Natera, Inc. (Nasdaq: NTRA) and Massachusetts-based Aveta Biomics, Inc. announced a clinical research collaboration integrating Natera’s Signatera tumor-informed circulating tumor DNA assay into Aveta’s global Phase III registrational trial of APG-157 in locally advanced head and neck squamous cell carcinoma. The partnership is material to both companies: APG-157 holds US FDA Fast Track and Orphan Drug Designations in this indication, and the Phase III trial — AVTA 30-01 (NCT07667296) — represents Aveta’s lead registrational program. Enrollment of approximately 826 patients is expected to begin in the second half of 2026 across North America, Europe, Asia-Pacific, and Australia. Financial terms were not disclosed.
APG-157 is an oral immunotherapy candidate intended to activate anti-tumor immunity in both immune-cold and immune-hot tumors. The AVTA 30-01 trial builds on previously reported Phase II monotherapy data that demonstrated favorable safety, evidence of tumor control, deep molecular responses, and encouraging event-free survival outcomes. The study includes two separate randomized cohorts for resectable and unresectable locally advanced disease, each with treatment and control arms. Signatera will serve as a secondary endpoint, with serial ctDNA testing used to assess molecular residual disease and treatment response across neoadjuvant, induction, and adjuvant settings.
The Aveta deal is consistent with Natera’s established pattern of embedding Signatera as a biomarker endpoint in Phase III oncology trials. In January 2026, Natera announced a structurally comparable collaboration with Exelixis, Inc., incorporating Signatera into the Phase III STELLAR-316 trial of zanzalintinib in colorectal cancer, both to identify MRD-positive patients for enrollment and to monitor treatment response. Natera also recently reported a successful readout of the prospective Phase II SINERGY trial supporting Signatera MRD-guided treatment in head and neck cancer, providing direct histology-specific precedent for the Aveta collaboration. In the LA-HNSCC setting, APG-157 competes in a field that includes checkpoint inhibitor-based regimens and investigational agents such as Merck’s Keytruda (pembrolizumab), which is established in recurrent/metastatic HNSCC, and AVEO Oncology’s ficlatuzumab, currently in a Phase III registrational study in HPV-negative recurrent or metastatic HNSCC.
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