Wednesday, May 27, 2020
ArcherDX, Inc., announced a strategic collaboration with AstraZeneca to develop assays to support multiple planned Phase 3 clinical trials for AstraZeneca's targeted immuno-oncology therapeutics.
Under the terms of the agreement, ArcherDX will perform Whole Exome Sequencing (WES) of resected non-small cell lung cancer (NSCLC) patient samples and generate patient-specific circulating tumor DNA (ctDNA) assays. ArcherDX plans to leverage the PCM assays to develop companion diagnostics (CDx) 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.
"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," said Jason Myers, Ph.D., Chief Executive Officer and co-founder, 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. 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 (PCM) development program is being developed by ArcherDX and is supported by a collaboration led by Professor Charles Swanton of UCL and the Francis Crick Institute to detect evidence of disease progression in lung cancer patients from cell-free ctDNA as part of the Cancer Research UK-funded UCL-sponsored TRACERx study. PCM applies ArcherDX's proprietary Anchored Multiplex PCR (AMP™) 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," said Charles Swanton, M.D., Ph.D., UCL and the Francis Crick Institute, lead researcher of the TRACERx study. "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."
José Baselga, Executive Vice President of Oncology R&D at AstraZeneca, said, "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. 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.