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Invivoscribe, Kronos Bio Partner on Companion Diagnostic Test for Leukemia Drug

NEW YORK – Invivoscribe and Kronos Bio announced Tuesday they are partnering on development of a companion diagnostic assay that could help determine who to treat with the investigational cancer drug entospletinib.

San Mateo, California-based Kronos Bio is conducting a clinical trial for the drug as a treatment for acute myeloid leukemia (AML) patients with a mutation in the nucleophosmin gene, or NPM1. The assay would screen for that mutation, which is present in about one third of AML patients, the companies said.

Kronos' AGILITY trial is designed to assess the efficacy and safety of entospletinib in approximately 180 adults who have been newly diagnosed with NPM1-mutated AML. In the trial, patients are being randomized to receive entospletinib or placebo, in combination with standard induction and consolidation chemotherapy. The primary endpoint of the trial is measurable residual disease negative complete response, with event-free survival as a key secondary endpoint to support potential full approval, the companies said.

Researchers from San Diego-based Invivoscribe have been working with Kronos Bio during the past year to develop the companion diagnostic. The companies said that they intend to seek premarket authorization of the assay from the US Food and Drug Administration at the same time Kronos Bio files a New Drug Application for entospletinib.

Invivoscribe already sells an FDA-approved PCR-based companion diagnostic for mutations in the fms-like tyrosine kinase 3 gene, or FLT3, which are also common in AML patients.