Clinical Trials

The ultrasensitivity of SAGA’s technology creates an array of new possibilities in clinical trials and in the development of new drugs. An example is the ability to find more patients eligible for a specific targeted therapy. When monitoring cancer patients, the technology we present provides crucial quantitative information, leading to breakthrough insights. The methods work equally well with liquid biopsies or tissue biopsies.

The implications of the improved sensitivity/specificity of SAGAsafe® and SAGAsign® are that a new window of possibility is opened to identify the patients carrying ctDNA even between 0.1% to 0.001% mutant allele fraction (MAF).

This results in more efficient trials, increased response and resistance biomarker knowledge, and shorter time from discovery to commercialization of new therapeutics.

Inquire about our services provided in our central laboratory in Lund, or for availability of SAGA kits.

Benefits of the SAGA technology

With SAGA technology, you can be certain you have chosen the best possible tool to assist you in your research and development. With SAGAsafe® and SAGAsign®, you get new information, vital for the results in your clinical studies and for your development of new therapies. Both are ultrasensitive and highly cost-effective methods with a short turn-around time. The possibility to choose between biopsy based on tissue or any suitable body fluid adds flexibility. The stability seen with chromosomal rearrangements, which are used in SAGAsign®, enables long-term use of the same initial fingerprint to monitor clonal evolution throughout a patient’s lifetime.

All of our assays can also be ordered as a service from our laboratory in Lund.

Patient stratification

In modern clinical trials, patient stratification is increasingly based on biomarker status, prognosis status, or tumor burden. We at SAGA can help you identify and stratify more patients into the correct categories with and without the biomarker(s) of interest using SAGAsafe®.

Furthermore, you can also stratify patients with/without residual disease – a readout with key clinical implications  – using SAGAsafe® or SAGAsign®.

Identify patients eligible for therapy – actionable mutations

With SAGAsafe® a higher proportion of the patients carrying a specific mutation can be identified and declared eligible for your therapy. We have shown that we can identify up to 83% more patients than with NGS (manuscript in preparation) making SAGAsafe® the ideal companion diagnostic.

Biomarker monitoring

Either with the use of a selection of SAGAsafe® point mutations or SAGAsign® chromosomal rearrangements, MRD can be measured with a new level of certainty. This may eventually lead to patients being defined as sufficiently low-risk after surgery to not require adjuvant systemic therapy, or conversely, to up-stage patients who clearly have residual cancer after primary surgery.

ctDNA analyses may be a way to improve response monitoring as they interrogate all tumors in the body simultaneously and can potentially measure tumor burden more precisely than other modalities such as imaging. For example, changes in very small tumors may be invisible or undiscernible on imaging. Moreover, radiologic pseudoprogression can give the false sense of disease progression when in fact the tumor is responding and shrinking but the mass appears larger because of inflammation. SAGA tests are inherently tumor-specific and highly quantitative. Depending on the cancer type and clinical setting, you can choose between SAGAsafe® or SAGAsign® to measure therapeutic response.

SAGAsafe® will enable an earlier detection of resistance mutations allowing for a more adequate therapeutic regimen. This may be particularly clinically relevant for EGFR T790M mutations in EGFR-driven non-small cell lung cancer, for which 3rd generation inhibitors that overcome this resistance are already FDA-approved. Other examples include ESR1 mutation and resistance to endocrine therapy in breast cancer and KRAS mutations and resistance to EGFR-TKI in colorectal cancer.

Relapse of cancer is the primary cause of disease mortality. SAGAsafe® or SAGAsign® can enable earlier detection of recurrences potentially improving the treatment strategy and outcome for the patient. Conceivably, identification of cancer relapse at the earliest moment may allow for change in therapy sooner, converting some (micro-)metastatic cancers to become chronic and even curable.

Credentials

SAGA is currently involved in a wide range of research-oriented studies in breast cancer, prostate cancer, lung cancer, ovarian cancer, melanoma, colorectal cancer, and AML. We are working with large and small biopharmaceutical companies in both research and clinical trials.

What our customers say

The possibility to choose a liquid biopsy solution for our clinical trial is breaking new ground in the study of colorectal cancer. The SAGAsign® method is well suited for our needs in our current phase II study with Foxy-5.
Peter Morsing, CEO of WntResearch