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Toronto, Ontario–(Newsfile Corp. – November 9, 2022) – Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the “Company” either “TELO”) is pleased to announces today that it is launching a clinical trial to monitor multiple myeloma disease progression in post-treated patients by measuring and profiling minimal residual disease (“MRD”) in these patients. The clinical trial is being conducted in collaboration with McGill University and the Jewish General Hospital in Montreal, Canada. The trial is listed on the National Library of Medicine website (clinicaltrials.gov): NCT05530096 (https://clinicaltrials.gov/ct2/show/NCT05530096).
The study will be conducted prospectively in patients diagnosed with MM who are eligible for bone marrow transplantation, and has two objectives that will potentially allow TELO to develop two prognostic tests to monitor the MRD of myeloma. MRD refers to the myeloma plasma cells that remained in the patient’s system after treatment. The two goals include: i) quantifying the number of circulating MRD cells in the patient’s blood after treatment, and ii) profiling circulating MRD cells using our TeloView technology to assess the aggressiveness of the disease in individual MRD cells. The two MRD tests for MM are designed to be based on liquid biopsy, which is at the forefront of precision medicine.
MRD monitoring in oncology is evolving to become an important prognostic tool to assess the depth of a patient’s response to treatment; it may also help identify patients at increased risk of relapse and potentially guide response-based treatment paradigms in various hematologic disorders, including MM. In North America there are approximately 180,000 million patients receiving treatment at any time in the different stages of the disease. Most of these patients may benefit from continued monitoring of response to treatment using MRD assessment. To date, the prognostic power of MRD assessment is not fully realized in the clinic for MM patients, this is due to the limited ability of current technologies, which can only report MRD cell count (enumeration). Over the years, enumeration alone was shown to be inadequate to provide an accurate representation of the risk of disease progression. Furthermore, each of the current MRD screening technologies has its own technical limitation that makes them inapplicable to various MM patient populations.
TeloView technology employs a proprietary liquid biopsy enumeration methodology that will facilitate MRD quantification in the vast majority of MM patients. In addition, TELO can assess the genomic instability of MRD cells using our TeloView technology, which has the potential to provide an accurate assessment of disease aggressiveness beyond cell counts, and has the potential to more accurately report the risk of disease progression.
Telo Genomics anticipates receiving the first patient samples during the first quarter of 2023. Clinical validation of the first MRD test in development, focused on MRD enumeration, is expected to be completed within 12 to 18 months, followed by validation of the second test with TeloView. to profile the genetic instability of MRD cells.
“We are very excited to launch the MM-MRD clinical trial,” said Sherif Louis, PhD and CEO of TELO. “Telo Genomics’ sensitive methodology has the potential to be the first of its kind to fill the MRD cell profiling gap by informing disease aggressiveness and allowing clinicians to fully harness the prognostic power of MRD.”
About multiple myeloma
Multiple myeloma is a challenging and life-threatening blood cancer that involves plasma cells, a type of blood cell that helps fight infection. It is the second most common blood cancer with an incidence of 35,000 new cases each year in the US and ~180,000 patients receiving treatment at any one time. Although the introduction of new generation therapy, including targeted immunotherapy, has increased the median survival rate to more than 5 years, MM is still considered incurable. Two asymptomatic precursors, MGUS and SMM, generally precede progression to classic symptomatic MM at annual rates of 1% for MGUS and 15% for SMM, respectively. To date, the identification of patients who will progress more rapidly to MM remains a significant unmet clinical need. MM treatment includes various drug combinations costing up to $150,000 per year per patient. Given that most patients will develop resistance to treatment and relapse within a median of 2 years, proactively identifying them remains another important and unmet need. Notably, the total addressable market for these two MM assays is over 750,000 tests per year in the US.
Telo Genomics Corp. is a biotechnology company pioneering the industry’s most comprehensive telomere platform with powerful applications and forecasting solutions. These include liquid biopsies and related technologies in oncology and neurological diseases. Liquid biopsy is a rapidly growing field of great interest to the medical community as it is less invasive and easier to replicate than traditional diagnostic approaches. By combining our team’s considerable experience in quantitative 3D telomere analysis with molecular biology and artificial intelligence to recognize genetic instability associated with disease, TELO is developing simple and accurate products that improve daily patient care by serving the needs of pathologists. , physicians, academic researchers, and drug developers. The benefits of our proprietary technology have been substantiated in more than 160 peer-reviewed publications and more than 30 clinical studies involving more than 3,000 patients with multiple cancers and Alzheimer’s disease. Our flagship application, TELO-MM, is being developed to provide important and actionable information to medical professionals in the treatment of multiple myeloma, a deadly form of blood cancer. For more information please visit www.telodx.com.
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Cautionary Note Regarding Forward-Looking Statements
Certain information contained in this document may constitute “forward-looking information” under Canadian securities legislation. In general, forward-looking information can be identified by the use of forward-looking terminology such as “intends,” “will” or variations of such words and phrases or statements that certain actions, events or results “will occur.” Forward-Looking Statements Regarding the Clinical Efficacy of the Products, the Commercial Viability of the Products, the Use of Proceeds, and the Capacity of TeloView® platform to deliver personalized medicine that results in better treatments and outcomes are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, level of activity, performance or Company’s achievements are materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no guarantee that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company will not update any forward-looking statements or forward-looking information that is incorporated by reference herein, except as required by applicable securities laws.
To view the original version of this press release, visit https://www.newsfilecorp.com/release/143557