Cambridge, Mass. – July 29, 2016 – Neon Therapeutics, an immunooncology company developing neoantigenbased therapeutic vaccines and T cell therapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for its lead program, NEO-PV-01. NEO-PV-01 is a personalized vaccine designed specifically for each patient based on the neoantigen mutations unique to that patient’s tumor DNA.
The IND enables Neon Therapeutics to initiate its first clinical study, which is a multicenter Phase 1b clinical trial evaluating the safety, tolerability and efficacy of NEO-PV-01 with Opdivo (nivolumab), a PD1 immune checkpoint inhibitor from Bristol Myers Squibb, in melanoma, nonsmall cell lung cancer and bladder cancer. The trial will evaluate immune responses in serial samples of peripheral blood and tumor tissue through a comprehensive immune monitoring program.
“We are in the midst of tremendous momentum for neoantigen biology in the field of cancer immunotherapy,” said Cary Pfeffer, M.D., interim chief executive officer of Neon Therapeutics. “This IND filing acceptance brings us one step closer to deliver on the promise of neoantigen science to bring truly personalized cancer therapies to patients living with this devastating disease.”
This clinical trial is expected to begin in 2016, and is anticipated to enroll a total of 90 patients from multiple clinical sites in the U.S. More information about the trial will be available at www.clinicaltrials.gov.
About Neon Therapeutics
Neon Therapeutics is an immunooncology company focused on developing novel therapeutics leveraging neoantigen biology to treat cancer. A neoantigenbased product engine allows Neon to develop multiple treatment modalities, including nextgeneration 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 Broad Institute and DanaFarber Cancer Institute, and is already in multiple clinical trials. For more information, please visit www.neontherapeutics.com.
Ten Bridge Communications, Inc.