Janssen Biotech and Adaptive Biotechnologies established a collaboration to develop the latter’s next-generation sequencing (NGS)-based clonoSEQ® Assay for measuring minimal residual disease (MRD) in multiple myeloma (MM) patients treated using Janssen’s Darzalex (daratumumab). Darzalex is a CD38-targeting antibody approved for treating relapsed or refractory MM. 

Janssen will pay Adaptive an undisclosed upfront technology access payment, plus development funding and potential future milestone payments. The partners aim to demonstrate the clinical utility of the clonoSEQ assay for monitoring MRD negativity in MM patients, and will also assess the drug’s ability to achieve MRD. Adaptive will be responsible for pursuing regulatory approval of and commercializing 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 cofounder 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.”

“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,” added Charles Sang, Adaptive’s senior vice president of diagnostics. “Adaptive’s clonoSEQ Assay can help accomplish this goal due to the robust validation of the assay.”

Adaptive Biotechnologies’ clonoSEQ Assay detects specified cancer-related DNA sequences, and has been developed to detect and quantify MRD in lymphoid malignancies, help monitor patients’ treatment response and remission status, and to aid early detection of disease relapse, potentially before symptoms recur.

Earlier this year, the firm teamed up with Amgen to develop and commercialize the clonoSEQ Assay for detecting MRD in patients with acute lymphoblastic leukemia.

Darzalex was first granted FDA accelerated approval in November 2015 as a monotherapy for MM patients who had received at least three prior lines of therapy. FDA approved the drug in November 2016 as a combination therapy with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, for the treatment of MM patients who have received at least one prior therapy. The European Commission granted full approval for the drug for the same indication, in April 2017.

Within the last week FDA extended approval of Darzalex as combination therapy with pomalidomide and dexamethasone for the treatment of MM patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

At the end of March 2017, Janssen halted a Phase II study evaluating Darzalex in three types of relapsed or refractory non-Hodgkin’s lymphoma after the first stage in the trial failed to meet its primary endpoints of overall response rates.
 








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