Resolution Bio to develop prostate cancer blood test for Janssen and Zejula

Red blood cells
Resolution Bioscience's blood test was granted a breakthrough device designation by the FDA in May and is currently being used in Zejula's late-phase development in prostate cancer. (Pixabay)

Janssen has tapped Resolution Bioscience to help develop a companion liquid biopsy test for the PARP inhibitor Zejula (niraparib) in patients with metastatic castration-resistant prostate cancer.

Resolution’s cell-free DNA assay is currently being used in Zejula’s phase 2 and 3 development against the disease to detect homologous recombination deficiency mutations and gene deletions.


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

The blood test was granted a breakthrough device designation by the FDA this past May. If approved, Resolution said it could be the first in vitro diagnostic to detect gene deletions from cell-free DNA and identify both single-copy and biallelic gene deletions.

Additionally, the Kirkland, Washington-based company said it expects the test will help identify more men seeking targeted therapies such as Zejula, especially late-stage patients from which tissue for a biopsy can be difficult to collect.

RELATED: Resolution Bio assay beats out Guardant360 in retrospective study of complex NSCLC gene fusions

In February, Janssen presented data from an open-label phase 2 study of Zejula demonstrating an objective response rate of about 40% in patients with metastatic castration-resistant prostate cancer and DNA-repair pathway defects including BRCA1 and BRCA2.

"It is encouraging to see this promising response rate, since patients with this DNA-repair pathway defect typically only have an objective response rate of less than 15% and a median progression-free survival of three months with currently available therapies," Janssen’s vice president of clinical development in prostate cancer Margaret Yu said at the time.

RELATED: Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparib

"Given these results, prospective biomarker testing could enable healthcare professionals to personalize therapy for patients with metastatic castration-resistant prostate cancer in the future," Yu said. In the study, patients tested positive for a repair pathway mutation in one of eight genes.

Previously approved in ovarian cancer, Janssen picked up the worldwide rights outside of Japan for Zejula in prostate cancer from Tesaro in April 2016.

RELATED: Johnson & Johnson to open JLabs virtual networking pod in Philadelphia

Separately, Janssen announced a data science research collaboration with the University of California, San Francisco and UC Berkeley offering a Bay Area fellowship program run by the universities and working with the product and platform teams within the Johnson & Johnson pharmaceutical arm.

Projects could include artificial intelligence-driven apps for spotting the early warning signs of disease or new methods of recruiting participants for clinical trials, according to Janssen. The agreement is part of a broader arrangement for sponsored research among the universities and Johnson & Johnson’s medical devices and consumer-focused companies, as well.

Suggested Articles

The FDA approved Bayer’s Gadavist MRI contrast agent to help gauge the blood supply of the heart muscle.

Machine learning-powered drug discoverer Recursion Pharmaceuticals has secured $121 million in new financing for its artificial intelligence programs.

GE Healthcare recalled two of its infant warmers due to side panels and latches that may crack, break or open, allowing infants to fall.