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

Natera’s clinical and real-world evidence helped inform the study, alongside its expertise in MRD-guided trial strategy and design.

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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

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261110610640/en/

Contacts (For Natera)
Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.

Key Terms

bispecific immunotherapy medical

An immunotherapy engineered to bind two different biological targets simultaneously, usually delivered as a single molecule (most commonly a bispecific antibody) or a modified cell product. One binding site typically recognizes a marker on a diseased cell (for example, a tumor antigen) while the other engages an immune-system component (for example, a T‑cell receptor or a second immune checkpoint), so the therapy either brings immune cells into contact with the target cell or blocks two disease-related pathways at once. Because the two-target design changes how the immune system is activated compared with single-target agents, bispecific immunotherapies have different dosing, safety profiles, and manufacturing complexities than conventional monoclonal antibody therapies.

adjuvant chemotherapy medical

Adjuvant chemotherapy is drug treatment given after the main cancer therapy, usually surgery, to kill leftover cancer cells and lower the chance the disease will come back. For investors it matters because approval, clinical success or broader use of adjuvant therapy can expand a drug’s eligible patient pool, influence regulatory decisions and materially change sales and long‑term revenue—like a follow-up insurance policy that determines ongoing demand and value.

mrd medical

MRD stands for minimal residual disease, the tiny number of cancer cells that can remain in the body after treatment and that may not show up on routine scans. Detecting MRD is like finding a few seeds left in a garden after clearing: it helps doctors predict the chance of relapse and measure how effective a therapy is, which investors watch because MRD results can influence clinical trial success, regulatory decisions, and a drug’s market potential.