Neon Therapeutics Announces Completion of Enrollment in Phase 1b Clinical Trial

Neon Therapeutics, Inc. recently announced the completion of enrollment in NT-002, its Phase 1b clinical trial evaluating NEO-PV-01 with KEYTRUDA (pembrolizumab) and chemotherapy in patients with untreated advanced or metastatic non-small cell lung cancer (NSCLC). NEO-PV-01 is a personal neoantigen vaccine custom-designed and manufactured based on the neoantigens identified by Neon’s proprietary bioinformatics engine, RECON, as being the most therapeutically relevant for an individual patient.

“Our NT-002 trial has the potential to demonstrate the effect that NEO-PV-01, our personal neoantigen vaccine, may have in combination with pembrolizumab and chemotherapy, the current standard of care in first-line metastatic NSCLC. While the pembrolizumab-chemotherapy regimen has shown improved clinical outcomes in first-line NSCLC, we believe NEO-PV-01 could improve the therapeutic efficacy of this combination by directing T cells to target neoantigens expressed in each patient’s tumor,” said Richard Gaynor, MD, President of Research and Development at Neon Therapeutics.

The trial, conducted in collaboration with Merck, is evaluating the safety, tolerability, and efficacy of NEO-PV-01 in the metastatic setting. Patients enrolled in the trial undergo an initial tumor biopsy and then begin 12 weeks of treatment with pembrolizumab and chemotherapy. They receive the NEO-PV-01 vaccination at week 12 and treatment with pembrolizumab continues throughout the trial. The primary endpoint of the trial is safety. In addition, Neon is evaluating immune responses and clinical outcomes. Neon expects to report immune and clinical outcome data from NT-002 over the course of 2020.

“This trial seeks to build on the proof-of-mechanism established in our NT-001 trial, which combines NEO-PV-01 with OPDIVO (nivolumab) in patients with metastatic melanoma, NSCLC and bladder cancer, and will highlight the impact of the addition of chemotherapy to our NEO-PV-01 and anti-PD-1 combination has on the potential to improve the suppressive tumor microenvironment found in many cancers,” Dr. Gaynor continued.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. OPDIVO is a registered trademark of Bristol-Myers Squibb Company.

NEO-PV-01 is a fully personal cancer vaccine targeting neoantigens that is custom-designed and manufactured for each individual patient based upon the tumor’s unique mutational fingerprint. The neoantigen-targeting peptides in NEO-PV-01 are intended to generate an anti-tumor immune response that directs patients’ T cells to target and kill their cancer cells. NEO-PV-01 is being studied in multiple ongoing Phase 1 clinical trials.

Neon Therapeutics is a clinical-stage immuno-oncology company and a leader in the field of neoantigen-targeted therapies, dedicated to transforming the treatment of cancer by directing the immune system towards neoantigens. Neon is using its neoantigen platform to develop both vaccine and T cell therapies, including NEO-PV-01, a clinical stage neoantigen vaccine for the treatment of metastatic melanoma, non-small cell lung cancer, and bladder cancer; NEO-PTC-01, a neoantigen T cell therapy for the treatment of solid tumors; and NEO-SV-01, a neoantigen vaccine for the treatment of a subset of estrogen-receptor-positive breast cancer. For more information,  visit