TeloView MRD solutions

What is MRD?

Minimal Residual Disease (MRD) tests are assessment of treatment effectiveness for cancer therapy. MRD can detect the presence of small number of cancer cells that survived the therapy, which could be a cause for disease recurrence.
An informative MRD assay can predict the long-term stability of a patient’s remission and guide evidence based clinical decisions, like stopping or escalating therapy.
MRD testing has emerged as a crucial prognostic tool in the clinic. With advancements in technology and a growing emphasis on personalized healthcare, the global MRD testing market size is expected to reach USD 4.1 billion by 2032. (Globe Newswire – August 14, 2023).
Despite these trends, the prognostic power of MRD assessment is not fully realized in the clinic for many cancers. Each of the current MRD technologies has its own technical limitation, rendering it inadequate or inapplicable to several patient populations. Crucially, a broadly shared limitation is that these technologies can only inform on MRD cell count (enumeration).

Minimal Residual Disease (MRD) tests aim to find if a small number of cancer cells could have survived after treatment.

The MRD assays in the market and in development aim to enumerate cancer cells post-treatment. However, these technologies do not directly count cancer cells but infer their number, from circulating markers of cancer such as cfDNA, cfRNA or protein. These assays also do not profile the identified MRD cells but rely only on the inferred quantity of these cells to make a prognostic assessment.

Telo Genomics MRD approach

An informative MRD assessment has the potential to predict a patient’s response to treatment and guide evidence based clinical decisions, like stopping or escalating therapy.

The TELO-DMRD Clinical Trial is validating a unique approach in the expanding field of MRD testing. The TELO-DMRD clinical trial is focused on the hematological malignancy multiple myeloma and has the potential to improve several aspects of the current clinical practice by generating 2 MRD assay options with superior characteristics.

TeloMRD-D (TeloMRD-Detect): Telo Genomics is validating an enumeration based MRD assay with with key advantages over other MRD enumeration assays currently being used in the clinic. The assay directly counts MRD cells, compared to other technology that infer to cell count by quantifying amplified genetic material (DNA or RNA).
TeloViewNG-MRD (TeloViewNewGeneration-MRD): More importantly, Telo Genomics is developing and validating an assay combining its enumeration MRD with the proprietary TeloView profiling. This assay has the potential to exceed the industry standard of MRD enumeration, and furthermore assess the disease severity of the identified cells, information that no other MRD technology provides.

TeloMRD-D

TeloMRD-D is based on circulating myeloma plasma cells (CTCs), isolated from peripheral blood using a proprietary technology. The isolated cells are then stained for myeloma surface markers followed by fluorescence microscopy. The samples are then scanned, and CTCs (MRD plasma cells) are immuno-phenotypically identified and enumerated. The count of cancer cells informs on the prognostic assessment.

1. Superior Sensitivity with Direct Cell Count
‍With laboratory prepared samples, a repeatable sensitivity of up to 10^-7 (detecting 1 cancer cell among 10 million cells) was achieved, potentially outperforming the current clinical sensitivity standards that can only achieve 10^-5-10^-6 (maximum of 1 in a million cells). Most importantly, the detection limit is for identified cancer cells directly and not inferred to through amplification of markers.

2. Pure Liquid Biopsy
TeloMRD-D is a complete liquid biopsy assay that works without initial tissue sampling and assay preparation (ID/calibration/baseline) stage, unlike the sequencing based MRDs in the clinic or in development, which require bone marrow sample for baseline. As a result, TeloMRD-D assay has shorter turnaround times (days vs weeks for other technologies), lower costs and less burden on the patients.

No Marrow Sample Required
Lower burden on the patient
Lower clinical costs
Broader applicability

No Calibration Stage Required

The current need to identify target mutations prior to an MRD assay significantly increases costs and delays the assay by weeks

TeloView®NG-MRD

Telo Genomics’ New Generation MRD is based on the same principles as TeloMRD-D; identifying CTCs (MRD plasma cells) from peripheral blood using microscopy and immunophenotyping. TeloView®NG-MRD then applies its proprietary TeloView analysis to every identified tumor cell to quantify their malignant potential. The prognostic assessment of this assay is based on assessing the level of genomic instability in the identified MRD cells.

1. Goes Beyond Enumeration with Single Cell Analysis
TeloView®M-MRD has the potential to profile the genomic instability of each identified circulating MRD cell.

2. Differentiates malignant potential of MRD
The genomic instability profiling enables differentiation of aggressive clones of MRD cells with a tendency to cause earlier relapse versus benign clones of MRD cells indicative of prolonged duration of remission, which in turn leads to a more actionable MRD result.

+ The advantages of a superior enumeration MRD
TeloView®M-MRD has the key advantages of TeloMRD-D: a sensitivity above industry standards that directly counts MRD cells, shorter turnaround times, lower costs and less burden on the patients.

About the TELO-DMRD Clinical Trial

Clinical Trial: NCT05530096
Principal Investigator: Rayan Kaedbey, MD
In collaboration with: Sir Mortimer B. Davis - Jewish General Hospital

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Patient’s Brochure

Study Objectives
‍
Objective 1 –Validate the sensitivity of TeloView®M-MRD and establish the clinical utility for MRD enumeration.

Objective 2 – Validate TeloView®M-MRD as a Prognostic Marker post transplantation in transplant eligible MM Patients: Assess the utility of TeloView® technology genomic profiling to stratify post-transplant MM patients, receiving uniform treatment, into relapse risk groups by analyzing MRD cells.

Telo Genomics MRD Solutions