgical analysis, only 21 patients warranted having their prostate removed and in the other 29, the cancer was not as aggressive as the standard needle biopsy predicted it was. And this correlated exactly with what we had predicted. Essentially, from a blood test, we correctly predicted the status of disease in each of the 50 patients. I firmly believe we are on the cusp of a much more accurate and universal biomarker that is minimally invasive and would be easy for patients and clinicians to incorporate throughout the surveillance and treatment phases with a simple blood test.
What’s the status of your participation in the PRECISE trial for prostate cancer?
We were invited into this two-year multi-center trial sponsored by the Canadian Urology Research Consortium. The lab protocols are now complete and we recently received and analyzed blood samples from the first cohort of patients. The PRECISE trial expects to enroll 450 biopsy-naïve individuals suspected of having prostate cancer and aims to determine whether non-invasive MRI-targeted biopsy can replace invasive prostate biopsies in men with an elevated PSA. By incorporating our blood-based test as a correlative biomarker, the trial is our first step toward validation and approval of a clinical risk assessment test for prostate cancer. We’re very pleased to be officially underway and leveraging 3D Signatures’ platform technology in this important trial.
And finally where does your Alzheimer’s disease test stand?
This year, we’ve also used TeloView in a confirmatory study to identify patients with AD and also distinguish between mild, moderate and severe forms of the disease using a cheek swab. The results of the study have been accepted for publication in the peer-reviewed Journal of Alzheimer’s Disease. Current diagnostic methods are not highly specific and we think our technology has the potential to be an accurate, non-invasive biomarker that can diagnose AD and indicate disease progression. We’re currently looking at opportunities to expand the scope of our AD program and fund development through non-dilutive financing such as a joint venture. Alzheimer’s is an enormous opportunity for our company and we hope to advance our development plans for this test in 2017.
Are you getting close to commercializing your tests in the U.S.?
We’re getting a lot of interest about bringing our tests to the U.S. market and we’re currently evaluating a variety of partnership models with lab companies that already have existing infrastructure and their own CLIA-approved lab. Our goal is to bring our first test for Hodgkin’s lymphoma to market in the first quarter next year and over the course of this year, we’ll determine whom to partner with. Our tests for prostate cancer, multiple myeloma and lung cancer are still two to three years away and longer-term, the game plan includes possibly having our own CLIA-approved lab.
How does TeloView dovetail with drug development?
There are two phases to this. One is an early engagement with drug developers who are considering which drug candidates to advance from their pipeline. Based on a chromosomal signature, we can provide those companies with feedback about whether specific drugs demonstrate toxicity or efficacy. Another aspect is a companion diagnostic and the opportunity to leverage 3D Signatures’ TeloView platform to identify and predict whether patients about to enter a clinical trial will be responders or non-responders to a company’s drug candidate, and to monitor those patients during the trial. We’re currently having discussions with Big Pharma about developing a companion diagnostic. This could become as large or larger than the true diagnostic testing part of our business.