More than 30 percent of later-line patients responded to the drug in an existing Phase II trial, but some biomarker cohorts fared better.

The company's clinical development plan comprises three global Phase III studies, including two focused on infants and a third for older patients.

Waiv, previously operating as Owkin Dx, will expand global access to a pipeline of AI-driven digital pathology and multimodal tests for cancer.

The firm said it expects to file an investigational new drug application for the autologous CAR T-cell therapy TPST-2003 in the US by the end of the year.