Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the "Company" or "TELO") is pleased to announce today that it is launching a clinical trial to monitor multiple myeloma disease progression in post-treated patients, by measuring and profiling the 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 website of the National Library of Medicine (clinicaltrials.gov): NCT05530096 (https://clinicaltrials.gov/ct2/show/NCT05530096).
The study will be conducted prospectively on diagnosed MM patients eligible for bone marrow transplantation, it has two objectives that will potentially enable TELO to develop two prognostic tests for monitoring myeloma MRD. MRD refers to myeloma plasma cells that remained in the patient's system post treatment. The two objectives include: i) quantify the number of MRD cells circulating in the patient's blood post treatment, and ii) profile the circulating MRD cells using our TeloView technology to assess disease aggressiveness in individual MRD cells. The two MRD tests for MM are designed to be liquid biopsy-based, which is at the forefront of precision medicine.
Monitoring MRD in oncology is evolving to be an important prognostic tool for assessing the depth of a patient's response to treatment; it can also help in identifying patients at higher risk of relapse and potentially guide response-based treatment paradigms in several hematological disorders including MM. In North America there are approximately 180,000 MM patients receiving treatment at any time across the different stages of the disease. Most of these patients may benefit from ongoing monitoring of treatment response 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 capability of the current technologies, which can only inform on MRD cell count (enumeration). Enumeration alone was proven over the years to be inadequate in providing accurate representation of the risk of disease progression. Furthermore, each of the current MRD assessment technologies has its own technical limitation rendering it inapplicable to several MM patient populations.
TeloView technology employs a patented liquid biopsy enumeration methodology that will facilitate the quantification of MRD in the vast majority of MM patients. In addition, TELO can assess the genomic instability of the MRD cells using our TeloView technology, which has the potential to provide accurate assessment of disease aggressiveness beyond merely the cell count, and has the potential to more accurately inform on the risk of disease progression.
Telo Genomics anticipates receiving the first patient samples during Q1 of 2023. The clinical validation of the first MRD test in development, focused on MRD enumeration, is expected to be completed within 12-18 months, followed by the validation of the second test using TeloView to profile the genetic instability of the MRD cells.
"We are very excited to launch the MM-MRD clinical trial," said Sherif Louis, PhD, and TELO's CEO. "Telo Genomics sensitive methodology has the potential to be the first in-kind to fill in the gap of profiling MRD cells informing on disease aggressiveness and allowing clinicians to take full advantage of the MRD prognostic power."
About Multiple Myeloma
Multiple myeloma is a challenging and potentially deadly blood cancer that involves plasma cells, a type of blood cell that helps to fight infection. It is the second most common blood cancer with an incidence of 35,000 new cases every year in the US, and ~180,000 patients receiving treatment at any given time. Although the introduction of new generation therapy, including targeted immunotherapy, has increased the median survival rate to over 5 years, MM is still considered incurable. Two asymptomatic precursors, MGUS and SMM generally precede the progression to classic, symptomatic MM at yearly rates of 1% from MGUS and at 15% from SMM, respectively. To date, identifying patients who will more rapidly progress to MM remains an important unmet clinical need. MM treatment includes various combinations of drugs with a cost as high as $150,000 per year per patient. As most patients will develop resistance to treatment and relapse within a median of 2 years, identifying them proactively remains another important and unmet need. Notably, the total addressable market for both of these MM assays is over 750,000 tests per year in the US.
About TELO
Telo Genomics Corp. is a biotech company pioneering the most comprehensive telomere platform in the industry with powerful applications and prognostic solutions. These include liquid biopsies and related technologies in oncology and neurological diseases. Liquid biopsy is a rapidly growing field of significant interest to the medical community for being less invasive and more easily replicated than traditional diagnostic approaches. By combining our team's considerable expertise in quantitative analysis of 3D telomeres with molecular biology and artificial intelligence to recognize disease associated genetic instability, TELO is developing simple and accurate products that improve day-to-day care for patients by serving the needs of pathologists, clinicians, academic researchers and drug developers. The benefits of our proprietary technology have been substantiated in 160+ peer reviewed publications and in 30+ clinical studies involving more than 3,000 patients with multiple cancers and Alzheimer's disease. Our lead application, TELO-MM is being developed to provide important, 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.
For further information, please contact:
Hugh Rogers,
Director
416-673-8487
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MaRS Centre, South Tower,
101 College Street, Suite 200,
Toronto, ON, M5G 1L7
www.telodx.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as such term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Cautionary Note Regarding Forward-Looking Statements
Certain information contained herein may constitute "forward-looking information" under Canadian securities legislation. Generally, 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 products, commercial viability of products, use of proceeds, and the ability of the TeloView® platform to deliver personalized medicine resulting 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 the actual results, level of activity, performance or achievements of the Company to be 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 assurance 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 are incorporated by reference herein, except as required by applicable securities laws.
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