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Janssen to Utilize Adaptive’s NGS-Based clonoSEQ Assay to Measure MRD in Darzalex Multiple Myeloma Trials

SEATTLE–(BUSINESS WIRE)–Adaptive Biotechnologies, the leader in combining Next Generation Sequencing (NGS) and expert bioinformatics to profile T- and B-cell receptors of the adaptive immune system, announces it has partnered with Janssen Biotech, Inc. to utilize Adaptive’s NGS-based clonoSEQ Assay for measuring minimal residual disease (MRD) in patients with Multiple Myeloma (MM) who have been treated with DARZALEX (daratumumab). DARZALEX is a CD38-directed cytolytic antibody approved for the treatment of patients with relapsed or refractory MM. Under the terms of the collaboration, Adaptive will receive an undisclosed upfront technology access payment in addition to development funding and potential future milestone payments. Adaptive will be responsible for seeking regulatory approvals for and commercialization of the clonoSEQ Assay in MM.

“Adaptive is thrilled to develop the technology to help measure the depth of response generated by DARZALEX in patients with MM,“ said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. “We look forward to advancing our strategic partnership with Janssen by incorporating the highly sensitive and quantitative clonoSEQ Assay into more trials with DARZALEX.”

Through this collaboration, the parties will work together to demonstrate the clinical utility of monitoring MRD negativity by the clonoSEQ Assay in MM patients who have been treated with DARZALEX, and to assess the medication’s ability to achieve MRD.

“Incorporating novel, proven molecular diagnostic tools into drug development and regulatory processes can enable clinicians to treat patients with the optimal interventions at the right time,” said Charles Sang, Adaptive’s Senior Vice President, Diagnostics. “Adaptive’s clonoSEQ Assay can help accomplish this goal due to the robust validation of the assay. We believe the shared commitment of both companies to monitor MRD negativity in patients with MM will drive the success of this collaboration.”

About Minimal/Measurable Residual Disease

Minimal/measurable residual disease (MRD) refers to cancer cells that remain in the body of a person with lymphoid cancer after treatment. These cells can be present at levels undetectable by traditional morphologic, microscopic examination of blood, bone marrow or a lymph node biopsy. Sensitive molecular technologies, such as next-generation sequencing utilized by the Adaptive Biotechnologies clonoSEQ Assay, are needed for reliable detection of MRD at levels below the limits of traditional assessment.

About the clonoSEQ® Assay

The Adaptive Biotechnologies clonoSEQ Assay enables physicians to utilize next-generation sequencing-based minimal/measureable residual disease (MRD) detection to inform clinical decision making for patients with lymphoid malignancies. The clonoSEQ Assay detects and quantifies DNA sequences found in malignant cells which can be tracked throughout treatment. This robust assay provides consistent, accurate measurement of disease burden which potentially allows physicians to monitor response to treatment over time to optimize patient management. Adaptive will be seeking marketing authorization from the FDA for the clonoSEQ Assay.

About Adaptive Biotechnologies®

Adaptive Biotechnologies is the pioneer and leader in combining in combining Next Generation Sequencing (NGS) and expert bioinformatics to profile T-cell and B-cell receptors. Adaptive is bringing the accuracy and sensitivity of its immunosequencing platform into laboratories around the world to drive groundbreaking research in cancer and other immune-mediated diseases. Adaptive also translates immunosequencing discoveries into clinical diagnostics and therapeutic development to improve patient care. For more information, please visit adaptivebiotech.com.

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