Telo Genomics Initiate Clinical Trial for Minimal Residual Disease in Multiple Myeloma

Rhea-AI Summary

Telo Genomics (TDSGF) has initiated a clinical trial for its TeloView MM-MRD assay at Cleveland Clinic Cancer Institute to assess minimal residual disease in multiple myeloma patients. This follows their initial MRD trial announced in February 2024 at McGill University. The TeloView MM-MRD test offers superior sensitivity in counting MRD cells and can profile individual cancer cell malignancy to help guide treatment decisions. The Cleveland Clinic collaboration expands patient recruitment, particularly for those receiving CAR-T therapies. With approximately 180,000 MM patients in North America requiring regular monitoring, the potential market reaches 800,000 tests annually. The collaboration may also validate other assays like TeloView SMM for smoldering MM patients.

Positive

• TeloView MM-MRD test provides industry-leading sensitivity for counting minimal residual disease cells
• Expansion of clinical trial to Cleveland Clinic broadens patient access and recruitment, particularly for CAR-T therapy patients
• Large addressable market of approximately 800,000 tests per year in North America
• Potential to expand validation to other hematological malignancy assays like TeloView SMM

Negative

• None.

Toronto, Ontario--(Newsfile Corp. - June 18, 2025) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the "Company" or "Telo"), a leader in the development of diagnostic and prognostic tests for human disease through its proprietary 3D analysis of the genomic instability of telomeres, is pleased to announce that it has initiated a multiple myeloma ("MM") clinical trial in collaboration with Cleveland Clinic Cancer Institute, Cleveland, OH. The samples are to be assessed and stratified between minimal residual disease ("MRD") patients that are active or in remission, in a clinical trial of the Company's TeloView MM-MRD assay.

Telo Genomics announced its initial MRD trial in MM on February 22, 2024, in collaboration with McGill University/Jewish General Hospital, Montreal, Canada (NCT05530096). The new collaboration with Cleveland Clinic allows Telo to expand access and recruitment from a broader spectrum of patient groups, including patients receiving new CAR-T therapies that are more prevalent in the USA, and can contribute to expediting the validation of TeloView MM-MRD.

MRD refers to the small number of remaining cancer cells post treatment. The TeloView MM-MRD test provides industry leading sensitivity for counting MRD cells, which is an established metric in assessing MRD. Critically, the TeloView MM-MRD test also offers the potential to profile the malignancy of individual cancer cells and stratify patients based on the aggressiveness of their remaining MRD. TeloView MM-MRD's proprietary approach of counting and profiling individual MRD cells has the potential to provide important, actionable information to clinicians and provide guidance in decision making, including; the extension of therapy, stopping therapy or resuming therapy, with the potential to improve clinical outcomes for MM patients post treatment.

In North America, there are approximately 180,000 MM patients receiving treatment across the spectrum of different stages of the disease. Most of these patients could benefit from ongoing monitoring of treatment response using MRD assessment. Depending on the stage of the disease, patients may be monitored on a quarterly basis, leading to a total addressable market of approximately 800,000 tests per year.

While the initial focus is on MM MRD, the collaboration allows for additional research that can validate assays for other utility cases in hematological malignancies, such as TeloView SMM, which is an assay that stratifies patients that are identified as having smoldering MM, a precursor to active MM. Stratifying SMM patients from low risk to high risk can help clinicians in determining whether to merely monitor MM patients or put them on invasive and costly therapy when necessary.

"We are pleased to be working with Cleveland Clinic," said Dr. Sabine Mai, Telo's Co-Founder. "This alliance supports Telo Genomics' ongoing efforts to redefine how disease progression and treatment response are monitored across the spectrum of Multiple Myeloma and provide better clinical outcomes for patients."

About MRD Assessment
MRD is defined as the small number of cancer cells that remain in the body after treatment, stratifying MRD cells as in remission or active provides important actionable information for clinicians. Also, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted unanimously in April 2024 to accept MRD as a clinical endpoint for accelerated approval of new multiple myeloma therapies, paving the way for faster drug approvals.

Minimal residual disease (MRD) testing is emerging as an important tool in assessing treatment response and guiding therapeutic decisions in oncology. With advancements in drug development technologies, and a growing emphasis on personalized healthcare, the MRD testing industry is expected to exhibit substantial global expansion in the coming years. The MRD global testing market size is expected to reach USD 4.1 billion by 2032 (Globe Newswire - August 14, 2023).

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. The introduction of next-generation therapies (including targeted treatments) has increased the median survival rate to over 5 years, but MM is still considered incurable. Two asymptomatic precursors, Monoclonal Gammopathy of Unknown Significance ("MGUS") and SMM generally precede the progression to classic symptomatic MM. While MGUS carries a steady risk of progression of 1% per year, SMM is more heterogenous with nearly 40% of patients progressing in the first 5 years, 15% in the next 5 years, reaching the same low risk as MGUS after 10 years. To date, identifying patients who will more rapidly progress to MM remains an important 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 clinical need. Notably, the total addressable market for both MM assays is over 750,000 tests per year in the US.

About Telo Genomics
Telo Genomics 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 Genomics 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 in30+ 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:
Guido Baechler
Executive Chairman
416-673-8487
info@telodx.com
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 "will", or variations of such words and phrases or statements that certain actions, events or results "will" occur. Certain forward-looking statements, including statements regarding the Company's receipt of TSXV acceptance of the stock option grant 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/255889

FAQ

What is the purpose of Telo Genomics' (TDSGF) new clinical trial at Cleveland Clinic?

The clinical trial aims to assess and stratify minimal residual disease (MRD) patients with multiple myeloma between active and remission states using their TeloView MM-MRD assay.

How does the TeloView MM-MRD test benefit multiple myeloma patients?

The test provides high sensitivity for counting MRD cells and can profile individual cancer cell malignancy, helping clinicians make decisions about extending, stopping, or resuming therapy to improve patient outcomes.

What is the market potential for Telo Genomics' (TDSGF) MRD test in North America?

With 180,000 multiple myeloma patients requiring quarterly monitoring, the total addressable market is approximately 800,000 tests per year in North America.

How does the Cleveland Clinic collaboration expand upon Telo Genomics' previous MRD trial?

The collaboration provides access to a broader spectrum of patients, particularly those receiving CAR-T therapies more common in the USA, and helps expedite the validation of TeloView MM-MRD.

What additional applications is Telo Genomics exploring through the Cleveland Clinic collaboration?

The collaboration may validate other assays for hematological malignancies, including TeloView SMM for stratifying smoldering multiple myeloma patients by risk level.