NEW YORK – Adaptive Biotechnologies and GlaxoSmithKline announced late Tuesday a collaboration to use Adaptive's ClonoSeq assay to assess minimal residual disease (MRD) across GSK's portfolio of hematology products.
Under the terms of the non-exclusive agreement, GSK may use the US Food and Drug Administration-cleared ClonoSeq test in its hematology clinical trials to generate data supporting the clinical value of monitoring MRD in the context of patient care. Adaptive will receive upfront and potential future regulatory milestone payments in certain geographies. Specific financial and other terms of the agreement were not disclosed.
"We are thrilled to collaborate with GSK to implement our leading MRD test across their groundbreaking hematology portfolio as a measure of treatment response and patient outcomes," Adaptive CEO and Cofounder Chad Robins, said in a statement. "MRD is increasingly used as an endpoint in clinical trials, and ClonoSeq has emerged as the premier test to reliably and accurately measure MRD to help advance novel therapies."
Adaptive's next-generation sequencing-based ClonoSeq test is cleared for use in MRD testing for chronic lymphocytic leukemia, multiple myeloma and B-cell acute lymphoblastic leukemia. In hematologic malignancies, it can be used to see if a patient is responding to treatment or if the cancer has returned.
The deal is the second portfolio-wide partnership related to MRD testing for Seattle-based Adaptive. In September 2019, the firm signed a similar deal with Amgen. Adaptive has also partnered with AbbVie and Genentech on MRD testing in clinical trials.
In August 2020, ClonoSeq received additional clearance from the FDA to detect and monitor MRD in blood or bone marrow from patients with CLL.