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 TeloViewTM contributed 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.”