For multiple development programs across its global blood cancer portfolio, Amgen has tapped Adaptive Biotechnologies to deliver next-generation sequencing (NGS) assays as it moves drugs toward approval.
Under a four-year agreement, Adaptive’s clonoSEQ Assay will be used to assess minimal residual disease (MRD) in ongoing and future clinical trials. In return, Amgen will pay out annual development fees plus sequencing payments and regulatory milestone awards.
“We are excited to continue working with Amgen as their preferred partner to support the development and regulatory approval of novel blood cancer treatments,” Adaptive co-founder and CEO Chad Robins said in a statement.
The two companies began working together in 2016 to assess MRD in acute lymphoblastic leukemia. The new deal aims to expand and validate the use of the biomarker as an outcomes measure across multiple cancers.
“This pan-portfolio partnership reflects Amgen’s confidence in the role that standardized NGS MRD testing with clonoSEQ plays in demonstrating drug efficacy in clinical trials and in day-to-day patient management,” Robins said.
As a single-site in vitro diagnostic performed at Adaptive’s lab, clonoSEQ uses multiplex immunosequencing to identify the DNA sequences found in malignant cells and can detect MRD at levels below one in 1 million cells.
It received a de novo clearance from the FDA last year for monitoring MRD in patients with multiple myeloma and B-cell acute lymphoblastic leukemia using bone marrow samples and is available as a laboratory-developed test for other lymphoid cancers.
"It is critical to know a patient’s MRD status because treating to MRD negativity has been shown to drive better clinical outcomes for patients in a variety of blood cancers," said Gregory Friberg, Amgen’s vice president of global development. “Standardized, highly sensitive, molecular detection of MRD using clonoSEQ supports the development of potential cancer therapies that can help patients with blood cancer live longer.”