Natera, Aveta Biomics Ink Partnership to Support Phase III Trial in Head and Neck Cancer

Editor’s Take: In patients with locally advanced head and neck cancers, this therapy may be able to enhance treatment.

Natera and Aveta Biomics are strategically partnering on a trial of Aveta’s immunotherapy for patients with head and neck cancers. The Phase III registrational trial is evaluating APG-157 in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Prevalence of Head and Neck Cancers

Nearly 1 million patients worldwide have incidences of head and neck cancer every year. Disease recurrence is a major cause of mortality.

APG-157, a first-in-class oral immunotherapy according to Aveta, has both Fast Track and Orphan Drug designations from the U.S. FDA. Its intent is expanding the benefits of immunotherapy to both immune-cold and immune-hot tumors in patients with LA-HNSCC.

The global Phase III clinical trial builds upon previously reported Phase II data of APG-157 monotherapy in several areas. These include favorable safety evaluation, evidence of tumor control, deep molecular response, and the encouragement of event-free survival outcomes.

Going forward, the Phase III trial will test for molecular residual disease (MRD), and treatment response, through therapy and follow-up. Commencing the second half of 2026, more than 800 patients will be enrolled across North America, Europe, Asia-Pacific, and Australia.

Natera recently announced the successful readout of the prospective Phase II trial (SINERGY) that supported MRD-guided treatment in this histology.

Aveta Ready to Partner with Natera

Circulating tumor DNA (ctDNA) is a promising approach to MRD detection, according to Aveta Founder and CEO Parag Mehta, PhD. Mehta said the Phase III testing will further validate ctDNA findings observed in Phase II.

“Patients with locally advanced head and neck cancer continue to face substantial risks of recurrence despite aggressive treatment,” Mehta said. “We believe APG-157 has the potential to transform treatment by activating anti-tumor immunity in both immune-cold and immune-hot tumors.”