Natera’s Signatera molecular residual disease (MRD) test will both select patients and serve as an endpoint in a Phase II trial of an Incyte immunotherapy, the companies announced Nov. 10.
The trial, announced Nov. 10, will evaluate an Incyte immunotherapy in patients with stage II and III colorectal cancer who have completed surgery and adjuvant chemotherapy. Following chemotherapy, patients will be tested with Signatera for up to 12 months. Those who test MRD-positive and have no evidence of radiographic disease may be eligible to enroll and be treated, Natera said, adding that Signatera will serve as both a primary and secondary endpoint, though the companies did not define either.
Financial and other terms of the deal were not disclosed.
“Across a growing portfolio of treatment on MRD (TOMR) studies, Signatera has been shown to enable early identification of patients at elevated risk of recurrence and supports enrollment into trials with treatment strategies that may alter the course of disease before radiographic progression occurs,” Eric Matthews, general manager of biopharma at Natera, said in a statement.
INCA33890 is an investigational bispecific antibody designed to block TGF-β signaling only in T cells expressing both TGFβR2 and PD-1. The approach could avoid the systemic toxicity seen with other TGF-β inhibitors. Patients with colorectal cancer who remain MRD-positive after surgery and chemotherapy “represent a population with substantial unmet need and a significantly elevated risk of recurrence,” Lois Erskine, Incyte VP and global program head for INCA33890, said in a statement.
The companies also did not disclose the trial’s enrollment target, start date, or primary endpoint definitions.