ArcherDx, Boulder, Colo, is collaborating with AstraZeneca, Cambridge, UK, to develop assays in support of multiple planned Phase 3 clinical trials for AstraZeneca’s targeted immunooncology therapeutics.
Under the terms of the agreement, ArcherDx will perform whole-exome sequencing of resected non-small cell lung cancer patient samples and generate patient-specific circulating tumor DNA (ctDNA) assays. ArcherDx plans to leverage the resulting personalized cancer monitoring assays to develop companion diagnostics for AstraZeneca’s associated therapies, and together the companies plan to seek global regulatory approval if the Phase 3 clinical trials are completed successfully. The assays are currently for investigational use only.
Jason Myers, PhD, ArcherDx.
“While there has been progress in improving adoption of precision oncology for patients with late-stage cancers, there is a pressing need to accelerate access to precision oncology for all patients diagnosed with cancer regardless of the stage or location of the care setting,” says Jason Myers, PhD, chief executive officer and cofounder of ArcherDx. “AstraZeneca shares this critical mission, and we are pleased to partner with them in the development of biomarker-driven therapies and the expansion of personalized cancer monitoring for all patients.
“Because Archer’s distributed model does not require a centralized laboratory, we intend to distribute regulated products globally,” adds Myers. “We believe our approach will revolutionize how cancer is managed by measuring cancer progression based on the genomic tumor profile of the individual cancer regardless of where the patient receives care.”
ArcherDx’s personalized cancer monitoring program is being developed by ArcherDx and is supported by a collaboration led by Charles Swanton, MD, PhD, of University College London and the Francis Crick Institute. The program is intended to detect evidence of disease progression in cell-free ctDNA specimens from lung cancer patients. The program is part of the TraceRx study, funded by Cancer Research UK, and sponsored by University College London. Personalized cancer monitoring applies ArcherDx’s proprietary anchored multiplex PCR technology to accurately detect exceedingly low levels of cancer-derived DNA from patient blood.
“Mermaid-1 is a novel randomized trial using ctDNA to identify patients at high risk of recurrence after surgery who may benefit from intervention with immunotherapy,” says Swanton. “We hope this approach will lead to better patient outcomes by intensifying treatment in patients most likely to relapse, while avoiding additional chemotherapy after surgery when not needed.”
“While detecting and monitoring for minimal residual disease has proven challenging in solid tumors, the Mermaid-1 trial and this partnership stand to break new ground in lung cancer,” says José Baselga, executive vice president of oncology research and development at AstraZeneca. “This innovative endeavor is reflective of our strategy to improve cancer outcomes by treating patients as early as possible. It is in this early setting that the chance of cure is higher and identifying personalized, effective treatments could increase survival and improve quality of life.”
The master collaboration agreement also allows for expansion into additional disease indications and therapeutic categories.
For more information, visit ArcherDx.
