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news.The US Food and Drug Administration (FDA) has accepted Neon Therapeutics' Investigational New Drug (IND) application for its lead program, NEO-PV-01.
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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 PD-1 immune checkpoint inhibitor from Bristol-Myers Squibb, in melanoma, non-small 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.