Isatuximab is an investigational anti-CD38 monoclonal antibody, which is currently under clinical development to treat newly diagnosed, relapsed and refractory MM.
Sanofi will use daptive’s NGS-based clonoSEQ assay to evaluate minimal residual disease (MRD) status in response to isatuximab.
The partnesrship will assess the clinical value of monitoring MRD negativity in isatuximab-treated MM patients.
Adaptive will take responsibility for regulatory approvals and commercialization of the clonoSEQ Assay for MM in select geographies.
As per terms of the deal, Adaptive is eligible to secure upfront payments and potential future milestone payments.
Adaptive Biotechnologies CEO and co-founder Chad Robins said: “Adaptive is thrilled to apply its technology to help determine the depth and duration of response to isatuximab in MM-treated patients.
“We look forward to kicking off our collaboration and applying our validated, highly sensitive and quantitative clonoSEQ Assay to measure MRD status as a clinical endpoint in Sanofi’s clinical trials.”
Adaptiv clonoSEQ assay allow physicians to use a molecular and NGS-based minimal/measureable residual disease (MRD) detection to inform clinical decisions in patients with lymphoid malignancies.
The assay holds capacity to detect and quantify DNA sequences determined in malignant cells, which can be tracked in patients longitudinally on and post-treatment.
Through offering consistent and accurate measurement of disease burden, the assay enabled physicians to evaluate response to therapy over time.
Adaptive is expecting 510(k) marketing authorization from the US Food and Drug Administration (FDA) for clonoSEQ assay. It is currently distributed as a CLIA certified service.
Adaptive diagnostics senior vice president Charles Sang said: “MRD status is being incorporated as an important clinical endpoint to assess response to therapy in patients with multiple myeloma and other lymphoid malignancies.”
