Natera and Neon Therapeutics are collaborating on NT-002 clinical trial.

Personalized cancer vaccines are developed based on the tumor-specific mutations for each patient. An ongoing clinical trial of one such cancer vaccine is the NT-002 clinical trial, which is being conducted by Neon Therapeutics in collaboration with Merck. The trial is intended to evaluate the safety, tolerability, and preliminary efficacy of NEO-PV-01. Neon Therapeutics’ personal cancer vaccine has been designed specifically for each patient based on their tumor DNA mutations and is intended to be used in combination with Keytruda and a chemotherapy regimen of pemetrexed and carboplatin in untreated patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). 

Recently, Neon Therapeutics announced another collaboration for the study — this one with biomarker assay developer Natera. During the trial, patient response to treatment will be assessed using Natera’s Signatera (RUO) circulating tumor DNA (ctDNA) assay. The Signatera (RUO) technology allows the development of custom ctDNA assays that match each patient's tumor profile to provide high specificity and sensitivity in measuring immunological and clinical treatment response.

As such, the NT-002 clinical trial is one of the first studies to combine personalized immunotherapy with a personalized ctDNA biomarker to better understand treatment response and resistance in patients with metastatic lung cancer, according to Natera's oncology medical director Alexey Aleshin.