CAMBRIDGE, Mass.--(BUSINESS WIRE)--Neon Therapeutics, an immuno-oncology company developing neoantigen-based therapeutic vaccines and T cell therapies to treat cancer, today announced that it has enrolled the first patient at the University of Texas MD Anderson Cancer Center in its first company-sponsored clinical trial evaluating its lead program, NEO-PV-01. NEO-PV-01 is a personalized cancer vaccine designed specifically for each patient based on the neoantigen mutations unique to that patient’s tumor.
Neon Therapeutics’ first clinical study is a multicenter Phase 1b clinical trial evaluating the safety, tolerability and efficacy of NEO-PV-01 combined with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor from Bristol-Myers Squibb, in patients with measurable metastatic melanoma, non-small cell lung cancer and bladder cancer. The trial will evaluate both clinical responses and immune responses in serial samples of peripheral blood and tumor tissue.
“Enrolling our first patient in this groundbreaking study is a critical milestone for the company and for patients,” said Hugh O’Dowd, chief executive officer of Neon Therapeutics. “We are assessing the safety and efficacy of this unique individualized product, alongside demonstrating the feasibility and practicality of this sophisticated supply chain.”
This clinical trial is anticipated to enroll a total of 90 patients in up to ten sites across the U.S. Patients undergo an initial biopsy, and a vaccine is manufactured that is customized to each patient’s tumor. While the vaccine is produced, patients receive nivolumab, then subsequently receive NEO-PV-01 in combination with nivolumab. More information about the trial is available at www.clinicaltrials.gov.
About Neon Therapeutics
Neon Therapeutics is an immuno-oncology company focused on developing novel therapeutics leveraging neoantigen biology to treat cancer. A neoantigen-based product engine allows Neon to develop multiple treatment modalities, including next-generation vaccines and T cell therapies targeting both personalized and shared neoantigens. Neon’s lead program is a personalized neoantigen vaccine that builds upon years of research and development at the Dana-Farber Cancer Institute and the Broad Institute, and is already in multiple clinical trials. For more information, please visit www.neontherapeutics.com.