Natera Announces Clinical Collaboration with Incyte on Interventional Phase II Study in Colorectal Cancer

Trial designed to improve outcomes through Signatera™-guided Treatment on MRD (TOMR), identifying high-risk patients for curative-intent treatment

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (Nasdaq:NTRA), a global leader in cell-free DNA and precision medicine, today announced that it has entered into a clinical collaboration agreement with Incyte (Nasdaq:INCY) for a new phase II study in colorectal cancer (CRC).

The trial will evaluate INCA33890, Incyte’s investigational bispecific immunotherapy, in patients with stage 2/3 CRC who have completed surgery and adjuvant chemotherapy (ACT), incorporating Signatera as both a primary and secondary endpoint. Following ACT, patients will undergo longitudinal testing with Signatera for up to 12 months, and those who test Signatera MRD-positive and have no evidence of radiographic disease may be eligible for enrollment and treatment in the study.

Natera’s clinical and real-world evidence, along with its expertise in MRD-guided clinical trial strategy and design, helped inform the study. Through the collaboration, Natera will also provide trial matching services to help identify patients for enrollment based on their Signatera MRD status and other eligibility criteria.

“We are excited by Incyte’s vision for this innovative trial, leveraging both our extensive real-world evidence and proven MRD capabilities,” said Eric Matthews, General Manager, BioPharma, Natera. “Across a growing portfolio of 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.”

“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,” said Lois Erskine, Vice President and INCA 33890 Global Program Head, Incyte. “We look forward to the valuable insights this collaboration will enable as we work to advance this promising treatment and aim to improve outcomes for patients with CRC.”

About Natera

Natera is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 475 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, San Carlos, California, and Boulder, Colorado. For more information, visit www.natera.com.

Forward-Looking Statements

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