3D Signatures Inc. (TSXV:DXD) (OTCQB:TDSGF) (FSE:3D0) is pleased to announce the successful and on-time development of the scoring model for Telo-HLTM, the Company’s lead test for Hodgkin’s lymphoma (“HL”), as well as completion of an analytical validation study to confirm the reproducibility of its Telo-HLTM test.
3D Signatures Inc. (TSXV:DXD) (OTCQB:TDSGF) (FSE:3D0) (the “Company” or “3DS”), a personalized medicine company with a proprietary software platform (TeloViewTM) based on the three-dimensional analysis of chromosomal signatures, is pleased to announce the successful and on-time development of the scoring model for Telo-HLTM, the Company’s lead test for Hodgkin’s lymphoma (“HL”), as well as completion of an analytical validation study to confirm the reproducibility of its Telo-HLTM test.
Powered by the Company’s proprietary TeloViewTM platform, Telo-HLTM is a predictive test performed on diagnostic lymph node biopsy specimens, intended to provide clinicians with the first biomarker capable of identifying the 15% – 20% of HL patients who will fail standard ABVD chemotherapy, and who should immediately be considered for more advanced treatment or inclusion into clinical trials with an emerging immunotherapy.
The study data from the Company’s multi-parametric telomeric analysis with TeloViewTM was analyzed by an independent statistical provider, BioStat Solutions Inc. (“BSSI”), to develop the Telo-HLTM scoring model from over 200 potential predictors that included different combinations of the telomeric nuclear organization, cell type, and clinical parameters. BSSI identified that a combination of at least three of the parameters analyzed by TeloViewTMcontributed to the scoring model with highly predictive characteristics. This included measures unique to 3DS’s platform, which can only be evaluated through three-dimensional analysis of telomeres, and for which current clinical data alone is insufficient to predict risk of relapse.
In addition, the Company reports it has successfully run an internal analytical validation of the test by processing and analyzing, in triplicate, archived samples from the same patients. This important step demonstrates the consistency of the Telo-HLTM test and reproducibility of TeloViewTM results under a variety of conditions.
“In keeping with best practices, external scientific peer-review is now essential to confirm our own evaluation of Telo-HLTM’s strong performance and reproducibility,” notes Dr. Kevin Little, CSO of 3DS. “The detailed findings will be submitted as quickly as possible for presentation in clinician meetings, and then publication in a top-level clinical journal in the latter half of 2018. This will build awareness with key opinion leaders and pharmaceutical companies that Telo-HLTM is ready and available to be incorporated into clinical trials as a correlative biomarker alongside new therapeutic interventions.”
“This is the most significant accomplishment for the Company yet, and I congratulate everyone involved for achieving this critical milestone as per our plan,” commented Jason Flowerday, CEO of 3DS. “This highly successful study is an important culmination of the work by Dr. Sabine Mai and the 3DS team, to develop the first clinically-compliant and validated test based on telomeric profiling, which can uniquely inform treatment decisions in Hodgkin’s lymphoma. Telo-HLTM represents a critical proof-of-principle for the Company’s TeloViewTM platform that we believe may establish an entirely new clinical paradigm for genome organization, and accelerate the development of our broader platform of TeloViewTM-based tests in prostate cancer, lung cancer and multiple myeloma.”
3DS (TSX-V:DXD; OTCQB:TDSGF; FSE:3D0) is a personalized medicine company with a proprietary software platform, TeloView™, that is designed to predict the course of certain diseases and to tailor treatment options for the individual patient. The technology is based on the three-dimensional analysis of telomeres, the protective caps at the ends of chromosomes. 3DS’ TeloView™ software platform measures the organization of the genome and its correspondence to; the stage of a given disease, the rate of progression of the disease, how different diseases will respond to various therapies, and a drug’s efficacy and toxicity. 3DS’ proprietary imaging software is designed to go beyond identifying whether a patient suffers from a specific disease or condition. Instead, the TeloViewTM platform is designed to inform clinicians and patients with respect to how to personalize treatment and best manage an individual’s disease based on their unique TeloView ScoreTM. As healthcare moves increasingly toward better informed, patient-centric approaches, the Company intends for the TeloViewTM platform to deliver personalized medicine that allows for better treatments, leading to better outcomes.
The TeloViewTM platform is supported by 25 clinical studies involving more than 3,000 patients and 20 different cancers, plus Alzheimer’s disease. 3DS benefits from twenty years of research, $25M of non-dilutive investment into its platform and more than 130 supporting publications, and holds a portfolio of patents related to three-dimensional telomere analysis for proliferative diseases, including (but not limited to) hematological disorders such as Hodgkin’s lymphoma, multiple myeloma, and chronic myeloid leukemia. 3DS’ intellectual property portfolio also covers prostate cancer, breast cancer, lung cancer, melanoma, colorectal cancer, and Alzheimer’s disease.
