Massachusetts biotech Nuvalent is turning to Guardant Health to develop companion diagnostics for its targeted cancer drugs, signing a multi-year deal to tap into Guardant’s “Infinity” platform.
The collaboration follows Guardant’s similar partnerships with drug giants Pfizer and Merck & Co. Financial terms were not disclosed.
Nuvalent, according to a statement, will use Guardant’s tissue and liquid biopsy tests to help identify patients for clinical trials and will “evaluate opportunities” to develop companion diagnostics to support potential regulatory approvals for Nuvalent’s current investigational drugs.
The two companies also plan to collaborate on global commercialization of the drugs and any associated diagnostics, if they are approved, Guardant said in a release.
Guardant’s liquid biopsy tests analyze fragments of tumor DNA circulating in the blood to spot biomarkers that can be used to better match patients to treatment or to monitor how well a therapy is working.
The collaboration “reflects the growing importance of precision diagnostics in oncology drug development, where biomarker-driven approaches are increasingly essential for identifying appropriate patient populations, improving trial efficiency and supporting regulatory approvals,” Guardant said.
Guardant did not name any specific drug candidates included in the agreement. However, Nuvalent last month submitted a new drug application for its ALK-selective tyrosine kinase inhibitor neladalkib to treat patients with advanced ALK-positive non-small cell lung cancer (NSCLC).
The company designed the drug to address the resistance and safety problems of existing TKIs and to work across any line of therapy. If approved, the drug could be a potential rival to Pfizer’s Lorbrena.
Nuvalent is also seeking FDA approval for its ROS1-selective inhibitor for patients with advanced ROS1-positive NSCLC. Both drugs are aimed at patients who previously failed other tyrosine kinase inhibitor therapies.
In addition to its companion diagnostics work, Guardant markets the Shield blood test for colorectal cancer screening.
