Natera and Incyte have entered into a clinical collaboration agreement to conduct an interventional Phase II study of INCA33890 in colorectal cancer (CRC).
The trial (NCT07823322) of Incyte’s investigational bispecific immunotherapy focuses on individuals with Stage 2/3 colorectal cancer who underwent surgical resection and completed adjuvant chemotherapy. It incorporates Signatera as a primary and secondary endpoint.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Under the protocol, patients will undergo longitudinal surveillance with Signatera for up to 12 months after finishing adjuvant chemotherapy.
Patients who show no radiographic signs of cancer but test positive for minimal residual disease (MRD) through Signatera may qualify to join the trial and receive treatment.
Incyte vice-president and INCA 33890 global programme head Lois Erskine said: “Patients with CRC who remain MRD-positive after surgery and chemotherapy represent a population with substantial unmet need and a significantly elevated risk of recurrence.
“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.”
Natera helped design the trial protocol by contributing its clinical data, real-world evidence (RWE), and expertise in MRD trial strategies.
Under the agreement, Natera will also provide clinical trial matching services to identify prospective participants using their Signatera status alongside other study criteria.
Natera BioPharma general manager Eric Matthews said: “We are excited by Incyte’s vision for this innovative trial, leveraging both our extensive real-world evidence and proven MRD capabilities.
“Across a growing portfolio of TOMR studies, Signatera has been shown to enable early identification of patients at elevated risk of recurrence and supports enrolment into trials with treatment strategies that may alter the course of disease before radiographic progression occurs.”
Natera focuses on cell-free deoxyribonucleic acid (DNA) and precision medicine across oncology, organ health, and women’s health.
The company operates laboratories in Boulder, Colorado; Austin, Texas; and San Carlos, California.
In June this year, Natera and Aveta Biomics entered into a strategic partnership to support the latter’s AVTA 30-01, a global Phase III head and neck cancer trial (NCT07667296) assessing APG-157 in patients with locally advanced head and neck squamous cell carcinoma.