For more information, visit the Company’s website at: http://www.3dsignatures.com.
For further information, please contact:
CEO & Director
Cautionary Note Regarding Forward-Looking Statements
This news release contains forward-looking statements which constitute “forward-looking information” within the meaning of applicable Canadian securities legislation (“Forward Looking Statements”). All statements included herein, other than statements of historical fact, are Forward-Looking Statements and are subject to a variety of known and unknown risks and uncertainties which could cause actual events or results to differ materially from those reflected in the Forward-Looking Statements. Often, but not always, these Forward-Looking Statements can be identified by the use of words such as “estimates”, “potential”, “open”, “future”, “assumes”, “projects”, “anticipates”, “believes”, “may”, “continues”, “expects”, “plans”, “will”, “to be”, or statements that events “could” or “should” occur or be achieved, and similar expressions, including negative variations. Statements with respect to 3DS’ scoring model for its Telo-HLTM test, validation of TeloViewTM, peer-review and publication of its findings and establishing a new clinical paradigm for genome organization, among others, are Forward-Looking statements.
Such Forward-Looking Statements reflect the Company’s current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by 3DS as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. Many risk factors could cause the Company’s actual results, performance, achievements, prospects or opportunities to be materially different from any future results, performance or achievements that may be expressed or implied by such Forward-Looking Statements, including risks related to the failure of 3DS’ scoring model for its Telo-HLTM test and its analytical validation; the risk that the Telo-HLTM test may not be commercially launched as an LDT or for research use by the first quarter of 2018, or at all; risks that its study results or scoring model may not be peer-reviewed or accepted for publication or presentation; uncertainties related to 3DS’ clinical studies and test development; risks related to the volatility of the price of 3DS’ common shares; risks related to the possibility that 3DS’ shareholders may experience dilution; risks related to 3DS’ requirements for additional financing and future access to capital, including the risk that the proceeds raised under the Private Placement may be insufficient to finance 3DS’ business objectives; the risk that a positive return on an investment in 3DS’ common shares is not guaranteed; risks related to 3DS’ intention to retain earnings and not pay cash dividends on its common shares in the foreseeable future; risks related to 3DS’ early stage of development; the risk that 3DS’ tests will not be successfully deployed; risks related to 3DS’ dependence on third parties, including collaborative partners, licensors and others; risks related to 3DS’ clinical study recruitment; that there is currently no market for 3DS’ products and that such market may be slow to develop if at all; risks related to 3DS’ reliance on key personnel; risks related to the competitive nature of the biotechnology industry; risks related to 3DS’ limited operating history, lack of revenue, history of losses and inability to assure that it will earn profits in the future or that profitability will be sustained; risks related to government regulation; risks related to rapid technological change; risks related to the fact that 3DS’ software may now or in the future contain undetected errors, bugs or vulnerabilities; the risk that 3DS or its directors and officers may be subject to a variety of civil or other legal proceedings, with or without merit, including product liability claims; risks related to the protection of 3DS’ intellectual property rights; risks related to 3DS’ limited sales, marketing and distribution experience; risks related to the possibility that 3DS’ directors and officers may be placed in a conflict of interest as a result of their employment or affiliation with third parties, risks related to 3DS’ use and storage of personal information and compliance with applicable privacy laws, as well as those risks discussed under the heading “Risk Factors” in the Company’s annual management’s discussion and analysis dated October 23, 2017 and filed on SEDAR. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in the Forward-Looking Statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended.
In making the Forward-Looking Statements, the Company has made various material assumptions including, but not limited to, 3DS’ scoring model for its Telo-HLTM test, internal validation of TeloViewTM, peer-review and publication of its findings and establishing a new clinical paradigm for genome organization all being successful, obtaining positive results from 3DS’ current and planned clinical studies and research and development initiatives; that the Telo-HLTM test will be commercially launched as an LDT or for research use by the first quarter of 2018; obtaining regulatory approvals with respect to 3DS’ clinical studies which are now ongoing or may in the future be commenced; 3DS’ ability to successfully develop its tests; assumptions regarding general business and economic conditions; that 3DS’ current positive relationship with third parties will be maintained; the availability of future financing on reasonable terms; 3DS’ ability to attract and retain skilled staff; assumptions regarding market competition and the products and technology offered by 3DS’ competitors; and 3DS’ ability to protect patents and proprietary rights.
3DS believes that the assumptions and expectations reflected in the Forward-Looking Statements in this press release are reasonable, but no assurance can be given that these expectations will prove to be correct. Forward-Looking Statements should not be unduly relied upon. This information speaks only as of the date of this press release, and 3DS will not necessarily update this information, unless required to do so by securities laws.
Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.