Veracyte Teams with AstraZeneca's Acerta on Oncology Testing

South San Francisco-based Veracyte entered a multi-year partnership with AstraZeneca’s hematology research and development unit, Acerta Pharma.

This is Veracyte’s first biopharma partnership since it acquired exclusive diagnostics rights to the NanoString nCounter platform and genomic tests in breast cancer and lymphoma on December 3, 2019. Under the collaboration deal with Acerta, Veracyte will offer genomic information in support of Acerta’s oncology development program. Financial details were not disclosed.

“We are excited to partner with Acerta Pharma and AstraZeneca, global leaders whose innovative medicines are benefiting millions of patients worldwide,” said Bonnie H. Anderson, Veracyte’s chairman and chief executive officer. “This collaboration reflects the significant value we can bring to biopharmaceutical companies through our expanding global footprint, as well as our ability to potentially inform diagnosis and treatment decisions in new oncology indications.”

Veracyte is a genomic diagnostics company. Its products combine RNA whole-transcriptome sequencing and machine learning to provide data to patients and physicians. The NanoString nCounter deal allowed the company to expand its business globally, particularly in Europe. At the time, Veracyte believed it would begin offering its Envisia classifier for use in idiopathic pulmonary fibrosis diagnosis to international customers in 2021 as a kit-based assay running on the nCounter system. It also planned to launch a nasal swab classifier for lung cancer diagnosis on the nCounter system in 2022, once the test is available in its CLIA laboratory in the U.S. in early 2021.

“Early lung cancer detection is key to saving lives,” said Carla R. Lamb, interventional pulmonologist at Lahey Hospital & Medical Center in Burlington, Massachusetts, at the time of the deal. Lamb is the principal investigator of the nasal swab test study. “However, today, when a potentially malignant lung nodule is found, physicians lack accurate and reliable tools to determine which patients require more invasive diagnostic evaluation and those who can be managed with noninvasive surveillance. Given the nasal classifier’s ability to more accurately classify cancer risk in patients with lung nodules, the test can help address this diagnostic gap, potentially helping to save more lives while also enabling patients to avoid unnecessary invasive procedures and reducing costs.”

As part of that deal, Veracyte picked up the NanoString Prosigna breast cancer prognostic test and LymphoMark lymphoma subtyping assay, which was under development.

In February 2016., AstraZeneca picked up a 55% ownership stake in Acerta, driven, the companies say, by Acerta’s lead investigational Bruton tyrosine kinase (BTK) inhibitor acalabrutinib, as well as the opportunity to build out its hematology/oncology pipeline. AstraZeneca has the option to acquire the remainder of Acerta and complete a full acquisition.

Acerta focuses on covalent binding technology, which is is applying to creating cancer therapies. Its research and discovery teams are based in Oss, The Netherlands. Its largest site is in South San Francisco.

Most recently, in August 2019, AstraZeneca and Acerta announced that the U.S. Food and Drug Administration had granted Breakthrough Therapy Designation for Calquence (acalabrutinib) as a monotherapy for adults with chronic lymphocytic leukemia (CLL). This was based on positive data from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials. They showed that Calquence alone or in combination significantly improved the time patients live without their cancer progression or death.

AstraZeneca and Acerta are evaluating Calquence in 26 company-sponsored clinical trials, including in multiple B-cell blood cancers such as CLL, MCL, diffuse large B-cell lymphoma, Waldenstrom’s macroglobulinemia, follicular lymphoma, and multiple myeloma and other hematologic cancers.