Natera and Neon Therapeutics Announce Clinical Trial Collaboration

Natera, Inc., a global leader in cell-free DNA testing, and Neon Therapeutics, Inc., a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, today announced a research collaboration using Natera's Signatera™ (RUO) circulating tumor DNA (ctDNA) assay as a biomarker to assess treatment response to NEO-PV-01 in Neon Therapeutics' NT-002 clinical trial.

Neon Therapeutics' NT-002 clinical trial is being conducted in collaboration with Merck, also known as MSD outside of the U.S. and Canada, and is designed to evaluate the safety, tolerability, and preliminary efficacy of NEO-PV-01 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). Natera will utilize its Signatera (RUO) ctDNA assay on patients in this study to correlate treatment response with data from these assays.

NEO-PV-01, a personal cancer vaccine, is Neon Therapeutics' most advanced product candidate and is designed specifically for each patient based on tumor-specific DNA mutations. Natera's Signatera (RUO) assay is a unique approach to deliver a custom ctDNA assay that matches the patient's tumor profile and is intended to offer high specificity and sensitivity in measuring immunological and clinical treatment response. "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," said Alexey Aleshin, M.D., M.B.A., Natera's oncology medical director.

"We are pleased to apply the Signatera technology to the patient samples that we will be receiving in connection with this clinical trial in order to measure the levels of ctDNA across multiple personal mutations," said Richard Gaynor, M.D., president of research and development at Neon Therapeutics. "We endeavor to employ novel tools in order to develop high-quality treatments for cancer patients and look forward to the information that we will receive from this collaboration."

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