NEW YORK (GenomeWeb) – Natera and Neon Therapeutics said on Thursday that they will collaborate to use Natera's Signatera circulating tumor DNA assay in assessing treatment response to NEO-PV-01, a clinical trial-stage neoantigen cancer vaccine.
Neon Therapeutics is evaluating NEO-PV-1 in the NT-002 clinical trial in collaboration with Merck to evaluate its safety, tolerability, and preliminary efficacy in combination with pembrolizumab (Keytruda) and a chemotherapy regimen of pemetrexed and carboplatin in untreated patients with advanced or metastatic non-squamous non-small cell lung cancer.
NEO-PV-1 is designed specifically for each patient based on tumor-specific DNA mutations, and Natera will use Signatera on patients to correlate treatment response with data from these assays. Signatera, which is currently designated for research use only, is designed to provide each patient with a customized blood test tailored to match the mutations found in that individual's tumor tissue, which maximizes sensitivity and specificity.
The assay identifies 16 unique, clonal, somatic variants individualized to each patient's tumor, followed by multiplex PCR and ultra-deep sequencing for longitudinal ctDNA analysis of whole blood samples, according to the company's website.
"This clinical trial is especially exciting for us because, for the very first time, we are combining a truly personal immunotherapy with a personalized ctDNA biomarker to better understand treatment response and resistance in patients with metastatic lung cancer," Alexey Aleshin, Natera's oncology medical director, said in a statement.